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Unlikely Angina Drug Improves A1c

Posted: Thursday, December 27, 2007

Antianginal agent, ranolazine, reduced incidence of newly increased HbA1c in people without diabetes.

According to data from a recent study, ranolazine extended-release tablets reduced HbA1c, increased the number of participants achieving the HbA1c treatment target and reduced the incidence of newly increased HbA1c in participants without diabetes.

David Morrow, MD, MPH, said in a press release that, “The results of the MERLIN TIMI-36 study confirm that ranolazine is a safe and effective anti-ischemic drug that also has favorable effects on arrhythmia and HbA1c.”

Morrow is with the cardiovascular division/TIMI study group at Brigham and Women’s Hospital, Harvard Medical School. He presented findings from the study at the American Heart Association’ 30th Annual Scientific Sessions, held in Orlando.

“The combination of the drug is effective in patients with coronary artery disease without raising a safety issue, while simultaneously lowering HbA1c.” “That is a valuable combination to have in a particular antianginal agent.”

The researchers conducted a multinational, double blind study to test the efficacy and safety of ranolazine (Ranexa, CV Therapeutics) during acute and long-term treatment. Data from 2,220 participants with diabetes from MERLIN TIMI-36, or the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes study were analyzed. The researchers randomly assigned participants to ranolazine or placebo.

“The reduction in HbA1c observed with ranolazine in the MERLIN TIMI-36 study is especially striking because the effects were observed on top of multiple other antidiabetic drugs used as part of standard therapy,” Morrow said.

At four months, HbA1c declined from 7.5% to 6.8% (0.7%), and declined 0.43% compared with placebo (P<.001).

The ranolazine group was more likely to reach an HbA1c treatment target <7.0%; 59% of patients with diabetes reached this target at four months. Participants without diabetes in the ranolazine group showed a 32% reduction in their risk for developing new hyperglycemia, new increases in HbA1c (>6.0%) or new fasting glucose (>110 mg/dL; P=.003).

At one year follow-up, the ranolazine group was 37% less likely to have worsening hyperglycemia, which was defined as an HbA1c increase >1.0% (P<.001). There was no increased hypoglycemia or weight gain in the ranolazine group compared with the placebo group.

“Additional work is needed to understand the mechanism of action and how this effect is brought about, but once we have a better understanding of this action, it has great potential and importance for clinicians,” Morrow said in an interview. “To have an agent that helps treat angina and lower HbA1c at the same time would be tremendously valuable in clinical practice.”

Ranolazine, sold under the trade name Ranexa™ by CV Therapeutics, is an antianginal medication. On January 31, 2006, ranolazine was approved for use in the United States by the FDA for the treatment of chronic angina.

Source: Diabetes In Control: Morrow DA, Scirica BM, Chaitman BR, et al. Effect of ranolazine on HbA1c in the MERLIN-TIMI 36 randomized controlled trial. #1798. Presented at: the American Heart Association Scientific Sessions; Nov. 4-7, 2007; Orlando.