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SAT0063 Bleeding time and platelet function in normal volunteers receiving meloxicam
  1. HM Rinder1,
  2. RP Gagnier2,
  3. M Souhrada2,
  4. CC Wood2
  1. 1Department of Laboratory Medicine, Yale School of Medicine, New Haven, USA
  2. 2Clinical Research, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, USA

Abstract

Background Traditional NSAIDs relieve the inflammation and pain of arthritis through inhibition of cycloxygenase (COX)-2, but adverse gastrointestinal and platelet side effects are common with inhibition of COX-1. Because meloxciam inhibits COX-2 to a greater degree than COX-1, it may therefore have inflammatory efficacy without adverse effects on platelet function.

Objectives This study assessed the effects of once daily meloxicam (7.5, 15, and 30 mg) on bleeding time and platelet function in healthy subjects as compared to placebo or extended-release indomethacin capsules (75 mg) as an active control.

Methods In this double-blind study, healthy male and female subjects were randomised to received 8 days of a single dose of meloxicam 7.5 mg (N = 16), 15 mg (N = 16), or 30 mg (N = 16), placebo (N = 16), or indomethacin ER 75 mg (N = 15). Subjects were serially evaluated with bleeding times (simplate method), platelet aggregation to Arachidonic acid (AA) and ADP, and serum thromboxane B2 (TXB2) levels. Changesfrom the pre-drug baseline were evaluated on Day 8 prior to drugdosing and at 3 and 6 h after dosing.

Results None of the meloxicam doses prolonged the bleeding time, either chronically (Day 8 predose) or acutely (Day 8, 3 and 6 hrs post-dose) in comparison with placebo. By contrast, indomethacin significantly prolonged the bleeding time 6 hrs after dosing on Day 8. Similar to the bleeding time results, there was no inhibitory effect of meloxicam at any dose on either ADP- or AA-induced platelet aggregation when compared with placebo; whereas indomethacin significantly inhibited platelet aggregation to ADP (Day 8, 3 and 6 hrs post-dose) and to AA (Day 8, pre-dose and 3 and 6 hrs post-dose (p < 0.05).

Abstract SAT0063 Table 1

Conclusion Meloxicam at higher than recommended doses had no acute or chronic effect on bleeding times and did not inhibit either AA or ADP induced platelet aggregation in healthy volunteers.

By contrast indomethacin ER 75 mg significantly reduced platelet aggregation and increased bleeding times.

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