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Original article
Quality of life and treatment persistence evaluation in Spanish patients treated with mirabegron. Results of the BELIEVE study
Resultados de la subpoblación española del estudio BELIEVE. Evaluación de la calidad de vida y persistencia al tratamiento de pacientes tratados con mirabegrón
C. Zubiaur Líbanoa,
Corresponding author
, J.L. Poza-Barrasúsb, E.M. Valero Fernándezc
a Servicio de Urología, Hospital de Basurto, Bilbao, Spain
b Servicio de Ginecología, Hospital Vall d’Hebron, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain
c Departamento Médico, Astellas Pharma S.A., Madrid, Spain
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such as OAB-q &#40;Overactive Bladder Questionnaire&#41;&#44; which has demonstrated high reliability&#44; validity and response capability in continent or incontinent patients&#46;<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">8</span></a> Generic questionnaires&#44; such as EQ-5D-5L&#44;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">9</span></a> allow assessing the severity of symptoms of OAB&#44; HRQoL and the well-being of patients&#46; The improvement in HRQoL and patient satisfaction are key factors in the persistence to treatment&#44; which is usually low &#40;&#8764;50&#37;&#41; in chronic conditions requiring long therapies&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">10</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Antimuscarinics have shown poor persistence among chronic pathologies &#40;26&#37; at 6 months of treatment&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">11</span></a> Despite being the first-line pharmacological treatment in patients with OAB&#44;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">7&#44;12</span></a> some patients experience a suboptimal response or unpleasant adverse events &#40;AA&#41;&#44; such as dry mouth and constipation&#44;<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">13</span></a> and others may feel a limited effect&#44; which leads to high rates of treatment discontinuation&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">7</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Mirabegron is the first beta-3 adrenergic receptor agonist drug&#59; a new oral treatment option for patients with OAB&#46;<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">7</span></a> There is a wide clinical development with mirabegron&#46;<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">7&#44;14&#44;15</span></a> The 3 main phase III studies show its efficacy in reducing the number of urinary incontinence &#40;UI&#41; episodes&#44; as well as urinary frequency and urgency&#46;<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">13&#44;16&#44;17</span></a> These studies also show a good tolerability of the drug&#58; 88&#37; of patients completed treatment and 4&#37; abandoned the study due to AA&#46;<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">13&#44;16&#44;17</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Mirabegron has demonstrated good efficacy and an adequate tolerability profile compared to anticholinergic treatment<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">18&#44;19</span></a> showing a better risk&#47;benefit balance&#46;<a class="elsevierStyleCrossRef" href="#bib0230"><span class="elsevierStyleSup">20</span></a> Therefore&#44; it can be considered a good treatment option for patients with OAB&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">It is well known that observational studies provide real world evidence &#40;RWE&#41; results based on actual clinical practice&#46; However&#44; there are no current publications with strong data on patients with OAB&#44;<a class="elsevierStyleCrossRefs" href="#bib0235"><span class="elsevierStyleSup">21&#8211;23</span></a> and several authors are looking forward to RWE results with mirabegron&#46;<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">15</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">With the purpose of giving more consistency to the treatment with mirabegron&#44; a real-world study was carried out in the EU &#40;BELIEVE&#41;&#44; with patients with overactive bladder &#40;OAB&#41; who were prescribed mirabegron as part of routine clinical practice&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The main objective of the present study was to evaluate&#44; from the data of the Spanish subpopulation of the BELIEVE study&#44; the change in the HRQL of patients with OAB according to the OAB-q&#46; Secondary objectives included assessment of treatment persistence&#44; dropout rate&#44; AAs&#44; and resource utilization&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methodology</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design</span><p id="par0045" class="elsevierStylePara elsevierViewall">The present study is focused on data from the Spanish subpopulation of the BELIEVE study&#44; a prospective&#44; non-interventional study&#44; carried out in the EU including 862 patients diagnosed with OAB&#44; who were prescribed mirabegron under conditions of routine clinical practice&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> The Gynecology Pelvic Floor and Functional Urology Units from 11 centers participated in Spain&#44; with a total of 153 patients &#40;18&#37; of the total study&#41;&#46; Follow-up period was 12 months &#40;remaining or not on mirabegron treatment&#41;&#44; with 2 follow-up windows &#40;2&#8211;4 months and 10&#8211;12 months&#41;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study population</span><p id="par0050" class="elsevierStylePara elsevierViewall">Male or female OAB patients &#8805;18 years&#46; All patients were included in the study before starting treatment with mirabegron and provided written informed consent before entering the study&#46; Patients with mixed incontinence with predominant stress&#44; patients at risk of acute urinary retention &#40;in the opinion of the Investigator&#41; and patients practicing intermittent catheterization or with an indwelling catheter&#44; were excluded from the study&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Evaluated variables</span><p id="par0055" class="elsevierStylePara elsevierViewall">All variables were assessed at baseline visit and at each scheduled visit within the 12 months of study duration&#46; The primary variable was change from baseline of the total OAB-q &#40;see description in Freeman et al&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a>&#41; and its subscales &#40;HRQoL and Symptom Bother Scale&#41;&#46; We also analyzed the percentage of patients who achieved minimal important difference &#40;MID&#41; in the OAB-q&#44; defined as a decrease of &#8805;10 points in symptom bother or an increase of &#8805;10 points in the total HRQL score from the baseline status&#46; Among secondary variables&#44; treatment persistence patterns were analyzed with the following data&#58; switching to other OAB drug and reasons associated with switch&#44; duration of treatment with mirabegron in monotherapy or combination and time until discontinuation&#44; switch or prescription of add-on oral therapy&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Another secondary variable was the HRQoL analysis through the generic and standardized questionnaire EQ-5D-5L&#44; which comprises five dimensions &#40;mobility&#44; self-care&#44; usual activities&#44; pain&#47;discomfort and anxiety&#47;depression&#41;&#46; Each dimension has five response levels&#58; no problems&#44; slight problems&#44; moderate problems&#44; severe problems and extreme problems&#46; In addition&#44; it has a visual analog scale &#40;VAS&#41; that elicits a self-rating by the respondent of his&#47;her health status&#46; The AEs were collected after informed consent was obtained and were summarized by Preferred Term &#40;PT&#41; and categorized by System Organ Class&#44; severity and relationship to study drug&#44; according to the Investigator&#39;s criteria&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Finally&#44; variables related to the utilization of healthcare resources were also collected&#44; specifically the number of patients who attended unscheduled OAB-related consultations and their corresponding specialist&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0070" class="elsevierStylePara elsevierViewall">As detailed in the BELIEVE<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> study&#44; descriptive statistics were used to summarize all collected variables for patients enrolled in the study&#46; For continuous variables&#44; these will include the number of subjects&#44; mean&#44; standard deviation &#40;SD&#41;&#44; median&#44; minimum and maximum&#46; Two-sided 95&#37; CI was calculated for mean changes from baseline&#46; For categorical variables&#44; the number and percentage of subjects by each category were tabulated by visit&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">The Full Analysis Set &#40;FAS&#41; included all enrolled patients who completed the OAB-q at baseline and at least one follow-up visit&#44; despite being on mirabegron therapy or not&#46; The Per Protocol Set &#40;PPS&#41; included all patients on mirabegron treatment at 10&#8211;12 months and who completed the questionnaire at baseline and at 10&#8211;12 months&#46; The Safety Analysis Set &#40;SAS&#41; included all patients who received at least one dose of mirabegron during the study period&#46; Statistical analysis has been described in the publication by Freeman et al&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a>&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Ethical considerations</span><p id="par0080" class="elsevierStylePara elsevierViewall">The BELIEVE<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> study received formal approval from the European Commission and from other regulatory bodies in all participating countries&#44; based on country-specific requirements&#46; In Spain&#44; the study protocol was approved by the corresponding Ethics Committees and was carried out in accordance with order SAS&#47;3470&#47;2009 of the Spanish Agency of Medicines and Medical Devices &#40;AEMPS&#41;&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Results</span><p id="par0085" class="elsevierStylePara elsevierViewall">Of the total Spanish population including 153&#44; 148 &#40;96&#46;7&#37;&#41; were included in SAF&#44; 141 &#40;92&#46;2&#37;&#41; in FAS and 69 &#40;45&#46;1&#37;&#41; in PPS&#44; maintaining the percentage of representativeness of the global study &#40;&#8764;18&#37;&#41;&#46; In FAS population&#44; 63&#46;1&#37; of the patients were women&#44; with a mean age of 66 years&#59; 60&#37; of the patients were &#8805;65 years old &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Primary variable</span><p id="par0090" class="elsevierStylePara elsevierViewall">The results of the OAB-q show an improvement in the scores for symptom bother and total HRQoL&#44; from baseline to 2&#8211;4 months and 10&#8211;12 months&#44; in the FAS and PPS populations &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46; The same results are observed in the HRQoL OAB-q subscales &#40;coping&#44; concern&#44; sleep and social interaction&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">The percentage of patients who achieved MID was higher at 10&#8211;12 months than at 2&#8211;4 months in the FAS and PPS populations &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Secondary variables</span><p id="par0100" class="elsevierStylePara elsevierViewall">Regarding persistence patterns&#44; 49&#37; of patients in the FAS population continued treatment with mirabegron at 10&#8211;12 months&#44; as monotherapy &#40;42&#46;6&#37;&#41; and in combination &#40;6&#46;4&#37;&#41;&#59; 9&#46;2&#37; of patients switched from mirabegron to another treatment for OAB&#44; and 18&#46;4&#37; discontinued treatment completely &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>&#41;&#46; The main reasons for discontinuation were insufficient symptom relief and poor treatment tolerability due to AEs&#46; Only one patient reported poor tolerability due to AEs as the switching cause&#46; Patients who switched treatment from mirabegron began receiving trospium chloride&#44; tolterodine&#44; solifenacin&#44; or oxybutynin&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">The results of the EQ-5D-5L questionnaire showed an improvement in the HRQoL at 10&#8211;12 months&#44; since the difference in the mean change was negative in 4 dimensions of the questionnaire&#44; and positive in the health status of the VAS &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">Table 4</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">The general incidence of AEs was consistent with the already known safety profile of mirabegron&#44; without observing unexpected safety problems&#46; AEs were reported by 44&#44;6&#37; of the SAF population&#44; and severe AEs were presented by 6&#46;1&#37; &#40;<a class="elsevierStyleCrossRef" href="#tbl0025">Table 5</a>&#41;&#46; In total&#44; 38 patients &#40;25&#46;7&#37;&#41; reported 48 AEs related to mirabegron&#46; Based on medical criteria&#44; the AEs of 16 of these patients were considered as possibly related to treatment&#44; 20 as probably related&#44; and the relationship could not be assessed in the last 2 cases&#46; The most common AEs related to mirabegron were gastrointestinal disorders &#40;9&#46;5&#37; of patients&#41; and lack of efficacy &#40;8&#46;8&#37;&#41;&#46; No patient reported any severe mirabegron-related AE&#46; Treatment discontinuation due to AEs not related to mirabegron was seen in 20&#46;3&#37; of patients&#44; while 18&#46;2&#37; discontinued it due to mirabegron-related AEs &#40;<a class="elsevierStyleCrossRef" href="#tbl0025">Table 5</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0025"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">Treatment with mirabegron had good tolerability&#44; as most AEs were considered mild &#40;33&#46;1&#37;&#41; or moderate &#40;4&#46;7&#37;&#41;&#46; Nine patients &#40;6&#46;1&#37;&#41; reported severe AEs such as gastrointestinal&#44; cardiac and respiratory disorders&#44; strokes or neoplasia&#44; among others&#59; none were related to treatment with mirabegron&#46; On the other hand&#44; there were 4 deaths during the study&#44; although these were not related to treatment with mirabegron&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">Regarding resource utilization&#44; 10&#46;1&#37; of the patients &#40;PPS&#41; and 11&#46;3&#37; of the FAS attended OAB-related medical consultations which were not scheduled in the study between the baseline visit and visit 2&#44; and 10&#46;1&#37; and 7&#46;8&#37; between visits 2 and 3&#44; respectively&#46; More than 70&#37; of these visits were to the primary care physician &#40;PC&#41;&#44; both in the PPS population and in the FAS&#59; the others were mainly carried out among specialized nurses &#40;14&#46;3&#37; and 6&#46;3&#37; in PPS and FAS between baseline visit and visit 2&#59; 0&#37; between visit 2 and 3&#41; and urology &#40;14&#46;3&#37; and 12&#46;5&#37; in PPS and FAS between baseline visit and visit 2&#59; 0&#37; between visit 2 and 3&#41;&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Discussion</span><p id="par0125" class="elsevierStylePara elsevierViewall">The BELIEVE study is the first one to be performed based on actual clinical practice data from European patients with OAB who are prescribed mirabegron&#44; including 11 participating centers in Spain&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> Based on the data from the Spanish subpopulation&#44; the present study evaluates HRQoL of these patients&#44; tolerability and persistence of treatment with mirabegron&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Patients treated with mirabegron showed improvements in the OAB-q&#44; symptom bother subscale&#44; and the HRQoL subscale for 10&#8211;12 months &#40;FAS&#59; symptom bother &#8722;22&#46;8&#44; total HRQL&#58; 15&#46;3&#41;&#46; Even better results were observed in patients who continued on mirabegron treatment during this time &#40;PPS&#59; &#8722;27&#46;3 and 18&#46;3&#44; respectively&#41;&#46; These results are comparable with those of the global BELIEVE study&#44; in which the mean change with FAS at 10&#8211;12 months was &#8722;20&#46;7 for symptom bother and 17&#46;4 for total HRQL&#59; it was &#8722;22&#46;7 and 19&#46;9&#44; respectively&#44; with PPS&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> The percentages of Spanish patients &#40;PPS&#41; who achieved MID in symptom bother and total HRQoL were 81&#46;2 and 72&#46;5&#44; respectively&#46; These results are slightly higher than those observed in the global BELIEVE study &#40;PPS&#41;&#58; 71&#46;2&#37; was observed in the MID in symptom bother and 63&#46;1&#37; in the total HRQL&#46; These results support those obtained by phase III clinical studies&#44; in which significant improvements in OAB-q are observed with mirabegron 50<span class="elsevierStyleHsp" style=""></span>mg compared to placebo at 12 weeks of treatment&#46;<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">13&#44;16&#44;17</span></a></p><p id="par0135" class="elsevierStylePara elsevierViewall">As in the global BELIEVE<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> study&#44; 50&#37; of the patients &#40;FAS&#41; from the Spanish subpopulation continued with treatment at 10&#8211;12 months&#44; which shows an acceptable treatment persistence with mirabegron&#44; compared to the low &#40;and decreasing&#41; rate of antimuscarinics of 26&#37;&#46;<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">11&#44;25</span></a> The main reasons for switching or discontinuing treatment were insufficient symptom relief and poor treatment tolerability due to AEs&#44; as in the global study&#46; Results are consistent with other RWE published studies&#44; in which a greater persistence of treatment with mirabegron is observed compared to tolterodine or antimuscarinics &#40;at 12 months&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">6</span></a> Specifically&#44; antimuscarinics are associated with low persistence due to their associated AEs<a class="elsevierStyleCrossRef" href="#bib0185"><span class="elsevierStyleSup">11</span></a> such as dry mouth or constipation&#44; which have a low incidence with mirabegron&#46;<a class="elsevierStyleCrossRefs" href="#bib0225"><span class="elsevierStyleSup">19&#44;20</span></a> Another retrospective study with hospital data of patients who had received mirabegron according to protocol&#44; also showed 48&#37; of patients for treatment persistence at 6 months&#46;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">23</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">The EQ-5D-5L questionnaire confirmed the improvement in the HRQoL of patients in the Spanish subpopulation treated with mirabegron&#46; Thus&#44; this generic questionnaire has proven to be a good tool to evaluate HRQoL in OAB patients&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">26</span></a></p><p id="par0145" class="elsevierStylePara elsevierViewall">The results on AEs were consistent with those obtained in the BELIEVE<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">24</span></a> global study&#44; with 26&#37; of patients reporting any AE related to mirabegron and ineffectiveness of the drug being one of the most common AEs&#46; Although 18&#37; of patients discontinued treatment due to mirabegron-related AEs&#44; no severe AEs were associated with mirabegron treatment&#44; unlike in the global study&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Approximately 10&#37; of patients &#40;in PPS and FAS&#41; attended unscheduled OAB-related medical visits&#46; As observed in the BELIEVE global study&#44; the results in the Spanish population &#40;PPS and FAS&#41; also showed that most unscheduled consultations were with primary care physicians&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">The limitations of this study are the potential bias due to the lack of randomization of the study&#44; which does not have a control group of patients&#44; and the possible differences in data collection among participating centers&#46; Another possible limitation of the study is based on the time difference between follow-up windows&#46; The follow-up of the BELIEVE study was for 12 months with visit windows at 2&#8211;4 and 10&#8211;12 months&#44; which correspond to the most common follow-up periods&#46; However&#44; there is an 8-month period between windows&#44; which could affect or delay data collection&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Even so&#44; the study has been based on outcomes of patients under conditions of routine clinical practice&#44; which provides very significant information about their HRQoL and their current persistence status&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">Through this non-interventional study carried out in real clinical practice&#44; the impact of mirabegron on HRQoL&#44; satisfaction with treatment and persistence of patients in the Spanish population has been analyzed&#46; In addition&#44; we aimed to find differences with patients from the BELIEVE study &#40;global&#41;&#46; The results in the Spanish subpopulation have been similar to the general population&#44; without showing relevant differences&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Conclusions</span><p id="par0170" class="elsevierStylePara elsevierViewall">This analysis with the Spanish subpopulation of the BELIEVE study shows that treatment with mirabegron in real clinical practice entails a good HRQoL of patients with OAB&#44; as well as good tolerability&#44; which is probably related to good persistence of treatment with mirabegron&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Funding</span><p id="par0175" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleGrantSponsor" id="gs1">Astellas Pharma Europe</span> B&#46;V was the sponsor of the BELIEVE study and has funded this manuscript&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Conflicts of interest</span><p id="par0180" class="elsevierStylePara elsevierViewall">Dr&#46; Jos&#233; Luis Poza-Barras&#250;s has received scholarships to attend medical congresses from Medtronic&#44; Pfizer&#44; Astellas&#44; Colpoplast&#44; Palex&#44; Neomedic&#44; Bard&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">Dr&#46; Carmen Zubiaur L&#237;bano has received scholarships to attend medical conferences from Astellas&#44; Pfizer and Pierre Fabre&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">Eva Mar&#237;a Valero Fern&#225;ndez works at the Spanish affiliate of Astellas Pharma&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The BELIEVE study is a European&#44; non-interventional study which includes patients with overactive bladder who were prescribed mirabegron as part of routine clinical practice&#46; Data from the Spanish subpopulation has been obtained for the present study&#44; aiming to analyze health-related quality-of-life &#40;HRQoL&#41; and treatment persistence of these patients&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Data from 11 Spanish hospitals of the BELIEVE study were analyzed&#46; The primary endpoint was to evaluate change of HRQoL from baseline with overactive bladder questionnaire &#40;OAB-q&#41;&#46; Secondary endpoints included treatment persistence&#44; HRQoL based on the EQ-5D-5L questionnaire and adverse events&#46; Study follow-up was 12 months&#44; with two visit windows at 2&#8211;4 months and 10&#8211;12 months&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">153 Spanish patients were enrolled in the study&#46; In the Full Analysis Set &#40;FAS&#41;&#44; 63&#46;1&#37; were women&#44; and the mean age was 66 years&#46; Symptom bother and HRQoL improved from baseline to 2&#8211;4 months and 10&#8211;12 months&#46; EQ-5D-5L questionnaire also showed an improved patients&#8217; HRQoL&#46; Treatment persistence was high&#44; as 49&#37; of patients remained with mirabegron at 10&#8211;12 months&#46; Adverse events were consistent with previous safety profile results of mirabegron&#44; and no unexpected safety issues were observed&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Spanish patients treated with mirabegron in real clinical practice reported improvements in HRQoL&#44; with a good tolerability and persistence to treatment&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Introduction and objective"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Materials and methods"
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          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
          ]
          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusions"
          ]
        ]
      ]
      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducci&#243;n y objetivo</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El estudio BELIEVE es un estudio europeo&#44; no intervencionista&#44; con pacientes con vejiga hiperactiva que recibieron mirabegr&#243;n en condiciones de pr&#225;ctica cl&#237;nica habitual&#46; El presente estudio incluye datos de la subpoblaci&#243;n espa&#241;ola&#44; y eval&#250;a su calidad de vida relacionada con la salud &#40;CVRS&#41; y su persistencia al tratamiento&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Materiales y m&#233;todos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Se analizaron los datos de los 11 centros espa&#241;oles del estudio BELIEVE&#46; La variable principal fue el cambio de la CVRS desde el estado basal&#44; a partir del cuestionario OAB-q&#46; Las variables secundarias incluyeron la persistencia al tratamiento&#44; la CVRS mediante el EQ-5D-5L y los acontecimientos adversos&#46; El periodo de seguimiento fue de 12 meses&#44; con 2 ventanas a los 2&#8211;4 meses y a los 10-12 meses&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Se incluyeron 153 pacientes espa&#241;oles&#46; En el <span class="elsevierStyleItalic">Full Analysis Set</span> &#40;FAS&#41;&#44; el 63&#44;1&#37; eran mujeres&#44; con una edad media de 66 a&#241;os&#46; Las puntuaciones de la molestia de s&#237;ntomas y la CVRS total mostraron una mejora hasta los 2-4 meses y los 10-12 meses&#46; El EQ-5D-5L tambi&#233;n mostr&#243; una mejora en la CVRS de estos pacientes&#46; La persistencia fue elevada&#44; ya que el 49&#37; de los pacientes segu&#237;an recibiendo mirabegr&#243;n a los 10-12 meses&#46; No se observaron problemas de seguridad inesperados y los acontecimientos adversos coincidieron con el perfil de seguridad conocido de mirabegr&#243;n&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Los pacientes espa&#241;oles que reciben mirabegr&#243;n en condiciones de pr&#225;ctica cl&#237;nica real reportan mejoras en su CVRS&#44; con una buena tolerabilidad y una persistencia aceptable al tratamiento&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Introducci&#243;n y objetivo"
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          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "Materiales y m&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusiones"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Please cite this article as&#58; Zubiaur Libano C&#44; Poza-Barras&#250;s JL&#44; Valero EM&#46; Resultados de la subpoblaci&#243;n espa&#241;ola del estudio BELIEVE&#46; Evaluaci&#243;n de la calidad de vida y persistencia al tratamiento de pacientes tratados con mirabegr&#243;n&#46; Actas Urol Esp&#46; 2020&#59;44&#58;224&#8211;232&#46;</p>"
      ]
    ]
    "multimedia" => array:6 [
      0 => array:7 [
        "identificador" => "fig0005"
        "etiqueta" => "Figure 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr1.jpeg"
            "Alto" => 2560
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        "descripcion" => array:1 [
          "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Improvements in mean change of OAB-q subscales from baseline to 2&#8211;4 months and 10&#8211;12 months&#46;</p>"
        ]
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      1 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at1"
            "detalle" => "Table "
            "rol" => "short"
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        "tabla" => array:2 [
          "leyenda" => "<p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">SD&#58; standard deviation&#59; FAS&#58; Full Analysis Set&#59; BMI&#58; body mass index&#59; PPS&#58; Per Protocol Set&#59; SAF&#58; Safety Analysis Set&#59; OAB&#58; overactive bladder&#46;</p>"
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                  \t\t\t\t">56 &#40;39&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">26 &#40;37&#46;7&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  """
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                  \t\t\t\t" scope="col">Mean baseline status&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Change vs&#46; baseline status &#40;mean&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#37; with &#8805;10 improvement points &#40;MID&#41;<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Mean&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Change vs&#46; baseline status &#40;mean&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&#37; with &#8805;10 improvement points &#40;MID&#41;<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">26&#46;2&#37; &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>37&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">81&#46;4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>Coping&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>Concern&nbsp;\t\t\t\t\t\t\n
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                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab2294505.png"
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          "notaPie" => array:2 [
            0 => array:3 [
              "identificador" => "tblfn0005"
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              "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Negative score<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>improved symptom bother score&#59; positive score<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>improved total HRQoL and all other subscales&#46;</p>"
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            1 => array:3 [
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        ]
        "descripcion" => array:1 [
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            "identificador" => "at3"
            "detalle" => "Table "
            "rol" => "short"
          ]
        ]
        "tabla" => array:3 [
          "leyenda" => "<p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">FAS&#58; Full Analysis Set&#59; OAB&#58; overactive bladder&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td-with-role" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col">Number of patients &#40;&#37;&#41;<a class="elsevierStyleCrossRef" href="#tblfn0015"><span class="elsevierStyleSup">a</span></a>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " colspan="2" align="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">FAS &#40;<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>141&#41;</th></tr><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">2&#8211;4 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">10&#8211;12 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="3" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Prescription and persistence status</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Mirabegron in monotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">47 &#40;33&#46;3&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">60 &#40;42&#46;6&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Mirabegron in combination treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6 &#40;4&#46;3&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#40;6&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Switched from mirabegron to another OAB treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#40;6&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">13 &#40;9&#46;2&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Treatment discontinuation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9 &#40;6&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">26 &#40;18&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>No data&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">70 &#40;49&#46;6&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">33 &#40;23&#46;4&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="3" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Reasons for switching to other OAB treatment</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Insufficient symptom relief&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Poor tolerability of treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Cost of co-pay&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>OAB symptoms stopped&#47;cured&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span> Told to stop by clinicians&#47;pharmacist&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Learnt to live without medication&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Other&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>No data&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " colspan="3" align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Reasons for treatment discontinuation</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Insufficient symptom relief&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Poor tolerability of treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">4&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Cost of co-pay&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>OAB symptoms stopped&#47;cured&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Told to stop by clinician&#47;pharmacist&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Learnt to live without medication&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
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                  \t\t\t\t\ttop\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Solifenacin&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Tolterodine&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  """
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                  \t\t\t\t\tvoid\n
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                  \t\t\t\t" scope="col">Mean baseline status&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
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                  \t\t\t\t\ttable-head\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Usual activities&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;6&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">&#8722;0&#46;2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1&#46;4&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;0&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Pain&#47;discomfort&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">2&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">1&#46;8&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;0&#46;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="char" valign="\n
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                  \t\t\t\t">2 &#40;1&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">2 &#40;1&#46;4&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">4 &#40;2&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">1 &#40;0&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1 &#40;0&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">1 &#40;0&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Respiratory failure&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="char" valign="\n
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        "texto" => "<p id="par0195" class="elsevierStylePara elsevierViewall">To all the Spanish centers and researchers who participated in the BELIEVE study&#46; We also appreciate the participation and collaboration of IQVIA &#40;Real-World Evidence Solutions-RWES&#41; for medical writing support&#46;</p>"
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