Generic Antihypertensive Drugs Research Articles

A Review: A Comparative Study of Branded and Generic Anti-Hypertensive Drugs

This comprehensive review investigates the market landscape of antihypertensive medications, undertaking a detailed comparative analysis of branded and generic options. In the face of rising global prevalence of hypertension, the study aims to provide a holistic perspective on the efficacy, safety, and market dynamics shaping the use of branded and generic drugs in the management of these chronic conditions. Utilizing data derived from market trends, sales analytics, and consumer preferences, the review scrutinizes the market behaviors and forces influencing the adoption of branded and generic antihypertensive drugs. Factors such as cost-effectiveness, patient adherence, and healthcare provider preferences are explored to shed light on the complexities associated with medication selection in the context of chronic disease management. Through an in-depth examination of industry strategies, regulatory frameworks, and the role of healthcare policies, the review aims to uncover the interplay between market dynamics and clinical considerations. It seeks to inform healthcare professionals, policymakers, and industry stakeholders about the evolving landscape of choices in antihypertensive therapies, fostering a nuanced understanding that can guide optimal decision-making in patient care and resource allocation.

A Review: A Comparative Study of Branded and Generic Anti- Diabetic Drugs

This comprehensive review investigates the market landscape of antihypertensive medications, undertaking a detailed comparative analysis of branded and generic options. In the face of rising global prevalence of hypertension, the study aims to provide a holistic perspective on the efficacy, safety, and market dynamics shaping the use of branded and generic drugs in the management of these chronic conditions. Utilizing data derived from market trends, sales analytics, and consumer preferences, the review scrutinizes the market behaviors and forces influencing the adoption of branded and generic antihypertensive drugs. Factors such as cost-effectiveness, patient adherence, and healthcare provider preferences are explored to shed light on the complexities associated with medication selection in the context of chronic disease management. Through an in-depth examination of industry strategies, regulatory frameworks, and the role of healthcare policies, the review aims to uncover the interplay between market dynamics and clinical considerations. It seeks to inform healthcare professionals, policymakers, and industry stakeholders about the evolving landscape of choices in antihypertensive therapies, fostering a nuanced understanding that can guide optimal decision-making in patient care and resource allocation.

Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China.

Background: The substitution of generic drugs can effectively alleviate the rapid growth of drug costs; however, the clinical effectiveness and medical costs of originator products and generics were barely studied in China. Objectives: To compare the effectiveness of antihypertensive drugs and hypertension-related medical costs between originator and generic initiators in Yinzhou, China. Methods: We conducted a population-based retrospective cohort study using the Chinese Electronic Health Records Research in Yinzhou (CHERRY), from July 1, 2011, to December 31, 2018. Hypertension patients initiating with originator products were compared with patients initiating with generic counterparts. We used 1:1 propensity score matching to pair the two groups based on sociodemographic, clinical, and health service utilization variables. Cox proportional regression was adopted to compare the rate of hospitalization for hypertension-related cardiovascular disease between matched originator and generic initiators. Wilcoxon matched-pairs signed-rank test was used to compare annual hypertension-related medical costs. Results: Matched pairs (10,535) of patients were included in the comparative study of originator products and generics, corresponding to seven antihypertensive drugs including amlodipine, felodipine, nifedipine, irbesartan, losartan, valsartan, and metoprolol. The average age of patients included in the analysis was around 60 years (originator vs. generics initiators: from 59.0 vs. 59.1 years in losartan to 62.9 vs. 63.6 years in nifedipine). Higher hospitalization rates among originator initiators were observed for three calcium channel blockers (hazard ratio[95% CI]: amlodipine, 3.18[1.43, 7.11]; felodipine, 3.60[1.63, 7.98]; and nifedipine, 3.86[1.26, 11.81]; respectively). The remaining four out of seven drugs of the clinical endpoint estimates showed comparable outcomes between originator products and generics (hazard ratio[95% CI]: irbesartan, 1.19[0.50, 2.84]; losartan, 1.84[0.84, 4.07]; valsartan, 2.04[0.72, 5.78]; and metoprolol, 1.25[0.56, 2.80]; respectively). Higher median annual hypertension-related medical costs were observed in originator initiators (all p < 0.001), except for metoprolol (p = 0.646). Conclusion: We observed comparable or even better clinical outcomes and less medical cost associated with the use of antihypertensive generics compared to originator counterparts. This could help increase patient and provider confidence in the efficacy of generic medicines to manage hypertension diseases.

Real-world effectiveness of generic antihypertensive drugs of pradhan mantri bhartiya janaushadhi kendra

Real-world effectiveness of generic antihypertensive drugs of pradhan mantri bhartiya janaushadhi kendra

Efficacy and safety outcomes of one generic nifedipine versus ADALAT long‐acting nifedipine for hypertension management

Data regarding the long-term outcomes of generic antihypertensive drugs are limited. This nationwide retrospective database analysis aimed to evaluate the efficacy and safety of a generic versus brand-name nifedipine for hypertension treatment. Patients who were prescribed generic or brand-name nifedipine between January 1, 2008, and December 31, 2013, were identified from the National Health Insurance Research Database of Taiwan. The efficacy outcomes included all-cause mortality and the composite cardiovascular (CV) outcome, including CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for heart failure. Safety outcomes included headache, peripheral edema, constipation, acute kidney injury, hypotension, syncope, new diagnosis of cancer, and cancer death. Among the 98335 patients who were eligible for analysis, 21087 (21.4%) were prescribed generic nifedipine. Both the generic and the brand-name groups included 21087 patients after propensity score matching. At a mean follow-up of 4.1years, the generic nifedipine was comparable to the brand-name drug with regard to all-cause mortality (7.2% vs. 7.1%; hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.95-1.09) and the composite CV outcomes (11.6% vs. 11.9%; HR 0.97; 95% CI 0.92-1.03). The generic nifedipine was associated with higher rates of headache, peripheral edema, and constipation but a modest reduction in the risk of newly diagnosed cancer (7.1% vs. 7.8%; subdistribution HR 0.90, 95% CI 0.84-0.97). The risks of acute kidney injury, hypotension, syncope, and cancer death were not significantly different between the two groups. In conclusion, the generic nifedipine was comparable to the brand-name drug with regard to the risks of all-cause mortality and the composite CV outcome. The finding of cancer risk could be chance and should be interpreted with caution.

P5712Research Network in Africa (RNA): quality assessment of antihypertensive generic drugs in 10 African countries

Abstract Introduction Hypertension results in more deaths than any other risk factor and has been on the rise in Sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. Purpose We performed a quality assessment of five commonly used antihypertensive generic drugs in ten Sub-Saharan African countries and studied the impact of price on quality. Methods Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. Results A total of 1185 samples were assessed, of which 70.0% were generic (n=830). Among the generic drugs, the percentage of poor quality drugs was 24.3% (n=202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2% to 111.3%; the majority (81.7%) of the poor quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. Conclusion In this study from ten Sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low and middle income countries. Figure 1. Percentage of poor quality in generic antihypertensive drugs according to the country of purchase. Acknowledgement/Funding Grant AAP-2014-042, ANSM (Agence Nationale Sécurité du Médicament

Substandard drugs among five common antihypertensive generic medications: an analysis from 10 African countries.

Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality. Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. A total of 1185 samples were assessed, of which 70.0% were generic (n = 830). Among the generic drugs, the percentage of poor-quality drugs was 24.3% (n = 202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2 to 111.3%; the majority (81.7%) of the poor-quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. In this study from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.

Abstract P251: Substitution to Generic Angiotensin II Receptor Blockers: Impact on Risk of Hospitalizations, Emergency Room Consultations and Mortality

Background: Substitution from brand-name to generic drugs is one way to reduce costs of pharmacological treatments. Generic drugs licensing is obtained through comparative bioavailability studies for which a variation of up to 20% is generally accepted. However, “real-life” efficacy and tolerance of generic drugs are not studied prior to commercialization. We aimed to evaluate the impact of brand-name to generic losartan, valsartan or candesartan substitution on serious adverse events (hospitalizations, emergency room consultations [ER] or mortality). Method: Three cohorts of persistent angiotensin II receptor blockers (ARB) users (losartan [brand-name and 8 generics], valsartan [brand-name and 5 generics] and candesartan [brand-name and 3 generics])aged ≥ 66 years were constituted using data from the Quebec Integrated Chronic Disease Surveillance System. Generic exposition was determined by substitution time-distribution matching. Time free of adverse events up to 365 days after the onset of generic exposition was compared between groups by survival analysis using Cox regression models adjusted for age, sex, comorbidities, concomitant treatments, socioeconomic status, previous brand-name drug, healthcare resources utilization and prescriber’s speciality, to provide hazard ratio (HR). Sensitivity analysis including non-persistent users was also conducted. Results: Within cohorts (losartan, n = 15,469; valsartan, n = 17,205; and candesartan, n = 25,008), proportions of exposed to generic substitution vs. unexposed who had at least one adverse event were respectively: 35% vs. 25%, 34% vs. 28% and 31% vs. 27% (all, p &lt;0.0001). When adjusted for potential confounders, risk of hospitalizations and ER were higher for those exposed to generic substitution. Specifically, HR for exposed to generic substitution are the following for losartan, valsartan and candesartan: hospitalizations (HR: 1.23 [ p &lt; 0.0001]; 1.22 [ p &lt; 0.0001] and 1.08 [ p = 0.0317]) and ER (HR: 1.55; 1.20 and 1.16, all = p &lt; 0.0001). Regarding mortality, HR were respectively: 0.63 [ p = 0.1456]; 0.95 [ p = 0.8487] and 0.43 [ p &lt; 0.0001]). Survival was not significantly different for exposed to generic losartan and valsartan substitution. However, even if the time free of hospitalizations and ER was 8% and 16% shorter for patients exposed to generic candesartan substitution, their survival was 2.3 times better when compared to patients who remained on brand-name candesartan (unexposed). Sensitivity analysis yield similar results. Conclusion: Substitution to generic antihypertensive drugs is associated with a significantly reduced delay before hospitalizations and ER for the three ARBs but a better survival for patients exposed to generic candesartan substitution only. Better bioavailability of generics versions of candesartan or differences in health cares between users could explain these differences.

COMBINED ANTIHYPERTENSIVE THERAPY IN REAL CLINICAL PRACTICE. FOCUS ON FIXED COMBINATIONS OF ANTIHYPERTENSIVE DRUGS (According to the Data of Outpatient Registries RECVASA and PROFILE)

On Behalf of the Working Groups of the Registries PROFILE and RE С VASA. Working Group of the PROFILE Registry : Akimova A.V., Voronina V.P., Dmitrieva N.A., Zakharova A.V., Zakharova N.A., Zagrebelnyy A.V., Kutishenko N.P., Lerman O.V., Lukina Yu.V., Tolpygina S.N., Martsevich S.Y. Working Group of the RECVASA Registry : Vorobyev A.N., Zagrebelnyy A.V., Kozminsky A.N., Lukina Yu.V., Loukianov M.M., Moseichuk K.A., Nikulina N.N., Pereverzeva K.G., Pravkina E.A., Boytsov S.A., Martsevich S.Yu., Yakushin S.S. Aim. To assess the frequency of prescription of different combinations of the main groups of antihypertensive drugs (AHD) and their fixed combinations to patients with arterial hypertension by physicians according to two outpatient registries. Material and methods . Hypertension was diagnosed in 3648 (98.9%) patients of the RECVASA registry and in 1230 patients of the PROFILE registry (80.3%). Data on doctor’s prescriptions reflected in the outpatient charts of patients of the both registries were analyzed. The following information of the prescribed antihypertensive therapy was studied in details: AHD, including fixed and free combinations, original and generic AHD. Data on the achievement/non-achievement of target blood pressure (BP) level in patients with hypertension were also analyzed. Results. Women were predominated among hypertensive patients of the RECVASA registry, (71.9%). The ratio of men and women was close to 1:1 in the PROFILE registry. Patients of the registry RECVASA were older: the average age was 66.2±12.8 years compared to 63.7±11.4 years in patients of the PROFILE registry, respectively. The majority of patients in the RECVASA registry (61.4%) had hypertension of the 3rd degree, patients of the PROFILE registry revealed mostly hypertension of the 2 degree (53.3%). Fixed combinations were prescribed to 14% of patients in the registry of RECVASA and to 16% of patients in the PROFILE registry. Doctors of the PROFILE registry often prescribed original AHD; 75% of patients from RECVASA registry received generics. The most popular combinations in both registries were combinations of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers with thiazide/thiazide-like diuretics. The target level of BP was more often achieved in the patients of the PROFILE registry: 37.6% vs 26.1% in the RECVASA registry. Conclusion . The results of the analysis of the presented registries demonstrate the low frequency of prescribing fixed combinations in real clinical practice, the inertness of physicians in achieving the target BP levels and the low efficiency of antihypertensive therapy.

Abstract 12799: Hospitalizations and Emergency Consultations Following Generic Antihypertensive Drugs Commercialization in Quebec

Introduction: Once patent of a brand-name drug expires, generic drugs are commercialized and substitution may occur. Few studies have assessed clinical impacts of generic drugs commercialization at a population level. Objective: We evaluated the impact for three generic versions of antihypertensive drugs on adverse events: hospitalizations and emergency room consultations. Methods: This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. The rate of adverse events for losartan (brand-name and 8 generics), valsartan (brand-name and 5 generics) and candesartan (brand-name and 3 generics) users aged ≥ 66 years (all: N=121 185 citizens) were calculated monthly, 12 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared with negative binomial segmented regression models for all users with a specific variable for generic and brand-name users. Results: There was an approximated monthly mean rate of 100 adverse events for 1000 exposed person-months to losartan, valsartan and candesartan. Monthly trend of adverse events was affected by generics commercialization. Generic users of losartan, valsartan and candesartan showed increased rate of adverse events of 11% (p=0.0034), 9% (p=0.0024) and 13% (p=0.0008) respectively right after generics commercialization (Figure 1) which was always higher compared to brand-name users (p&lt;0.05). The monthly trend of hospitalizations was affected for losartan users up to 1 year after generics commercialization (generics: +1.2%, brand-name: -2.2, p=0.0094). Conclusion: Generics commercialization impacted population rates of adverse events. A significant adverse events increase was observed right after generics commercialization for all antihypertensive drugs studied, among generic users. More studies are required to identify differences in drugs or users, which could explain this increase.

Les médicaments génériques et l’évolution de la consommation des antihypertenseurs au Maroc

To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population.

Generic drugs for hypertension: are they really equivalent?

Many antihypertensive drugs are now available in generic formulations at fractions of the cost of their branded counterparts. In the United States, marketing approval for generic medications is usually granted by the Food and Drug Administration on the basis of two simple studies involving dissolution rates and bioavailability in 24 - 36 healthy people, without data regarding antihypertensive efficacy, safety, or long-term outcomes. This process leaves many true disciples of "Evidence-Based Medicine" in a quandary: prescribe only brand-name medications that have been demonstrated in clinical trials to both lower blood pressure and prevent cardiovascular events, or instead recommend lower-priced generic agents that are usually supported by no such data. This review summarizes the current evidence that generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients, but, by law, must have a different physical appearance than the original product.

Choice of generic antihypertensive drugs for the primary prevention of cardiovascular disease--a cost-effectiveness analysis.

BackgroundHypertension is one of the leading causes of cardiovascular disease (CVD). A range of antihypertensive drugs exists, and their prices vary widely mainly due to patent rights. The objective of this study was to explore the cost-effectiveness of different generic antihypertensive drugs as first, second and third choice for primary prevention of cardiovascular disease.MethodsWe used the Norwegian Cardiovascular Disease model (NorCaD) to simulate the cardiovascular life of patients from hypertension without symptoms until they were all dead or 100 years old. The risk of CVD events and costs were based on recent Norwegian sources.ResultsIn single-drug treatment, all antihypertensives are cost-effective compared to no drug treatment. In the base-case analysis, the first, second and third choice of antihypertensive were calcium channel blocker, thiazide and angiotensin-converting enzyme inhibitor. However the sensitivity and scenario analyses indicated considerable uncertainty in that angiotensin receptor blockers as well as, angiotensin-converting enzyme inhibitors, beta blockers and thiazides could be the most cost-effective antihypertensive drugs.ConclusionsGeneric antihypertensives are cost-effective in a wide range of risk groups. There is considerable uncertainty, however, regarding which drug is the most cost-effective.

Norwegian patients on generic antihypertensive drugs: a qualitative study of their own experiences

ObjectivesThe aim of this study was to investigate experiences with and attitudes toward generic substitution in patients on antihypertensive medication.Materials and methodsStudy participants were 22 patients from pharmacies in Oslo who had taken brand antihypertensive products as well as substituted generic products. Five focus- group discussions were held.ResultsOnly a few participants claimed to take their medications as prescribed. Most reported low drug adherence before and after generic substitution. Fourteen said that their blood pressure was not under control. Most patients did not know what it meant to get a generic product. They normally accepted what the pharmacy offered, even if they thought the generics were of a lower quality than the brand products. Five participants experienced new side effects. Differences in name, color, form, or taste caused confusion. The patients had been told in the pharmacy that the effect of a generic product was as good as that of the brand product but were still confused, as in most cases the doctor said nothing to them about the substitution.ConclusionGeneric substitution works well in Norway as an economic health strategy, but drug adherence remains suboptimal under those circumstances. Patients are insecure with respect to the difference between the old and the new product when it comes to the drug’s physical attributes and perceived quality. Patients would feel safer if the doctor had a more active role in informing them about the system.

Analyse de la consommation des antihypertenseurs au Maroc : période 1991-2005

The medical assumption of responsibility of the chronic diseases in Morocco, in particular arterial hypertension, remains problematic. To evaluate the consumption, segmentation and the share of the market of generic antihypertensive drugs during the period: 1991-2005. The data were elaborate starting from the declarations of IMS health (Intercontinental Marketing Service) for Morocco. These data related to the sales with only the pharmacies and were expressed as daily defined dose (DDD)/1000 inhabitant-days. The consumption of the antihypertensive drugs increased from 2 to 10 DDD/1000 between 1991 and 2005. The family of diuretics drugs was the most consumed (3.5 DDD/1000) followed by nonassociated beta-blockers (2 DDD/1000) in 2005. The segmentation was primarily represented by the diuretics (34%) and the beta-blockers (20%). The market of generic antihypertensive drugs passed from 3.3% in 1991 to 21.7% in 2005. The consumption of the antihypertensive drugs in Morocco remains too low in spite of an increasing tendency to depend especially on the generic drugs.

Coronary Artery Disease and Hypertension: Outcomes of a Pharmacist‐Managed Blood Pressure Program

To assess the effectiveness of a pharmacist-managed service in improving hypertension control among patients with coronary artery disease. Prospective cohort study. Setting. Health maintenance organization. Three hundred seventy-six patients with uncontrolled hypertension and coronary artery disease. Pharmacist-managed, physician-supervised population-management approach to optimize evidence-based drug management. Blood pressure reduction and control were evaluated, as well as the use of angiotensin-converting enzyme inhibitors and generic antihypertensive drugs during 7-month follow-up. At baseline, mean +/- SD age was 70.4 +/- 8.8 years, 247 (65.7%) were men, 201 (53.5%) had a history of myocardial infarction, and 237 (63.0%) had diabetes mellitus. Baseline mean systolic blood pressure was 151 mm Hg, and none had achieved their blood pressure goal. During follow-up, mean systolic blood pressure decreased 16.1 mm Hg overall (p<0.001), and 179 (47.6%) patients achieved their goal blood pressure (p<0.001). Blood pressure reductions were 14.7 and 18.4 mm Hg in patients with and patients without diabetes, respectively (p<0.001). The target dose for angiotensin-converting enzyme inhibitors was achieved in 252 (67.0%) patients compared with 102 (27.1%) at baseline (p<0.001). Generic fill rates for antihypertensive drugs continued to be higher than 95% during follow-up (p=0.723). A pharmacist-managed, physician-supervised population-management approach in patients with coronary artery disease significantly improved blood pressure control. Clinically meaningful reductions in blood pressure were achieved by using evidence-based, cost-effective drug regimens.