Technology | February 09, 2010

Popular Statin Cleared to Help Reduce Stroke, Heart Attack, Revascularization

February 9, 2010 – The FDA approved CRESTOR (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease. The new indication is for patients with an increased risk of cardiovascular disease (CVD) based on age, high-sensitivity C-reactive, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.

The FDA approval was based on data from the landmark JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study, which evaluated the impact of CRESTOR 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population. In JUPITER, CRESTOR significantly reduced the relative risk of heart attack by 54 percent, stroke by 48 percent and arterial revascularization by 46 percent vs. placebo.

JUPITER included 17,802 men (age 50 and older) and women (age 60 and older) who had no clinically evident cardiovascular disease. The study population had an estimated baseline coronary heart disease risk of 11.6 percent over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58 percent), low HDL-C levels (23 percent), cigarette smoking (16 percent), or a family history of premature CHD (12 percent).

Results from JUPITER were originally presented in November 2008 at the American Heart Association’s Annual Scientific Sessions, and published in the New England Journal of Medicine.

CRESTOR is already indicated in the United States as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also indicated as an adjunct to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C and LDL-C to target levels.

For more information: www.astrazeneca.com

Related Content

ultrasound-activated microbubbles, heart attack, pig model, NIBIB, human clinical trials

An ultrasound-stimulated microbubble burrows through a fibrin clot (green) allowing penetration of the surrounding fluid into the clot (yellow). Image courtesy of Christopher Acconci and David Goertz, University of Toronto.

News | Ultrasound Imaging| February 11, 2016
Researchers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) used ultrasound-activated...

Image courtesy of Boston Scientific

Feature | Business| February 10, 2016 | Dave Fornell
After five years of almost constant lobbying efforts and numerous attempts by the U.S.
CeloNova, COBRA REDUCE trial, first patient enrolled, Cobra PzF coronary stent
News | Stents| February 10, 2016
CeloNova BioSciences Inc. announced this week that the first patient has been enrolled in its COBRA REDUCE trial. The...
News | Business| February 09, 2016
February 9, 2016 — Cigna has entered into an...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
Watchman, left atrial appendage closure, LAA occluder
Technology | Left Atrial Appendage (LAA) Occluders| February 09, 2016
February 9, 2016 — Boston Scientific Corp.
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
medtronic corevalve, tavr
News | February 03, 2016 | Dave Fornell
Medtronic announced Feb. 3 that the U.S.
Medtronic, CE Mark, Resolute Onyx DES, drug-eluting stent, expanded sizes and indications
News | Stents Drug Eluting| February 02, 2016
Medtronic plc announced the recent CE Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES,...
Overlay Init