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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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Yet another embodiment of the invention encompasses processes for producing rosuvastatin calcium salt substantially free of impurities comprising the steps of: reacting a C 1 to C 4 ester of rosuvastatin with a base in a two phase system of water and acetonitrile; concentrating the water phase to obtain a residue; adding a source of calcium and water to the residue to form a solution in water; and recovering rosuvastatin calcium as a precipitate.

Compared with Caucasian patients residing in the US, median rosuvastatin exposure (peak plasma concentration and AUC) is approximately twofold higher in Asian patients.

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This prediction was inconsistent with the observed multiple dose clinical PK profile of this compound, which suggested no net change in its clearance over this dosing period (i.

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Patients with additional risk factors require more aggressive treatment, even if their blood cholesterol is not particularly high.

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Three of the cases (one in the rosuvastatin group and two in the placebo group) did not have corroborating evidence in the form of a confirmatory diagnostic test, initiation of anticoagulation therapy, or death that was likely to have been due to pulmonary embolism.

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