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Ranexa (Ranolazine) - Summary

 
 



RANEXA SUMMARY

Ranexa™
ranolazine extended-release tablets

Ranexa™ (ranolazine) is available as an extended-release tablet for oral administration.

Ranexa is indicated for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs. Ranexa should be used in combination with amlodipine, beta-blockers or nitrates. The effect on angina rate or exercise tolerance appeared to be smaller in women than men.


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NEWS HIGHLIGHTS

Published Studies Related to Ranexa (Ranolazine)

Use of ranolazine in patients with incomplete revascularization after percutaneous coronary intervention: design and rationale of the Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (RIVER-PCI) trial. [2013]
CONCLUSIONS: RIVER-PCI is a novel, large-scale, international, randomized,

Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). [2013]
angina... CONCLUSIONS: Among patients with diabetes and chronic angina despite treatment

Ranolazine improves angina in women with evidence of myocardial ischemia but no obstructive coronary artery disease. [2011.05]
OBJECTIVES: We conducted a pilot study for a large definitive clinical trial evaluating the impact of ranolazine in women with angina, evidence of myocardial ischemia, and no obstructive coronary artery disease (CAD). BACKGROUND: Women with angina, evidence of myocardial ischemia, but no obstructive CAD frequently have microvascular coronary dysfunction. The impact of ranolazine in this patient group is unknown... CONCLUSIONS: In women with angina, evidence of ischemia, and no obstructive CAD, this pilot randomized, controlled trial revealed that ranolazine improves angina. Myocardial ischemia may also improve, particularly among women with low CFR. These data document approach feasibility and provide outcome variability estimates for planning a definitive large clinical trial to evaluate the role of ranolazine in women with microvascular coronary dysfunction. (Microvascular Coronary Disease In Women: Impact Of Ranolazine; NCT00570089). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Relationship between nonsustained ventricular tachycardia after non-ST-elevation acute coronary syndrome and sudden cardiac death: observations from the metabolic efficiency with ranolazine for less ischemia in non-ST-elevation acute coronary syndrome-thrombolysis in myocardial infarction 36 (MERLIN-TIMI 36) randomized controlled trial. [2010.08.03]
CONCLUSIONS: Nonsustained VT is common after admission for non-ST-elevation acute coronary syndrome, and even short episodes of VT lasting 4 to 7 beats are independently associated with the risk of SCD over the subsequent year. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00099788.

Effect of ranolazine on A1C and glucose levels in hyperglycemic patients with non-ST elevation acute coronary syndrome. [2010.06]
CONCLUSIONS: Ranolazine, when added to concurrent antidiabetes treatment, lowers FPG and A1C in patients with cardiovascular disease and poorly controlled diabetes.

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Clinical Trials Related to Ranexa (Ranolazine)

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion [Recruiting]
Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib).

After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility.

Maximum treatment duration is 112 days (16 weeks).

A Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination in Patients With Paroxysmal Atrial Fibrillation (HARMONY) [Recruiting]
The purpose of this study is to evaluate whether treatment with ranolazine or low dose dronedarone reduces atrial fibrillation burden (AFB) in subjects with paroxysmal atrial fibrillation (PAF), and whether combination therapy (ranolazine and low dose dronedarone) is superior to individual drug therapy in reducing AFB.

Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities [Recruiting]
The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

Study the Effects of Ranolazine on Myocardial Perfusion Assessed by Serial Quantitative Exercise SPECT Imaging [Recruiting]
The purpose of this study is to evaluate if ranolazine can improve blood flow to your heart (myocardial perfusion) by SPECT MPI when taken prior to exercise.

Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina [Recruiting]
This study will evaluate the safety and efficacy of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM).

The purpose of this study is to evaluate if ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day.

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Reports of Suspected Ranexa (Ranolazine) Side Effects

Rhabdomyolysis (7)Drug Interaction (6)Chest Pain (6)Renal Failure Acute (6)Syncope (6)Confusional State (5)Death (5)Nausea (5)Asthenia (5)Transaminases Increased (4)more >>


Page last updated: 2014-12-01

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