ALTITUDE study of aliskiren (Tekturna®) stopped due to increased kidney and stroke risks - American Heart Association Comment

DALLAS – December 21, 2011 ― Novartis has announced that the international Phase III ALTITUDE study, investigating the drug aliskiren (Tekturna^®) in high risk patients with type 2 diabetes and decreased kidney function, has been stopped when cumulative data showed an increased risk of high potassium levels, worsening kidney function and non-fatal stroke. 

 

In an interim review of the placebo-controlled ALTITUDE study,  the Data and Safety Monitoring Board found that patients were unlikely to benefit from treatment with aliskiren when given in addition to “optimal cardiovascular treatment” including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).   The review also found an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension when these medications were combined.

 

Aliskiren, under brand-names Rasilez in Europe and Tekturna in the United States, was approved in 2007 for use in Europe and the U.S. as a single use treatment option or as a combination treatment option for hypertension.   While most of the combinations include aliskiren with other blood pressure medications, such as a diuretic or fluid pill, or a calcium channel blocker, one of the approved combinations, Valturna^®, includes aliskiren with valsartan, an ARB or angiotensin receptor blocker.

 

In a statement, Novartis, the maker of Rasilez/Tekturna, said as a precautionary measure it “will cease promotion of aliskiren-based products for use in combination with an ACE-inhibitor or ARB.”   Novartis is also recommending that “ALTITUDE investigators remove aliskiren-based products from their patients’ treatment regimen and review their high blood pressure medication.” Novartis says it is also reviewing the findings with Data Monitoring Committees overseeing other clinical studies involving aliskiren-based products and combination therapies.

 

The American Heart Association recommends that diabetic patients taking aliskiren along with an ACEi (angiotensin converting enzyme inhibitor) or with an ARB (angiotensin receptor blocker) consult with their healthcare provider to determine whether a change in their medication should be considered.  This should be done whether they are taking the combination within a single pill or as two separate pills. 

 

If you are uncertain whether or not you are taking an ACEi or an ARB, these drugs are listed on the AHA website at  http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/Types-of-Blood-Pressure-Medications_UCM_303247_Article.jsp for ACE inhibitorsand http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/Types-of-Blood-Pressure-Medications_UCM_303247_Article.jsp for ARBs.

 

 

The American Heart Association/American Stroke Association receives funding mostly from individuals. Foundations and corporations donate as well, and fund specific programs and events. Strict policies are enforced to prevent these relationships from influencing the association’s science content. Financial information for the American Heart Association, including a list of contributions from pharmaceutical companies and device manufacturers, is available at www.heart.org/corporatefunding.