Posts Tagged ‘simvastatin’

October 7th, 2011

FDA Approves Juvisync, Combination of Sitagliptin and Simvastatin

The FDA has approved a fixed-dose combination tablet consisting of sitagliptin and simvastatin, two drugs previously approved for type 2 diabetes and hypercholesterolemia. Merck will market the new drug as Juvisync. “This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, the […]

June 12th, 2011

CardioExchange Panel: Whither High-Dose Simvastatin?

Last week, the FDA issued a warning high-dose simvastatin because of the risk of myopathy. CardioExchange got the reactions from a panel we assembled. Whose views do you agree with? What points did our panelists miss? See a similar panel’s reactions the publication of the SHARP Trial here. Given the FDA warning, do you see any role […]

June 12th, 2011

CardioExchange Panel: Ezetimibe + Simvastatin for Chronic Kidney Disease — What’s the Point of SHARP?

Last week saw the publication of the SHARP trial (Study of Heart and Renal Protection) in which some 9,200 patients with chronic kidney disease (CKD) were randomized to  either placebo or the combination of simvastatin and ezetimibe. CardioExchange put questions about these data to a panel of experts. Whose views do you agree with? What points did […]

June 8th, 2011

SHARP Results Published in Lancet

The main results of SHARP (Study of Heart and Renal Protection) have now been published in the Lancet, following their preliminary presentation last November at the American Society of Nephrology meeting. The results are also posted online on the trial’s website. In brief, SHARP randomized 9270 patients with chronic kidney disease (CKD) — one-third of whom were on […]

June 8th, 2011

FDA Recommends Limiting Use of High-Dose Simvastatin

The FDA today recommended significant limitations in the use of high-dose (80 mg) simvastatin because of the increased risk for myopathy. The FDA said the 80-mg dose should be used only in people who have been taking the high dose for at least one year and have had no evidence of myopathy. The high dose […]

January 27th, 2011

HPS Results Suggest Baseline CRP Doesn’t Predict Statin Efficacy

Analysis of data from the Heart Protection Study (HPS) indicates that a CRP measurement obtained at baseline does not predict the effect of statin therapy. In a paper published online in the Lancet, the HPS Collaborative Group report the results of the more than 20,000-patient HPS study based on CRP category at baseline. As previously reported, […]

November 22nd, 2010

SHARP: A Tale of Two Press Releases

Two press releases were issued about the SHARP trial : one from Merck, the much-maligned and criticized manufacturer of Vytorin (the combination of ezetimibe and simvastatin), and one from the group running the trial, the highly-respected Clinical Trials Service Unit (CTSU) at Oxford. Here’s the surprise: compared to the Oxford press release, the Merck release is a paragon, […]

November 9th, 2010

Intensive Statin Therapy Examined in Meta-Analysis and SEARCH Trial

A new meta-analysis and a large clinical trial shed new light on the additive effects of intensive statin therapy over standard therapy. The meta-analysis from the Cholesterol Treatment Trialists’ Collaboration and the results from SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) are published online in the Lancet. The meta-analysis examined individual […]