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) |
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Authors: | Claudia Zemmrich MD Stephan Lüders MD Andrea Gansz MS Rolf Fimmers PhD Jennifer Nadal MS Roland E Schmieder MD PhD Joachim Schrader MD PhD Peter Bramlage MD PhD |
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Institution: | 1. Institut für Pharmakologie und präventive Medizin, Mahlow and Cloppenburg Germany ; 2. St. Josephs Hospital, Cloppenburg Germany ; 3. Institut für Medizinische Biometrie, Informatik und Epidemiologie, Universitätsklinikum Bonn, Germany ; 4. Medizinische Klinik 4, Universitätsklinikum Erlangen, Germany |
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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 32 mg candesartan followed by olmesartan/amlodipine 40/10 mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6 mm Hg (P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7 mm Hg). The reduction in office BP was 9.4±18.4/4.0±9.6 mm Hg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90 mm Hg using office BP and <135/85 mm Hg 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 40 mg/amlodipine 10 mg. |
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