Two Drug Therapy Recommended for Hypertension
The most effective way to reduce blood pressure in hypertensive patients is the use of a combination of drugs rather than one single drug, according to a study published in the Lancet today.
Prof Morris J Brown, Addenbrooke's Hospital, Cambridge and University of Cambridge, UK, and colleagues conducted a double-blind, randomised, parallel-group, superiority trial (ACCELERATE) at 146 primary and secondary care sites in ten countries, with enrolment from Nov 28, 2008, to July 15, 2009.
Patients eligible for enrolment had essential hypertension, were aged 18 years or older, and had systolic blood pressure between 150 and 180 mm Hg.
The researchers state ACCELERATE is the first trial to test the medium-term efficacy and safety of full doses of two antihypertensive drugs as first-line treatment for patients with a systolic blood pressure greater than 150 mm Hg, by comparison with sequential add-on treatment with the same drugs.
Patients were randomly assigned (1:1:2) to treatment with 150 mg aliskiren plus placebo (n=315), 5 mg amlodipine plus placebo (n=315), or 150 mg aliskiren plus 5 mg amlodipine for treatment the first 16 weeks (n=617). From 16–32 weeks, all patients received combination therapy with 300 mg aliskiren plus 10 mg amlodipine.
The primary endpoints, assessed on an intention-to-treat basis (ie, in patients who received the allocated treatment), were the adjusted mean reduction in systolic blood pressure from baseline over 8 to 24 weeks, and then the final reduction at 24 weeks.
Patients given initial combination therapy had a 6·5 mm Hg (95% CI 5·3 to 7·7) greater reduction in mean systolic blood pressure than the monotherapy groups (p
At 24 weeks, when all patients were on combination treatment, the difference was 1·4 mm Hg (95% CI –0·05 to 2·9; p=0·059).
Adverse events caused withdrawal of 85 patients (14%) from the initial aliskiren plus amlodipine group, 45 (14%) from the aliskiren group, and 58 (18%) from the amlodipine group. These adverse events were peripheral edema, hypotension, or orthostatic hypotension.