Chronic stable angina, the most common coronary artery disease (CAD) symptom, can be a debilitating heart condition. Because CAD is more extensive in diabetics, and they have a high prevalence of angina-related chest pain, researchers tested therapeutic strategies for this population. Mikhail Kosiborod, M.D., associate professor of medicine at the University of Missouri and cardiologist at St. Luke’s Mid America Heart Institute has good news. His randomized, double-blind, placebo-controlled parallel study found that adding the angina drug Ranolazine to background antianginal therapy in stable angina patients with Type 2 diabetes reduced their weekly angina episodes significantly.
Exploring the TERISA Study
Scientists randomized 949 patients for the Phase 4 TERISA (Type 2 Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study. The mean age of the 927 evaluable subjects was 64, and 61 percent were male. They had a mean diabetes duration of 7.5 years with a mean baseline hemoglobin A1c (the HbA1c laboratory measure of blood glucose) level of 7.3 percent. At randomization, 56 percent of patients were receiving one antianginal agent while 44 percent were taking two.
During the four-week, single-blind, placebo run-in phase, average weekly angina frequency and sublingual (under the tongue) Nitroglycerin use were similar in all participants. Then 462 randomized patients received a 500-milligram Ranolazine tablet twice daily while 465 in the control group took a matching placebo. Everyone also received background antianginal therapy. The investigators upped the Ranolazine dosage to 1000 milligrams twice daily on day eight of the eight-week study.
Using electronic diaries, patients documented their number of angina episodes and sublingual Nitroglycerin doses they took on a daily basis. During weeks two through eight, average weekly angina frequency and sublingual Nitroglycerin use were remarkably lower with Ranolazine versus placebo. The primary efficacy endpoint was average angina frequency during the last seven weeks. In prespecified subgroup analyses, Ranolazine efficacy was consistent, irrespective of baseline average weekly angina episodes, number of antianginal medications, age and gender.
A substantial difference occurred in the effect of Ranolazine versus placebo on the primary endpoint by the geographic region of enrollment. The average number of weekly angina episodes between Ranolazine and placebo subjects from Russia, Ukraine and Belarus wasn’t significantly different statistically. But among patients from other countries, the reduction in average weekly angina episodes was considerable in the Ranolazine group versus placebo.
According to the NYU Langone Medical Center, when your heart isn’t getting enough blood, it produces chest pain or discomfort. Angina pectoris is a serious condition, but you can take steps to treat it and maybe even keep it from occurring. Normally, angina starts as an aching, tightening, uncomfortable pressure, fullness, squeezing or pain in the center of your chest. It may spread to your neck, jaw, shoulder, left arm or back. Other symptoms may include sweating, shortness of breath, indigestion and nausea. The American Heart Association notes that many other types of chest discomfort — like heartburn, lung infection and inflammation — aren’t the same as angina.
To work properly, your heart muscle needs your large blood vessels, or coronary arteries, to supply blood containing oxygen and nutrients. The harder your heart pumps, the more oxygen-rich blood it needs. If your heart doesn’t get enough oxygen, angina occurs. The main cause of angina is coronary artery disease, which instigates fat and other materials to build up on the walls of your coronary arteries gradually. When this plaque narrows or blocks your arteries, ischemia reduces the blood supply to your heart.
Stable angina occurs when your heart needs more oxygen than your reduced blood flow can supply. Severely narrowed arteries may allow enough blood to reach your heart when its demand for oxygen is low, such as when you’re sitting. But your heart works harder and needs more oxygen during physical exertion — like walking up a hill or climbing stairs. Other activities that can increase your heart’s demand for oxygen include extreme temperatures, smoking, eating large meals, stress and strong emotions. Stable angina lasts a short time — usually 5 minutes or less. Resting, taking Nitroglycerin or both can provide relief.
Unstable angina occurs without any cause or trigger. It may signal such excessive narrowing of your arteries that your heart can’t get enough blood — even at rest. Or plaque may have broken off your artery walls, causing a blockage. Unstable angina requires immediate medical treatment or it can lead to a heart attack quickly, which can cause permanent damage.
Following Your Treatment Plan
When you receive a stable angina diagnosis, your condition is chronic but predictable and manageable. Ranexa (Ranolazine ER) is an extended-release tablet that can relieve your painful symptoms. This medication is not a diabetes treatment, and you should not use it as such. Acting on sodium-dependent calcium channels, Ranolazine reduces the incidence of ischemia by as much as 30 percent. You may take Ranolazine in combination with nitrates, beta-blockers, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors and angiotensin receptor blockers.
Nitrates relax and widen your blood vessels, allowing more blood to flow to your heart. The most common type for angina, Nitroglycerin, comes in patches and a sublingual liquid pump that you spray under your tongue. Discuss appropriate treatment protocols with your doctor. You might use Nitroglycerin when angina strikes, before engaging in pain-triggering activities and/or on a long-term preventive basis. If you also have Type 2 diabetes, follow that medication regimen carefully as well.