Statin 계열 약물의 제네릭 및 브랜드 제품 간 임상 치료결과 비교를 위한 체계적 문헌 고찰
Systematic Review on Clinical Equivalence of Generic and Brand-name Drugs in Statin Therapy
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Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers ratherthan the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object ofthis paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published beforeSeptember 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes includedblood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, ofwhich 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinicalequivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statinsignificantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data oncomparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic reviewsuggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.
Abstract
Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers ratherthan the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object ofthis paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published beforeSeptember 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes includedblood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, ofwhich 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinicalequivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statinsignificantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data oncomparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic reviewsuggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.
참고문헌 (32)
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