Risk of adverse events after Omicron XBB-adapted BNT162b2 COVID-19 vaccination in the United States.

Background: Limited data exists regarding the safety of the COVID-19 2023-2024 vaccine formulations and whether the safety profiles differ from the original formulations. We evaluated the association between the BNT162b2 XBB COVID-19 vaccine and the risk of 20 pre-specified adverse events of special interest (AESIs).

Methods: We identified commercially-insured individuals in the US age ≥ 6 months who received the BNT162b2 XBB COVID-19 vaccine between September 11, 2023 and January 15, 2024 within the Optum pre-adjudicated database.

Development and Validation of Claims-Based Algorithms for Conjunctivitis and Keratitis.

Background: Ocular surface disorders have been reported among patients with various medical conditions, including atopic dermatitis (AD). Nonetheless, validated algorithms to identify conjunctivitis and keratitis in claims data are lacking.

Objective: Develop validated, claims-based algorithms for conjunctivitis and keratitis among patients with AD using medical records.

Comparative safety of conjugated estrogens/bazedoxifene versus estrogen/progestin combination hormone therapy among women in the United States: a multidatabase cohort study.

Objective: To assess the risk of select safety outcomes including endometrial cancer, endometrial hyperplasia, and breast cancer among women using conjugated estrogens/bazedoxifene (CE/BZA) as compared with estrogen/progestin combination hormone therapy (EP).

Methods: We conducted a new-user cohort study in five US healthcare claims databases representing more than 92 million women. We included CE/BZA or EP new users from May 1, 2014, to August 30, 2019.

Inpatient Constipation Among Migraine Patients Prescribed Anti-calcitonin Gene-Related Peptide Monoclonal Antibodies and Standard of Care Antiepileptic Drugs: A Retrospective Cohort Study in a United States Electronic Health Record Database.

Introduction: Erenumab, an anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody (mAb), was approved by the US Food and Drug Administration in May 2018. Constipation with serious complications was added to the Warning and Precautions section in the erenumab Prescribing Information in October 2019 after events were observed during post-marketing surveillance. We aimed to assess and compare the risk of inpatient constipation, and, separately, inpatient constipation with serious complications, among patients with migraine treated with CGRP mAbs and standard of care antiepileptic drugs (AEDs).

Trends in COVID-19 patient characteristics in a large electronic health record database in the United States: A cohort study.

Background: Electronic health record (EHR) databases provide an opportunity to facilitate characterization and trends in patients with COVID-19.

Methods: Patients with COVID-19 were identified based on an ICD-10 diagnosis code for COVID-19 (U07.1) and/or a positive SARS-CoV-2 viral lab result from January 2020 to November 2020.

Delayed pregnancy detection and return to fertility with extended levonorgestrel-containing oral contraceptives: A real world setting cohort study.

Purpose: As part of the European risk management plan of a 91-day extended levonorgestrel-containing combined oral contraceptive (COC ), a study was performed to assess its safety. This analysis was conducted to examine delayed pregnancy detection and return to fertility with extended combined oral contraceptives (COC).

Methods: We conducted a retrospective cohort study in new users of 91-day COC or 28-day COC within a US-based healthcare claims database from 2006 to 2017.

Identification of pregnancies and infants within a US commercial healthcare administrative claims database.

Purpose: Health care insurance claims databases are becoming a more common data source for studies of medication safety during pregnancy. While pregnancies have historically been identified in such databases by pregnancy outcomes, International Classification of Diseases, 10th revision Clinical Modification (ICD-10-CM) Z3A codes denoting weeks of gestation provide more granular information on pregnancies and pregnancy periods (i.e.

Predictors of critical care, mechanical ventilation, and mortality among hospitalized patients with COVID-19 in an electronic health record database.

Background: There are limited data on risk factors for serious outcomes and death from COVID-19 among patients representative of the U.S.

Population: The objective of this study was to determine risk factors for critical care, ventilation, and death among hospitalized patients with COVID-19.

Assessment of a Claims-Based ICD-9 and ICD-10 Medication-Related Osteonecrosis of the Jaw Algorithm in the United States.

Purpose: Medication-related osteonecrosis of jaw (MRONJ) is associated with certain drug therapies. Pharmacoepidemiologic studies often rely on electronic healthcare data to assess adverse events following drug exposure. Few studies have developed and validated claims-based MRONJ identification algorithms.

Long-term safety of extended levonorgestrel-containing oral contraceptives in the United States.

Objectives: To compare the safety profile of Seasonique, a 91-day levonorgestrel-containing combined oral contraceptive (COC), to 28-day COC regarding the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE).

Study Design: A new user cohort study was conducted in a US health care database from 2006 to 2017. Each 91-day COC treatment episode in females was matched to up to four 28-day COC treatment episodes by propensity score.

Predictive values of diagnostic codes for identifying serious hypocalcemia and dermatologic adverse events among women with postmenopausal osteoporosis in a commercial health plan database.

Background: Post-marketing safety studies of medicines often rely on administrative claims databases to identify adverse outcomes following drug exposure. Valid ascertainment of outcomes is essential for accurate results. We aim to quantify the validity of diagnostic codes for serious hypocalcemia and dermatologic adverse events from insurance claims data among women with postmenopausal osteoporosis (PMO).

Evidence of herd immunity and sustained impact of rotavirus vaccination on the reduction of rotavirus-related medical encounters among infants from 2006 through 2011 in the United States.

Background: Rotavirus (RV) is the leading cause of severe acute gastroenteritis among young children. Since the US licensure of the pentavalent RV vaccine (RV5) and the monovalent RV vaccine (RV1), a decline of RV activity has been observed.

Objective: To describe patterns of RV-related health care utilization among infants receiving RV vaccines (RVVs).

Modifying roles of glutathione S-transferase polymorphisms on the association between cumulative lead exposure and cognitive function.

Background: Glutathione-S-transferase gene (GST) polymorphisms can result in variable ability of these enzymes to remove electrophilic substrates. We investigated whether the GSTP1 Val105 and GSTM1 deletion polymorphisms modify the lead-cognitive function association.

Methods: We used repeated measures analysis to compare the association between cumulative lead biomarkers-bone lead measured using K-shell X-Ray Fluorescence-and Mini-Mental State Exam (MMSE) score by GST variants, adjusted for covariates, among Normative Aging Study participants, a Boston-based prospective cohort of men.

Effectiveness of an incomplete RotaTeq (RV5) vaccination regimen in preventing rotavirus gastroenteritis in the United States.

Background: Effectiveness of the pentavalent rotavirus vaccine (RV5) after administration of the complete (3 dose) regimen has been demonstrated in a real-world setting. This study assessed the effectiveness of RV5 following partial completion of the 3-dose regimen.

Methods: Using a large national health insurance claims database, 2 cohorts of infants (those who received RV5 and a concurrent group who received diphtheria-tetanus-acellular pertussis, but not RV5) were followed through the 2007 and 2008 rotavirus seasons (January 1 to May 31) to identify cases of rotavirus gastroenteritis and all-cause gastroenteritis resulting in medical care encounters.

Postmarketing evaluation of the short-term safety of the pentavalent rotavirus vaccine.

Background: A pentavalent rotavirus vaccine (RV5) demonstrated efficacy and safety in a large clinical trial before US licensure in 2006. The primary objective of this observational study was to assess the occurrence of intussusception (IS) among infants who received RV5 in routine use. Secondary objectives assessed the occurrence of Kawasaki disease (KD) and general safety.

Effectiveness of the pentavalent rotavirus vaccine in preventing gastroenteritis in the United States.

Objective: In clinical trials, the pentavalent rotavirus vaccine (RV5) was efficacious in preventing severe rotavirus gastroenteritis (RGE) and related health care encounters. We assessed the vaccine effectiveness (VE) of RV5 among US infants during the first 2 rotavirus seasons after vaccine licensure.

Methods: Using a large, national, health insurance claim database, we monitored 2 cohorts of infants (infants who received 3 doses of RV5 and a concurrent group of infants who received 3 doses of diphtheria-tetanus-acellular pertussis vaccine but did not receive RV5) through the 2007 and 2008 rotavirus seasons (January 1 to May 31), to identify cases of RGE and all-cause acute gastroenteritis (AGE) resulting in medical care encounters.

Modifying effects of the HFE polymorphisms on the association between lead burden and cognitive decline.

Background: As iron and lead promote oxidative damage, and hemochromatosis (HFE) gene polymorphisms increase body iron burden, HFE variant alleles may modify the lead burden and cognitive decline relationship.

Objective: Our goal was to assess the modifying effects of HFE variants on the lead burden and cognitive decline relation in older adults.

Methods: We measured tibia and patella lead using K-X-ray fluorescence (1991-1999) among participants of the Normative Aging Study, a longitudinal study of community-dwelling men from greater Boston.