Efficacy and safety of olmesartan medoxomil/amlodipine fixed-dose combination for hypertensive patients uncontrolled with monotherapy

다국어 초록 (Multilingual Abstract)

This study aimed to evaluate the efficacy andsafety of olmesartan medoxomil (OM)/amlodipine (AML)20/5 mg fixed-dose combination tablet in Chinese mild tomoderately hypertensive patients with inadequate bloodpressure (BP) control on monotherapy. Two multicenter,randomized, double-blind, double-dummy, active-controlled,parallel group clinical trials were conducted. Afterscreening and a 2-week placebo run-in period, patients with95 mmHg B seated diastolic blood pressure (SeDBP) \110 mmHg received monotherapy with OM 20 mg (inStudy 1) or AML 5 mg (in Study 2), once daily for4 weeks. Patients with 90 mmHg B mean SeDBP \110 mmHg at the end of the monotherapy period wererandomized to receive OM/AML 20/5 mg treatment orcontinue with the monotherapy, once daily for 8 weeks. OM/AML (20/5 mg) treatment significantly lowered bothsystolic and diastolic BP at 4 and 8 weeks compared to40 mg olmesartan or 5 mg AML. The incidence of drugrelatedadverse effects did not differ significantly betweenthe groups. OM/AML 20/5 mg was superior to OM 40 mgor AML 5 mg monotherapy in lowering BP in Chinesemild to moderately hypertensive patients with inadequateBP control on monotherapy. No new or unexpected safetyissues were identified with OM/AML combination therapycompared to monotherapy.

참고문헌 (Reference)

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