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Letter to the Director
Denosumab - Where are we?
Denosumab. ¿Dónde estamos?
B. Estero Serrano de la Cruz
Corresponding author
belen.estero07@gmail.com

Corresponding author.
, J.L. Laguillo Cadenas, M. Ruano Santiago, M. Echevarría Moreno
Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario de Valme, Sevilla, Spain
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and is currently indicated as a treatment for osteoporosis in postmenopausal women and in men at high risk of bone fracture&#44; as it has been shown to reduce the risk of vertebral and hip fractures&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">It is also indicated in men receiving hormone suppression therapy for prostate cancer and in bone loss associated with long-term systemic glucocorticoid therapy&#46; Some of the most important side effects of denosumab are an increased risk of infection due to weakening of the immune system&#44; and more recently&#44; the risk of multiple vertebral fractures following withdrawal of the drug&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The constant influx of new biological agents makes it difficult to maintain recommendations current&#46; Most are not based on evidence from clinical trials&#44; but rather on expert opinion&#44; clinical cases&#44; or extrapolation of experiences obtained with similar drugs&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The Spanish Society of Rheumatology &#40;SER&#44; in its Spanish acronym&#41; published an updated consensus statement in 2019 that includes denosumab&#44; teriparatide and rh-PTH 1-84&#44; which have a very different mechanisms of action and safety profile from other biologicals&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> This document&#44; however&#44; only discusses temporary withdrawal of denosumab in patients undergoing extensive oral surgery with associated risk factors &#40;diabetes&#44; periodontal disease&#44; immunodeficiencies&#44; smoking&#41;&#44; and recommends that prolonging suspension unnecessarily should be avoided&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In the United States&#44; we only found one clinical practice guideline on perioperative medication from the University of Wisconsin&#44;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> which makes the following recommendation&#58; &#8220;Coordinate calcitonin and denosumab perioperative plans with the surgeon and prescribing provider&#46; &#40;UW Health strong recommendation&#44; low quality of evidence&#41;&#46;&#8221;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The aim of this letter is to draw attention to the difficulty in locating clinical practice guidelines on the management of denosumab in non-dental elective surgery&#44; since there are no clear recommendations&#46; This is particularly relevant in light of recent meta-analyses on infections<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> and the health alert<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> issued regarding the risk of multiple vertebral fractures<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> after withdrawal of denosumab&#44; which are described below&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">In the literature&#44; several meta-analyses have found that denosumab-treated patients may have a higher overall incidence of serious adverse events&#44; mainly respiratory and gastrointestinal infections&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> None of the evidence in this meta-analysis derives from patients during the perioperative period&#44; when surgical stress could increase susceptibility to infection&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Suspension of denosumab or delayed dosing is also associated with adverse events&#44; insofar as withdrawal appears to be associated with an increased risk of multiple vertebral fractures&#44;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> which is why the drug is currently under judicial investigation&#46; In 2019&#44; the Spanish Agency of Medicines and Medical Devices published an alert<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> regarding this rebound effect and recommended using denosumab only in patients at high risk of fractures&#44; and in the context of its authorised indications&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Because of the dearth of information on this drug&#44; suspending administration in the context of a pre-anaesthetic evaluation due to ignorance of its complications or lack of information on its perioperative management can lead to important complications&#46;</p></span>"
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Article information
ISSN: 23411929
Original language: English
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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