Two posters presented at the American Psychiatric Association's 2018 Annual Meeting examined the factors patients with schizophrenia consider when deciding whether or not to take their medications and outcomes of a new medication to treat patients with schizophrenia and alcohol use disorder.
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Patients living with schizophrenia weigh a number of factors when considering whether or not to take their medications. In a poster presented at the American Psychiatric Association's 2018 Annual Meeting, patients with schizophrenia or schizoaffective disorder were surveyed on the importance of efficacy and side effects on treatment decisions.1
The survey went to 250 patients with clinical diagnoses of schizophrenia or schizoaffective disorder with the goal of assessing the relative importance to patients of trying a new antipsychotic that might improve symptoms.
“Information from surveys, such as this one, can provide pilot guidance [on] what might be acceptable [versus] unacceptable tradeoffs when considering new therapies for schizophrenia,” the authors wrote.
Efficacy and side effects were both identified as important attributes of schizophrenia medication. In total, 88.5% of patients said the ability to think more clearly was important. In addition, 94.3% of respondents said efficacy and 84% of respondents said side effects were important drivers of taking their prescribed medicine.
Weight gain (61.5%), physical restlessness (60.4%), and somnolence (58.9%) were identified as “very” or “most” important side effects of current treatments. Weight gain has a strong negative influence on a patient’s willingness to try a new antipsychotic. Less than half (44.9%) said they would decline a medication that would lead to weight gain between 3 pounds and 11 pounds. A larger anticipated weight gain of between 11 and 20 pounds was associated with far fewer patients willing to try a new medication (70.8%).
The findings highlighted the importance of understanding what factors might influence a patient’s willingness to take his or her prescribed medication.
“It is important for clinicians to assess patient-specific concerns and develop a comprehensive treatment plan to maximize adherence to prescribed therapies,” the authors concluded.
A second poster compared olanzapine monotherapy (OLZ+PBO) with samidorphan as a combination drug (ALKS3831) in adults with schizophrenia and alcohol use disorder (AUD) who experience at least 10 drinking days and at least 2 heavy drinking days in the past month. Recent disease symptom exacerbation was screened.2
The primary outcome was event of exacerbation of disease symptoms rate, plus a post hoc analysis assessed for change in Positive and Negative Syndrome Scale (PANSS) scores and Clinical Global Impression-Severity (CGI-S) by Mixed Model for Repeated Measurements, as well as change in alcohol use as a percentage of heavy drinking days and World Health Organization (WHO) drinking level.
AUD is a common comorbidity of schizophrenia, and there are currently no effective pharmacological treatments.
“Treatment barriers have included hesitancy to conduct clinical trials in this high-risk population, lack of sound biologic models with preclinical promise, and methodological challenges in recruitment, retention, and outcome assessments,” the authors explained.
A total of 229 patients were randomized 1:1 into the OLZ+PBO and ALKS3831 arms. Only 58 patients in the OLZ+PBO arm and 53 patients in the ALKS3831 arm completed the study (9 months). In both arms, alcohol use was reduced over the course of follow-up. There were differences in the post hoc analysis with ALKS3831 showing greater improvements in PANSS score (—6.9) at month 9 compared with OLZ+PBO (–3.3) from a baseline of 64.7.
The ALKS3831 group also showed a greater change in CGI-S scores at month 9 (—0.5) compared with OLZ+PBO (–0.2). However, there were no differences in alcohol behavior change and there were similar results for WHO drinking risk.
“Consistent with the primary outcome results, this post-hoc analysis showed no differences between ALKS3831 and olanzapine monotherapy in alcohol behavior, but revealed a general reduction of alcohol use in both arms,” the authors concluded.
Both studies were funded by Alkermes.
1. Achtyes ED, Simmons A, Skabeev A, et al. Patient preferences concerning the efficacy and side effect profile of schizophrenia medication: a survey of patients living with schizophrenia. Presented at the American Psychiatric Association 2018 meeting, May 7, 2018; New York, New York. Abstract #P6-146.
2. Brunette MF, O’Malley S, Citrome LL, et al. Schizophrenia complicated by comorbid alcohol use disorder: symptom outcomes from a phase 2 randomized controlled trial. Presented at the American Psychiatric Association 2018 meeting, May 7, 2018; New York, New York. Abstract #P6-149.