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.

Source: FiercePharma

Popularity: 2% [?]

FDA approved Novartis’ Tekturna HCT® tablets as initial therapy for hypertensive patients likely to need multiple blood pressure medications. The drug is a single-pill combination of the direct renin inhibitor, aliskiren (Tekturna/Rasilez), and the diuretic hydrochlorothiazide (HCT).

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Tekturna HCT was first approved in the U.S. in January 2008 as a second-line treatment for high blood pressure, and in the EU in January 2009. Novartis says that it is also developing other single-pill aliskiren combinations including a combination with Diovan (valsartan) and one with amlodipine.

The single-agent direct renin inhibitor, Tekturna, was first approved in March 2007 and is now available in over 70 countries. Most recently in July 2009 it entered Japan.

Source: GEN News

Popularity: 4% [?]

According to a recommendation made by the European Medicines Agency (EMEA), the label for Novartis’ hypertension drug Rasilez (aliskiren) should include a contra-indication stating that the medication must not be used in patients who have previously experienced angioedema when taking the product.

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In addition, the EMEA said the label for Rasilez should include a warning advising that patients who develop signs of angioedema should discontinue treatment and seek medical attention. The agency concluded that current evidence indicates that “the benefits of aliskiren-containing medicines in the treatment of essential hypertension continue to outweigh their risks, but that angioedema can occur as a rare and serious side effect with these medicines.”

The regulator indicated that the recommendations also apply to other aliskiren-containing drugs.

Source: FirstWord

Popularity: 2% [?]