The long-term antihypertensive efficacy and safety of a new felodipine-metoprolol combination tablet. The Swedish/UK and German Study Groups
Abstract
The long-term antihypertensive efficacy and tolerability of a new extended-release tablet containing the vascular selective calcium antagonist felodipine and the beta 1-selective adrenoceptor blocker metoprolol were assessed in two European studies. In a Swedish/UK study, patients were treated with the combination for 12 (n = 122) or 24 (n = 53 of 122) months; in a German study (n = 162), patients were treated for 12 months only. In both studies, the study medication was administered once daily and the antihypertensive effect evaluated 24 h after dose. The dose was individually titrated until blood pressure control was achieved. In the Swedish/UK study, hydrochlorothiazide at 12.5 or 25 mg daily was added if necessary. Results of both studies were similar and the antihypertensive effect was well maintained during long-term treatment with decreases in mean supine systolic/diastolic blood pressure in the order of 25-30/20 mmHg after 12 months of treatment. A similar antihypertensive efficacy was recorded after 24 months of treatment in the Swedish/UK study. In both the Swedish/UK and the German study, the treatment was well tolerated. Overall, the withdrawal rate due to adverse events during the first 12 months of treatment was 6.7%. In both studies, adverse events were generally reported during the first 6 months of treatment and subsequently more rarely. The most commonly reported adverse events were peripheral oedema and headache. No clinically relevant changes in any…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 162 participants or records.
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