New Study Says Tekturna® May be Harmful in Type 2 Diabetics with Heart, Kidney Problems

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New Study Says Tekturna® May be Harmful in Type 2  Diabetics with Heart, Kidney Problems Overview: A new study found significantly higher rates of serious adverse events associated with Tekturna® compared to other hypertension therapies in Type 2 diabetics with kidney impairment or cardiovascular problems. According to the authors of the study, Tekturna should not be combined with other similar drugs in patients with Type 2 diabetes and cardiovascular or renal issues.

  • Study in NEJM finds that Tekturna is associated with a higher incidence of “primary endpoints” compared to those taking ACE inhibitor or ARB with placebo
  • Primary endpoints were defined by heart attack, non-fatal stroke, renal disease, cardiovascular death, death attributable to kidney failure and other serious events
  • This study supports the current recommendation that Tekturna should not be taken in combination with ARBs or ACE inhibitors in Type 2 diabetics with cardiovascular problems, kidney impairment or both    

Product: Tekturna® (aliskiren), also sold under the brand name Rasilez outside the US

Manufacturer: Novartis

Side Effects & Complications

  • Strokes
  • Heart attacks
  • Acute renal failure
  • Renal complications
  • Hyperkalemia (high levels of potassium)
  • Hypotension (low blood pressure)
  • Syncope

The Study

The study, which was published on Saturday in the New England Journal of Medicine (NEJM), included 8,561 patients who had Type 2 diabetes who had either cardiovascular or kidney problems. The participants were randomly assigned to take either 300 mg of Tekturna (aliskiren) or a placebo with an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB). The study analyzed the occurrence of “end points” among these patients, defined as cardiovascular death, death attributable to kidney failure or a first occurrence of cardiac arrest with resuscitation, nonfatal stroke or heart attack, hospitalization due to heart failure, end stage renal disease or the need for a kidney transplant. After a median follow-up time of approximately 32 months, 18.3 percent of the patients taking Tekturna had experienced such events, compared to the 17.1 percent of the placebo group. The Tekturna group also had a higher proportion of patients with hyperkalemia (high potassium) and hypotension (low blood pressure); 11.2 percent of Tekturna users exhibited hyperkalemia compared to 7.2 percent for placebo and 12.1 percent reported hypotension versus 8.3 percent.

The authors concluded that “The addition of aliskiren to standard therapy with renin–angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful.”

Background

Tekturna was approved in 2007 to treat patients with high blood pressure. Recent research has linked the drug was serious side effects, particular in Type 2 diabetics with renal or cardiovascular issues. Researchers have studied the drug’s effect on these patients in the hopes that Tekturna would provide added benefit with ACE inhibitors or ARBs. Recent research, however, seems to suggest the opposite. In December, the ALTITUDE clinical trials were halted in such as study due to reports of non-fatal stroke, renal complications hyperkalemia (high potassium) and hypotension (low blood pressure). In April, the U.S. Food and Drug Administration (FDA) warned against using Tekturna in combination with ACE inhibitors or ARBs among this patient population.