Novartis’ Tekturna Under Review After Clinical Trial Halted

Novartis’ high blood pressure drug, Tekturna, is under review after a clinical trial was suddenly halted over unwanted side effects and reduced benefits. Tekturna is in a class of drugs known as direct rennin inhibitors, is known generically as aliskiren, which is sold in the United Kingdom, and elsewhere, under the brand name Rasilez.

The halted study is a major blow for drug maker, Novartis, which launched Tekturna in 2007 for the treatment of high blood pressure and conducted a number of trials to determine if Tekturna could protect vital organs when taken for longer time frames, said The Wall Street Journal.

The trial that was ceased involved 8,606 Type 2 diabetes patients determined to be at increased risk for heart or kidney failure and who were taking Rasilez prescribed in addition to receiving “standard heart treatment,” said The Journal. The committee overseeing the halted study discovered greater-than-expected, unwanted adverse events once Rasilez was added to traditional treatments. Novartis ceased marketing all of its Rasilez-based products that are used in collaboration with some blood-pressure lowering drugs, noted The Journal.

The halted study revealed increased rates of nonfatal stroke, renal complications, and other problems and also indicated that the drug failed to prove more efficacious versus placebo treatment, said The Journal. Trial participants either took aliskiren or a placebo, as well as whatever blood pressure medication they had been prescribed (either an ACE inhibitor or an angiotensin receptor blocker). The study was one of a number of large, costly trials Novartis funded in an attempt to broaden Tekturna and Rasilez use and, according to Novartis, sales “are likely to be negatively impacted by the study results going forward.” Eric Althoff, a Novartis spokesman also said that the drug maker will review other, ongoing trial data, wrote The Journal, which noted that Novartis shares fell following the news.

Europe’s key drug regulator, the European Medicines Agency (EMA) announced that it was initiating a review of aliskiren’s benefits and risks and has advised doctors to stop prescribing the medication to diabetic patients also taking older generation hypertension medications (ACE inhibitors, angiotensin receptor blockers), said The Journal. Novartis said it will stop marketing aliskiren for use with ACE-inhibitors and angiotensin receptor blockers until regulators determine if the aliskiren’s marketing license needs to be amended.

We previously wrote about a study published in the American Journal of Hypertension in 2007 that called into question aliskiren’s efficacy. The study, conducted at Weill Medical College of Cornell University in New York that involved “A review of six clinical trials of aliskiren involving [more than] 5,000 patients with mild to moderate hypertension indicated that this first of a new class of orally active antihypertensive drugs is no more effective than angiotensin-converting enzyme inhibitors (CEIs), angiotensin receptor blockers (ARBs), or diuretics for lowering blood pressure,” the authors wrote.

Aliskiren is intended to reduce the body’s production of the enzyme renin, which has been shown to increase blood pressure. “Although aliskiren suppresses plasma renin activity, it causes much greater reactive rises in plasma renin concentration than does any other antihypertensive class tested,” therefore, the “consequences of its greater reactive increases in plasma renin concentration appear to offset its net ability to lower blood pressure, especially with higher doses.” In other words, the possibility exists that aliskiren actually leads to increases in blood pressure in patients with “highly reactive renin levels,” the authors added.

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