Daytime Systolic Ambulatory Blood Pressure With a Direct Switch Between Candesartan Monotherapy and the Fixed-Dose Combination Olmesartan/Amlodipine in Patients With Uncontrolled Essential Hypertension (SEVICONTROL-1)

Abstract

A direct switch of candesartan to the fixed-dose combination olmesartan/amlodipine in uncontrolled hypertension is a frequent clinical requirement but is not covered by current labeling. An open-label, prospective, single-arm phase IIIb study was performed in patients with 32mg candesartan followed by olmesartan/amlodipine 40/10mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6mmHg (P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7mmHg). The reduction in office BP was 9.4±18.4/4.0±9.6mmHg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90mmHg using office BP and <135/85mmHg using ambulatory BP measurement. There were 8 adverse events with a possible relation to study drug and 1 unrelated serious adverse events. In conclusion, patients with uncontrolled moderate arterial hypertension being treated using candesartan monotherapy achieve a further reduction of BP when switched directly to a fixed-dose combination of olmesartan 40mg/amlodipine 10mg.