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In late December 2011, Novartis announced the termination of ALTITUDE study with Tekturna (generic: aliskiren) in high-risk patients with diabetes and renal impairment.
The Tekturna new warning and why the study was terminated is because of a greater risk for non-fatal Tekturna stroke and kidney problems.
This was the first trial of its kind to investigate Tekturna for more than one year in a specific population of patients with Type 2 diabetes and kidney impairment who already have a high risk of heart related and kidney related problems based on their medical condition.
ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of Tekturna to reduce the risk of heart and kidney events in this patient population. ALTITUDE was the first randomized, double-blind, placebo-controlled study to investigate the high blood drug. In the United States the drug is known as Tekturna and outside the U.S., itís called Rasilez.
In the trial, Tekturna was given along with optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
ACE inhibitors have been around almost 15-20 years longer than ARBs. There is no conclusive answer as to which is better for hypertension. Both are beneficial to people with heart failure. Both ACE inhibitors and ARBs can be said to be useful in preventing or delaying progression of non-diabetic patients into type 2 diabetes.
Have you or a loved one suffered serious harm since the Tekturna new warning?