Rofecoxib, but not celecoxib or naproxen, increases mean 24-hour systolic blood pressure: results of a randomized double blind controlled trial in treated hypertensive patients with osteoarthritis (OA) and type 2 diabetes mellitus

Abstract

Hypertension (HTN) is prevalent in type 2 diabetic patients (T2DM) and contributes strikingly to the high incidence of CVD morbidity/mortality; BP control markedly reduces associated morbidity and mortality. T2DM is commonly accompanied by OA; thus the impact of NSAIDs and COX-2 inhibitors on BP in these patients is important. We evaluated the impact COX 2 inhibitors on 24 hr BP after 6 and 12 weeks in T2DM patients on ACE inhibitors. This was a double-blind, randomized, 12 week study. Patients received celecoxib (C) 200 mg QD (n=136), rofecoxib (R) 25 mg QD (n=138), or naproxen (N) 500 mg BID (n=130). 24-hour ambulatory BP measurements (ABPM) were performed at baseline, week 6 and week 12. Primary outcome measure was the mean change from baseline to week 6 of the average 24-hour systolic BP (SBP). Arthritis efficacy assessments were performed at baseline and weeks 6 and 12. Rofecoxib, but not celecoxib or naproxen, at doses providing equal efficacy, induced a significant increase in SBP. Celecoxib 200 mg QD has a more favorable BP side effect profile than rofecoxib 25 mg QD in high risk patients with HTN and T2DM using ACE inhibitors.