A drug commonly used to treat high-blood pressure may pose a serious risk if used in combination with some other hypertension drugs, according to recent research.
In a study published in the November 3 issue of The New England Journal of Medicine, researchers concluded that the combination of Aliskiren with angiotensin-converting enzyme (ACE) inhibitors and angiotensis II receptor blockers (ARBs) is dangerous in patients with Type 2 diabetes or chronic kidney disease. However, the risk may extend to other patients as well.
Known as the ALTITUDE study (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints), the research involved more than 8,500 patients who took 300 mg daily of Aliskiren or placebo in combination with ACE inhibitors or ARBs. Researchers evaluated whether the drug would reduce the instance of death or complications of heart or kidney disease more than using ACE inhibitors or ARBs alone.
As a result of the preliminary findings, researchers ended the trial early, after determining the combination of the drugs caused more harm than good to the patients.
Aliskiren is sold under the brand names Valturna, Tekturna and Amturnide. It was introduced to the market in 2007 by Novartis as a direct renin inhibitor to treat high blood pressure. The drug works by inhibiting the kidney enzyme renin, which helps with the regulation of blood pressure through the renin-angiotensin system.
When taken in combination, patients experienced a higher risk of worsening kidney disease, low blood pressure and high potassium levels.
The Tekturna label was already revised in February, warning patients of potential kidney damage as a side effect. The results of the trial were identical to the results when ACE inhibitors and ARBs are given in combination.
ACE inhibitors are sold under the brand names Lotensin, Vasotec, Monpril, Zestril and Accupril. Edarbi, Atacand, Avapro, Benicar and Diovan are all brand name versions of ARBs.
ISMP Accuses FDA of Downplaying Risks
The FDA issued an alert in April of this year warning against the use of Aliskiren in combination with ACE inhibitors and ARBs in patients with type 2 diabetes or kidney disease. However, in a recent issue of Quarter Watch, published by the Institute for Safety Medication Practices (ISMP), a nonprofit organization dedicated to promoting the safe use of medication and monitoring FDA MedWatch reports, the FDA was accused of downplaying the detrimental findings of the study and use of the drug.
“We think the agency has not kept doctors and patients well informed about the risks and safe use of Aliskiren,” ISMP said in the QuarterWatch publication, highlighting the FDA’s handling of the results. “Safety withdrawals are rare, typically trigger national publicity, and may spur some searching questions about whether people were exposed to unsafe drugs and why. This withdrawal went virtually unnoticed.”
Research for the trial revealed nearly 94% of the expected number of primary events, such as cardiac arrest, stroke or kidney failure. ISMP officials say they are concerned about the safety of patients and information given regarding the drug’s use in light of the FDA’s supposed downplaying of such overwhelmingly severe results.