BACKGROUND AND OBJECTIVE
For patients with moderate hypertension (grade 2, defined as systolic blood pressure [SBP] 160-179 mmHg and/or diastolic blood pressure [DBP] 100-109 mmHg), current guidelines recommend initial combination therapy and rapid dose-adjustment to achieve blood pressure goal. In this study we investigated the efficacy and tolerability of the single pill combination of amlodipine 10 mg plus valsartan 160 mg (A 10 + Val 160) in patients not controlled by the free combination of amlodipine 10 mg plus olmesartan 20 mg (A 10 + O 20).
METHODS
In this prospective, open-label, non-randomized trial, 257 patients with mean sitting DBP of 100-109 mmHg at trough entered a 4 week treatment phase with A 10 + O 20 in free combination once daily. Patients in whom DBP remained uncontrolled were switched in a second 4 week treatment phase to A 10 + Val 160. The primary efficacy variable was the reduction in DBP at week 8 compared to week 4 in the intent-to-treat population.
RESULTS
In the total cohort, baseline SBP/DBP of 164.2 +/- 9.8/103.6 +/- 2.1 mmHg decreased by 19.2 +/- 12.4/14.1 +/- 7.4 mmHg at week 4. In patients who did not achieve BP control (n = 175), subsequent treatment with A 10 + Val 160 for 4 weeks reduced SBP from 149.6 +/- 11.1 at week 4 by 7.9 mmHg at week 8 (95% CI: 6.1-9.6, p < 0.0001) and DBP from 93.4 +/- 3.9 mmHg by 9.1 mmHg (95% confidence interval: 8.1-10.2, p < 0.0001). The combination of A 10 + Val 160 was well tolerated, and the observed adverse events (15.3% of patients in phase 2) were consistent with the known drug profiles.
CONCLUSIONS
In a study designed to reflect typical clinical practice, in patients not controlled by the free combination of A 10 + O 20, the single pill combination of A 10 + Val 160 produced a statistically and clinically significant additional BP reduction and was well tolerated. Potential limitations of the design (open-label, non-controlled design, short term treatment) have to be taken into account.