Evaluation of Blood Pressure Lowering Effect by Generic and Brand-Name Antihypertensive Drugs Treatment: A Multicenter Prospective Study in China
Hypertension is a prevalent medical condition and a leading cause of cardiovascular diseases (CVDs) and stroke worldwide. In China, the prevalence of hypertension has increased rapidly over the past few decades, with 244 to 300 million (23%–45%) Chinese adults having hypertension. However, hypertension remains inadequately controlled, with treatment and control rates less than 50% and 15%, respectively. The economic burden of hypertension is particularly high in low- and middle-income populations, contributing to reduced life expectancy. Despite China’s healthcare reforms, which have expanded health insurance coverage, many patients still face significant out-of-pocket costs for medications and outpatient visits. The affordability of antihypertensive drugs remains a major barrier to medication adherence, especially in rural areas.
Generic drugs, which are chemically equivalent to their brand-name counterparts, offer a cost-effective alternative for hypertension management. They are typically marketed after the expiration of the brand-name drug’s market exclusivity period and are often priced significantly lower. However, concerns persist among healthcare providers and patients regarding the effectiveness and safety of generic drugs. While bioequivalence studies have demonstrated that generic drugs are pharmacokinetically equivalent to brand-name drugs, many of these studies have small sample sizes and short follow-up periods, limiting their ability to assess long-term clinical outcomes.
This multicenter, community-based, prospective study aimed to address these concerns by evaluating the long-term antihypertensive efficacy, cost-effectiveness, and cardiovascular outcomes of generic drugs compared with brand-name drugs in a large cohort of hypertensive patients in China. The study included 7955 patients who were followed for an average of 2.5 years. Propensity-score matching (PSM) was used to match patients using brand-name drugs to those using generic drugs in a 1:2 ratio, resulting in 2176 patients in the brand-name group and 4352 patients in the generic group.
The study found no significant differences between generic and brand-name drugs in terms of blood pressure (BP)-lowering efficacy, BP control rate, or cardiovascular outcomes, including coronary heart disease (CHD) and stroke. The adjusted mean reduction in systolic BP (SBP) was –7.9 mmHg (95% CI, –9.9 to –5.9) in the brand-name group and –7.1 mmHg (95% CI, –9.1 to –5.1) in the generic group after adjusting for age, sex, body mass index, number of antihypertensive drugs, and traditional cardiovascular risk factors. Among patients aged <60 years, brand-name drugs showed a higher BP control rate (47% vs. 41%; P = 0.02) and a greater SBP-lowering effect, with a between-group difference of 1.5 mmHg (95% CI, 0.2–2.8; P = 0.03). Male patients using brand-name drugs also had a higher BP control rate compared to those using generic drugs (46% vs. 40%; P = 0.01).
The cost-effectiveness analysis revealed that generic drugs were significantly more cost-effective than brand-name drugs. The average annual cost per patient was $220.4 for generic drugs and $472.7 for brand-name drugs, resulting in an average incremental cost-saving of $252.3 per patient annually. The cost-effectiveness ratio (CER) was 31.0 for generic drugs and 59.8 for brand-name drugs, indicating that generic drugs yielded an incremental cost-effectiveness ratio (ICER) of $315.4 per mmHg decrease in SBP compared to brand-name drugs.
The study’s findings suggest that generic antihypertensive drugs are suitable and cost-effective for improving hypertension management, particularly in low- and middle-income areas. The results provide reassurance to healthcare providers and patients regarding the clinical equivalence of generic drugs to brand-name drugs in terms of BP-lowering efficacy and cardiovascular outcomes.
The study’s design and methodology were robust, with data collected from 18 clinic centers across 12 provinces in China. The use of PSM helped to minimize potential biases by ensuring that the baseline characteristics of patients in the generic and brand-name groups were well-balanced. The study also conducted several sensitivity analyses to address potential confounding factors, such as self-reported BP data and cross-over between generic and brand-name drug use during the follow-up period. These analyses confirmed the consistency of the primary findings.
The study’s results are particularly significant given the high prevalence of hypertension in China and the economic challenges faced by many patients in accessing affordable medications. By demonstrating the clinical equivalence and cost-effectiveness of generic antihypertensive drugs, the study supports the broader use of generics to improve hypertension control and reduce the burden of CVDs in China and other low- and middle-income countries.
In conclusion, this large-scale, multicenter prospective study provides strong evidence that generic antihypertensive drugs are as effective as brand-name drugs in lowering BP and preventing cardiovascular outcomes. The cost-effectiveness of generic drugs makes them a viable option for improving hypertension management, particularly in resource-limited settings. The findings underscore the importance of promoting the use of generic drugs to enhance public health benefits and reduce the economic burden of hypertension.
doi.org/10.1097/CM9.0000000000001360
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