Effects of amlodipine and lisinopril on intima-media thickness in previously untreated, elderly hypertensive patients (the ELVERA trial)

Objective To compare the effects of the calcium channel blocker amlodipine and the angiotensin-converting enzyme inhibitor lisinopril on intima-media thickness (IMT) in elderly, previously untreated hypertensive individuals. Design A double-blind randomized parallel-group trial (the ELVERA trial). Patients The study population comprised 166 newly diagnosed hypertensive individuals (aged 60-75 years) with diastolic blood pressure between 95 and 115 mmHg or systolic blood pressure between 160 and 220 mmHg, or both. Intervention Patients were allocated randomly to groups to receive amlodipine 5-10 mg or lisinopril 10-20 mg for 2 years. Results After 2 years of treatment, amlodipine decreased IMT by 0.089 mm [95% confidence interval (CI) 0.144 to 0.037]. Lisinopril decreased IMT by 0.065 mm (95% CI 0.124 to 0.010). No differences between the two drugs were found (P = 0.18). Both treatment regimens achieved the greatest reduction of IMT after 1 year, with a slight increase after the second year, whereas the reduction in blood pressure was maintained. Comparing the carotid and femoral arteries, a significant treatment difference in the change from baseline in favour of amlodipine was observed in the IMT of the elastic common carotid artery (P < 0.05). The effects of the two drugs on the muscular common femoral artery were not different. Conclusion In a long-term study, amlodipine and lisinopril reduce IMT to a similar extent in newly diagnosed elderly hypertensive patients. It is suggested that the two drugs have different effects on arteries that are not prone to atherosclerosis. Main outcome measures Before and after 1 and 2 years of treatment, IMT was measured in three carotid and two femoral arterial sites by B-mode ultrasound. The primary endpoint was the change from baseline of the combined mean maximum far wall IMT of carotid and femoral arteries, evaluated by repeated measurement analysis of the treatment effect in an intention-to-treat analysis.