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Prospective Indian Study of DILI with Confirmed Causality Using the Roussel Uclaf Causality Assessment Method (RUCAM): A Report of Excellence
Rolf Teschke
,
Corresponding author
rolf.teschke@gmx.de

Correspondence and reprint request:
, Gaby Danan**
* Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Hanau, Teaching Hospital of the Medical Faculty, Goethe University Frankfurt / Main, Germany
** Pharmacovigilance Consultancy, Paris, France
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    "titulo" => "Prospective Indian Study of DILI with Confirmed Causality Using the Roussel Uclaf Causality Assessment Method (RUCAM): A Report of Excellence"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="p0120" class="elsevierStylePara elsevierViewall">One of the highlights of this issue of <span class="elsevierStyleItalic">Annals of Hepatology</span> is the analysis of DILI cases from India by Rathi&#44; <span class="elsevierStyleItalic">et al</span>&#46;&#44; since all cases were prospectively evaluated with RU-CAM&#44; the widely used tool for causality assessment worldwide&#46; This approach provided valuable well-established results on various aspects of DILI&#46;</p><p id="p0125" class="elsevierStylePara elsevierViewall">The study of Rathi&#44; <span class="elsevierStyleItalic">et al&#46;</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> from the Department of Gas-troenterology of the Lokmanya Tilak Municipal Medical College and General Hospital in Sion&#44; Mumbai&#44; Maharashtra in India is an outstanding report on drug induced liver injury &#40;DILI&#41; and will serve as a paradigm how future cases of DILI should be analyzed and prepared for publication&#46; Their careful analysis of a 2-year single center prospective cohort study illustrates the challenging aspects of DILI and especially causality assessment&#46;</p><p id="p0130" class="elsevierStylePara elsevierViewall">The authors Rathi&#44; <span class="elsevierStyleItalic">et al&#46;</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> decided to use prospectively the Roussel Uclaf Causality Assessment method &#40;RU-CAM&#41;&#44; a structured&#44; standardized diagnostic approach specific to liver injury established in 1993<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">2&#44;3</span></a> and updated in 2016&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Since its launch 25 years ago&#44; RUCAM has been the most applied causality assessment method &#40;CAM&#41; for DILI and herb induced liver injury &#40;HILI&#41; worldwide&#44; as evidenced by the high numbers of published epidemiological studies and case reports using this method&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Consequently&#44; RUCAM-based results in India<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> can easily be compared with those obtained in other countries such as Iceland&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">5</span></a> Spain&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">6</span></a> or China&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">7</span></a></p><p id="p0135" class="elsevierStylePara elsevierViewall">Because the Indian study was a prospective cohort study&#44; the suspected DILI cases were well defined and a complete case data collection as well as causality assessment were possible while the patient was still under medical care&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> The prospective use is one of the cornerstones of RUCAM and strongly recommended&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Indeed&#44; complete case data in the Indian study resulted in high RU-CAM scores and thereby high causality gradings among 90 patients&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> Causality was probable in 63&#47;90 cases &#40;70&#37;&#41;&#44; highly probable in 15&#47;90 cases &#40;18&#37;&#41;&#44; possible in 4&#47;90 cases &#40;5&#37;&#41;&#44; and unlikely or excluded in 8&#47;90 cases &#40;9&#37;&#41;&#46;</p><p id="p0140" class="elsevierStylePara elsevierViewall">The prospective use of RUCAM ensured early recognition of alternative causes in 8 cases of the Indian cohort study&#58; Acute hepatitis E virus &#40;HEV&#41; in 3 patients&#44; autoimmune hepatitis in 2 patients&#44; and hepatitis A&#44; B&#44; and sar-coidosis in 1 patient each&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> HEV exclusion was systematically included in the investigations not only because HEV is endemic in India&#44; but also because such exclusion is mandatory in any suspected DILI or HILI cases&#46;<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">4&#44;7-15</span></a> This study confirmed that alternative causes can be excluded only if the patients are correctly investigated at the early phase of the liver injury DILI<a class="elsevierStyleCrossRefs" href="#bib0020"><span class="elsevierStyleSup">3&#44;8&#44;9</span></a> or HILI&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">10-15</span></a></p><p id="p0145" class="elsevierStylePara elsevierViewall">Most importantly&#44; the Indian study convincingly demonstrated that for complete DILI case evaluation a prospective approach is feasible that includes the use of RUCAM with its many advantages &#40;<a class="elsevierStyleCrossRef" href="#t0010">Table 1</a>&#41; as compared to other CAMs&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> Such prospective approach provides reliable results without the need of large costly DILI networks&#44; dependent on subjective expert opinion&#46;</p><elsevierMultimedia ident="t0010"></elsevierMultimedia><p id="p0150" class="elsevierStylePara elsevierViewall">The study of Rathi&#44; <span class="elsevierStyleItalic">et al&#46;&#44;</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">1</span></a> although mainly based on cases due to antitubercular drugs&#44; antiepileptic drugs&#44; herbal complementary and alternative medicines&#44; confirmed that DILI leads to overall mortality of 16&#37; that could be predicted at the time of DILI recognition by the presence of jaundice and encephalopathy&#44; and at one week by the presence of encephalopathy&#44; high MELD score&#44; and elevated alkaline phosphatase&#46; These independent risk factors are those related to the severity of the liver injury due to any offending drug and need to be confirmed by other studies in different countries&#46;</p><span id="s0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="st0010">Potential Competing Interests</span><p id="p0155" class="elsevierStylePara elsevierViewall">None&#46;</p></span></span>"
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        "fuente" => "Compilation from a previous report&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">4</span></a> DILI&#58; Drug induced liver injury&#46; RU-CAM&#58; Roussel Uclaf Causality Assessment Method"
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                  <table border="0" frame="\n
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                  \t\t\t\t">Advantages of RUCAM<ul class="elsevierStyleList" id="l0010"><li class="elsevierStyleListItem" id="u0010"><span class="elsevierStyleLabel">&#8226;</span><p id="p0010" class="elsevierStylePara elsevierViewall">Prospective use and timely decision&#46;</p></li><li class="elsevierStyleListItem" id="u0015"><span class="elsevierStyleLabel">&#8226;</span><p id="p0015" class="elsevierStylePara elsevierViewall">Stepwise first clinical approach&#44; followed by RU- CAM&#46;</p></li><li class="elsevierStyleListItem" id="u0020"><span class="elsevierStyleLabel">&#8226;</span><p id="p0020" class="elsevierStylePara elsevierViewall">User-friendly and cost-saving method&#46;</p></li><li class="elsevierStyleListItem" id="u0025"><span class="elsevierStyleLabel">&#8226;</span><p id="p0025" class="elsevierStylePara elsevierViewall">Effective use without the need of an expert panel&#46;</p></li><li class="elsevierStyleListItem" id="u0030"><span class="elsevierStyleLabel">&#8226;</span><p id="p0030" class="elsevierStylePara elsevierViewall">Timely use at the bedside of the patient&#46;</p></li><li class="elsevierStyleListItem" id="u0035"><span class="elsevierStyleLabel">&#8226;</span><p id="p0035" class="elsevierStylePara elsevierViewall">Clearly defined key items of clinical features and course&#46;</p></li><li class="elsevierStyleListItem" id="u0040"><span class="elsevierStyleLabel">&#8226;</span><p id="p0040" class="elsevierStylePara elsevierViewall">Full consideration of comedication and alternative causes&#46;</p></li><li class="elsevierStyleListItem" id="u0045"><span class="elsevierStyleLabel">&#8226;</span><p id="p0045" class="elsevierStylePara elsevierViewall">Consideration of prior known hepatotoxicity&#46;</p></li><li class="elsevierStyleListItem" id="u0050"><span class="elsevierStyleLabel">&#8226;</span><p id="p0050" class="elsevierStylePara elsevierViewall">Incorporation of unintentional reexposure results&#46;</p></li><li class="elsevierStyleListItem" id="u0055"><span class="elsevierStyleLabel">&#8226;</span><p id="p0055" class="elsevierStylePara elsevierViewall">Hepatotoxicity specific method&#46;</p></li><li class="elsevierStyleListItem" id="u0060"><span class="elsevierStyleLabel">&#8226;</span><p id="p0060" class="elsevierStylePara elsevierViewall">Structured&#44; liver related method&#46;</p></li><li class="elsevierStyleListItem" id="u0065"><span class="elsevierStyleLabel">&#8226;</span><p id="p0065" class="elsevierStylePara elsevierViewall">Individual scoring system of all key items&#46;</p></li><li class="elsevierStyleListItem" id="u0070"><span class="elsevierStyleLabel">&#8226;</span><p id="p0070" class="elsevierStylePara elsevierViewall">Quantitative&#44; liver related method&#46;</p></li><li class="elsevierStyleListItem" id="u0075"><span class="elsevierStyleLabel">&#8226;</span><p id="p0075" class="elsevierStylePara elsevierViewall">Validated method &#40;gold standard&#41;&#46;</p></li><li class="elsevierStyleListItem" id="u0080"><span class="elsevierStyleLabel">&#8226;</span><p id="p0080" class="elsevierStylePara elsevierViewall">Worldwide use&#46;</p></li><li class="elsevierStyleListItem" id="u0085"><span class="elsevierStyleLabel">&#8226;</span><p id="p0085" class="elsevierStylePara elsevierViewall">Use by international registries&#46;</p></li><li class="elsevierStyleListItem" id="u0090"><span class="elsevierStyleLabel">&#8226;</span><p id="p0090" class="elsevierStylePara elsevierViewall">Use by regulatory agencies&#46;</p></li><li class="elsevierStyleListItem" id="u0095"><span class="elsevierStyleLabel">&#8226;</span><p id="p0095" class="elsevierStylePara elsevierViewall">Use by DILI case reports and case series&#46;</p></li><li class="elsevierStyleListItem" id="u0100"><span class="elsevierStyleLabel">&#8226;</span><p id="p0100" class="elsevierStylePara elsevierViewall">Transparent documentation&#46;</p></li><li class="elsevierStyleListItem" id="u0105"><span class="elsevierStyleLabel">&#8226;</span><p id="p0105" class="elsevierStylePara elsevierViewall">Possible reevaluation by peers&#46;</p></li></ul>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t">Limitations of RUCAM&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
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                  \t\t\t\t"><ul class="elsevierStyleList" id="l0015"><li class="elsevierStyleListItem" id="u0110"><span class="elsevierStyleLabel">&#8226;</span><p id="p0110" class="elsevierStylePara elsevierViewall">RUCAM was not designed for suspected chronic DILI&#44; which is mostly an unrecognized preexisting liver disease</p></li><li class="elsevierStyleListItem" id="u0115"><span class="elsevierStyleLabel">&#8226;</span><p id="p0115" class="elsevierStylePara elsevierViewall">RUCAM was also not designed when a suspected injury occurs on preexisting liver diseases&#44; a complex condition where expert hepatologists are required&#46;</p></li></ul>&nbsp;\t\t\t\t\t\t\n
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                            0 => "Rathi C&#46;"
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                            3 => "Ingle M&#46;"
                            4 => "Phadke A&#46;"
                            5 => "Sawant P&#46;"
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos