This double-blind, placebo-controlled, four-way balanced design crossover study included hypertensive patients aged 60-85 years with mean office-measured sitting systolic blood pressure (SBP) 160-179 mm Hg and daytime SBP X135 mm Hg. After a 2-week run-in period, during which previous medications were discontinued, each patient received the following four treatments in randomized order for 4 weeks each: lercanidipine 10 mg (L), enalapril 20 mg (E), lercanidipine 10 mg plus enalapril 20 mg (L/E) and placebo (P). At the end of each treatment period, office trough blood pressure (BP) was measured and a 24-h Ambulatory Blood Pressure Monitoring (ABPM) was performed. Seventy-five patients (mean age 66 years, office BP 168/92 mm Hg, daytime SBP 151 mm Hg) were randomized and 62 completed the study with four valid postbaseline ABPMs. The administration of P, L, E and L/E was associated with a mean 24-h SBP of 144, 137, 133 and 127 mm Hg, respectively. All active treatments significantly reduced the mean 24-h SBP in comparison with placebo, but L/E was significantly more effective than L and E alone. Similarly, office SBP was significantly more reduced with L/E (À16.9 mm Hg) than with L (À5.0 mm Hg) or E (À5.9 mm Hg). A BP o140/90 mm Hg was recorded in 18% of patients with L, 19% with E and 45% with L/E. Two patients on P and two on L/E were withdrawn from the study due to adverse events. In conclusion, combination therapy with L/E has additive antihypertensive effects on both ambulatory and office BP in elderly patients and is well tolerated.
The study was set up to evaluate the long-term effects on mortality of a comprehensive rehabilitation and secondary prevention programme lasting 3 years after acute myocardial infarction. The study group consisted of 375 consecutive, non-selected patients under 65 years of age randomly allocated to an intervention group (188 patients) or a control group (187 patients). After 15 years follow-up significantly lower incidence of sudden death (16.5% vs 28.9%, P = 0.006) and coronary mortality (47.9% vs 58.5%, P = 0.04) were seen in the intervention group compared with controls. Total mortality was 64.4% and 66.8%, respectively (ns). The incidence of cancer death was 16 in the intervention group and three in the controls. Cardiac failure, enlarged heart, New York Heart Association functional class II or more and membership in the control group were significantly associated with coronary mortality during the first 3 years, and after 3 years enlarged heart, diabetes and reinfarction were associated with late coronary death. Thus, comprehensive multifactorial intervention after acute myocardial infarction had favourable long-term effects on coronary mortality and sudden death but no effect on total mortality.
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