Source: Respiration  |  Posted 4 years ago

By Danny Kucharsky

NEW ORLEANS, LA -- March 27, 2007 -- Aliskiren produces sustained blood pressure reductions over 6 months which are superior to those seen with ramipril, according to a study presented here at the 56[^]th[] annual scientific session of the American College of Cardiology (ACC).

The 26-week, randomised, double-blind study, presented March 26[^]th[], compared the long-term efficacy and tolerability of the oral direct renin inhibitor aliskiren and the angiotensin-converting enzyme inhibitor ramipril, alone and in combination with hydrochlorothiazide (HCTZ), in patients with hypertension.

Lead investigator Karl Andersen, MD, associate professor of medicine, Landspitali University Hospital, Reykjavik, Iceland, noted that despite the availability of a wide range of different antihypertensive drugs, blood pressure control is inadequate for many patients, with as many as three quarters not reaching recommended targets. Poor long-term adherence to therapy is a major problem, with treatment tolerability having an important influence.

Dose titration to aliskiren 300 mg/ramipril 10 mg and subsequent HCTZ addition at a dose of 12.5 mg, titrated to 25 mg if required, were permitted at weeks 6, 12, 18 and 21 for patients with blood pressure greater than 140/90 mm Hg.

In all, 687 patients (81.6%) completed the 26-week active treatment period -- 338 on aliskiren (80.5%) and 349 on ramipril (82.7%). The main reasons for discontinuation were withdrawal of consent in 56 patients (6.7%) and adverse events in 43 (5.1%).

More patients in the ramipril group required addition of HCTZ (49.5% vs. 46.1%; []P[] = .334) and significantly more required HCTZ titration to 25 mg (31.3% vs. 22.0%; []P[] = .0024) than in the aliskiren group.

Patients receiving aliskiren-based therapy alone or in combination with HCTZ had significantly greater reductions in mean sitting diastolic blood pressure ([]P[] = .025) and mean sitting systolic blood pressure ([]P[] = .0036) at week 26 compared with those receiving ramipril-based therapy.

At week 26, blood pressure control rates (<140/90 mm Hg) were significantly higher with aliskiren- than ramipril-based therapy (61.4% vs 53.1%, []P[] = .021). As well, fewer patients in the aliskiren group required addition of HCTZ (46.1%) or titration to HCTZ 25 mg (21.9%) than in the ramipril group (49.5% and 31.3%, respectively).

Adverse events were similar with aliskiren (61.3%) and ramipril (60.4%), as were rates of discontinuation due to adverse events (aliskiren, 5.7%; ramipril, 4.7%). Cough was more frequent with ramipril (9.5%) than aliskiren (4.1%).

"This is a very effective drug and it's even more effective than ramipril in the doses given in this study," said Dr. Andersen. He noted that aliskiren represents a highly effective option for the treatment of hypertension.

He added that the effects of aliskiren on renal function remain to be seen.

The study was supported by Novartis Pharmaceuticals Corporation.

[Presentation title: Aliskiren-Based Therapy Lowers Blood Pressure More Effectively Than Ramipril-Based Therapy in Patients With Hypertension: A 6-Month, Randomized, Double Blind Trial. Abstract 1014-173]