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TERISA: Ranolazine reduced angina in patients with diabetes
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SAN FRANCISCO — Results from an international trial demonstrate that ranolazine was safe and effective for patients with type 2 diabetes, coronary artery disease and persistent chronic angina.
Mikhail Kosiborod, MD, from St. Luke’s Mid America Heart Institute and University of Missouri, Kansas City, presented data that showed that ranolazine (Ranexa, Gilead) significantly reduced angina frequency and sublingual nitroglycerin use, and was safe and well tolerated.
Following a single blind, 4-week placebo run-in phase, 949 patients were randomly assigned to 8 weeks of ranolazine (target dose, 1,000 mg twice daily) or matching placebo. The mean age of the patients’ was 64 years; 61% were men; mean diabetes duration was 7.5 years; and mean baseline HbA1c was 7.3%.
“Ranolazine was previously shown to be an effective anti-anginal agent, and may have the additional property of lowering HbA1c. However, this is the first clinical trial to study its efficacy specifically in patients with diabetes,” Kosiborod said at a press conference.
The primary endpoint was number of self-reported angina episodes between weeks 2 and 8 of treatment. Weekly angina frequency was significantly reduced in patients assigned to ranolazine compared with placebo (3.8 vs. 4.3; P=.008). A secondary endpoint was frequency of sublingual nitroglycerin use during the same study period, which was also lower in the ranolazine group vs. placebo (1.7 vs. 2.1 doses per week; P=0.003).
There was no difference in the incidence of serious adverse events between groups.
The researchers also found that ranolazine was especially effective in patients with worse glucose control.
“If the glucose-lowering action of ranolazine is confirmed in future studies, patients with diabetes and angina may derive a dual benefit from this drug,” Kosiborod stated in a press release.
The TERISA trial was conducted at 104 centers in 14 countries. At baseline, 44% of patients were taking one anti-angina agent and 56% were taking two anti-angina agents. The use of guideline-recommended therapy was high: 88% taking antiplatelet agents, 83% taking statins, 88% taking ACE inhibitors/angiotensin receptor blockers and 90% taking beta-blockers.
Compliance with self-reports in an electronic diary was 98% in both groups, Kosiborod said. – by Samantha Costa
For more information:
Kosiborod M. Late-breaking clinical trials III: Chronic CAD/stable ischemic heart disease. Presented at: American College of Cardiology Scientific Sessions; March 9-11, 2013; San Francisco.
Kosiborod M. J Am Coll Cardiol. 2013;doi:10.1016/j.jacc.2013.02.011.
Disclosure: The study was funded by Gilead Sciences. Kosiborod reports consultancy fees/honoraria from Boehringer Ingelheim, CardioMEMS, Genentech, Gilead, Hoffman-La Roche, Kowa Pharmaceuticals, Medtronic Minimed and Sanofi-Aventis, and research grants from Genentech, Gilead, Glumetrics and Medtronic Minimed.
Perspective
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C. Noel Bairey Merz, MD, FACC, FAHA
These results are consistent with the post-FDA approval experience with ranolazine and indicate that anti-anginal efficacy extends to a variety of populations, including those with diabetes. Ongoing work is testing that the anti-anginal effect is due to the reduction of ischemia, while additional study is evaluating the mechanisms and significance of the improvement in HbA1c levels observed in this and other ranolazine trials.
Perspective
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Miguel A. Quinones, MD, MACC
In many European countries, particularly in the countries that participated in this study, there is still more of a conservative approach to the management of patients with angina. They are stable, they use more medications and less interventions than we do in the United States.
Now, there are new criteria for revascularization and we are being encouraged to treat people medically — to treat them properly — if they respond to drugs. In the United States, we might be moving a little more in that direction.
Ranolazine already has been shown to be effective, so the question researchers were looking [to answer] was whether patients with diabetes benefit from this drug. Diabetics, as we know, have problems with reduction in coronary reserve, myocardial function, diabetic cardiomyopathy, muscle stiffness and more.
The other interesting point is that patients with HbA1c levels greater than 7% had strikingly better effect response than those with HbA1c less than 7%. This becomes very interesting in terms of possible mechanisms of this drug.
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