ALISKIREN WITH OR WITHOUT HYDROCHLOROTHIAZIDE LOWERS BLOOD PRESSURE EFFECTIVELY IN PATIENTS WITH STAGE 2 HYPERTENSION AND METABOLIC SYNDROME: PP.38.505

Abstract

Objectives: More than one-third of patients with hypertension have metabolic syndrome, a condition characterized by the co-occurrence of inter-related metabolic abnormalities that increase the risk of cardiovascular disease. These patients typically require treatment with two or more antihypertensive agents to achieve blood pressure (BP) control. This 8-week, double-blind study assessed the efficacy and safety of the direct renin inhibitor aliskiren, alone and in combination with the diuretic hydrochlorothiazide (HCT), in patients with stage 2 systolic hypertension (baseline mean sitting systolic BP [msSBP] 160–<200 mmHg) and metabolic syndrome (as defined by NCEP ATP III criteria). Methods: After an initial washout (1–4 weeks), 532 patients were randomized to once-daily aliskiren/HCT 150/12.5 mg or aliskiren 150 mg for 1 week. Doses were then doubled and treatment continued for another 7 weeks. Changes from baseline in msSBP and mean sitting diastolic BP (msDBP) were evaluated using ANCOVA with treatment and region as factors, and baseline BP as a covariate. The proportion of patients achieving BP goal (msSBP/DBP <140/90 mmHg) was also assessed. Results: Overall baseline BP was 165.9/95.6 mmHg. Both aliskiren/HCT and aliskiren provided large BP reductions from baseline at week 8 endpoint (Table). The BP reductions differed significantly between treatments, with least-squares mean differences of –10.2 mmHg (95% CI; –12.9, –7.5; p < 0.0001) for msSBP and –4.4 mmHg (95% CI; –6.0, –2.8; p < 0.0001) for msDBP. A significantly greater proportion of patients treated with aliskiren/HCT achieved BP goal at week 8 endpoint than with aliskiren alone (58.7% vs 34.5%; p < 0.0001). Both treatments were generally well tolerated. Conclusion: Aliskiren monotherapy provided large SBP reductions (–20 mmHg) in patients with stage 2 hypertension and metabolic syndrome. Aliskiren/HCT provided even greater SBP reductions (–30 mmHg) and brought more patients to BP goal. Aliskiren, alone or in combination with HCT, is a highly effective treatment option for patients with stage 2 hypertension and metabolic syndrome.