Efficacy, Safety, and Effects on Blood Pressure of Naproxcinod 750 mg Twice Daily Compared With Placebo and Naproxen 500 mg Twice Daily in Patients With Osteoarthritis of the Hip: A Randomized, Double-Blind, Parallel-Group, Multicenter Study
Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T
Arthritis Rheum. 2010;62:3635-3644
Introduction
The mainstays of medical therapy for the symptoms of osteoarthritis (OA) are nonsteroidal anti-inflammatory agents (NSAIDs). Unfortunately, NSAIDs can have significant adverse effects which limit their use. These adverse effects include gastrointestinal and renal injury, hypertension, and perhaps increased risk for cardiovascular disease events. Naproxcinod is a member of a new class of anti-inflammatory agents termed cyclooxygenase-inhibiting nitric oxide donators (CINODs). As they are metabolized, CINODs release their nitric oxide (NO) moiety, with released NO leading to improved vascular tone and mucosal blood flow. As a result of these effects, CINODs may abrogate some of the adverse effects of NSAIDs including gastrointestinal injury and hypertension. These authors investigated whether the CINOD naproxcinod (naproxen with a NO moiety) would be efficacious in relieving hip OA-related pain; they also investigated the safety parameters of naproxcinod compared to standard naproxen.