PERINDOPRIL PLUS NIFEDIPINE VERSUS PERINDOPRIL PLUS HYDROCHLOROTHIAZIDE IN MILD TO SEVERE HYPERTENSION - A DOUBLE-BLIND MULTICENTER STUDY

Thiazide diuretics are considered as the choice drug to combine with A CE inhibitors for the treatment of hypertension. However, there is muc h evidence showing that the combination of ACE inhibitors with a calci um channel blocker is effective and safe. We compared the safety and e fficacy of perindopril 8 mg once daily plus nifedipine SR 1 0 mg twice daily with perindopril 8 mg once daily plus hydrochlorothiazide (HCTZ ) 12.5 mg once daily in a two phase three month study. After a one mon th placebo run-in period, patients whose DBP averaged 95-125 mmHg rece ived perindopril 4 mg once daily for the first open phase (n = 524). A fter one month those whose DBP remained > 90 mmHg were prescribed peri ndopril 8 mg once daily for a second month. Among them, those whose DB P were still > 90 mmHg entered the second phase for one month, in a do uble-blind fashion. Fifty-three patients received HCTZ (BP: 161.2/99.2 +/- 2.0/0.9 mmHg), 57 received nifedipine (BP: 161.4/98.7 +/- 2.2/0.7 mmHg). Five patients withdrew due to side-effects, three patients in the perindopril plus nifedipine group and two in the perindopril plus HCTZ group. After one month there was a significant drop in BP-(P < 0. 01) in both groups: perindopril plus HCTZ (-13.9/-11.9 mmHg) and perin dopril plus nifedipine (-12.1/-10.8 mmHg). Heart rate was not signific antly modified: perindopril plus HCTZ (-1.30 beats/min), perindopril p lus nifedipine (+0.54 beats/min). There were no significant difference between the two combinations for BP reduction and heart rate. The inc idence of adverse experiences was similar in both groups. We conclude that in patients with an inadequate BP control with perindopril 8 mg a lone, the addition of HCTZ or nifedipine provides a further reduction in BP without affecting the safety profile.