ERICA researchers randomized patients to an initial dose of mg twice daily or placebo for one week followed by 1, mg twice daily or placebo for six weeks. At the 1,mg dose, ranolazine was associated with a mean of 3. Patients in CARISA were randomized to 12 weeks of treatment with twice-daily ranolazine at mg, 1, mg, or placebo. All patients received daily doses of atenolol 50 mg, amlodipine 5 mg or diltiazem CD mg.
In this trial, patients treated with ranolazine went 24 seconds longer on the treadmill, by Bruce protocol, 12 hours after dosing than patients in the placebo group. Ranolazine is contraindicated for patients with pre-existing QT prolongation or hepatic impairment. It is also contraindicated for patients already assigned QT prolonging drugs or potent and moderately potent CYP3A inhibitors. Issue: March Read next.
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You've successfully added to your alerts. You will receive an email when new content is published. ERICA Study In this placebo controlled study, patients were randomized to receive a 1 week loading regimen of mg Ranexa or placebo twice daily, followed by a 6 week regimen of mg Ranexa or placebo twice daily, in combination with 10 mg amlodipine once daily.
Trial data showed that Ranexa significantly decreased frequency of angina attacks mean 3. The drug was seen to have higher efficacy in male patients. CARISA Study This placebo controlled study enrolled patients, who received one of two twice daily doses of Ranexa mg or mg or placebo, in combination with continued background therapy 50 mg atenolol, 5 mg amlodipine, or mg diltiazem CD.
Both doses significantly reduced angina frequency mg: 2. There was no significant difference in efficacy between the two doses of Ranexa. Adverse events associated with the use of Ranexa may include, but are not limited to, the following:. Other drugs associated with significant QTc prolongation have been associated with torsades de pointes-type arrhythmias and sudden death. Further, the drug's QTc-prolonging effects are increased in patients with hepatic dysfunction, and in patients on medication which inhibits the metabolic enzyme CYP3A.
Ranolazine is contra-indicated for subjects with existing QTc prolongations, in patients with all-grade liver disease and in patients on drugs which inhibit CYP3A including azole antibiotics, macrolide antibiotics, HIV protease inhibitor, and others. Subjects are advised to monitor symptoms of QTc prolongation closely, in collaboration with their physicians.
Ranexa's mechanism of action has not been fully characterized. The drug has been shown to exert its anti-anginal and anti-ischemic effects without reducing heart rate or blood pressue. The drug does not increase the rate-pressure product at maximal exercise levels. It is suspected that the drug exerts some of its effects by eliciting changes in cardiac metabolism.
European Heart Journal Jan;27 1 Epub Sep Abdallah H, Jerling M Effect of hepatic impairment on the multiple-dose pharmacokinetics of ranolazine sustained-release tablets.
Journal of Clinical Pharmacology Jul;45 7 Studies to investigate the pharmacokinetic interactions between ranolazine and ketoconazole, diltiazem, or simvastatin during combined administration in healthy subjects.
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