Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada: A Population-Based Time Series Analysis.
نویسندگان
چکیده
BACKGROUND Once the patent of a brand-name drug expires, generic drugs are commercialized, and substitution from brand-name to generics may occur. Generic drug equivalence is evaluated through comparative bioavailability studies. Few studies have assessed outcomes after generic drug commercialization at a population level. We evaluated the impact of 3 generic angiotensin II receptor blockers commercialization on adverse events: hospitalizations or emergency room consultations. METHODS AND RESULTS This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for losartan, valsartan, and candesartan users (N=136 177) aged ≥66 years were calculated monthly, 24 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared by negative binomial segmented regression models. Sensitivity analyses were also conducted. For all users, there was a monthly mean rate of 100 adverse events for 1000 angiotensin II receptor blocker users before and after generic commercialization. Among generic users of losartan, valsartan, and candesartan, there was an increase in rates of adverse events of 8.0% (difference of proportions versus brand-name, 7.5% [95% confidence interval, -0.9% to 15.9%]; P=0.0643), 11.7% (difference of proportions, 17.1% [95% confidence interval, 9.9%-24.3%]; P<0.0001), and 14.0% (difference of proportions, 16.6% [95% confidence interval, 7.9%-25.3%]; P<0.0001), respectively, the month of generic commercialization. The monthly trend of adverse events was affected for generic versus brand-name losartan users only (difference of proportions, 2.0% [0.7%-3.4%]; P=0.0033) ≤1 year after generics commercialization. Similar results were found in sensitivity analyses. CONCLUSIONS Among generic users, immediate or delayed differences in adverse events rates were observed right after generic commercialization for 3 antihypertensive drugs. Rates of adverse events remained higher for generic users. Increases were more pronounced for generic candesartan, which is the studied product with the largest difference in comparative bioavailability. Risk and survival analysis studies controlling for several potential confounding factors are required to better characterize generic substitution.
منابع مشابه
Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada
متن کامل
The pivotal link between ACE2 deficiency and SARS-CoV-2 infection
Angiotensin converting enzyme-2 (ACE2) receptors mediate the entry into the cell of three strains of coronavirus: SARS-CoV, NL63 and SARS-CoV-2. ACE2 receptors are ubiquitous and widely expressed in the heart, vessels, gut, lung (particularly in type2 pneumocytes and macrophages), kidney, testisand brain. ACE2 is mostly bound to cell membranes and only scarcely present in the circulation in a s...
متن کاملRationalization of Physicochemical and Structural Requirement of Some Substituted 5-(Biphenyl-4-ylmethyl)Pyrazole as Angiotensin II Receptor Antagonist: A QSAR Approach
A series of angiotensin II (A II) receptor antagonist of some substituted 5-(biphenyl-4-ylmethyl) pyrazole were subjected to QSAR analysis using Hansch and Fujita-Ban model, by using combination of thermodynamic, electronic, spatial descriptor and presence or absence of substituent respectively. Several QSAR model were obtained using stepwise regression analysis. Two models from both the ...
متن کاملNew modalities for treatment of diabetic nephropathy: a mini review
Background and aims: Diabetic nephropathy (DN) is the most common cause of end-stage renal failure which could increase the risk of cardiovascular disease and morbidity and mortality in patients. The aim of this study was to investigate new modalities for treatment of diabetic nephropathy. Methods:This study was a mini-review research to investigate drugs that are used for DN treatment. Resul...
متن کاملInhibitors of Angiotensin-converting Enzyme or Blockers of Angiotensin-2 Receptor in COVID-19 Patients with Comorbid Cardiovascular or Pulmonary Diseases
Following the skyrocketing spread of SARS-CoV-2 into almost all the countries over five continents, diverse clinical strategies are urgently needed to defeat its pandemic, considering that an magic-bullet antiviral vaccine or treatment is presently unavailable. WHO later proclaimed the viral outbreak as a pandemic. Despite this fast speed of the pandemic, any recommended treatment must first...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Circulation. Cardiovascular quality and outcomes
دوره 10 10 شماره
صفحات -
تاریخ انتشار 2017