Characteristics and outcomes of pregnancies in the Maternal Outcomes Masterset real-world database.

PURPOSE: Describe patient characteristics and pregnancy outcomes among all pregnant patients, and additionally describe infant outcomes among the subset with linked infants in the Maternal Outcomes Masterset (MOM). METHODS: We used closed claims within the MOM data to identify publicly and privately insured patients at the first record of pregnancy January 1, 2018-December 1, 2021, with ≥180 days baseline enrollment. We described characteristics during baseline and follow-up (until an observed pregnancy endpoint, disenrollment, or 42-week maximum). We described maternal and infant characteristics overall and by infant linkage and contextualized them within national statistics. RESULTS: Among the 1 438 861 pregnant patients meeting the study criteria, the most common pregnancy endpoint recorded was live birth (42%) followed by spontaneous abortion (14%). Among 602 721 patients with a live birth, 99% had a week-specific gestational age recorded and 35% had at least one linked infant. Patients with infant linkage and sufficient follow-up (N = 155 621) had similar baseline comorbidities, pregnancy complications, and gestational age at delivery as those without any linkage. However, more patients with linkage had commercial coverage (70% vs. 31%), and were therefore older (50% vs. 31% aged ≥30 years) and more likely to have an unknown race (57% vs. 34%). CONCLUSIONS: In this large sample of pregnant patients, maternal and infant characteristics generally align with national statistics, providing confidence in the use of this data source for pregnancy research. Further, confirmation that the subset of patients with infant linkage is similar to the overall pregnancy cohort provides assurance that this subset can be considered representative.

Treatment Patterns and Healthcare Resource Utilization Among Newly Diagnosed Psoriasis, Psoriatic Arthritis, Axial Spondyloarthritis, and Hidradenitis Suppurativa Patients with Past Diagnosis of an Inflammatory Condition: A Retrospective Cohort Analysis of Claims Data in the United States.

INTRODUCTION: Psoriasis (PSO), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and hidradenitis suppurativa (HS) are chronic inflammatory diseases (CIDs) often diagnosed and treated individually. However, genetic overlaps exist among CIDs, and patients with one are at risk of developing others within the same spectrum. This analysis characterized treatment patterns along with clinical and economic burdens of newly diagnosed CIDs among patients with an additional past diagnosis of PSO, PsA, axSpA, or HS. METHODS: This study used MarketScan® databases to examine demographics, treatment patterns, and healthcare resource utilization for patients with ≥ 1 claim for PSO or HS or ≥ 2 claims for PsA or axSpA, and continuous enrollment in the year before (baseline period) and following (follow-up period) the date of first diagnosis (incident diagnosis). Comorbidities and new CID diagnoses with a past diagnosis of PSO, PsA, axSpA, or HS, were examined. RESULTS: The analysis included 298,794 patients (maximum of 1202 patients with ≥ 1 incident diagnoses): 134,233 had incident PSO; 9914 had incident PsA; 115,194 had incident axSpA; and 40,655 had incident HS. Prevalence of ≥ 1 CID diagnosis among patients with past diagnosis of PSO, PsA, axSpA, or HS was 4959/134,233 (3.7%), 5256/9914 (53.0%), 3205/115,194 (2.8%), and 1180/40,655 (2.9%), respectively. In patients with incident axSpA and past PsA diagnosis, incident axSpA and past HS diagnosis, and incident HS and past PSO diagnosis, steroid and opioid use were high across baseline and follow-up periods and use of biologic disease-modifying antirheumatic drugs increased from baseline to follow-up. Disease-related costs increased absolutely and increased or remained high as a proportion of all-cause costs. CONCLUSION: Patients with newly diagnosed CIDs and additional past diagnosis of PSO, PsA, axSpA, or HS experienced high treatment utilization and healthcare costs. These findings highlight the need for payers, health technology assessment agencies, clinicians, and other stakeholders to explore the co-management of CIDs, rather than treating them separately.

A comparison of postpartum opioid consumption and opioid discharge prescriptions among opioid-naïve patients and those with opioid use disorder.

BACKGROUND: Management of patients with opioid use disorder during the acute postpartum period remains clinically challenging as obstetricians aim to mitigate postdelivery pain while optimizing recovery support. OBJECTIVE: This study aimed to evaluate postpartum opioid consumption and opioids prescribed at discharge among patients with opioid use disorder treated with methadone, buprenorphine, and no medication for opioid use disorder, as compared with opioid-naïve counterparts. STUDY DESIGN: We conducted a retrospective cohort study of pregnant patients who underwent delivery at >20 weeks' gestation at a tertiary academic hospital between May 2014 and April 2020. The primary outcome of this analysis was the mean daily quantity of oral opioids consumed after delivery while inpatient, in milligrams of morphine equivalents. Secondary outcomes included the following: (1) quantity of oral opioids prescribed at discharge, and (2) prescription for oral opioids in the 6 weeks after hospital discharge. Multiple linear regression was used to compare differences in the primary outcome. RESULTS: A total of 16,140 pregnancies were included. Patients with opioid use disorder (n=553) consumed 14 milligrams of morphine equivalents per day greater quantities of opioids postpartum than opioid-naïve women (n=15,587), (95% confidence interval, 11-17). Patients with opioid use disorder undergoing cesarean delivery consumed 30 milligrams of morphine equivalents per day greater quantities of opioids than opioid-naïve counterparts (95% confidence interval, 26-35). Among patients who underwent vaginal delivery, there was no difference in opioid consumption among patients with and without opioid use disorder. Compared with patients prescribed methadone, patients prescribed buprenorphine, and those prescribed no medication for opioid use disorder consumed similar opioid quantities postpartum following both vaginal and cesarean delivery. Among patients undergoing cesarean delivery, opioid-naïve patients were more likely to receive a discharge prescription for opioids than patients with opioid use disorder (77% vs 68%; P=.002), despite lower pain scores and less inhospital opioid consumption. CONCLUSION: Patients with opioid use disorder, regardless of treatment with methadone, buprenorphine, or no medication for opioid use disorder consumed significantly greater quantities of opioids after cesarean delivery but received fewer opioid prescriptions at discharge.

Using primary care data to assess comparative effectiveness and safety of apixaban and rivaroxaban in patients with nonvalvular atrial fibrillation in the UK: an observational cohort study.

OBJECTIVE: To compare real-world effectiveness and safety of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation (AFib) for prevention of stroke. STUDY DESIGN AND SETTING: A comparative cohort study in UK general practice data from The Health Improvement Network database. PARTICIPANTS AND INTERVENTIONS: Before matching, 5655 patients ≥18 years with nonvalvular AFib who initiated at least one DOAC between 1 July 2014 and 31 December 2020 were included. DOACs of interest included apixaban, rivaroxaban, edoxaban and dabigatran, with the primary comparison between apixaban and rivaroxaban. Initiators of DOACs were defined as new users with no record of prescription for any DOAC during 12 months before index date. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was stroke (ischaemic or haemorrhagic). Secondary outcomes included the occurrence of all-cause mortality, myocardial infarction (MI), transient ischaemic attacks (TIA), major bleeding events and a composite angina/MI/stroke (AMS) endpoint. RESULTS: Compared with rivaroxaban, patients initiating apixaban showed similar rates of stroke (HR: 0.93; 95% CI 0.64 to 1.34), all-cause mortality (HR: 1.03; 95% CI 0.87 to 1.22), MI (HR: 0.95; 95% CI 0.54 to 1.68), TIA (HR: 1.03; 95% CI 0.61 to 1.72) and AMS (HR: 0.96; 95% CI 0.72 to 1.27). Apixaban initiators showed lower rates of major bleeding events (HR: 0.60; 95% CI 0.47 to 0.75). CONCLUSIONS: Among patients with nonvalvular AFib, apixaban was as effective as rivaroxaban in reducing rate of stroke and safer in terms of major bleeding episodes. This head-to-head comparison supports conclusions drawn from indirect comparisons of DOAC trials against warfarin and demonstrates the potential for real-world evidence to fill evidence gaps and reduce uncertainty in both health technology assessment decision-making and clinical guideline development.

Prescription opioid fills following surgical abortion.

OBJECTIVE: To characterize opioid fills after surgical abortion among US commercially-insured women. STUDY DESIGN: We identified women aged 15-50 years with an outpatient claim for dilation and curettage or evacuation surgical abortion (D&C/D&E) in IBM MarketScan 2015-2018 and excluded patients with > 1 opioid fill in the prior 90 days, evidence of opioid dependence or abuse in the prior 180 days (baseline), miscarriage in 7 days prior, or mifepristone use in 3 to 7 days prior. We describe the frequency of an oral opioid fill within 7 days after abortion, refill within 42 days of initial fill, and chronic use (≥ 6 fills) in 1 year after abortion. We used multivariable logistic regression to evaluate predictors of opioid fill including patient and procedure characteristics. RESULTS: Among 28,252 patients who underwent induced surgical abortion, 2,340 (8.3%) filled an opioid prescription within 7 days. The strongest predictors of opioid fill were non-Northeast region, use of moderate sedation for the procedure, and baseline depression. Among 2,250 patients with an initial fill and sufficient follow-up, 10.0% had a refill within 42 days of initial fill. Among 15,353 patients with sufficient follow-up, patients with an opioid fill after abortion had a higher percentage of subsequent chronic use than those without (2.1% and 0.4%, respectively). CONCLUSION: The frequency of an opioid fill after surgical abortion among commercially-insured women was notable given it is not recommended for post-procedural analgesia. Opioid prescribing contrary to recommendations may be associated with subsequent chronic use or abuse. IMPLICATIONS STATEMENT: Despite public health efforts to decrease opioid prescribing, these findings suggest opioid prescribing after surgical abortion as a potential source of overprescribing among commercially insured patients in the United States. As surgical abortion is a minimally-invasive procedure, prescribing opioids for use in this setting may contribute to chronic use.

Outcomes Associated With Oral Anticoagulants Plus Antiplatelets in Patients With Newly Diagnosed Atrial Fibrillation.

Importance: Patients with nonvalvular atrial fibrillation at risk of stroke should receive oral anticoagulants (OAC). However, approximately 1 in 8 patients in the Global Anticoagulant Registry in the Field (GARFIELD-AF) registry are treated with antiplatelet (AP) drugs in addition to OAC, with or without documented vascular disease or other indications for AP therapy. Objective: To investigate baseline characteristics and outcomes of patients who were prescribed OAC plus AP therapy vs OAC alone. Design, Setting, and Participants: Prospective cohort study of the GARFIELD-AF registry, an international, multicenter, observational study of adults aged 18 years and older with recently diagnosed nonvalvular atrial fibrillation and at least 1 risk factor for stroke enrolled between March 2010 and August 2016. Data were extracted for analysis in October 2017 and analyzed from April 2018 to June 2019. Exposure: Participants received either OAC plus AP or OAC alone. Main Outcomes and Measures: Clinical outcomes were measured over 3 and 12 months. Outcomes were adjusted for 40 covariates, including baseline conditions and medications. Results: A total of 24 436 patients (13 438 [55.0%] male; median [interquartile range] age, 71 [64-78] years) were analyzed. Among eligible patients, those receiving OAC plus AP therapy had a greater prevalence of cardiovascular indications for AP, including acute coronary syndromes (22.0% vs 4.3%), coronary artery disease (39.1% vs 9.8%), and carotid occlusive disease (4.8% vs 2.0%). Over 1 year, patients treated with OAC plus AP had significantly higher incidence rates of stroke (adjusted hazard ratio [aHR], 1.49; 95% CI, 1.01-2.20) and any bleeding event (aHR, 1.41; 95% CI, 1.17-1.70) than those treated with OAC alone. These patients did not show evidence of reduced all-cause mortality (aHR, 1.22; 95% CI, 0.98-1.51). Risk of acute coronary syndrome was not reduced in patients taking OAC plus AP compared with OAC alone (aHR, 1.16; 95% CI, 0.70-1.94). Patients treated with OAC plus AP also had higher rates of all clinical outcomes than those treated with OAC alone over the short term (3 months). Conclusions and Relevance: This study challenges the practice of coprescribing OAC plus AP unless there is a clear indication for adding AP to OAC therapy in newly diagnosed atrial fibrillation.