In a multicentre ONTARGET study, a total of 25,620 patients with hypertension underwent randomization to three groups «ONTARGET Investigators., Yusuf S, Teo KK ym. Telmi...»1. For the first 2 weeks after randomization, 8542 patients were assigned to receive 80 mg of telmisartan once daily, 8576 were assigned to receive 5 mg of ramipril once daily, and 8502 were assigned to receive a combination of the two drugs (combination therapy). After 2 weeks, the dose of ramipril was increased to 10 mg per day. Follow-up visits occurred at 6 weeks, at 6 months, and then every 6 months until the last scheduled visit.
A total of 25,577 patients (99.8%) were followed until a primary event occurred or until the end of the study (median, 56 months).
The primary outcome – death – occurred in 1412 patients (16.5%) in the ramipril group, in 1423 patients (16.7%) in the telmisartan group, and in 1386 patients (16.3%) in the combination-therapy group.
The secondary outcome – death from cardiovascular causes, myocardial infarction, or stroke – occurred in 1210 patients (14.1%) in the ramipril group and in 1190 patients (13.9%) in the telmisartan group (relative risk, 0.99; 95% confidence interval [CI], 0.91 to 1.07; P=0.001 for noninferiority). The results were consistent for all components of the primary outcome. Combination therapy was not significantly better than ramipril alone (relative risk, 0.99; 95% CI, 0.92 to 1.07).
There were no significant differences in the rates of secondary outcomes, except for renal dysfunction, which occurred in 871 patients (10.2%) in the ramipril group, 906 patients (10.6%) in the telmisartan group, and 1148 patients (13.5%) in the combination-therapy group. As compared with the ramipril group, the telmisartan group had a similar relative risk of renal impairment (1.04), whereas the combination-therapy group had a significant increase in the relative risk (1.33, P<0.001).