Novartis will not pursue an outcomes trial of its high blood pressure med Tekturna (aliskiren) in combination with standard therapy for heart attack patients after the drug failed to demonstrate a statistically significant benefit in preventing changes in the heart's shape and worsening of its blood pumping ability, the company said today.
Patients receiving Tekturna in the ASPIRE trial, which included 820 patients, also had a higher rate of hyperkalemia, hypotension and kidney dysfunction compared with the group receiving standard therapy alone. ASPIRE is one of 14 trials in the ASPIRE HIGHER clinical trial program evaluating Tekturna's potential benefit beyond blood pressure reduction.
"Our results... showed no benefit and potentially greater risk of adverse events when combining two inhibitors of the renin-angiotensin system," said Dr. Scott Solomon of Brigham and Women's Hospital in Boston, who presented the data at the American College of Cardiology scientific meeting in Atlanta, according to Reuters. "Given these results, we are not currently recommending the use of this agent in addition to other inhibitors of the renin-angiotensin system in this specific patient population," he added.
Tekturna is the first in a new class of medicines known as direct renin inhibitors, which target an enzyme responsible for triggering a process that can contribute to high blood pressure. When it was approved in 2007, analysts predicted that it would gradually replace the company's blockbuster Diovan--which had $6 billion in sales last year--when the patent on that drug expires. Tekturna--or Rasilez, as it is known elsewhere--had sales of $290 million last year.
- see the Novartis release
- check out the Reuters' coverage