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

European interventional cardiology market, drug-eluting stents, Abbott Laboratories, Boston Scientific, Medtronic

Boston Scientific's Eluvia drug-eluting vascular stent system. Image courtesy of Boston Scientific.

Feature | Stents| July 31, 2015
According to a new report on the Europe market for interventional cardiology by iData Research, drug-eluting stents...
Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | Robotic Systems| July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | Atherectomy Devices| July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.
News | Cath Lab| July 22, 2015
The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company...
Xarelto, anticoagulant protocol, discharge, outcomes, DVT, PE
News | Antiplatelet and Anticoagulation Therapies| July 21, 2015
Two companion papers published in Academic Emergency Medicine  address the question of when it is appropriate to...
Boston Scientific, fully absorbable scaffold, FAST study, resorbable
Feature | Stents Bioresorbable| July 20, 2015
Boston Scientific has initiated a study of the company's first fully resorbable drug-eluting scaffold system. The Fully...
Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD
News | Stents Peripheral| July 17, 2015
Veryan Medical announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum...
cardiac rehab after angioplasty, rehabilitation, ACC, Randal J. Thomas, referral
Feature | Cardiac Rehabilitation| July 17, 2015
Hospitals in the Midwest were more likely than others to refer patients for guideline-recommended cardiac...
ACC, health policy statement, heart team, cardiovascular health
Feature | Cardiovascular Surgery| July 17, 2015
Building teams that include advanced practice providers can help cardiovascular practices meet the challenges of modern...
Overlay Init