NEWS HIGHLIGHTSMedia Articles Related to Ranexa (Ranolazine)
Xanodyne Announces FDA Approval Of Lysteda(TM) (Tranexamic Acid) For Treatment Of Women With Heavy Menstrual Bleeding
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.11.17]
Xanodyne Pharmaceuticals, Inc., an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women's healthcare and pain management, announced today that Lysteda(TM) (tranexamic acid) oral tablets has received U.S. Food and Drug Administration (FDA) approval for treatment of women suffering from cyclic heavy menstrual bleeding (HMB), also known as menorrhagia.
FDA Says Yes to Nonhormonal Menorrhagia Drug
Source: MedPage Today OB/Gyn [2009.11.16]
The FDA has okayed tranexamic acid tablets (Lysteda) for the treatment of menorrhagia, the agency announced.
FDA Approves Lysteda To Treat Heavy Menstrual Bleeding
Source: Endocrinology News From Medical News Today [2009.11.14]
The U.S. Food and Drug Administration approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods.
Published Studies Related to Ranexa (Ranolazine)
Ranolazine improves endothelial function in patients with stable coronary artery disease. [2009.08]
OBJECTIVES: We investigated the effect of ranolazine on endothelial-dependent vasodilatation (EDV), serum markers of endothelial dysfunction, and inflammation. BACKGROUND: Endothelial dysfunction has been shown to be independently associated with the occurrence of cardiovascular events. We sought to investigate whether ranolazine, a novel antianginal medication with no effect on heart rate or blood pressure, improves endothelial function in patients with stable coronary artery disease (CAD)... CONCLUSION: Ranolazine improves endothelial function, asymmetric dimethylarginine, and C-reactive protein levels in a group of patients with stable CAD. Our results suggest a novel mechanism of action of ranolazine.
Efficacy of ranolazine in patients with chronic angina observations from the randomized, double-blind, placebo-controlled MERLIN-TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Segment Elevation Acute Coronary Syndromes) 36 Trial. [2009.04.28]
OBJECTIVES: We aimed to evaluate the efficacy and safety of ranolazine in a larger and more diverse group of patients with angina than previously studied. BACKGROUND: Ranolazine is an antianginal shown to reduce angina and improve exercise performance in selected patients with early-positive exercise testing and those with frequent angina... CONCLUSIONS: In this largest study of ranolazine in patients with established coronary artery disease, ranolazine was effective in reducing angina with favorable safety in a substantially broader group of patients with angina than previously studied. (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes; NCT00099788).
Ischemia detected on continuous electrocardiography after acute coronary syndrome: observations from the MERLIN-TIMI 36 (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction 36) trial. [2009.04.21]
OBJECTIVES: The purpose of this study was to assess the relationship between ischemia detected on continuous electrocardiographic (cECG) recording and cardiovascular outcomes after acute coronary syndrome (ACS). BACKGROUND: The small size of prior studies evaluating cECG prevented full evaluation of the risk associated with ischemia across subpopulations and compared with other methods of risk stratification. Ranolazine, a new antianginal agent, reduces ischemic symptoms in patients with chronic angina and after ACS but the anti-ischemic effect, as detected by cECG, is not known... CONCLUSIONS: In more than 6,300 patients with ACS, ischemia detected on cECG occurred frequently and was strongly and independently associated with poor cardiovascular outcomes, including cardiovascular death. Continuous ECG monitoring to detect ischemia after ACS may help to identify patients at increased risk. (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes [MERLIN]; NCT00099788).
Evaluation of the glycometabolic effects of ranolazine in patients with and without diabetes mellitus in the MERLIN-TIMI 36 randomized controlled trial. [2009.04.21]
CONCLUSIONS: Ranolazine significantly improved HbA(1c) and recurrent ischemia in patients with diabetes mellitus and reduced the incidence of increased HbA(1c) in those without evidence of previous hyperglycemia. The mechanism of this effect is under investigation.
Ranolazine shortens repolarization in patients with sustained inward sodium current due to type-3 long-QT syndrome. [2008.12]
INTRODUCTION: One form of the hereditary long-QT syndrome, LQT3-Delta KPQ, is associated with sustained inward sodium current during membrane depolarization. Ranolazine reduces late sodium channel current, and we hypothesized that ranolazine would have beneficial effects on electrical and mechanical cardiac function in LQT3 patients with the SCN5A-DeltaKPQ mutation... CONCLUSION: Ranolazine at therapeutic concentrations shortened a prolonged QTc interval and improved diastolic relaxation in patients with the LQT3-Delta KPQ mutation, a genetic disorder that is known to cause an increase in late sodium current.
Clinical Trials Related to Ranexa (Ranolazine)
Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes [Completed]
MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled,
parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine
during acute and long-term treatment in approximately 5,500 patients with non-ST elevation
acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint
in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of
cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST
elevation ACS receiving standard therapy. The study also evaluates the safety of long-term
treatment with ranolazine compared to placebo.
Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy [Recruiting]
This study will evaluate the effects of Ranexa (ranolazine) in patients with coronary artery
disease who have painful peripheral neuropathy.
Microvascular Coronary Disease In Women: Impact Of Ranolazine [Recruiting]
1. To evaluate the impact of ranolazine extended-release tablets in women with
subendocardial ischemia due to microvascular endothelial dysfunction on myocardial
ischemia (CMR extent, severity).
2. To evaluate the impact of ranolazine extended-release tablets in women with
subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of
angina (SAQ, WISE angina frequency, DASI and SF-36).
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.
Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction [Recruiting]
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