Estimating Changes in Weight and Metabolic Parameters Before and After Treatment With Cariprazine: A Retrospective Study of Electronic Health Records.

PURPOSE: Weight gain and associated negative cardiometabolic effects can occur as a result of mental illness or treatment with second-generation antipsychotics (SGAs), leading to increased rates of morbidity and mortality. In this analysis, we evaluated the effect of the SGA cariprazine on weight and metabolic parameters in a real-world, retrospective, observational dataset. METHODS: Electronic health records from the Optum Humedica database (October 1, 2014-December 31, 2020) were analyzed during the 12-month period before starting cariprazine (baseline) and for up to 12 months following cariprazine initiation; approved and off-label indications were included. Body weight trajectories were estimated in the overall patient cohort and at 3-, 6-, and 12-month timepoints (primary objective). Changes in hemoglobin A1c (HbA1c), low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides were also evaluated (secondary objectives). Percentages of patients with clinically relevant shifts in body weight, total cholesterol, and fasting triglycerides were also determined. Discontinuation rates for metabolic regulating medications were calculated. Average predicted values were estimated by linear mixed-effects regression models. FINDINGS: A total of 2,301 patients were included; average duration of follow-up was 133.7 days. Average predicted weight change for patients during the cariprazine overall follow-up period was +2.4 kg, with predicted weight changes of +0.8 kg (n = 811), +1.1 kg (n = 350), and +1.4 kg (n = 107) at months 3, 6, and 12, respectively. Overall, the majority of patients did not experience clinically significant (≥7%) weight gain (82.8%) or loss (90.5%) after starting cariprazine. Average predicted HbA1c levels (n = 189) increased during baseline (0.15%/year) and decreased during cariprazine treatment (-0.2%/year). Average predicted triglyceride levels (n = 257) increased during baseline (15.0 mg/dL/year) and decreased during cariprazine treatment (-0.7 mg/dL/year). Predicted LDL (n = 247) and HDL (n = 255) values decreased during baseline (-7.3 and -1.1 mg/dL/year, respectively); during cariprazine treatment, LDL increased by 5.6 mg/dL/year and HDL decreased by -0.6 mg/dL/year. During follow-up, most patients did not shift from normal/borderline to high total cholesterol (<240 to ≥240 mg/dL; 522 [90.2%]) or fasting triglyceride (<200 to ≥200 mg/dL; 143 [88.8%] patients) levels; shifts from high to normal/borderline levels occurred in 44 (61.1%) patients for total cholesterol and 38 (57.6%) patients for fasting triglycerides. After starting cariprazine, the discontinuation rate per 100 patient-years was 60.4 for antihyperglycemic medication and 87.4 for hyperlipidemia medication. IMPLICATIONS: These real-world results support short-term clinical trial findings describing a neutral weight and metabolic profile associated with cariprazine treatment and they expand the dataset to include long-term follow-up.

Women's perceptions and treatment patterns related to contraception: results of a survey of US women.

OBJECTIVES: The aim of this survey was to understand US women's contraception journey from her first prescribed method to her current one including reasons for choosing and stopping/switching methods, healthcare provider relationships, and bleeding preferences. STUDY DESIGN: We administered a nationally-representative, web-based survey of US women aged 16 to 50 years currently using (N=1656) or had previously used (N=1448) prescription contraception, or who had never used it but would consider using it in the future (N=103). Statistical analyses were based on overlap formulae with sample weights adjusted to 2010 US census demographic benchmarks. RESULTS: The survey was sent to 11,906 women, and 5957 responded (50% response rate). Among qualified respondents, 3104 had experience with prescription contraception. Oral contraceptives (OC) remain the most frequently prescribed method as first or subsequent contraception. However, as women switch to their current prescription method, more chose IUD contraception. As reported by respondents, only 48% of current users received counseling on how to use specific methods, and 58% were counseled on bleeding patterns to expect, while 67% were offered counseling on potential side effects. Many of the side effects reported in this study for first and current prescription contraception were nonspecific and may be related to a nocebo effect, lack of understanding about normal bodily fluctuations, or poor compliance. Many women (34%) reported 'making their periods lighter' as a reason for using their current prescription method, and 53% would prefer to skip their monthly period altogether. CONCLUSIONS: Misperceptions about contraception are common, and prescription contraception choice can be quite complex. Clinicians can enhance patient satisfaction by providing adequate information and matching methods to women's lifestyles, reproductive choices, and pregnancy risk. IMPLICATIONS: This study provides insight into modern women's attitudes and views toward prescription contraception that may be important to clinicians and women themselves.