Authors: J D Wark W Bensen C Recknor O Ryabitseva J Chiodo P Mesenbrink T J de Villiers
Publish Date: 2011/02/19
Volume: 23, Issue: 2, Pages: 503-512
Abstract
Patients treated with intravenous zoledronic acid 5 mg for osteoporosis may experience postdose influenzalike symptoms Oral acetaminophen/paracetamol or ibuprofen administered 4 h postinfusion reduced the proportion of patients with increased oral temperature and worsening postinfusion symptom scores vs placebo thus providing an effective strategy for the treatment of such symptomsOnceyearly intravenous zoledronic acid 5 mg is a safe and effective treatment for postmenopausal osteoporosis This study assessed whether transient influenzalike postdose symptoms associated with intravenous infusion of zoledronic acid can be reduced by postdose administration of acetaminophen/paracetamol or ibuprofenIn an international multicenter randomized doubleblind doubledummy parallelgroup study bisphosphonatenaïve postmenopausal women with osteopenia n = 481 were randomized to receive zoledronic acid 5 mg + acetaminophen/paracetamol n = 135 ibuprofen n = 137 or placebo n = 137 or placebo + placebo n = 72 Acetaminophen/paracetamol and ibuprofen were administered every 6 h for 3 days beginning 4 h postinfusionThe proportion of patients with increased oral temperature ≥1°C above 375°C and with worsening postinfusion symptom scores over 3 days was significantly lower in patients receiving ibuprofen 368 and 485 or acetaminophen/paracetamol 373 and 463 vs those receiving placebo 635 and 759 respectively all p 00001 compared with background rates of 111 and 167 respectively in the absence of any active treatment Overall incidence of adverse events was comparable for patients receiving acetaminophen/paracetamol or ibuprofenThe authors would like to thank all the patients who participated in the study and the following study investigators—Australia Philip CliftonBligh Michael Hooper Bronwyn Stuckey Peter Nash Stephen Stranks Canada Jeannette Janzen Jack Kooy Richard Kremer JeanPascal Ouellet Brian Zidel Ben Lasko Russia Sergey Mazurenko Svetlana Rodionova Valentina Soroskaya Lidia Benovolenskaya South Africa Graham Ellis Stanley Lipschitz SL Brown USA James Dreyfus Susan Nattrass Theodore Rooney Suzanne Trupin Thomas KleinJD Wark is employed by the University of Melbourne He has received consultancy fees speaker’s bureau contract research and investigatorinitiated research grants from Novartis He has received industry support from Novartis Servier Amgen SanofiAventis/Procter Gamble Eli Lilly UCB Pharma Government support from Australian NHMRC Australian Research Council and other support from the Gardiner Foundation Arthritis Australia Scoliosis Research Society Cancer Council of Victoria Curtin University of TechnologyW Bensen is a clinical professor of medicine at St Joseph’s Hospital and McMaster University He has received consultancy fees speaker bureau fees contract research and advisory board fees from Amgen/Wyeth BMS Roche Abbott UCB ScheringPlough Pfizer Merck Procter Gamble SanofiAventis Eli Lilly Servier and Novartis
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