Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Dec 2020
Alzheimer's disease and related dementias risk: Comparing users of non-selective and M3-selective bladder antimuscarinic drugs.
Bladder antimuscarinic (BAM) drug use is associated with increased risk of Alzheimer's disease and related dementias (ADRD). It is hypothesized that BAMs with non-selective receptor binding may increase ADRD risk more than M3-selective BAMs. This study compared ADRD risk for users of non-selective and M3-selective BAMs and examines ADRD risk associated with overall BAM use. ⋯ Non-selective and M3-selective BAM users had similar odds of ADRD incidence, and BAM use overall was significantly associated with ADRD incidence.
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Pharmacoepidemiol Drug Saf · Nov 2020
Improving transparency to build trust in real-world secondary data studies for hypothesis testing-Why, what, and how: recommendations and a road map from the real-world evidence transparency initiative.
Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. Recent examples include the approval of palbociclib in combination with endocrine therapy for male breast cancer and the inclusion of RWE in the label of paliperidone palmitate for schizophrenia. This interest has created an urgency to develop processes that promote trust in the evidence-generation process. ⋯ The plan includes specifying the rationale for registering HETE RWE studies, the studies that should be registered, where and when these studies should be registered, how and when analytic deviations from protocols should be reported, how and when to publish results, and incentives to encourage registration. Table 1 summarizes the rationale, goals, and potential solutions that increase transparency, in addition to unique concerns about secondary data studies. Definitions of terms used throughout this report are provided in Table 2.
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Pharmacoepidemiol Drug Saf · Aug 2020
ReviewConsiderations for pharmacoepidemiological analyses in the SARS-CoV-2 pandemic.
The coronavirus disease 2019 (COVID-19) pandemic has triggered several hypotheses regarding use of specific medicines and risk of infection as well as prognosis. Under these unique circumstances, rapid answers require quick engagement in data collection and analyses; however, appropriate design and conduct of pharmacoepidemiologic studies are needed to generate valid and reliable evidence. In this paper, endorsed by the International Society for Pharmacoepidemiology, we provide methodological considerations for the conduct of pharmacoepidemiological studies in relation to the pandemic across eight domains: (1) timeliness of evidence, including the need to prioritise some questions over others in the acute phase of the pandemic; (2) the need to align observational and interventional research on efficacy; (3) the specific challenges related to "real-time epidemiology" during an ongoing pandemic; (4) what design to use to answer a specific question; (5) considerations on the definition of exposures; (6) what covariates to collect; (7) considerations on the definition of outcomes; and (8) the need for transparent reporting.
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Pharmacoepidemiol Drug Saf · Aug 2020
Incidence rates of and risk factors for opioid overdose in new users of prescription opioids among US Medicaid enrollees: A cohort study.
To measure incidence rates of and risk factors for opioid overdose among new users of prescription opioids in the Medicaid population. ⋯ In Medicaid enrollees in four study states during 2002 to 2012, opioid overdose incidence rate per 100 000 person-years among apparent new users of prescription opioids was 247.1, with 251.0 in 2002 and 225.5 in 2012. Younger ages, white race/ethnicity, higher MME opioid daily doses, prior substance use disorders, mental health conditions, and benzodiazepine prescriptions were associated with a higher risk of opioid overdose incidence.