F Degner1, R Sigmund, H Zeidler. 1. Therapeutic Area CNS/General Diseases, Boehringer Ingelheim GmbH, Germany.
Abstract
BACKGROUND:Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-2 without affecting platelet aggregation. OBJECTIVE: The goal of this study was to assess the efficacy and tolerability of meloxicam under natural prescribing conditions for up to 6 months. METHODS: This was a multicenter, prospective, observational cohort study. Participating centers were randomized to 1 of 2 groups: the meloxicam-only group, and the group who received comparator NSAIDs (ie, diclofenac, ibuprofen, piroxicam, or indomethacin). RESULTS: A total of 4526 patients received eithermeloxicam (n = 2530) or a comparator NSAID (n = 1996). Treatment groups were comparable in terms of observed efficacy measures. Meloxicam patients had significantly lower rates of reported gastrointestinal (GI) adverse drug reactions (1.80% vs 3.20%; P = 0.003), including dyspepsia (0.08% vs 0.35%; P = 0.049), abdominal pain (0.91% vs 1.90%; P = 0.006), gastritis (0.08% vs 0.60%; P = 0.002), and GI bleeding (0.08% vs 0.50%; P = 0.007), compared with those receiving comparator NSAIDs. CONCLUSION: There was evidence that meloxicam was prescribed preferentially to patients who had not responded to NSAIDs previously, who had previously experienced NSAID-induced side effects (and so were at high risk for developing NSAID-induced GI toxicity), or who were more seriously impaired. The nonrandomized and unblinded nature of this study limits the conclusions that can be drawn concerning efficacy or tolerability. Nevertheless, the study results are consistent with the favorable GI tolerability seen with meloxicam in double-blind comparative trials.
RCT Entities:
BACKGROUND:Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-2 without affecting platelet aggregation. OBJECTIVE: The goal of this study was to assess the efficacy and tolerability of meloxicam under natural prescribing conditions for up to 6 months. METHODS: This was a multicenter, prospective, observational cohort study. Participating centers were randomized to 1 of 2 groups: the meloxicam-only group, and the group who received comparator NSAIDs (ie, diclofenac, ibuprofen, piroxicam, or indomethacin). RESULTS: A total of 4526 patients received either meloxicam (n = 2530) or a comparator NSAID (n = 1996). Treatment groups were comparable in terms of observed efficacy measures. Meloxicampatients had significantly lower rates of reported gastrointestinal (GI) adverse drug reactions (1.80% vs 3.20%; P = 0.003), including dyspepsia (0.08% vs 0.35%; P = 0.049), abdominal pain (0.91% vs 1.90%; P = 0.006), gastritis (0.08% vs 0.60%; P = 0.002), and GI bleeding (0.08% vs 0.50%; P = 0.007), compared with those receiving comparator NSAIDs. CONCLUSION: There was evidence that meloxicam was prescribed preferentially to patients who had not responded to NSAIDs previously, who had previously experienced NSAID-induced side effects (and so were at high risk for developing NSAID-induced GI toxicity), or who were more seriously impaired. The nonrandomized and unblinded nature of this study limits the conclusions that can be drawn concerning efficacy or tolerability. Nevertheless, the study results are consistent with the favorable GI tolerability seen with meloxicam in double-blind comparative trials.
Authors: Helga Radner; Sofia Ramiro; Rachelle Buchbinder; Robert B M Landewé; Désirée van der Heijde; Daniel Aletaha Journal: Cochrane Database Syst Rev Date: 2012-01-18