Rosuvastatin approved for reducing cerebral/cardiovascular events in LDL normal individuals

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FDA has approved to expand the label of rousuvastatin (Crestor, Astra Zeneca).  The new label allowed rousuvastatin to be used to reduce the risk of stroke, MI and revascularization procedures in individuals who have normal LDL levels and no coronary heart disease but who have an increased risk based on age, CRP levels, and the presence of at least one additional CVD risk factor.

The revised label is based on the results from the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) study.

Results from JUPITER (n=17,802) indicated that rosuvastatin 20 mg was effective in reducing relative risk of heart attack by 54%, stroke by 48% and arterial revascularization by 46% vs. placebo in the above patient type who has at least one additional risk factor.

Nonetheless, it is important to point out that a higher percentage of rosuvastatin-treated patients discontinued study due to myalgia (muscle pain).

Hs-CRP is not widely used in clinical practice due to concerns of variability between individuals or on repeat testing.  Earlier recommendations suggested testing hs-CRP twice and then taking the average to guide decisions have complicated clinical practice and create inconvenience among patients.

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