BACKGROUND: Generic drugs are bioequivalent to their brand-name counterparts; however, concerns still exist regarding the effectiveness and safety of generic drugs because of small sample sizes and short follow-up time in most studies. The purpose of this study was to evaluate the long-term antihypertensive efficacy, cost-effectiveness and cardiovascular outcomes of generic drugs compared with brand-name drugs. METHODS: In a multicenter, community-based study including 7955 hypertensive patients who were prospectively followed up for an average of 2.5 years, we used the propensity-score-matching method to match the patients using brand-name drugs to those using generic drugs in a ratio of 1:2, 2176 patients using brand-name drugs and 4352 patients using generic drugs. RESULTS: There were no significant differences between generic drugs and brand-name drugs in blood pressure (BP)-lowering efficacy, BP control rate, and cardiovascular outcomes including coronary heart disease and stroke. The adjusted mean (95% confidence interval [CI]) of systolic BP (SBP)-lowering was -7.9 mmHg (95% CI, -9.9 to -5.9) in the brand-name drug group and -7.1 mmHg (95% CI, -9.1 to -5.1) in the generic drug group after adjusting for age, sex, body mass index, number of antihypertensive drugs and traditionally cardiovascular risk factors. Among patients aged <60 years, brand-name drugs had a higher BP control rate (47% vs. 41%; P = 0.02) and a greater effect in lowering SBP compared with generic drugs, with the between-group difference of 1.5 mmHg (95% CI, 0.2-2.8; P = 0.03). BP control rate was higher in male patients using brand-name drugs compared with those using generic drugs (46% vs. 40%; P = 0.01). Generic drugs treatment yielded an average annual incremental cost-effectiveness ratio of $315.4 per patient per mmHg decrease in SBP compared with brand-name drugs treatment. CONCLUSIONS Our data suggested that generic drugs are suitable and cost-effective in improving hypertension management and facilitating public health benefits, especially in low- and middle-income areas.
Aged ; Antihypertensive Agents/therapeutic use* ; Blood Pressure ; China ; Drugs, Generic/therapeutic use* ; Humans ; Male ; Prospective Studies

Drugs, Generic ; Humans ; Imatinib Mesylate/therapeutic use* ; Leukemia, Myelogenous, Chronic, BCR-ABL Positive/drug therapy* ; Pyrimidines/therapeutic use* ; Quality of Life ; Treatment Outcome

To address the debate on the safety of generic substitution quantitatively, the author compared the change in AUC in virtual patients who were simulated for several different scenarios of generic substitution. In four scenarios of original (branded) to generic and generic to generic substitution, 5,000 virtual patients were simulated per scenario using the programming software R. The mean population AUC of generics ranged from 90-110% (scenarios A and B) and 80-123.5% (scenarios C and D) of the AUC of the original. Those patients who had an AUC change (ratio) as a result of drug substitution of less than 0.67 or greater than 1.5 were considered to be in potential danger due to the substitution. We found that less than 6% of patients fell outside of the cutoff range of 0.67-1.5 as a result of original to generic substitution. However, in the case of generic to generic substitution, the proportion was as high as 9-12%. This alerts us to the potential danger of generic substitution, especially for drugs with narrow therapeutic indices.
*Area Under Curve ; Attitude to Health ; Computer Simulation ; Drug Prescriptions ; Drugs, Generic/*pharmacokinetics/therapeutic use ; Humans ; Patients/psychology/statistics & numerical data ; Software ; Therapeutic Equivalency