| Popis: |
An open multicentre study, performed in 340 overweight (body mass index: BMIor = 25), hypertensive (95 mmHgor = DBP115 mmHg) patients, evaluated the clinical and metabolic safety of trandolapril and confirmed its antihypertensive activity. After a two-week washout period, the patients received trandolapril 2 mg as a single morning dose for 12 weeks. Doubling of the dosage was authorized after the first four weeks when the DBP remained higher than 90 mmHg with a fall in DBP10 mmHg. Of the 287 patients who completed the study, 15.1% had to receive a double dose of trndolapril during the second treatment period. After four weeks of treatment, SBP was decreased by 18.6 mmHg, DBP was decreased by 13.4 mmHg and 63.1% of patients were controlled. After three months of treatment, SBP was decreased by 23.3 mmHg, DBP was decreased by 16.8 mmHg and 84.7% of patients were controlled. Subgroup analysis, according to the BMI (BMIor = or30), showed that the fall in blood pressure was identical regardless of the BMI; the proportion of patients treated with a double dose of trandolapril was also independent of the BMI. A second subgroup analysis, according to the waist/hips ratio, did not reveal any difference according to the android or gynoid profile of excess weight. Twelve patients (3.9%) dropped out of the trial because of adverse events, 10 of which were attributable to treatment; 6.5% of patients reported an adverse effect attributable to treatment. Laboratory assays performed before and after three months of treatment demonstrated the very good metabolic safety profile of trandolapril, in view of the slight but significant reduction of total cholesterol, triglycerides and blood glucose. However, an average weight loss of one kilogram was reported. The global safety was considered to be good or excellent by the investigators in 94.8% of cases. |
