Retrospective study of incidence/prevalence of pigmentary maculopathy and retinopathy in patients receiving pentosan polysulfate sodium.

Purpose: To evaluate prevalence and incidence rates of pigmentary maculopathy and retinopathy (PM/PR), and visual acuity (VA) changes in patients exposed to pentosan polysulfate sodium (PPS) and in patients with interstitial cystitis (IC) not exposed to PPS.

Methods: This is a retrospective cohort study (January 2015-March 2021) which included adult de-identified patients from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) and Komodo Health database. Three patient cohorts were identified: two PPS-exposed patient cohorts, and Non-PPS-exposed IC patient cohort.

Incidence of fibrosing colonopathy with pancreatic enzyme replacement therapy in patients with cystic fibrosis.

Background: High daily doses of pancreatic enzyme replacement therapy (PERT) were historically associated with risk of fibrosing colonopathy (FC) in people with cystic fibrosis (pwCF), leading to development of PERT dosing guidelines and reformulated products. This study quantified incidence of FC in pwCF treated with PERT following those measures.

Methods: This large prospective cohort study included eligible pwCF enrolled in the Cystic Fibrosis Foundation Patient Registry with ≥1 clinic visit in 2012-2014 and follow-up through 2020.

Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US.

Objective: The risk of retinal detachment (RD) following exposure to fluoroquinolone (FQ) has been assessed in multiple studies, however, results have been mixed. This study was designed to estimate the risk of RD following exposure to FQ, other common antibiotics, and febrile illness not treated with antibiotics (FINTA) using a self-controlled case series (SCCS) study design to reduce risk of confounding from unreported patient characteristics.

Design: Retrospective database analysis-SCCS.

Baseline risk characterization of early versus later adopters of long-acting paliperidone palmitate formulations.

Early Post-Marketing Phase Vigilance (EPPV) is a unique system that encourages reporting of serious adverse reactions for medications newly introduced to Japan. When a once-monthly paliperidone palmitate formulation (PP1M) was introduced in Japan in 2013, EPPV detected a signal of increased mortality, but this signal was not subsequently confirmed. To clarify whether that signal reflected increased adverse event reporting or an atypically high baseline mortality risk among early adopters of PP1M, we evaluated the baseline risk characteristics of early, mid, and later adopters of PP1M in a Japanese database and did a similar evaluation of PP1M and the three-monthly formulation (PP3M) in two US databases.

Risk of aortic aneurysm and dissection following exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US.

Objective: Recent observational studies suggest increased aortic aneurysm or dissection (AAD) risk following fluoroquinolone (FQ) exposure but acknowledge potential for residual bias from unreported patient characteristics. The objective of our study is to evaluate the potential association between FQ, other common antibiotics and febrile illness with risk of AAD using a self-controlled case series (SCCS) study design.

Design: Retrospective database analysis-SCCS.

Medications for attention-deficit/hyperactivity disorder in Japan: A retrospective cohort study of label compliance.

Aim: To assess label compliance in prescription of medications approved for treatment of attention-deficit/hyperactivity disorder (ADHD) in Japan at the time of this study: methylphenidate (MPH), atomoxetine, and guanfacine.

Methods: Retrospective descriptive study was conducted in prevalent-user cohorts from the Japan Medical Data Center database. Patients who were prescribed a study drug between January 1, 2013 and September 30, 2018 and were in the database for ≥30 days were included.

Understanding patient journey in ulcerative colitis prior to biologic initiation: a 5-year exploration.

Background: There has been a more pronounced shift toward earlier, more aggressive therapies in Crohn's disease than in ulcerative colitis (UC). The aim of this study was to describe the pre-biologic treatment and health care experience, including co-morbidities and overall health care utilization, for UC patients who initiated biologic therapies, in the 5 years prior to the initiation of the first biologic agent.

Methods: UC patients who initiated a biologic agent approved for UC between 9/15/2005 and 1/30/2018 were identified from the IBM® MarketScan® Commercial Database, a large US database.

Stroke Risk Among Elderly Users of Haloperidol and Typical Antipsychotics Versus Atypical Antipsychotics: A Real-World Study From a US Health Insurance Claims Database.

Background: We estimated stroke risk associated with new exposure to haloperidol, or any typical antipsychotic, versus atypical antipsychotic among patients aged ≥65 years regardless of dementia status.

Methods: IBM MarketScan Medicare Supplemental Database data (January 1, 2001 to December 31, 2017) were used. Stroke risk for new users of typical antipsychotics (T1 cohort) or haloperidol (T2 cohort) was compared with new users of atypical antipsychotics (C1 cohort) aged ≥65 years.

Channeling Bias in the Analysis of Risk of Myocardial Infarction, Stroke, Gastrointestinal Bleeding, and Acute Renal Failure with the Use of Paracetamol Compared with Ibuprofen.

Introduction: Observational studies estimating severe outcomes for paracetamol versus ibuprofen use have acknowledged the specific challenge of channeling bias. A previous study relying on negative controls suggested that using large-scale propensity score (LSPS) matching may mitigate bias better than models using limited lists of covariates.

Objective: The aim was to assess whether using LSPS matching would enable the evaluation of paracetamol, compared to ibuprofen, and increased risk of myocardial infarction, stroke, gastrointestinal (GI) bleeding, or acute renal failure.

Evaluation of disability in patients exposed to fluoroquinolones.

Background: Fluoroquinolones are used for conditions including sinusitis, bronchitis, and urinary tract infections. It has been suggested that exposure to fluoroquinolones for these conditions is associated with disability resulting from adverse events in 2 or more organ systems. The objectives were to: describe: 1) fluoroquinolone, azithromycin, and sulfamethoxazole / trimethoprim utilization for these infections; 2) the rate of disability associated with exposure to each of these antibiotic classes and adverse events in 2 or more system organ classes, and 3) compare outcome rates for each of the antibiotic classes.

Developing Predictive Models to Determine Patients in End-of-Life Care in Administrative Datasets.

Introduction: In observational studies with mortality endpoints, one needs to consider how to account for subjects whose interventions appear to be part of 'end-of-life' care.

Objective: The objective of this study was to develop a diagnostic predictive model to identify those in end-of-life care at the time of a drug exposure.

Methods: We used data from four administrative claims datasets from 2000 to 2017.

All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population.

Background: Treatment-resistant depression (TRD) may represent a substantial proportion of major depressive disorder (MDD); however, the risk of mortality in TRD is still incompletely assessed.

Methods: Data were obtained from Optum Clinformatics™ Extended, a US claims database. Date of the first antidepressant (AD) dispensing was designated as the index date for study entry and 6 months prior to that was considered the baseline period.

Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe.

Background And Objective: Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures.

Methods: In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM.

Corrigendum to "Treatment resistant depression incidence estimates from studies of health insurance databases depend strongly on the details of the operating definition" [Heliyon 4 (7) (July 2018) e00707].

[This corrects the article DOI: 10.1016/j.heliyon.

Treatment resistant depression incidence estimates from studies of health insurance databases depend strongly on the details of the operating definition.

Background: Health services databases provide population-based data that have been used to describe the epidemiology and costs of treatment resistant depression (TRD). This retrospective cohort study estimated TRD incidence and, via sensitivity analyses, assessed the variation of TRD incidence within the range of implementation choices.

Methods: In three US databases widely used for observational studies, we defined TRD as failure of two medications as evidenced by their replacement or supplementation by other medications, and set maximum durations (caps) for how long a medication regimen could remain in use and still be eligible to fail.

Database Studies of Treatment-Resistant Depression Should Take Account of Adequate Dosing.

Background: The objective of this study was to estimate how commonly patients with pharmacologically treated depression (PTD) do not receive adequate doses of antidepressant (AD) medications. Such prescribing would have epidemiologic and clinical implications. Patients with PTD have treatment-resistant depression (TRD) if they do not benefit from ≥ 2 AD medications taken with reasonable compliance for adequate durations at adequate doses.

Medication changes after switching from CONCERTA® brand methylphenidate HCl to a generic long-acting formulation: A retrospective database study.

Background: Observational studies of switching from branded to generic formulations of the same drug substance often lack appropriate comparators for the subjects who switched. Three generic formulations were deemed equivalent to Concerta: an authorized generic (AG) identical except for external packaging, and two other generics (EG).

Objective: Compare the incidence of a combined endpoint (switching back to Concerta, changing the use of immediate release methylphenidate (MPH), stopping all long-acting methylphenidate, or starting a new medication) among people switched from Concerta to the AG versus the EG.

Inferring pregnancy episodes and outcomes within a network of observational databases.

Administrative claims and electronic health records are valuable resources for evaluating pharmaceutical effects during pregnancy. However, direct measures of gestational age are generally not available. Establishing a reliable approach to infer the duration and outcome of a pregnancy could improve pharmacovigilance activities.

Finding treatment-resistant depression in real-world data: How a data-driven approach compares with expert-based heuristics.

Background: Depression that does not respond to antidepressants is treatment-resistant depression (TRD). TRD definitions include assessments of treatment response, dose and duration, and implementing these definitions in claims databases can be challenging. We built a data-driven TRD definition and evaluated its performance.

Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications.

Introduction: Over-the-counter analgesics such as paracetamol and ibuprofen are among the most widely used, and having a good understanding of their safety profile is important to public health. Prior observational studies estimating the risks associated with paracetamol use acknowledge the inherent limitations of these studies. One threat to the validity of observational studies is channeling bias, i.

Epidemiology of pharmaceutically treated depression and treatment resistant depression in Taiwan.

Epidemiologic data on treatment resistant depression (TRD) in Asia-Pacific countries are limited. We estimated the incidence of TRD in Taiwan using a cohort of 704,265 adults randomly sampled from Taiwan's National Health Insurance Research database for 2005. TRD was defined as a patient having pharmaceutically treated depression (PTD) not adequately responding to 2 antidepressant (AD) regimens, i.

Quantification of missing prescriptions in commercial claims databases: results of a cohort study.

Purpose: This study aims to quantify the magnitude of missed dispensings in commercial claims databases.

Methods: A retrospective cohort study has been used linking PharMetrics, a commercial claims database, to a prescription database (LRx) that captures pharmacy dispensings independently of payment method, including cash transactions. We included adults with dispensings for opioids, diuretics, antiplatelet medications, or anticoagulants.

Improving the Identification of Out-of-Hospital Sudden Cardiac Deaths in a General Practice Research Database.

Background: The ascertainment of sudden cardiac death (SCD) in electronic health databases is challenging.

Objectives: Our objective was to evaluate the applicability of the validated computer definition of SCD developed by Chung et al. in a retrospective study of SCD and domperidone exposure in the Clinical Practice Research Datalink (CPRD).