EFFECTIVENESS AND SAFETY OF DILTIAZEM OR LISINOPRIL IN TREATMENT OF HYPERTENSION AFTER HEART-TRANSPLANTATION - RESULTS OF A PROSPECTIVE, RANDOMIZED MULTICENTER TRIAL

Objectives. The purpose of this study was to determine the effectivene ss and safety of diltiazem or lisinopril for treatment of hypertension after heart transplantation. Background. Systemic hypertension is com mon after heart transplantation,and to date there are no randomized, p rospective multicenter treatment trials. Methods. Members of the Cardi ac Transplant Research Database Group developed and implemented a pros pective, randomized multicenter trial of the effectiveness and safety of diltiazem or lisinopril in the treatment of hypertension in cyclosp orine-treated patients after heart transplantation. Results. One hundr ed sixteen patients with hypertension (blood pressure greater than or equal to 140/90 mm Hg) after heart transplantation were randomized for greater than or equal to 3 months of treatment. Of 55 diltiazem-treat ed patients, 21 (38%) were responders (diastolic blood pressure <90 mm Hg), 23 (42%) were nonresponders (diastolic blood pressure greater th an or equal to 90 mm Hg), and 11 (20%) were withdrawn from the study. Of 61 lisinopril-treated patients, 28 (46%) were responders, 22 (36%) were nonresponders, and 11 (18%) were withdrawn. There was no differen ce in baseline characteristics or percent responders between the two g roups. Systolic pressure decreased from 157 +/- 2.3 to 130 +/- 2.0 mm Hg (mean +/- 1 SEM) in the diltiazem-treated responders and from 153 /- 2.1 to 127 +/- 2.7 mm Hg in the lisinopril-treated responders (p < 0.0001). Diastolic pressure decreased from 100 +/- 0.9 to 85 +/- 1.6 m m Hg in the diltiazem-treated responders and from 100 +/- 1.0 to 84 +/ - 2.0 mm Hg in the lisinopril-treated responders (p < 0.0001). There w ere a total of 35 reported adverse events, 22 of which led to withdraw al of the patient from the study. All drug related side effects were c onsidered minor and resolved with discontinuation of the drug. Conclus ions. These results indicate that both diltiazem and lisinopril are sa fe for treatment of hypertension after heart transplantation, although titrated monotherapy with either drug controlled the condition in <50 % of patients.