If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Rosuvastatin Approved for US Adults With No Clinically Evident Cardiovascular Disease LONDON -- February 8, 2010 -- The US Food and Drug Administration (FDA) has approved rosuvastatin to reduce the risk of stroke, myocardial infarction, and arterial revascularisation procedures in individuals without clinically evident coronary heart disease (CHD) but with an increased risk of cardiovascular disease (CVD). The CVD risk is determined by age (men >=50 and women >=60), high-sensitivity C-reactive protein (hsCRP) >=2 mg/L, and the presence of at least 1 additional CVD risk factor, such as hypertension, low levels of high-density lipoprotein cholesterol (HDL-C), smoking, or a family history of premature CHD. The FDA approval was based on data from the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study which evaluated the impact of rosuvastatin 20 mg on reducing major cardiovascular (CV) events in a previously unstudied population. In JUPITER, rosuvastatin significantly reduced the relative risk of heart attack by 54% (P < .001), stroke by 48% (P = .002), and arterial revascularisation by 46% (P < .001), versus placebo. In the JUPITER study, the effect of rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 men (>=50 years) and women (>=60 years) who had no clinically evident cardiovascular disease, LDL-C levels <130 mg/dL (3.3 mmol/l) and hs-CRP levels >=2 mg/L. The study population had an estimated baseline CHD risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%). Study participants had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L. Study participants were randomly assigned to placebo (n = 8,901) or rosuvastatin 20 mg once daily (n = 8,901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects. In a post-hoc subgroup analysis of JUPITER subjects (n = 1,405; rosuvastatin = 725, placebo = 680) with a hsCRP >=2 mg/L and no other traditional risk factors (smoking, blood pressure >=140/90 or taking hypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with rosuvastatin treatment. 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. SOURCE: AstraZeneca
|
