Comparative multicentre study of the tolerability and efficacy of epanolol versus nifedipine in patients with stable angina pectoris. 1989

A S Readman
ICI Pharmaceuticals, Macclesfield, Cheshire, United Kingdom.

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)

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009543 Nifedipine A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. Adalat,BAY-a-1040,Bay-1040,Cordipin,Cordipine,Corinfar,Fenigidin,Korinfar,Nifangin,Nifedipine Monohydrochloride,Nifedipine-GTIS,Procardia,Procardia XL,Vascard,BAY a 1040,BAYa1040,Bay 1040,Bay1040,Monohydrochloride, Nifedipine,Nifedipine GTIS
D011412 Propanolamines AMINO ALCOHOLS containing the propanolamine (NH2CH2CHOHCH2) group and its derivatives. Aminopropanols
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004361 Drug Tolerance Progressive diminution of the susceptibility of a human or animal to the effects of a drug, resulting from its continued administration. It should be differentiated from DRUG RESISTANCE wherein an organism, disease, or tissue fails to respond to the intended effectiveness of a chemical or drug. It should also be differentiated from MAXIMUM TOLERATED DOSE and NO-OBSERVED-ADVERSE-EFFECT LEVEL. Drug Tolerances,Tolerance, Drug,Tolerances, Drug
D005260 Female Females
D005996 Nitroglycerin A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives. Glyceryl Trinitrate,Anginine,Dynamite,Gilustenon,Nitrangin,Nitro-Bid,Nitro-Dur,Nitrocard,Nitroderm,Nitroderm TTS,Nitroglyn,Nitrol,Nitrolan,Nitrong,Nitrospan,Nitrostat,Perlinganit,Susadrin,Sustac,Sustak,Sustonit,Transderm Nitro,Tridil,Trinitrin,Trinitrolong,Nitro Bid,Nitro Dur,NitroBid,NitroDur,Trinitrate, Glyceryl
D006439 Hemodynamics The movement and the forces involved in the movement of the blood through the CARDIOVASCULAR SYSTEM. Hemodynamic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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