Gender Differences in Efficacy and Tolerability of Opicapone in Add on of Levodopa. A Single-Center Retrospective Cohort Study.

INTRODUCTION

Opicapone is a peripheral catechol-O-methyltransferase inhibitor (COMT), approved an add on to levodopa in Parkinson's disease (PD) patients with motor fluctuations. We carried out a retrospective cohort study to evaluate gender differences in efficacy and tolerability of opicapone.

METHODS

PD patients with motor fluctuations who started opicapone and who were followed up for at least 6 months were retrospectively enrolled. Total daily OFF (at baseline and follow-up), presence or worsening of dyskinesia, or presence of other adverse events (AE) at follow-up, were recorded.

RESULTS

Seventy-seven PD patients (51 men; 66.2%) with a disease duration of 11.0 ± 4.2 years were enrolled. At follow-up, a significant reduction of the total daily OFF time was observed in men with PD. Overall, 41.6% of PD patients reported some AEs, of which the presence or worsening of dyskinesia was the most common. Incidence of AEs was significantly higher among women (65.4% versus 29.4%; p-value 0.002) and at multivariate analysis, female sex was significantly associated with the presence of AEs (OR 4.08; 95% CI 1.46-11.4; p-value 0.007); At 6 months 27.3% patients discontinued opicapone and women had significantly higher odds of discontinuation (OR 3.00; p-value 0.04).

DISCUSSION: Opicapone is highly effective for the treatment of motor fluctuations. The occurrence of AEs is more frequent among women may be attributed to a higher levodopa bioavailability. To avoid an early discontinuation due to AEs, levodopa dosage should be reduced in women before the introduction of opicapone.

CONCLUSION

Our study provides novel insights regarding gender differences in PD treatment.