Clinical review: impact of statin substitution policies on patient outcomes.
BACKGROUND
The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the consequences for primary care are under-researched. Our objective was to review data on intensive statin therapy and generic substitution in patients at high cardiovascular risk.


RESULTS
Current treatment guidelines for the prevention of cardiovascular disease are consistent in their recommendations regarding statin therapy and treatment targets. Clinical trials demonstrate that to reduce cardiovascular events, a statin is more effective than placebo, intensive statin therapy is more effective than moderate statin therapy in patients with established coronary disease, and in patients receiving intensive statin therapy the lowest risk is associated with the lowest low-density lipoprotein levels. However, in clinical practice, patients at high cardiovascular risk are prone to be undertreated. Observational studies suggest that mandatory statin substitution may increase the gap between achieved and recommended therapeutic targets.


CONCLUSIONS
Substitution of generic statins may be cost-saving, particularly at the primary prevention level. However, statin substitution policies have not been adequately studied on a population level. Data raise concern that mandated statin substitution may lead to unfavourable treatment choices at the level of the individual high-risk patient.
Atar
Dan
D
Division of Cardiology, Aker University Hospital and Faculty of Medicine, University of Oslo, Oslo, Norway. dan.atar@online.no
Carmena
Rafael
R
Clemmensen
Peter
P
K-Laflamme
Annik
A
Wassmann
Sven
S
Lansberg
Peter
P
Hobbs
Richard
R
D002318:Cardiovascular Diseases / Q000517:prevention & control*; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D005060:Europe; D006291:Health Policy; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D017410:Practice Guidelines as Topic; D012051:Reimbursement Mechanisms; D012307:Risk Factors
D016568:Drugs, Generic; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors