This real-world study suggests that patients with schizophrenia or BD who began receiving LAIs had better medication adherence and lower discontinuation risk than those who changed to a different oral antipsychotic monotherapy.

Besides direct healthcare costs, BDI was associated with substantial direct non-healthcare and indirect costs. More effective treatments and practices are needed to optimize therapeutic strategies and contain direct and indirect costs.

IntroductionFew studies have compared adherence between long-acting injectable antipsychotics, especially for newer agents like aripiprazole once-monthly 400 mg (AOM 400; aripiprazole monohydrate) and oral antipsychotics, in patients with schizophrenia or bipolar I disorder (BD-I) in a real-world setting.MethodsTwo separate retrospective cohort analyses using Truven MarketScan data from January 1, 2012 to June 30, 2016 were conducted to compare medication adherence and discontinuation in patients with schizophrenia or BD-I who initiated treatment with AOM 400 vs. patients changed from one oral antipsychotic monotherapy to another. Adherence was defined as proportion of days covered (PDC) ≥ 0.80 in the year following the index date. Linear regression models examined the association between AOM 400 and oral antipsychotic cohorts and medication adherence. Kaplan–Meier curves and Cox regression estimated time to and risk of discontinuation, while adjusting for baseline covariates. A sensitivity analysis was conducted using a combination of propensity score matching and exact matching to create matched cohorts.ResultsFinal cohort sizes were as follows—Schizophrenia: AOM 400 n = 408, oral antipsychotic n = 3361; BD-I: AOM 400 n = 413, oral antipsychotic n = 15,534. In patients with schizophrenia, adjusted mean PDC was higher in patients in the AOM 400 cohort vs. the oral antipsychotic cohort (0.57 vs. 0.48 P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuing treatment vs. the AOM 400 cohort (HR 1.45, 95% CI 1.29–1.64). For patients with BD-I, adjusted mean PDC was higher for the AOM 400 cohort (0.59 vs. 0.44, P < 0.001), and patients in the oral antipsychotic cohort had a higher risk of discontinuation (HR 1.71, 95% CI 1.53–1.92).ConclusionsIn a real-word setting, AOM 400 resulted in a significantly higher percentage of patients with a PDC ≥ 0.80 and significantly longer time to treatment discontinuation compared to patients with schizophrenia or BD-I who received treatment with an oral antipsychotic.FundingOtsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0785-y) contains supplementary material, which is available to authorized users.

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Background: It is well established that the different antipsychotics used for schizophrenia symptoms differ substantially in their side effects. However, relatively little is known about the impact of these side effects on functioning from the patient's perspective. We aimed to understand how key side effects of second-generation antipsychotics impact the functioning and quality of life (QoL) of patients with schizophrenia. Methods: This is a cross-sectional, web-based survey of patient-reported side effect burden of antipsychotic drugs in adults with schizophrenia. The survey was deployed in the United States, Canada, Australia, Spain, Italy, Norway, and Denmark. It included sociodemographic and clinical questions, the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF), and the Glasgow Antipsychotic Side-Effect Scale (GASS). Eight pre-defined key side effects classified as activating ("Shaky hands or arms, " "Restlessness, " and "Difficulty sleeping"), sedating ("Sleepy during the day", "Feeling drugged or like a zombie, " and "Feeling dizzy/Fainted") or other side effects ("Problems enjoying sex" and "Gaining weight"), and additional questions related to impacts on function and quality of life were asked. Results: In total, 435 participants (mean age: 38 years, 53.8% female) were included. The total Q-LES-Q-SF score indicated overall medium satisfaction with their quality of life (score of 44.3; possible range 14-70). The most prevalent side effects were "Sleepy during the day" (83.2%), "Difficulty sleeping" (74.7%), "Dry mouth" (63.9%), "Problems enjoying sex" (53.4%) and "Gaining weight" (52.4%). Women reported the side effects of "Sleepy during the day", "Problems enjoying sex" and "Gaining weight" more frequently than men. Key side effects impacted physical, social, occupational and psychological aspects of functioning. Patients with key side effects often felt frustrated by their experiences. Total Q-LES-Q-SF score showed a significant inverse correlation with the score of pre-defined groups of side effects indicating worse QoL in association with more severe key side effects in these patients. Conclusion: Stable patients with schizophrenia taking second-generation antipsychotics live with many side effects, including activating and sedating side effects, sexual side effects, and weight gain. Presence of these side effects is associated with substantial impacts across all aspects of daily functioning and lower quality of life and satisfaction.

BackgroundBipolar disorder type I (BD-I) is a chronic condition characterized by mania episodes followed by syndromic recovery periods, usually permeated by depressive symptoma-tology and recurring acute manic episodes. It requires long-term pharmacological treatment; thus, it is critical to understand the patterns of drug therapy use and medication compliance to better plan health care policies and needs. This systematic literature review aims to study these data among patients with BD-I in the USA, focusing on medications to treat mania.MethodsArticles published in the last 10 years to October 2016 were searched on MEDLINE and Embase. Studies on patterns of drug therapy, concordance of prescription with clinical practice guidelines, and adherence and persistence with pharmacological treatments for BD-I in the USA under observational conditions, with focus on treatments for mania, were selected.ResultsTreatment prevalence for BD-I is low in the USA, with the most current study showing a 46% 12-month rate. There is a lack of studies addressing the use of long-acting injectable (LAI) antipsychotics. Second-generation antipsychotics (SGAs) have been used by nearly all patients receiving oral antipsychotics since the 2000s. However, 30%–60% of individuals with BD do not receive appropriate treatment, and adherence to oral therapies is poor, with medication possession ratios ≥80% seen in only approximately 60% of patients. For persistence rates, results suggest that treatment duration is short for a condition with recommendation for at least 6 months of maintenance therapy. Literature indicates that LAI SGAs may be related to better adherence and persistence.ConclusionThere is a need for studies addressing specifically patterns of therapy and adherence to pharmacological treatment in BD-I patients in the USA to better understand the value of current standards, and an urgent need to improve the rates of adherence and persistence to BD-I pharmacotherapy and to increase the understanding of LAI SGAs’ potential to address this issue.

The goal of this 21-year naturalistic study of clozapine treated patients was to examine the cardiovascular risk factors following clozapine initiation and resultant mortality estimates from cardiovascular disease. Data was collected from medical records of clozapine treated patients with schizophrenia or schizoaffective disorder from January 1992 to February 2012. Demographics, clozapine dosage and laboratory results were extracted at 12-month intervals. At clozapine initiation, the mean age of 96 patients was 36.4 years ±7.6 years; N=27(28%) were women. The mean duration of clozapine use was 13 years. The Kaplan-Meier estimate for 21-year cardiovascular events was 29%, while the Kaplan-Meier estimate for 21-year mortality from cardiovascular disease was 10%. The mean cardiovascular risk increased during the first ten years (p<.01), while a slight decrease occurred beyond ten years (p<.01). Patients involved in cardiometabolic research showed a greater decrease in cardiovascular risk factors over 21 years (p = .05). The Kaplan-Meier estimate for 21-year all-cause mortality was 22%. Forty-one patients were diagnosed with diabetes (42.7%), compared to a nationwide prevalence of 13.7% in a similar age group. These results support the hypothesis that clozapine-treated patients are at risk for cardiovascular events and death secondary to an increased risk of medical disorders. Interventions that target weight loss, smoking cessation, and lipid profile improvement may alleviate the increased risk of cardiovascular mortality.

Our analyses indicate that a substantial number of patients received diagnoses of both SCZ and BD-I, based on claims, in a 2.5-year period. Patients with a diagnosis of both SCZ and BD-I had higher health care utilization and costs than patients with either diagnosis alone. We identified differential patient characteristics, utilization of medications and health care services, and health care costs among the cohorts.