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Rosuvastatin

A Review of its Use in the Prevention of Cardiovascular Disease in Apparently Healthy Women or Men with Normal LDL-C Levels and Elevated hsCRP Levels

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Abstract

Rosuvastatin (Crestor®) is an HMG-CoA reductase inhibitor (statin) that has both lipid-lowering and anti-inflammatory effects. The drug has various indications in the US, including the primary prevention of cardiovascular disease (CVD) in patients with no clinical evidence of coronary heart disease who are at increased risk of CVD based on their age, a high-sensitivity C-reactive protein (hsCRP) level of ≥2mg/L, and at least one other CVD risk factor.

The efficacy of rosuvastatin in apparently healthy women (aged ≥60 years) or men (aged ≥50 years) with normal low-density lipoprotein cholesterol (LDL-C) levels and elevated hsCRP levels was demonstrated in the large, randomized, double-blind, multinational, JUPITER trial. Relative to placebo, rosuvastatin 20mg once daily for a median follow-up of 1.9 years significantly reduced the occurrence of first major cardiovascular events in this trial (primary endpoint). A between-group difference in favor of rosuvastatin was also demonstrated for various other endpoints, including overall deaths and the nonatherothrombotic endpoint of venous thromboembolism. Rosuvastatin remained more effective than placebo when primary endpoint results were stratified according to various baseline factors, including in patient subgroups thought to be at low risk of CVD.

In addition, rosuvastatin was associated with reductions in LDL-C and hsCRP levels, and these reductions appeared to occur independently of each other. The greatest clinical benefit was observed in rosuvastatin recipients achieving an LDL-C level of <1.8mmol/L (<70mg/dL) and an hsCRP level of <2mg/L or, even more so, <1mg/L.

Rosuvastatin was well tolerated in the JUPITER trial, with most adverse events being mild to moderate in severity. Myalgia, arthralgia, constipation, and nausea were the most commonly occurring treatment-related adverse events, and the incidence of monitored adverse events and laboratory measurements was generally similar in the rosuvastatin and placebo groups.

It is not yet known whether the mechanism of benefit of rosuvastatin is via lipid effects, anti-inflammatory effects, or a mixture of both, and the use of rosuvastatin solely on the basis of elevated hsCRP levels is controversial. Nonetheless, the drug remains an important pharmacologic option in the prevention of CVD, and has demonstrated efficacy in preventing major cardiovascular events in apparently healthy women (aged ≥60 years) or men (aged ≥50 years) with normal LDL-C levels and elevated hsCRP levels.

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    Natalie J. Carter

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Additional information

Various sections of the manuscript reviewed by: M.J. Banach, Department of Cardiology, Medical University of Lodz, Lodz, Poland; L. Masana, Lipid Research Unit, Sant Joan University Hospital, Reus, Spain; B. Pitt, Division of Cardiology, University of Michigan Hospital, Ann Arbor, Michigan, USA; B. Tomlinson, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong; N.D. Wong, UCI Heart Disease Prevention Program, University of California at Irvine, Irvine, California, USA.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘rosuvastatin’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘rosuvastatin’ and (‘c-reactive’ or ‘c-reactive-protein’ or ‘CRP’ or ‘prevention’). Searches were last updated 8 September 2010.

Selection: Studies in apparently healthy women or men with normal LDL-C levels and elevated hsCRP levels who received rosuvastatin. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: rosuvastatin, cardiovascular disease prevention, hsCRP, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Carter, N.J. Rosuvastatin. Am J Cardiovasc Drugs 10, 383–400 (2010). https://doi.org/10.2165/11204600-000000000-00000

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