Posts Tagged ‘simvastatin’

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November 17th, 2014

IMPROVE-IT Meets Endpoint and Demonstrates Real But Modest Clinical Benefit for Ezetimibe

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo […]


June 9th, 2014

Selections from Richard Lehman’s Literature Review: June 9th

This week’s topics include the CORONARY trial, the association of azithromycin with mortality and CV events among older patients hospitalized with pneumonia, and more.


May 18th, 2014

Statins Disappoint In COPD And ARDS

Two NHLBI studies have failed to find any benefit for statin therapy in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). Previous observational studies had raised the possibility that statins, perhaps due to their anti-inflammatory effects, might improve outcomes in people with these serious diseases. But both trials were stopped early by […]


April 7th, 2014

Selections from Richard Lehman’s Literature Review: April 7th

This week’s topics include SYMPLICITY HTN-3, CoreValve, MADIT-CRT, and more.


July 9th, 2013

Low Rate of Problems with Statins in Study of Quarter Million Patients

A very large analysis of previously published studies finds that statins are generally safe and well tolerated, but helps confirm previous links to a small increased risk for diabetes and elevation of liver enzymes. Some statins were better tolerated than others, and lower-dose statins were better tolerated than high doses. In a paper published in Circulation: Cardiovascular […]


January 25th, 2012

FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin

The FDA rejected a new indication for Merck’s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of SHARP (Study of Heart and Renal Protection), which found that the drug combination reduced the incidence […]


November 22nd, 2011

Long-Term Follow-up of HPS Shows Extended Benefits of Statins

Long-term follow-up of patients enrolled in the Heart Protection Study (HPS) demonstrates continued benefits in the group originally randomized to receive simvastatin instead of placebo. The main results of the HPS, published in 2002, showed a significant 23% reduction at 5.3 years in major vascular events associated with simvastatin treatment among the 20,536 patients with coronary […]


November 15th, 2011

AIM-HIGH: No Benefit for Niacin on Top of Statins

The AIM-HIGH investigators aimed for the lofty target of proving the beneficial effects of niacin therapy. They did not succeed. Their findings were presented Tuesday morning at the AHA  and published simultaneously in the New England Journal of Medicine. In AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes), 3414 […]


November 3rd, 2011

FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Wednesday strongly supported the combination of ezetimibe and simvastatin (Vytorin, Merck) to prevent cardiovascular events in pre-dialysis chronic kidney disease (CKD) patients. But the panel voted against recommending Vytorin for patients with end-stage renal disease on dialysis. The votes were 16-0 in favor of the pre-dialysis […]


October 31st, 2011

FDA Gives Favorable Review to SHARP Ahead of Vytorin Advisory Panel

In preparation for Wednesday’s meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, an FDA reviewer has generally endorsed the positive interpretation of the SHARP trial of Vytorin (ezetimibe and simvastatin) in chronic kidney disease (CKD). Based on the results of SHARP (Study of Heart and Renal Protection), Merck is seeking an expansion of its […]