Efficacy of Olmesartan/Amlodipine Single-Pill Combination on 24-h Mean Systolic Blood Pressure Measured by Ambulatory Monitoring in Non-Responders to Valsartan or Candesartan Monotherapy.

Abstract

The aim of this study was to evaluate the efficacy of olmesartan/amlodipine (OLM/AML) single-pill combination (SPC) therapy using ambulatory blood pressure monitoring (ABPM) in non-responders to valsartan or candesartan monotherapy. Isolated systolic hypertension (ISH) is the most prevalent form of hypertension in middle-aged and elderly individuals. Patients aged over 55 years who did not achieve the target systolic blood pressure (SBP < 140 mmHg) with valsartan 80 mg or candesartan 8 mg for at least 4 weeks were included. Doses were escalated from 20/5 mg to 40/5 mg and finally to 40/10 mg of OLM/AML SPC until patients reached the target SBP. Efficacy was assessed via ABPM by comparing baseline values with those in the 12th week. Office blood pressure (OBP) and brachial-ankle pulse wave velocity (baPWV) were assessed at baseline, weeks 4, 8, and 12. Fifty-four patients (average age 64 ± 6 years; 33 males) participated. The 24-h mean BPs decreased significantly from an average of 146.2 ± 12.7/93.3 ± 9.2 mmHg to 129.7 ± 14.3/83.4 ± 10.7 mmHg (p < 0.001), and pulse pressures (PPs) from ABPM were reduced (p < 0.001). Additionally, significant reductions in night-time SBP standard deviations (SDs) (14.7 ± 4.7 vs. 12.5 ± 3.9, p = 0.029) were observed at 12 weeks compared to baseline. OBPs significantly dropped from 151.1 ± 9.7/89.3 ± 8.3 mmHg to 125.5 ± 13.8/77.8 ± 8.8 mmHg after 12 weeks of SPC therapy (p < 0.001). Reductions in PPs of OBP and baPWVs were also observed. OLM/AML SPC therapy effectively reduced the 24-h mean BP, as measured by ABPM, in hypertensive patients over 55 years old who failed to achieve a target SBP (< 140 mmHg) with angiotensin receptor blocker (ARB) monotherapy using valsartan 80 mg or candesartan 8 mg. Trial Registration: ClinicalTrials.gov identifier: NCT01713920.