Novartis Pharmaceuticals AG (BASEL, Switzerland) reported new trial data showing that patients with osteoarthritis (OA), who also have controlled hypertension, experienced a slight decrease in average daily blood pressure (BP) when treated with the selective COX-2 inhibitor Prexige® (Lumiracoxib) compared with a slight increase in those taking ibuprofen, a commonly-used nonsteroidal anti-inflammatory drug (NSAID).

The study was a 4-week, multicenter, randomized, double-blind, double-dummy, parallel group trial of 787 hypertensive OA patients age 50> with ambulatory BP of 140/90 mm Hg or lower, who were being treated with an antihypertensive medicine. A total of 741 patients completed the study, which compared Prexige 100 mg once-daily with ibuprofen 600 mg taken three times daily.

At the end of the study, patients on Prexige showed a decrease in mean ambulatory systolic BP of 2.7 mm Hg compared with a 2.2 mm Hg increase in patients taking ibuprofen, giving an estimated difference of 5 mm Hg between the groups (P <.001). Mean ambulatory diastolic BP decreased by 1.5 mm Hg in Prexige patients compared with a 0.5 mm Hg increase in those on ibuprofen, an estimated difference of 2 mm Hg (P <.001). Results also showed that Prexige and ibuprofen had similar efficacy as well as a comparable incidence of adverse events.

According to Novartis, approximately 40% of patients with OA also have hypertension. Independent research shows that even small elevations in BP can contribute to an increased risk of cardiovascular events. NSAIDs, including some inhibitors of COX-2, have been associated with raised BP.

Prexige has a unique chemical structure to other COX-2 inhibitors—it does not contain a sulphur molecule, which has been associated with sulphur-related skin reactions in some patients. Prexige also has a short plasma half-life of approximately 4 hours, yet provides 24-hour pain relief with a once-daily dose.
 
The clinical trial database for Prexige comprises approximately 40,000 patients, making it one of the largest bodies of evidence for any drug in its class. In a trial involving more than 18,000 patients, Prexige, compared to ibuprofen and naproxen, reduced the incidence of upper gastrointestinal complications by 79%.

—A. Techman

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