Carranza MJ, Alvarado JMR, Aguirre CIA

Language: Spanish
References: 15
Page: 273-281
PDF size: 112.27 Kb.

ABSTRACT

Background: If different brands of captopril are equal in concentration and bioavailability, then their therapeutic effect must be also similar.
Objective: To determine the therapeutic equivalence of two brands of captopril in comparison with the original in single dose of 25 and 50 mg in female hypertensive patients.
Patients and methods: A prospective, randomized, placebo-controlled, double blind trial was made in 21 female hypertensive patients, whom in three seven-patient blocks in a Latin-square model received 25 and 50 mg single doses of the original captopril, a generic captopril and a captopril formulation distributed by the Mexican Health Secretariat. Blood pressure and heart rate were evaluated by means of an Omrom HEM-713C electronic device of control at 1, 2, 3, 4, 5, 12 and 24 h after treatments.
Results: There were significant differences on systolic blood pressure between the original captopril and the one of the Mexican Health Secretariat at 12 and 24 h with both doses. On diastolic blood pressure there were differences at 12 h between the original and the generic captopril at 50 mg dose, and at 12 and 24 h with the Mexican Health Secretariat one at both doses studied.
Conclusions: There were significant differences in antihypertensive effect between the original captopril and the generic and the Mexican Health Secretariat ones, especially at 50 mg dose. Longer studies to confirm these differences are needed, but this kind of clinical trials may be useful for the periodic monitoring of generic and similar drugs.

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