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Haemoglobin decreases in NSAID users over time: an analysis of two large outcome trials.

ABSTRACT: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with clinically significant decreases in haemoglobin dependent and independent of acute bleeding events.To evaluate the incidence and time to a clinically meaningful decrease in haemoglobin in two double-blind, prospective randomised clinical trials comparing NSAIDs in patients with osteoarthritis (OA) or rheumatoid arthritis (RA).In CLASS, patients with OA/RA who were aged ? 18 years and required continuous NSAID treatment were included; patients who were Helicobacter pylori positive and/or using aspirin were not excluded. In contrast, in the CONDOR trial, comparing celecoxib alone to diclofenac sustained release (plus omeprazole), patients were aged ? 60 years or ? 18 years with a history of gastroduodenal ulcer and were H. pylori negative; aspirin or other anti-platelet users were excluded. To make a parallel post hoc analysis we limited our study to 6 months and the populations to only the non-aspirin users in CLASS and those patients receiving either celecoxib or diclofenac. A decrease in haemoglobin of ? 2 g/dL defined the primary end point.At 6 months, in the CLASS and CONDOR trials, 1.9% and 2.0% of patients treated with celecoxib and 3.3% and 5.7% of patients treated with diclofenac developed a ? 2 g/dL decrease in haemoglobin, respectively, [CLASS: odds ratio (OR) 1.80 (95% confidence interval (CI), 1.22-2.65) and CONDOR: OR 2.93 (95% CI, 2.06-4.15), respectively].IN these two large, independent trials, clinically-meaningful decreases in haemoglobin ? 2 g/dL occurred in a relatively similar fashion over time despite differences in trial designs.

SUBMITTER: Goldstein JL

PROVIDER: S-EPMC3201839 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Haemoglobin decreases in NSAID users over time: an analysis of two large outcome trials.

Goldstein J L JL Chan F K L FK Lanas A A Wilcox C M CM Peura D D Sands G H GH Berger M F MF Nguyen H H Scheiman J M JM

Alimentary pharmacology & therapeutics 20110802 7

<h4>Background</h4>Nonsteroidal anti-inflammatory drugs (NSAIDs) have been associated with clinically significant decreases in haemoglobin dependent and independent of acute bleeding events.<h4>Aim</h4>To evaluate the incidence and time to a clinically meaningful decrease in haemoglobin in two double-blind, prospective randomised clinical trials comparing NSAIDs in patients with osteoarthritis (OA) or rheumatoid arthritis (RA).<h4>Methods</h4>In CLASS, patients with OA/RA who were aged ≥ 18 year ...[more]

PMID: 21810115

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Dataset Information

Haemoglobin decreases in NSAID users over time: an analysis of two large outcome trials.

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Haemoglobin decreases in NSAID users over time: an analysis of two large outcome trials.

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