Zeeshan Mansuri1, Abhishek Reddy2, Ramu Vadukapuram3, Chintan Trivedi4, Amy Amara5. 1. Dr. Mansuri is with the Department of Psychiatry, Boston Children's Hospital/Harvard Medical School in Boston, Massachusetts. 2. Dr. Reddy is with the Department of Psychiatry, Virginia Tech Carilion School of Medicine in Roanoke, Virginia. 3. Dr. Vadukapuram is with the Department of Psychiatry, Icahn School of Medicine at Mount Sinai in New York, New York. 4. Dr. Trivedi is with St. David Medical Center in Austin, Texas. 5. Dr. Amara is with the Department of Neurology at the University of Alabama at Birmingham in Birmingham, Alabama.
Abstract
Background: Up to 60 percent of patients with Parkinson's disease (PD) develop Parkinson's disease psychosis (PDP). PDP is associated with a significant economic burden. The management of PDP has been divided into two approaches-one focuses on decreasing the doses of anti-Parkinsonian medications and the other involves prescribing atypical antipsychotics. Of these atypical antipsychotics, pimavanserin is United States (US) Food and Drug Administration (FDA)-approved specifically for the treatment of PDP. Objective: The goal was to evaluate the safety and efficacy of pimavanserin in the treatment of PDP based on data from randomized clinical trials. Methods: All the articles, which assessed pimavanserin's effect on the treatment of PDP, were retrieved from Google Scholar, PubMed, and abstracts from annual scientific sessions. The data on dose, therapy duration, patient numbers, and study duration were collected. These data were analyzed with random effect modeling using the inverse variance method and the Mantel-Haenszel method. Results: Four studies comparing pimavanserin to a placebo provided data on 680 patients (263 placebo, 417 pimavanserin). Treatment with pimavanserin was associated with a significant reduction in scores using the Scale of Assessment of Positive Symptoms, Hallucinations, and Delusion (SAPS-H+D) (mean difference [MD]: -1.55 [-2.71, -0.379], p=0.009). The groups had similar composite scores for Unified Parkinson's Disease Rating Scale II and III (UPDRS II and III) (MD: 0.093 [-1.28, 1.46], p=0.89). Interestingly, pimavanserin was protective against orthostatic hypotension (risk ratio: 0.33 [0.30, 0.37], p<0.001). All other adverse events were similarly distributed across both groups. Conclusion: There was a significant improvement in psychosis symptoms in patients with PD who took pimavanserin. Pimavanserin was also shown to be protective against orthostatic hypotension.
Background: Up to 60 percent of patients with Parkinson's disease (PD) develop Parkinson's disease psychosis (PDP). PDP is associated with a significant economic burden. The management of PDP has been divided into two approaches-one focuses on decreasing the doses of anti-Parkinsonian medications and the other involves prescribing atypical antipsychotics. Of these atypical antipsychotics, pimavanserin is United States (US) Food and Drug Administration (FDA)-approved specifically for the treatment of PDP. Objective: The goal was to evaluate the safety and efficacy of pimavanserin in the treatment of PDP based on data from randomized clinical trials. Methods: All the articles, which assessed pimavanserin's effect on the treatment of PDP, were retrieved from Google Scholar, PubMed, and abstracts from annual scientific sessions. The data on dose, therapy duration, patient numbers, and study duration were collected. These data were analyzed with random effect modeling using the inverse variance method and the Mantel-Haenszel method. Results: Four studies comparing pimavanserin to a placebo provided data on 680 patients (263 placebo, 417 pimavanserin). Treatment with pimavanserin was associated with a significant reduction in scores using the Scale of Assessment of Positive Symptoms, Hallucinations, and Delusion (SAPS-H+D) (mean difference [MD]: -1.55 [-2.71, -0.379], p=0.009). The groups had similar composite scores for Unified Parkinson's Disease Rating Scale II and III (UPDRS II and III) (MD: 0.093 [-1.28, 1.46], p=0.89). Interestingly, pimavanserin was protective against orthostatic hypotension (risk ratio: 0.33 [0.30, 0.37], p<0.001). All other adverse events were similarly distributed across both groups. Conclusion: There was a significant improvement in psychosis symptoms in patients with PD who took pimavanserin. Pimavanserin was also shown to be protective against orthostatic hypotension.
Authors: Clive Ballard; Stuart Isaacson; Roger Mills; Hilde Williams; Anne Corbett; Bruce Coate; Rajesh Pahwa; Olivier Rascol; David J Burn Journal: J Am Med Dir Assoc Date: 2015-08-01 Impact factor: 4.669
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