Abstract
Objective:
This study used simulation to compare the effectiveness of rosuvastatin 20 mg vs atorvastatin 40 mg, and rosuvastatin 40 mg vs atorvastatin 80 mg in preventing MACE in a range of patient populations with varying baseline cardiovascular risk.
Research design and methods:
The Archimedes Model was used to simulate head-to-head clinical trials in nine patient populations: Framingham Risk Score (FRS) ≥ 5%, 5–10%, 10–20%, > 20%, EURO-SCORE ≥ 5% and >10%, diagnosed diabetes, secondary prevention (history of myocardial infarction or stroke, CVD), and acute coronary syndrome (ACS). Simulated patients, aged 45–70 at trial start, were based on the NHANES 1999–2006. Treatments were modeled using results from the STELLAR, JUPITER, CARDS, ASCOT-LLA, and TNT trials. Treatment models were confirmed using trial validations.
Results:
Comparing rosuvastatin 20 mg vs atorvastatin 40 mg, the 5-year numbers needed to treat to prevent one MACE event (NNT) were 525, 70, and 55 for the FRS ≥ 5%, CVD, and ACS groups, respectively. Comparing rosuvastatin 40 mg vs atorvastatin 80 mg the corresponding NNT values were 468, 63, and 51. The 20-year relative risks of MACE in the FRS ≥ 5% population were 0.907 (0.901–0.913) for rosuvastatin 20 mg vs atorvastatin 40 mg and 0.892 (0.884–0.901) for rosuvastatin 40 mg vs atorvastatin 80 mg. The relative risks were similar for the remaining populations.
Conclusions:
This study found that rosuvastatin 20 mg and 40 mg lowers the risk of MACE more than atorvastatin 40 mg and atorvastatin 80 mg. While simulation models cannot replace real-world clinical trials, this study bridges gaps in the evidence, and identifies high risk cohorts that would likely see additional benefit from treatment with rosuvastatin rather than atorvastatin.
Transparency
Declaration of funding
This research was supported by funding from AstraZeneca Pharmaceuticals Ltd.
Declaration of financial/other relationships
CAS, AvH, PA, and BP are employees of Archimedes Inc., who were paid consultants to AstraZeneca in connection with the development of the manuscript. JH and SG are employees of AstraZeneca.
The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.
Acknowledgment
This study has previously been presented at ISPOR 16th Annual International Meeting, Baltimore, MD, USA, May 21–25, 2011; and ISPOR 14th Annual European Congress, Madrid, Spain, November 5–8, 2011.