The long-term antihypertensive efficacy and safety of a new felodipine-metoprolol combination tablet. The Swedish/UK and German Study Groups.
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 laboratory variables were observed. The results of these trials confirm that the extended-release formulation combining felodipine and metoprolol maintains a significant antihypertensive effect during long-term treatment and is well tolerated.
Hosie
J
J
The Surgery, Glasgow, UK.
Dahlöf
B
B
Klein
G
G
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004338:Drug Combinations; D004562:Electrocardiography / Q000187:drug effects; D015736:Felodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008790:Metoprolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged
D000959:Antihypertensive Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D008790:Metoprolol; D015736:Felodipine