Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Nov 2014
ReviewMortality rate in so-called "metformin-associated lactic acidosis": a review of the data since the 1960s.
The aim of this study is to study the mortality rate in so-called "metformin-associated lactic acidosis" (MALA) from the 1960s to date and to establish whether the rate has changed over time. ⋯ The overall mortality rate for MALA was around 50% during the period 1960-2000 but has since fallen to around 25%.
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Pharmacoepidemiol Drug Saf · Nov 2014
Cardiovascular and mortality risks in older Medicare patients treated with varenicline or bupropion for smoking cessation: an observational cohort study.
To compare cardiovascular and mortality risks in elderly patients treated with varenicline or bupropion for smoking cessation. ⋯ Cardiovascular and mortality risks were not increased in older patients treated with varenicline compared with bupropion for smoking cessation. A potential increase in the risk of stroke with varenicline could not be excluded. Treatment persistence with either drug was low. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.
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Pharmacoepidemiol Drug Saf · Nov 2014
Risk of Guillain-Barré syndrome following pandemic influenza A(H1N1) 2009 vaccination in Germany.
A prospective, epidemiologic study was conducted to assess whether the 2009 pandemic influenza A(H1N1) vaccination in Germany almost exclusively using an AS03-adjuvanted vaccine (Pandemrix) impacts the risk of Guillain-Barré syndrome (GBS) and its variant Fisher syndrome (FS). ⋯ The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany.
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Peginesatide, a long-acting erythropoiesis-stimulating agent, was recalled in February 2013 following reports of serious and sometimes fatal hypersensitivity reactions in dialysis patients who received a first dose. We assessed the relative risks of mortality and morbidity in peginesatide-treated and matched epoetin alfa-treated patients. ⋯ Relative to administration of epoetin alfa, first administration of peginesatide in dialysis patients was acutely associated with higher risk of death or hospitalization as a result of cardiovascular morbidity or symptoms.
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Pharmacoepidemiol Drug Saf · Oct 2014
First-trimester exposure to bupropion and risk of cardiac malformations.
Bupropion is a drug uniquely used both to treat depression and as an aid to smoking cessation. We investigated previously reported associations between first-trimester exposure to bupropion and cardiac defects. ⋯ We did not confirm previously reported associations for left-sided defects overall but had too few exposed cases to evaluate specific defects in this category. We did observe an elevated risk of VSD following first-trimester bupropion use, particularly when used without other antidepressants. This pattern for bupropion alone was observed in all our risk comparisons and was not explained by higher doses or gestational timing.