Neurology: What is the risk of long-term hospitalization and death in patients with Parkinson's disease, taking pimacillin?

Pimavanserin (topiramate Maxi Lin) is a US Food and Drug Administration Bureau ( the FDA ) approved a new antipsychotic, for the treatment of Parkinson's disease hallucinations and delusions
.

Pimavanserin blocks 5-HT2A serotonin receptors and has no affinity for dopaminergic, histaminergic, muscarinic or adrenergic receptors

Manage FDA

It was previously observed in randomized and observational studies that pimacillin may affect mortality and spontaneous reports of adverse events
.

A phase III randomized trial of 199 patients reported that 11 patients (11%) in the pimacillin group had serious adverse events compared with 4 patients (4%) in the placebo group

There were 2 deaths in the Pima Vancerin group and 1 death in the placebo group
.

In the long-term open-label population, 11% of the 497 patients treated with pimavanserin died, but there was no comparison group
.

In a retrospective, single-center, observational study of 676 Parkinson's disease patients, the unadjusted mortality comparison between pimavancerin-treated and untreated patients did not show a significant difference

The US Food and Drug Administration later reviewed the 893 deaths reported in post-marketing surveillance
.

It pointed out that most of the reports occurred in people with a high basic mortality rate.

Given that a previous study showed that typical and atypical antipsychotic drugs more than doubled the risk of death in Parkinson’s disease patients, Y.
Joseph Hwang of Hopkins University in the United States and others explored the relationship with Pima The risk of hospitalization and death associated with cillin
.

The risks of hospitalization and death associated with pimacillin were explored
.

They conducted a retrospective cohort study of adults 65 years and older with Parkinson’s disease from November 1, 2015 to December 31, 2018, using a medical insurance-certified long-term care facility Resident's administrative data set and linked medical insurance claim data
.

Propensity score-based inverse probability of treatment weighting (IPTW) was used to balance the 24 baseline characteristics of pimacillin users and non-users
.

The Fine-Gray competing risk and Cox proportional hazard regression models were used to estimate the hospitalization and death risks within one year

The study cohort included 2,186 Pima Vaseline users and 18,212 non-users
.

The 30-day hospitalization risk with and without Pimavanserin is higher (IPTW adjusted hazard ratio [aHR] 1.
24, 95% confidence interval [CI] 1.

Compared with non-use, the 90-day mortality rate of Piavanserin increased (aHR 1.
20, CI 1.
02-1.
41), and it persisted after 180 days (aHR 1.
28, CI 1.
13-1.
45) and 1 year (aHR 1.
56, CI 1.
42-1.
72)
.

The significance of this study is that it found that compared with those who did not use pimacillin, the elderly people who used pimacillin had an increased risk of hospitalization one month after the start of use
.

At the same time, the risk of death one year after use also increases

Compared with those who do not use pimacillin, the risk of hospitalization for the elderly using pimacillin and one month after the start of use is increased
.
At the same time, the risk of death one year after use also increases
.

In a large real-world cohort in a long-term care facility, these findings may help provide a decision-making basis for the risk-benefit balance of Parkinson's disease patients
.

 

Original Source:
Hwang YJ, Alexander GC, An H, Moore TJ, Mehta HB.
Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease.
Neurology.
Published online August 13, 2021:10.
1212/WNL.
0000000000012601.
doi :10.
1212/WNL.
0000000000012601

Hwang YJ, Alexander GC, An H, Moore TJ, Mehta HB.
Risk of Hospitalization and Death Associated With Pimavanserin Use in Older Adults With Parkinson Disease.
Neurology.
Published online August 13, 2021:10.
1212/WNL.
0000000000012601.
doi:10.
1212/ WNL.
0000000000012601 leave a message here