Short-term efficacy of oral verapamil in rest angina. A double-blind placebo controlled trial in CCU patients. 1981

J Mehta, and C J Pepine, and M Day, and J R Guerrero, and C R Conti

To determine the efficacy and safety of oral verapamil in patients with rest angina admitted to the Coronary Care Unit (CCU), a double-blind placebo-controlled trial was undertaken. Of the 65 patients with rest angina screened for the study, 15 met the inclusion criteria (at least two episodes of chest pain associated with ST-T segment changes per 24 hours) during single-blind placebo phase (Day 1). Patients were then randomized to receive either placebo or verapamil (80 mg every 6 hours) on Day 2. Protocol was designed such that those who did not respond to the placebo (nonresponders) received verapamil, 80 mg every 6 hours, whereas verapamil nonresponders received increased doses (120 mg every 6 hours) on Day 3. Those who did respond (responders) continued to receive their medication. Similar action was taken on Day 4, depending on chest pain frequency and clinical evaluation. The study drug was unblinded on Day 4. At the end of the four-day period, 13 patients were receiving verapamil (nine patients, 80 mg every 6 hours, and four patients, 120 mg every 6 hours) and all but one were responders. One patient received placebo all through the period of the study and was also considered to be a responder. In the remaining one patient evidence of myocardial necrosis developed after he received a single dose of verapamil (80 mg on Day 2). Except for the prolongation of PR interval in two patients while taking verapamil, no side effects from verapamil therapy were observed. These data demonstrate the efficacy of oral verapamil in reducing episodes of myocardial ischemia in the majority of all patients with rest angina.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003325 Coronary Care Units The hospital unit in which patients with acute cardiac disorders receive intensive care. Care Unit, Coronary,Care Units, Coronary,Coronary Care Unit,Unit, Coronary Care,Units, Coronary Care
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
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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