Korean J Clin Pharm.  2017 Jun;27(2):105-112. 10.24304/kjcp.2017.27.2.105.

Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy

• Shim H
• Lee IH

• KMID: 2387591
• DOI: http://doi.org/10.24304/kjcp.2017.27.2.105

Abstract

BACKGROUND
Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients.
METHODS
Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality.
RESULTS
511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001).
CONCLUSION
Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

Keyword

Generics; brand drug; statin; clinical equivalence; adherence

MeSH Terms

Atorvastatin Calcium
Drugs, Generic
Health Services Needs and Demand
Healthy Volunteers
Hospitalization
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors*
Mortality
Simvastatin
Therapeutic Equivalency
Treatment Outcome
Uncertainty
Atorvastatin Calcium
Drugs, Generic
Simvastatin