ANTIHYPERTENSIVE EFFECT AND TOLERABILITY OF PERINDOPRIL IN INDIAN HYPERTENSIVE AND TYPE-2 DIABETIC-PATIENTS - 1-YEAR RANDOMIZED, DOUBLE-BLIND, PARALLEL STUDY VS ATENOLOL

Objective: This study compared the antihypertensive effect and accepta bility of a perindopril-based group with that of an atenolol-based gro up in Indian hypertensive type 2 (non-insulin-dependent) diabetic pati ents. Design and Setting: 100 ambulant patients aged between 35 and 69 years were recruited into this monocentric, randomised, double-blind study in two parallel groups for 1 year after a 1-month washout period on placebo. The setting was a tertiary care institution. Patients: Al l patients had stable, essential hypertension between 95mm Hg and 115m m Hg, type 2 diabetes with glycosylated haemoglobin (HbA(1C)) <12%, an d albuminuria between 300mg and 3.5g/24 hours. There were 50 patients per treatment group and two patient population groups were studied, in tention-to-treat (ITT) and per-protocol (PP). The former constituted a ll patients, whilst the latter included those without major protocol d eviation and who completed the 12-month study. Interventions: The stud y drugs were perindopril 4 to 8mg once daily or atenolol 50 to 100mg o nce daily. In each group therapeutic adjustment was planned by doublin g the dose and then by the addition of hydrochlorothiazide 25mg daily. Nifedipine 30 to 60mg daily was subsequently added if the desired dro p in blood pressure was not obtained. The ITT group was analysed by St udent's t-test, and a 2-way analysis of variance was performed for the PP population. Main Outcome Measures: A comparison of the control of hypertension, biochemical abnormalities, blood sugar and adverse effec ts was performed in the atenolol group versus the perindopril group. R esults: On single-dose therapy after 1 month 17 patients (60%) had nor mal blood pressure [diastolic blood pressure (DBP) less than or equal to 90mm Hg] on atenolol 50mg daily, while 13% (30.23%) had normal bloo d pressure (DBP less than or equal to 90mm Hg) on perindopril 4mg dail y (p = 0.013). In the HT group the sitting systolic blood pressure (SB P) decreased by 14.4 +/- 22.3mm Hg at the end of the treatment period on atenolol from 174.4 +/- 17.9mm Hg at the initial period, and the si tting SEP decreased by 21.6 +/- 20.3mm Hg at the end of perindopril tr eatment from an initial value of 172.1 +/- 20.3mm Hg (probability 0.09 1). The sitting DBP decreased by 18.6 +/- 8.7mm Hg on atenolol from 10 0.5 +/- 4.8mm Hg at the initial period and by 15.8 +/- 9.1mm Hg on per indopril from 100.6 +/- 5.2mm Hg (probability 0.112). Glycaemic contro l was similar for HbA(1C) fasting and postprandial glucose in the ITT population, while fasting glucose increased over time from 10.7 +/- 4. 1 to 12.0 +/- 3.4 mmol/L; p < 0.001 in the PP population in the atenol ol group. Conclusions: The percentage of normalised patients (sitting DBP less than or equal to 90mm Hg) was similar in both groups. Patient s on perindopril monotherapy required more additional antihypertensive drugs compared with atenolol monotherapy. There was a significant inc rease in fasting blood sugar in the atenolol-based group (p < 0.001).