This article is more than 5 years old. Information may no longer be current.
Ranexa reduces HbA1c, glucose control measures in adults with type 2 diabetes
BOSTON – The antianginal agent Ranexa may significantly reduce HbA1c levels in addition to providing cardioprotective benefits in adults with type 2 diabetes, according to study findings presented here.
In a worldwide randomized, double blind, placebo-controlled, multicenter phase 3 study of adults with poorly controlled type 2 diabetes, researchers also found that Ranexa (ranolazine, Gilead) a first-in-class antianginal drug, improved glucose control with minimal adverse events and no incidents of hypoglycemia.
The findings, presented in a Diabetes Care symposium at the American Diabetes Association’s 75th Scientific Sessions, will be published in the July issue of Diabetes Care.
Robert H. Eckel , MD, of the University of Colorado, Denver, and colleagues at other institutions analyzed data from 465 adults between the ages of 18 and 75 years (mean age, 56 years; 50.9% female; mean baseline HbA1c, 8.04%) with type 2 diabetes, and a baseline HbA1c level of between 7% and 10%. Patients had fasting serum glucose measurements of 130 mg/dL-240 mg/dL at screening and at the end of a 14-day, pre-randomization qualifying period. Within the cohort, 233 participants were assigned 500 mg twice daily of ranolazine before increasing the dose to 1,000 mg twice daily after 7 days; 232 participants were assigned a matching placebo.
Robert H. Eckel
Researchers measured HbA1c levels, fasting serum glucose, fasting serum insulin, fasting serum C-peptide and fasting plasma glucagon at weeks 6, 12, 18 and 24 of the study. They also measured fasting lipid profiles, administered electrocardiograms and administered mixed-meal tolerance tests at weeks 12 and 24.
At 24 weeks, 41.2% of participants assigned ranolazine achieved an HbA1c level of 7% or lower, compared with 25.6% of patients assigned placebo (P = .0004). Fasting serum glocuse was also decreased in the ranolazine group vs. placebo (P = .0266); 2-hour postprandial glucose and incremental change in 2-hour postprandial glucose were also improved with ranolazine. Participants assigned ranolazine also showed a greater decrease in fasting serum insulin at week 24 (P = .0507).
The drug was well tolerated and safe, according to researchers, with the overall number of adverse events similar between groups (41.8% ranolazine vs. 38.4% placebo). The most common adverse effects reported for ranolazine were constipation, headache, nausea and dizziness. No cases of hypoglycemia were reported.
“The results of this study suggest ranolazine could be an option for the management of patients with concurrent chronic angina and type 2 diabetes,” the researchers wrote. “Given the neutral-to-negative glycemic effects of currently available antianginal drugs, such patients may be uniquely suited to be managed with ranolazine.”
Ranolazine, approved in 2006 for the treatment of chronic angina, is not approved for the treatment of type 2 diabetes, though the drug was associated with reduction in HbA1c levels in post hoc analyses of pivotal angina trials, Eckel said. – by Regina Schaffer
Reference s :
Eckel RH, et al. Effect of ranolazine monotherapy on glycemic control in subjects with type 2 diabetes. Doi: 10.2337/dc14-2629. Presented at: American Diabetes Association’s 75th Scientific Sessions; June 5-9, 2015; Boston.
Eckel, RH, et al. Diabetes Care. 2015;doi:10.2337/dc14-2629
Disclosure: Eckel reports receiving consulting fees from Amgen, Amylin Pharmaceuticals, Espirion, Johnson & Johnson, Novo Nordisk, Regeneron, Sanofi, Vivus and Eli Lilly and Company, as well as research funding from Esperion, GlaxoSmithKline, Janssen, and Sanofi. Please see the full study for all other authors’ relevant financial disclosures.