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Adverse drug event profile associated with pregabalin among patients with and without cancer: analysis of a spontaneous reporting database
Author(s) -
Kose Eiji
Publication year - 2018
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/jcpt.12683
Subject(s) - pregabalin , medicine , adverse effect , database , cancer , adverse event reporting system , odds ratio , context (archaeology) , anesthesia , paleontology , computer science , biology
Summary What is known and objective Pregabalin is used for the relief of neuropathic pain in patients with and without cancer. However, no report has examined whether there is a difference in the adverse drug event ( ADE ) profile of pregabalin in each context. We aimed to establish whether pregabalin's ADE profile was different between patients with and without cancer. This study was based on the Japanese Adverse Drug Event Report ( JADER ) database, which is a spontaneous reporting database. Method Reports obtained from the JADER database were analysed from April 2004 to December 2016 for ADE s, using reporting odds ratios ( ROR s), a method of disproportionality analysis. We evaluated the association between the ROR s and ADE s of pregabalin and compared the age, dosage and time at which ADE s occurred in patients with and without cancer. The primary outcome was ROR s. Secondary outcomes were expression age and time‐to‐onset of ADE among patients with and without cancer. Results and discussion In total, 426 216 reports from the JADER database were analysed. The major side effects associated with pregabalin among both patient groups were interstitial pneumonia, renal failure, liver failure, altered consciousness, heart failure and rhabdomyolysis. The pregabalin dose was significantly higher in patients with cancer than in those without cancer. Furthermore, the times to reporting of interstitial pneumonia, altered consciousness and liver failure were significantly shorter in patients with cancer than in those without cancer. What is new and conclusion The ADE profiles of pregabalin were broadly similar among patients with and without cancer, but time‐to‐onset and type of some ADE s may be different.