Study backs Novartis hypertension drug combination

LONDON (Reuters) - Patients with high blood pressure treated with a combination of a Novartis hypertension drug and a generic medicine do better than if they take only one of the drugs alone, trial data released on Thursday showed.

The results of a study known as ACCELERATE also showed that patients who switched from single drug treatment to combined therapy improved their response, but not to the same level as those who started their treatment with the combination.

The findings, by researchers at the Swiss drugmaker and at Britain's University of Cambridge, could boost prospects for Novartis's Tekamlo tablet, a single-pill treatment which combines the two drugs tested -- aliskiren, also made by Novartis, and the generic blood pressure medicine amlodipine.

"One of the benefits we think will come out of this research is that patients should now receive combination therapy from the start (of their treatment)," said Morris Brown at Cambridge University, who led the study.

Experts not directly involved in the research, which was published in The Lancet medical journal, agreed and said treatment guidelines should now be changed.

"ACCELERATE puts into proper context the importance of starting with combination antihypertensives to lower blood pressure toward guideline goals for the general population ... A change in guidelines is clearly necessary," Ivana Lazich and George Bakris of the University of Chicago Pritzker School of Medicine in the United States wrote in a commentary.

Aliskiren, sold under the brand names Tekturna and Rasilez, had global sales for Novartis of $290 million in 2009. It was launched in 2007 after it was found in clinical trials to lower blood pressure better than an ACE inhibitor, one of the types of drugs currently given to heart attack patients.

Tekturna's success is crucial for Novartis since Diovan, also a high blood pressure treatment, loses patent protection in 2012.

The combination pill Tekamlo was approved in August last year by the U.S. Food and Drug Administration.

An estimated 1 billion people globally have high blood pressure, or hypertension, which is a major risk factor for cardiovascular disease, the leading cause of death globally.

If left untreated high blood pressure can cause strokes, heart attacks, heart failure and organ damage, including kidney failure and vision problems.

In Brown's study, all patients had high systolic blood pressure of between 150 and 180 mm Hg. Normal blood pressure is usually below 140 mm Hg systolic.

The researchers compared patients given either aliskiren alone, amlodipine alone, or a combination of both for 16 weeks. After the first 16 weeks, those on single drugs switched to the combination and those taking the combination continued doing so.

The researchers found that patients given initial combination therapy had an average of 6.5 mm Hg greater reduction in mean systolic blood pressure than those taking the single drugs. At 24 weeks, when all patients were on combination treatment, the difference had decreased to 1.4 mm Hg.

Side effects such oedema or fluid retention and low blood pressure occurred at similar rates in both groups, with between 14 and 18 percent of patients stopping treatment as a result.

(Editing by Greg Mahlich)