Carelon Research, Inc.

Minimal data are available on mid- and long-term outcomes following COVID-19 vaccine-associated myocarditis/pericarditis. The COVID Vaccine-Associated Myocarditis/Pericarditis (CAMP) study aims to characterize the mid- and long-term sequelae of myocarditis/pericarditis following administration of any Pfizer-BioNTech COVID-19 vaccine (herein referred to as COMIRNATY®). Herein we describe the rationale and design of CAMP.

This ongoing and actively enrolling multicenter observational cohort study across 32 North American pediatric cardiac centers will include at least 200 patients <21 years-old who presented ≤21 days from COMIRNATY® vaccination and meet the Centers for Disease Control and Prevention (CDC) case definition of probable or confirmed myocarditis/pericarditis or isolated pericarditis. The comparison cohort will consist of 100 patients <21 years-old with COVID-19 associated myocarditis/pericarditis, including those who meet the contemporaneous CDC case definition of multisystem inflammatory syndrome (MIS-C). The study will collect detailed hospital and follow-up data for up to 5 years following illness onset. Electrocardiograms, echocardiograms, and cardiac magnetic resonance (CMR) examinations will be interpreted in core laboratories. The primary outcomes are 1) composite of left ventricular ejection fraction <55% by echocardiogram, findings of myocarditis by original or revised Lake Louise criteria on CMR, and/or the presence of high-grade arrhythmias or conduction system disturbances at 6 months after myocarditis/pericarditis onset; 2) complications, such as death, and non-cardiac morbidities; and 3) patient-reported outcomes of global health, functional status, and quality of life. Analyses will include descriptive statistics and regression modeling.

Still enrolling, with 273 participants currently enrolled as of 10/16/2024 (173 vaccine-associated myocarditis/pericarditis, 100 COVID-19-associated myocarditis/pericarditis) CONCLUSIONS: With long-term follow-up and core laboratories for standardized assessments of cardiac testing, the CAMP study will make important contributions to our understanding of the mid- and long-term cardiac and non-cardiac sequelae of COVID-19 vaccine-associated myocarditis/pericarditis.

Antidepressant treatment patterns may change after women with breast cancer (BC) initiate tamoxifen, potentially impacting health outcomes. We characterized trajectories of antidepressant use after initiating tamoxifen among young and middle-aged women with BC, identifying risk factors for trajectory group membership.

A retrospective cohort included women 18-64 years-old with BC and antidepressant treatment history who received a new tamoxifen dispensing (index date). We measured longitudinal antidepressant use post-index date as 12, monthly, proportion of days covered (PDC) measurements in a 25% random sample of IQVIA PharMetrics® Plus for Academics US claims, 2006-2022. Group-based trajectory models identified latent subgroups of antidepressant use by testing 2-6-group representations; the best model fit determined by the lowest Bayesian Information Criterion, clinical interpretability, and each subgroup comprising ≥ 5% of the cohort. Using multinomial logistic regression, baseline covariates including demographics, depression status and the CYP2D6-inhibitory strength of antidepressants were evaluated as risk factors for the trajectory of antidepressant use after tamoxifen initiation.

Our sample of 851 women followed four distinct antidepressant adherence trajectories after tamoxifen initiation: 12% exhibited immediately decreasing use [mean PDC (sd) 8% (± 7)]; 7% exhibited delayed decreasing use [41% (± 14)]; 20% exhibited dynamic-moderate use [54% (± 15)]; and 60% exhibited consistently high use [91% (+ 7)]. Age, depression, and treatment with non CYP2D6-inhibiting antidepressants were associated with women's trajectory of antidepressant use after initiating tamoxifen.

Nearly 40% of women were nonadherent to antidepressants after tamoxifen initiation. Future research should explore cancer-related and mental health implications of this nonadherence.

The study objective was to describe characteristics and utilization patterns of tirzepatide users with type 2 diabetes (T2D) using the Healthcare Integrated Research Database in the USA.

Adults (≥18 years) included had T2D diagnosis; ≥1 tirzepatide claim (May 2022-January 2023; first claim date = index date); and continuous medical and pharmacy enrollment during the 6-month baseline and follow-up periods from the index date. Baseline demographics, clinical characteristics, and 6-month follow-up dosing and treatment patterns were summarized descriptively.

The study included 15,665 patients with T2D initiating tirzepatide (mean age: 53.2 years; 58.5% women; 76.7% non-Hispanic white). During the 6-month baseline period, hypertension (69.2%), dyslipidemia (69.2%), overweight/obesity (58.4%), and obstructive sleep apnea (22.8%) were commonly reported comorbidities. Over half of the patients (51.2%) had used glucagon-like peptide-1 (GLP-1) receptor agonist (RA) before initiating tirzepatide. The mean glycated hemoglobin (HbA1c) was 7.6% (n = 5175), and 58.4% of these patients had HbA1c ≥7%. The mean body mass index (BMI) was 38.7 kg/m² (n = 3459), and 87.8% of these patients either had Class 1, 2, or 3 obesity. Among patients with a single prescription on each fill date (N = 14,986), 84.1% initiated tirzepatide at ≤5 mg dose. During sixth prescription refill (n = 7304), 56.5% were receiving tirzepatide doses of <10 mg. During the 6-month follow-up period, 69.6% of patients had ≥1 dose escalation and 17.2% had ≥1 dose de-escalation. The mean time to first dose escalation was 59.1 days and first dose de-escalation was 104.8 days. Tirzepatide adherence (proportion of days covered [PDC] ≥80%) was 57.5% and persistence (45-day gap) was 73.3% at 6 months. Of patients who discontinued tirzepatide (n = 4177; 26.7%), 29.1% re-initiated tirzepatide (45-day gap).

Patients with T2D initiating tirzepatide had multimorbidity; uncontrolled diabetes; and mean BMI was consistent with Class 2 obesity. Patients showed favorable tirzepatide adherence and persistence profiles, and the majority remained at <10 mg doses during the 6-month follow-up period.