Comparative multicentre study of the tolerability and efficacy of epanolol versus nifedipine in patients with stable angina pectoris.
The primary aim of this multicentre, randomised, double-blind, crossover study in 529 patients with stable angina pectoris was to compare the tolerability of epanolol, a novel antianginal agent, administered as a single oral daily dose of 200mg, with an oral retard formulation of twice-daily nifedipine 20mg and to determine patient preference (VISA 2). Confirmation of equal efficacy and safety monitoring were secondary aims of the study. Treatment consisted of 4 weeks on each therapy, and at the end of the study each patient was asked to state their treatment preference. 448 patients (85%) answered the preference question. Preliminary analysis of the data showed that 61% of patients preferred epanolol vs 31% who preferred nifedipine (p less than 0.001). Reason for a preference for epanolol were mainly fewer adverse experiences (11% vs. 23% with nifedipine), a general improvement in well-being (16% vs 10% with nifedipine) and a decrease in the number of angina attacks (11% vs 10% with nifedipine). A tolerability questionnaire comprising 43 questions and covering 7 different body systems showed that epanolol had a better profile than nifedipine for the following 7 side effects: poor sleep, abdominal pain, flushing, swollen ankles, palpitations, headache and a general feeling of being unwell. Four patients died during the study; none of the deaths were associated with the study treatment. Treatment with nifedipine resulted in 63 patient withdrawals compared with 31 patient withdrawals during epanolol treatment; there were 5 patient withdrawals from both treatments. The main reasons for withdrawal of patients from nifedipine treatment were adverse events (9% vs 4% with epanolol) and a lack of efficacy (3% vs 2% with epanolol).(ABSTRACT TRUNCATED AT 250 WORDS)
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ICI Pharmaceuticals, Macclesfield, Cheshire, United Kingdom.
D000319:Adrenergic beta-Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000787:Angina Pectoris / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D044482:Benzeneacetamides; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009543:Nifedipine / Q000009:adverse effects* / Q000627:therapeutic use; D005996:Nitroglycerin / Q000008:administration & dosage / Q000627:therapeutic use; D011412:Propanolamines / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D000319:Adrenergic beta-Antagonists; D044482:Benzeneacetamides; D011412:Propanolamines; C038616:epanolol; D005996:Nitroglycerin; D009543:Nifedipine