No abstract

Hypertensive patients over the age of 60 years were admitted to a double-blind placebo-controlled trial. Patients in the actively treated group received a combined potassium-losing and -sparing diuretic (triamterene 50 mg plus hydrochlorothiazide 25 mg; n = 416); this dose could be doubled and methyldopa (up to 2g, daily) was added in 35% of patients when blood pressure remained high. The placebo group (n = 424) received matching capsules and tablets. Adverse effects were assessed in the double-blind period of the trial by calculating the incidence of abnormal biochemical results, investigator reports of diseases and prescriptions of concomitant therapy and a self-administered symptom questionnaire completed by patients. In 1000 hypertensive subjects over 60 years of age, 1 year of active treatment would prevent 11 fatal cardiac events, 6 fatal and 11 non-fatal strokes and 8 cases of severe congestive heart failure. No unexpected adverse treatment effects were observed. A significant excess incidence rate @er 1000 person years) was found in the active group compared with placebo for: (1) impaired renal function, a serum creatinine > 180 pmolll (2.0 mgldl); (2) mild hypokalaemia, a serum potassium < 3.5 rnmolll; (3) reports of gout; and (4) an elevated serum uric acid >0.52 mmolll in men or >0.46 in women. Elevated blood sugar and prescriptions for hypoglycaemic drugs tended to be more frequent in the actively treated group, but this difference was not statistically significant. In both groups, there was a low incidence ( < 7 per 1000 person years) of anaemia and depression and diseases of the liver, gall bladder or pancreas. More patients reported a dr, mouth, blocked nose and diarrhoea in the active treatment group compared with placebo (P < 0.05). Dry mouth and diarrhoea were associated with methyldopa rather than diuretic. We conclude that the adverse effects do not outweigh the benefits of treatment in preventing stroke events, cardiac deaths and heart failure.Journal of Hypertension 1991, 9225-230

4 Nicardipine was tolerated very well, and orthostatic hypotension was never observed. There was no change in heart rate. Plasma renin activity (PRA) was measured in eight patients. There was no correlation between PRA and the antihypertensive effect of nicardipine.5 A pharmacokinetic study performed in 15 elderly patients showed a fast rate ofabsorption and also higher plasma levels than those observed in hypertensive adults (mean age, 54 years). 6 This trial demonstrates the effectiveness of nicardipine in elderly hypertensive patients.

1. A total of 450 hypertensive patients above the age of 60 years have entered the double-blind multicentre trial of the European Working Party on High blood pressure in Elderly (EWPHE). After stratification and randomization half were treated with one capsule daily containing 25 mg of hydrochlorothiazide and 50 mg of triamterene and half were given placebo. In those receiving active treatment, if blood pressure control was not adequate they were given a second capsule and if necessary up to 2 g of methyldopa/day. 2. No significant differences between the groups were present before randomization. A significant blood pressure difference of 25/10 mmHg was obtained between the groups and maintained during 4 years of follow-up. No major disturbances in serum potassium or serum sodium were noted with the present drug combination. 3. During the initial phase an increase in serum creatinine and serum uric acid was noted in the actively treated group, which was maintained during the later years. This increase in serum creatinine in the actively treated group was related (P = 0·003 and r = −0·247) to the decrease in sitting systolic blood pressure. Changes in serum uric acid were (r = 0·3 and P = 0·003) correlated with the changes in serum creatinine both in the placebo and in the actively treated group, but independent of the change in creatinine; the serum uric acid was on average 1 mg higher in the actively treated than in the placebo group. 4. Fasting blood glucose did not change significantly in the placebo-treated group but in the active treatment group the rise was statistically significant. 5. A favourable influence on prognosis by active treatment can be expected on the basis of the blood pressure reduction and in the absence of major electrolytes disturbances. However, the balance between this decreased risk and the increased risk produced by the rise in blood glucose and the other treatment effects remains to be determined. Therefore the trial continues and more patients are being admitted.

The Syst-Eur trial is a randomised, double-blind, placebo-controlled trial that examines the hypothesis that antihypertensive treatment can prevent or delay cardiovascular complications in elderly patients (> 60 years) with isolated systolic hypertension. On March, 1st 1993 a total of 1395 patients with a sitting systolic blood pressure on placebo averaging 160-219 mmHg and a diastolic blood pressure < 95 mmHg were randomised into this trial. The placebo and active treatment groups were similar at randomisation with respect to age (72 +/- 7 years, mean +/- SD), percentage of women (68%), percentage of patients with cardiovascular complications (30%) and sitting blood pressures (175 +/- 12/85 +/- 6 mmHg). The fall in sitting systolic and diastolic blood pressures from baseline to 2 years was significantly more pronounced (p < 0.001) in the actively treated (-22 +/- 18/-6 +/- 9 mmHg) as compared with the placebo treated Syst-Eur patients (-10 +/- 20/-1 +/- 9 mmHg). Active treatment consists of nitrendipine if necessary associated with a converting-enzyme inhibitor and a thiazide. Whether treatment with these antihypertensive agents results in a clinically meaningful reduction of cardiovascular morbidity and mortality is the subject of investigation in this trial.