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 i...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.展开更多
基金国家自然科学基金青年项目(71702134)国家自然科学基金重点项目(71532011)+2 种基金国家自然科学基金青年项目(71702177)广东省教育厅青年创新人才类项目(2018WQNCX185)信阳师范学院‘南湖学者奖励计划’青年项目(Nanhu Scholars Program for Young Scholars of XYNU)资助。
基金China National Center for Biotechnology Development fund(Nos.2018YFC1312400,2018YFC1312405)National Science and Technology Pillar Program during the Twelfth Five-year Plan Period(No.2011BAI11B04)Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences(No.2016-I2M-1-006)。
文摘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.
