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. 2022 Nov 24:13:1042992.
doi: 10.3389/fphar.2022.1042992. eCollection 2022.

Adverse event profiles of adjuvant treatment with opicapone in Parkinson's disease: A systematic review and meta-analysis

Luwen Xie  1 , Xiaoyi Qi  2 , Xuan Wang  1 , Bing He  3 , Yu Wang  4 , Wei Zhang  1 , Zehui Yu  1   5 , Mingming Deng  1 , Sicheng Liang  1   3   5   6 , Muhan Lü  1   5   6
Affiliations

Adverse event profiles of adjuvant treatment with opicapone in Parkinson's disease: A systematic review and meta-analysis

Luwen Xie et al. Front Pharmacol. .

Abstract

Background: Opicapone, a novel third-generation catechol-O-methyltransferase inhibitor, has demonstrated efficacy in Parkinson's Disease (PD) patients with end-of-dose motor fluctuations. Objective: This study aimed to compare the short-term (<6 months) and long-term (≥6 months) tolerability of opicapone adjuvant treatment in PD patients. Method: Electronic databases including PubMed, Embase, Web of Science and Cochrane library were searched for randomized controlled trials (RCTs) and observational studies. The end points included any treatment-related adverse events (TEAEs), serious TEAEs (SAEs) and treatment discontinuation. A random-effects model was used to generate overall incidences of TEAE. Results: Three RCTs, three RCT extension studies and three open-label studies involving 2177 PD patients were evaluated. In the short-term studies, there were reports of TEAEs with an incidence of ≥5% in individuals treated with opicapone 50 mg, including dyskinesia (14.1%), elevated blood creatine phosphokinase levels (8.0%) and urinary tract infection (6.0%). Any TEAEs, SAEs and treatment discontinuation all occurred at rates of 62.9%, 4.8% and 9.3%, respectively. TEAEs with opicapone 50 mg that were reported by more than 5% of patients in long-term studies included dyskinesia (16.1%), dry mouth (12.1%), medication effect decreased (12.1%), PD exacerbated (7.8%), blood creatine phosphokinase level raised (7.4%), nausea (6.1%) and insomnia (5.1%). The incidence of any TEAEs, SAEs and treatment discontinuation were, correspondingly, 73.2%, 8.7% and 8.4%. Conclusion: These studies demonstrated that opicapone was generally well-tolerated and had a low risk of adverse events, suggesting that it could be a valuable therapeutic choice for people with PD.

Keywords: Parkinson’s disease; adjunctive treatment; adverse events; meta-analysis; opicapone.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Prisma flow diagram.
FIGURE 2
FIGURE 2
Risk of bias summary.
FIGURE 3
FIGURE 3
Forest plot of the pooled incidence of any TEAE, SAE and treatment discontinuation in the short-term studies. CI, confidence interval; ES, estimate; SAE, serious treatment-related adverse event; TEAE, treatment-related adverse event.
FIGURE 4
FIGURE 4
Forest plot of the pooled incidence of any TEAE, SAE and treatment discontinuation in the long-term studies. CI, confidence interval; ES, estimate; SAE, serious treatment-related adverse event; TEAE, treatment-related adverse event.
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