The results from the MERLIN TIMI-36 study confirm that Renexa is a safe and effective anti-ischemic drug that also has favorable effects on arrhythmia and hemoglobin A1c, according to the company.
In patients with diabetes treated with Ranexa, at four months hemoglobin A1c (HbA1c) had declined by approximately 0.7%, from a starting mean baseline of 7.5 to 6.8%, and 0.43% compared to placebo. Patients taking Ranexa were significantly more likely to achieve the HbA1c treatment target of less than 7%, with 59% of diabetic patients on Ranexa achieving this target at four months.
Dr David Morrow of the TIMI study group, said: “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 anti-diabetic drugs used as part of standard therapy.”
In accordance with a special protocol assessment agreement between the FDA and CV Therapeutics, the company believes that data from the study could support expansion of the existing Ranexa indication to first line angina. In September 2007, the company submitted a supplemental new drug application to the FDA seeking a new indication for first line angina and a significant reduction in cautionary language.
Ranexa is currently indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates.