Tekturna To Undergo Canadian Safety Review

High blood pressure drug, Tekturna, will undergo a Canadian Safety Review after a clinical study was halted by drug maker, Novartis, over unexpected adverse reactions.

“Specifically, when used in combination with other blood pressure-lowering drugs known as angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), Rasilez was associated with an increased risk of non-fatal stroke, kidney complications, hyperkalemia (high levels of potassium in the blood), and low blood pressure,” Health Canada said, wrote CBC News. Tekturna is in a class of drugs known as direct rennin inhibitors, and is known generically as aliskiren, which is sold in Canada and elsewhere, under the brand name Rasilez.

When blood pressure increases to high levels, explained CBC News, the pressure forces the heart to work harder, increasing death risks from a number of causes, including heart disease and stroke. Tekturna is intended to reduce the body’s production of the enzyme renin, which has been shown to increase blood pressure.

Drug maker Novartis, announced it was halting the multinational clinical trial created to determine if adding Tektuma to tradition treatments in people diagnosed with Type 2 diabetes and kidney impairment could lower risks for cardiac and kidney problems, explained CBC News. Novartis also 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. Novartis said it is speaking with global health authorities about the implications of the trials findings, “As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB,” the company said, wrote CBC News.

Patients enrolled in the clinical trial—known as ALTITUDE—should speak with their study site for guidance and are advised not to cease treatment until they have spoken to their health care provider, said Novartis and Health Canada.

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. The halted study is a major blow for Novartis, which said 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. Novartis shares fell following the news.

Novartis launched Tekturna in 2007 for the treatment of high blood pressure, conducting a number of trials to determine if Tekturna could protect vital organs when taken for longer periods. The ceased trial involved 8,606 Type 2 diabetes patients at increased risk for heart or kidney failure and who took Tekturna in addition to receiving traditional heart treatment. Participants came from 36 countries, noted CBC News. The committee overseeing the study discovered greater-than-expected, unwanted adverse events once the drug was added to traditional treatments, including higher rates of nonfatal stroke, renal complications, and other problems. The committee also found the drug failed to prove more effective than a placebo.

Just prior, we wrote that Europe’s key drug regulator, the European Medicines Agency (EMA) announced it was initiating a review of aliskiren’s benefits and risks and had advised doctors to stop prescribing the medication to diabetic patients also taking older generation hypertension medications (ACE inhibitors, angiotensin receptor blockers).

We also previously wrote about a study published in the American Journal of Hypertension in 2007 that called into question the drug’s efficacy. The study, conducted at Weill Medical College of Cornell University in New York. “A review of six clinical trials of aliskiren involving 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.