Here’s a breakdown of the safety findings from the provided text:
Adverse Events Assessed:
Investigators assessed adverse events every 2 weeks for 8 weeks, and then again at 12 weeks.
Specific Adverse Events Reported:
More likely in solifenacin group:
Dry mouth
Dry skin
Pain and/or burning with urination
Urinary tract Infection (UTI):
1 patient in the solifenacin group
1 participant in the behavioral therapy group
Constipation:
No difference observed between groups.
Falls:
6 falls in the drug therapy (solifenacin) group. No falls in the behavioral therapy group.
1 fall in the drug therapy group was associated with a hip fracture. This patient remained in the study after rehabilitation.
Participant Dropouts and Discontinuation due to AEs:
Solifenacin group dropouts:
Only 4 participants dropped out after randomization.
1 dropout was due to treatment-emergent aes. Participants requesting to stop drug use due to AEs:
8 patients (19.5%) requested to stop solifenacin due to treatment-emergent AEs but remained in the trial for outcome assessments.
Other Safety-Related Observations:
Dose Increase: 9 participants (22%) in the drug therapy group opted to increase their solifenacin dose to 10 mg daily due to inadequate symptom control.
overall Safety Conclusion from Authors:
The increased falls in the solifenacin group highlight the need to carefully consider the risk-benefit ratio of medications for urinary symptoms, especially in individuals with Parkinson’s Disease (PD) who are already at increased risk of falls.
Given the potential adverse effects and burden of drug therapy, behavioral therapy may be a suitable initial treatment approach, even for individuals with PD and mild cognitive dysfunction.
