Generic vs. brand-name pramipexole: effectiveness, safety, and cost comparison in a multicenter retrospective cohort study.

BACKGROUND

Generic pramipexole is widely prescribed for Parkinson's disease (PD), yet clinical equivalence to the brand-name formulation remains debated. We aimed to compare generic and brand-name pramipexole dihydrochloride tablets in real world.

METHODS

We conducted a multicenter retrospective propensity score-matched cohort study. Prescription data of outpatients using either generic or brand-name pramipexole dihydrochloride tablets for PD or Parkinson's syndrome were extracted at five research hospitals from July 1, 2018, to June 30, 2023. Effectiveness was assessed by changes in levodopa equivalent dose (LED) over time, while safety was evaluated by adverse events (AEs) from enrollment to follow-up completion. Medication costs were also compared between the two groups.

RESULTS

A total of 1,063 patients in the brand-name drug group and 1,287 in the generic drug group were included. A total of 161 AEs occurred in the generic drug group and 182 in the brand-name drug group. There was no significant difference in AE occurrence between the two groups (P = 0.898). And no significant difference was found in the change degree of LED level between generic drug and brand-name drug group over time (H = 1.514, P = 0.824). The daily cost of pramipexole and antiparkinsonian drug, as well as the average prescription cost over 1 year of follow-up in the generic drug group were significantly lower than those in the brand-name drug group (P < 0.05).

CONCLUSION

With comparable efficacy and safety, our results indicate the generic pramipexole should be considered a valuable alternative to the brand-name drug. Future prospective research is needed to confirm these findings in clinical practice.