COMBINATION THERAPY WITH ALISKIREN+HYDROCHLOROTHIAZIDE REDUCES 24-HOUR AMBULATORY BLOOD PRESSURE MORE EFFECTIVELY THAN RAMIPRIL IN OBESE PATIENTS WITH STAGE 2 HYPERTENSION: PP.5.191

Abstract

Objective: Ambulatory blood pressure monitoring (ABPM) is a better predictor of cardiovascular events than clinic blood pressure (BP). Analysis of ABPM in a subset of patients in clinical trials is important to confirm observed changes in clinic BP. We previously showed in an 8-week, prospective, multicenter, randomized, double-blind study (N=380) that a single-pill combination of aliskiren (A) with hydrochlorothiazide (HCTZ) provided greater clinic BP reductions than ramipril (R) in obese patients (average body mass index = 35.3 ± 4.4 kg/m2) with hypertension (mean sitting systolic BP [SBP] >=160 mmHg and <200 mmHg). Here we present the efficacy and safety of A+HCTZ vs R on BP control in a subset of patients who underwent ABPM (n=89). Design and Methods: After a 1–4 week washout period, eligible patients received A+HCTZ 150/12.5 mg (n=45) or R 5 mg (n=44) for 1 week; force-titrated to A+HCTZ 300/25 mg or R 10 mg for 7 weeks. Results: Significantly greater reductions in both clinic BP and 24-hour ambulatory blood pressure (ABP) were observed at week 8 with A+HCTZ vs R (P < 0.05). Reductions in the hourly daytime (6AM-10PM) mean ambulatory systolic BP (maSBP), mean ambulatory diastolic BP (maDBP), and hourly nighttime (10PM-6AM) maDBP were also significantly greater for A+HCTZ vs R (Table). In the overall study, adverse event rates were similar in both groups (35.8%, A+HCTZ vs 37.3%, R), the most common being headache, nasopharyngitis, dizziness, and fatigue. Conclusion: The ABPM results suggest that A+HCTZ provides more effective and consistent 24-hour BP reductions than R in obese patients with stage 2 hypertension.