Something about the side effects of Ranolazine

06/12/2013 16:19

Ranolazine is a medication that belongs to the drug class known as cardiovascular agents. Ranexa is prescribed for the treatment of chronic angina. Common side effects of Ranexa include dizziness, nausea, constipation, headache, swelling in hands, ankles, or feet, slow, fast, or irregular heartbeats, tremors, blood in the urine and shortness of breath.

Ranolazine(CAS NO: 95635-55-5 )is indicated for the treatment of chronic angina; it may be used in combination with beta blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. It has been shown to decrease angina episodes in individuals with coronary artery disease on maximal doses of amlodipine.

In addition, it has been shown to both decrease angina episodes and increase exercise tolerance in individuals taking concomitant atenolol, amlodipine, or diltiazem.

Unlike other antianginal medications, such as nitrates and beta blockers, ranolazine(CAS NO:95635-55-5) does not significantly alter either the heart rate or blood pressure, so it is of particular use in individuals with angina who are not responsive to maximal tolerated doses of other antianginal medications.

It would seem from the mechanism of action--that ranolazine may be of benefit in individuals with non-ST-elevation acute coronary syndromes (ACS) and acute myocardial infarction (heart attack). However the recently completed Merlin/TIMI-36 trial showed no benefit in this population.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 2,018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with Ranolazine, 1,026 were enrolled in three double-blind, placebocontrolled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks' duration. In addition, upon study completion, 1,251 patients received treatment with Ranolazine in open-label, long-term studies; 1,227 patients were exposed to RANEXA for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years.

In controlled clinical trials of angina patients, the most frequently reported treatment-emergent adverse reactions ( > 4% and more common on RANEXA than on placebo) were dizziness (6.2%), headache (5.5%), constipation (4.5%), and nausea (4.4%). Dizziness may be doserelated. In open-label, long-term treatment studies, a similar adverse reaction profile was observed.

At recommended doses, about 6% of patients discontinued treatment with Ranolazine because of an adverse event in controlled studies in angina patients compared to about 3% on placebo. The most common adverse events that led to discontinuation more frequently on Ranolazine than placebo were dizziness (1.3% versus 0.1%), nausea (1% versus 0%), asthenia, constipation, and headache (each about 0.5% versus 0%). Doses above 1000 mg twice daily are poorly tolerated.

 

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