Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer’s Disease: Timing and Duration of Adverse Events - Report - MDSpire
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Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer’s Disease: Timing and Duration of Adverse Events
Safety Profile of Brexpiprazole for Agitation in Alzheimer’s Disease: Timing and Duration of Adverse Events
Overview
Brexpiprazole at 2 or 3 mg/day demonstrated a safety profile comparable to placebo in managing agitation in Alzheimer’s dementia over 12 weeks, with similar timing and duration of adverse events. Participants discontinuing due to adverse events did so earlier on placebo than on brexpiprazole, and tolerability was maintained through 24 weeks in extension trials.
Background
Agitation affects approximately half of patients with Alzheimer’s dementia and significantly impacts quality of life and caregiver burden. Pharmacological treatments, often off-label atypical antipsychotics, have limited efficacy and notable safety concerns, including increased mortality risk. Brexpiprazole is an atypical antipsychotic approved specifically for agitation in Alzheimer’s dementia, with prior trials showing efficacy and a generally favorable safety profile. Understanding the timing and duration of adverse events is critical to optimizing treatment and minimizing risks in this vulnerable population.
Data Highlights
Adverse Event Category
Brexpiprazole (%)
Placebo (%)
Insomnia
3.7
2.8
Somnolence
3.4
1.8
Nasopharyngitis
2.7
2.6
Urinary Tract Infection
2.6
1.5
Cerebrovascular Events
0.5
0.3
Cardiovascular Events
3.7
2.3
Extrapyramidal Symptoms
5.3
3.1
Orthostatic Hypotension/Dizziness
4.6
4.9
Accidents (Falls/Fractures)
2.3
4.1
Somnolence (Including Sedation)
3.7
1.8
Deaths
0.9
0.3
Key Findings
Adverse events occurred at similar times and durations in brexpiprazole (2 or 3 mg/day) and placebo groups during 12-week trials.
Participants discontinuing due to adverse events did so earlier on placebo than on brexpiprazole.
Common adverse events with brexpiprazole included insomnia, somnolence, nasopharyngitis, and urinary tract infections, each occurring in ≥2% of patients and slightly more than placebo.
Incidences of cerebrovascular, cardiovascular, extrapyramidal, orthostatic hypotension/dizziness, and accident-related adverse events were low and generally comparable between brexpiprazole and placebo.
Extension trials up to 24 weeks showed brexpiprazole remained well tolerated without cognitive worsening in participants who tolerated initial 12 weeks.
Few deaths occurred and were deemed unrelated to brexpiprazole treatment.
Clinical Implications
Brexpiprazole offers a tolerable treatment option for agitation in Alzheimer’s dementia with adverse event timing and duration comparable to placebo, supporting its use with careful monitoring. Clinicians can counsel patients and caregivers that adverse events, if they occur, are unlikely to necessitate early discontinuation and that longer-term treatment up to 24 weeks is generally well tolerated. Vigilance remains important given the vulnerable population and potential risks associated with antipsychotic use.
Conclusion
These analyses reinforce brexpiprazole’s favorable safety and tolerability profile for agitation in Alzheimer’s dementia, with adverse events occurring at similar rates and durations as placebo and sustained tolerability over 24 weeks. This supports its clinical utility as a treatment option in this challenging condition.
References
Brexpiprazole Clinical Trials and Safety Analysis 2023 -- Safety Evaluations of Brexpiprazole for Managing Agitation in Alzheimer’s Disease
