Efficacy and safety of captopril in the treatment of severe childhood hypertension: report of the International Collaborative Study Group.

The safety and efficacy of captopril therapy in children with severe and refractory hypertension has been evaluated in a collaborative international study which enrolled a group of 73 patients, 15 years of age or younger. Most patients had hypertension associated with renal disease or vascular abnormalities. Captopril was administered for periods of less than 3 months to more than 1 year. A significant decrease in both systolic and diastolic blood pressures was produced by the administration of captopril, usually in conjunction with other antihypertensive agents (most commonly diuretics and/or beta-blockers). Systolic blood pressures were normalized in 62% and 53% and diastolic blood pressures in 56% and 45% of reported patients after the second and sixth months of captopril therapy, respectively. The response to captopril was sustained over a 12-month period. Adverse reactions were reported in 49% of the 73 patients; 48% of patients had experienced adverse reactions to other antihypertensive agents prior to entering the study. The reactions most frequently observed during captopril therapy were hypotension, vomiting, postural symptoms, anemia, rash, and anorexia. Leukopenia was reported in six patients, all of whom had renal impairment. Two of these patients had received concomitant therapy with immunosuppressants, and one had systemic lupus erythematosus. Captopril was discontinued in two of these six children. Statistically significant increases in mean serum urea nitrogen and potassium concentrations and decreases in mean serum CO2 levels were observed during the course of therapy. These effects could not be exclusively attributed to captopril administration as the study population received multidrug therapy and had significant intrinsic disease. Captopril was demonstrated to be an effective and safe drug for the treatment of children with severe hypertension.