The survey results demonstrate an unmet need for new oral antipsychotics with favorable risk-benefit profiles, researchers said.
A recent online survey of patients with schizophrenia sought to assess oral antipsychotic (AP) side effects and their perceived impacts on social functioning and treatment adherence.
The survey identified patient preferences for symptom and side effect relief for a hypothetical new oral AP, with a focus on the extent to which weight gain was a bothersome side effect.
While AP medications are generally effective at managing schizophrenia symptoms, weight gain and drowsiness are common side effects; bothersome side effects may be a barrier to adherence, and suboptimal treatment with oral AP is common.
Two hundred patients participated, split evenly between males and females, with an average age of 41.9.
The survey asked about 12 common side effects, and each of the side effects were experienced by more than half of participants. The side effects in the survey were weight gain, sexual dysfunction, trouble concentrating, feeling like a “zombie,” feeling drowsy or tired, anxiety, restlessness, feeling a lack of emotion, involuntary spasms, dry mouth, digestive problems, and dizziness or fainting.
While most participants (92%) reported that their oral AP improved their symptoms, and 67% indicated that they needed their medication, only half (51%) thought that oral AP did more good than harm.
The 3 most common side effects were feeling anxious (88%), feeling drowsy or tired (86%), and trouble concentrating (85%). Weight gain and sexual dysfunction were reported by the largest proportion of participants to be “extremely bothersome” (29% and 33% respectively) or “very bothersome” (27% and 22%).
Between 81% to 91% of participants reported oral AP side effects that impacted their social functioning, with those who experienced very/extremely bothersome weight gain noting more limitations with work and social functioning versus those with less bothersome or no weight gain. Embarrassment was reported by 33% to 57% of participants because of side effects, with 50% indicating feeling embarrassment about weight gain.
Side effects also led patients to stop using their medication. The top 3 side effects that led to stopping were feeling like a “zombie” (22%), feeling drowsy or tired (21%), and experiencing weight gain (20%).
The top 3 symptoms participants wanted successfully controlled with a hypothetical new oral AP were anxiety (55%), inability to concentrate or think clearly (45%), and social withdrawal (42%). The top 3 side effects participants wanted to avoid were anxiety (45%), feeling like a “zombie” (39%), and weight gain (38%).
When asked to trade off improvement in symptoms versus side effects in a hypothetical medication, more than two-thirds chose symptom improvement over side effect relief.
The survey results demonstrate an unmet need for new oral APs with favorable risk-benefit profiles, researchers said.
The study was funded by Alkermes, which is planning to file a New Drug Application in the fourth quarter for ALKS 3831 (olanzapine/samidorphan) for both bipolar 1 and schizophrenia. Participants were not asked about any specific medication, said Leona Bessonova, PhD, director of Health Economics and Outcomes Research for Alkermes, but she said the company thinks it is important "patient perspectives and patient voices" in the development of new candidates; ALKS 3831 is designed to provide the efficacy of olanzapine without the associated weight gain.
Doane MJ, Sajatovic M, Mahler S, et al. Antipsychotic treatment experiences of individuals with schizophrenia: Findings from an online survey. Poster presented at: 2019 Psych Congress; October 3-6, 2019; San Diego, CA.