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

OBJECTIVE: The study purpose was to develop a drug information leaflet for the elderly and to evaluate it with performance-based user-testing. METHODS: We performed a stratified randomized controlled trial. We recruited 62 elderly patients with age of 65 or above who were taking antidiabetic medications at the point of participating and excluded those who suffered illiteracy. We randomly allocated them into the intervention group with a leaflet for the elderly and the control group with a leaflet for the general public. Main outcome measures were to ‘be able to find information’ and to ‘be able to understand information.’ We measured outcome variables by employing performance-based user-testing and analyzed data to find any differences between two groups with t-tests, chi-squared tests or Fisher's exact tests accordingly. RESULTS: More participants in the intervention group understood how to store their medications than those in the control group (intervention group 93% vs. control group 70%; p=0.02). There were no significant differences in other information items between two groups. Mostly ‘being able to understand information’ was lower than ‘being able to find information.’ The gaps between two outcome variables were about 10% in the intervention group and about 18% in the control group. The lowest understanding was observed in information relating to drug names and their potential adverse events. CONCLUSION: Without providing personalized drug information, it might be hard for the elderly to improve their drug knowledge even with leaflets that were developed specifically for the elderly.
Aged ; Health Literacy ; Humans ; Hypoglycemic Agents ; Literacy ; Outcome Assessment (Health Care)