Tekturna ALTITUDE Study Halted
Posted by
Michael MonheitFebruary 13, 2012 8:58 AM
Millions of individuals in the U.S. suffer from high blood pressure—a major risk factor for cardiovascular disease, the number one leading cause of death in the U.S. In addition to lifestyle changes many people rely on medication to regulate their blood pressure. In 2007 the FDA approved the blood pressure medication aliskiren, sold in the U.S. under the brand name Tekturna. Tekturna was the first in a new class of blood pressure drugs known as “renin inhibitors”. Renin inhibitors are unique in that they regulate the kidney’s production of renin, which is an enzyme that regulates blood pressure.
Upon its release, Novartis, the maker of Tekturna, embarked on what was known as the ALTITUDE study, which examined the potential benefits of Tekturna in reducing cardiovascular and renal events in patients with type 2 diabetes, who are particularly prone to both cardiovascular and kidney issues. But now Novartis has announced that it is discontinuing the study because preliminary results show no added benefit and an increase in adverse events for patients who participated in the study.
The ALTITUDE study involved the participation of over 8,500 patients from 36 countries who were receiving traditional cardiovascular treatment, including angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). The purpose of the study was to see if patients would benefit from receiving Tekturna in addition to these traditional treatments. The results clearly show the answer is no—and that it in fact increases the risks to those patients.
As compared to patients who received a placebo, patients receiving Tekturna saw no added benefit to their cardiovascular treatment. Instead, there was an increase in the incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension. Given these findings, the ALTITUDE study has been discontinued and participating physicians are to remove Tekturna from their patients’ treatment regimen. Patients who were receiving Tekturna as part of the study are likewise advised to consult with their physicians about adjusting their treatment.
The termination of this study coincides with news that Europe’s primary drug regulation body is undertaking a review of whether Tekturna (marketed as Rasilez in Europe) increases the risk of nonfatal stroke and kidney problems. In the meantime, doctors are being told not to prescribe Tekturna/Rasilez to diabetic patients on ACE inhibitors or ARBs.