Page 47 - AN-2-1
P. 47

Advanced Neurology                                                         Piribedil for Parkinson’s disease




            Table 2. Evidences for piribedil in treatment of motor symptoms of PD
             Study, year  Region      Trial design  Patients  Treatment     Primary      Main results  Evidence
                                                                            outcome                    levela
            Rondot and   France       Multicenter,   Patients with PD,   Piribedil   NA  Three-month    IV
            Ziegler, 1992 [40]        open-label,   mainly I–II stages  monotherapy      treatment
                                      single-cohort  (n = 113)  (150 – 250 mg/day)       with piribedil
                                      study                                              monotherapy
                                                                                         may significantly
                                                                                         improve motor
                                                                                         symptoms, such
                                                                                         as tremors,
                                                                                         bradykinesia, and
                                                                                         rigidity
            Ziegler et al.,   France  Multicenter,   Non-fluctuating   Piribedil (150 mg/day,  The percentage of  In 6 months, the   I
            2003 [42]                 randomized,   PD patients   n = 61) as adjunct   responders defined  response rateb in
                                      double-blind,  insufficiently   to levodopa placebo   by a 30% decrease  the piribedil group
                                      placebo-   controlled by   group (n = 54)  from baseline   was significantly
                                      controlled   levodopa (n = 115)       on the UPDRS   higher than that in
                                      trial                                 III score and   the placebo group
                                                                            the change from   (61.8 vs. 39.6%;
                                                                            baseline     P = 0.02)
            Suwantamee    Thailand    Multicenter,   Patients with   Piribedil (150 mg/  The change in   Through 6-month   IV
            et al., 2004 [41]         open-label,   early PD, poorly   day, combined with   UPDRS part III   treatment of
                                      single-cohort  controlled by   levodopa in the   score versus baseline  piribedil, UPDRS
                                      clinical trial  levodopa (n = 29)  first 3 months, and   and the percentage  III scores were
                                                             later switched to   of responders   decreased
                                                             monotherapy)   defined by at least   significantly by
                                                                            30% decrease from  13.3±10.3 points
                                                                            baseline of the total  (P < 0.0001),
                                                                            UPDRS part III   response rate was
                                                                            score        93.1%b
            Evidente et al.,   Philippines  Phase IV,   Advanced PD   Piribedil (up to 150   Part III of UPDRS An 8-week   IV
            2004 [36]                 open-label,   patients with   mg/day) combined     treatment of
                                      prospective   fluctuating   with levodopa          piribedil may
                                      clinical trial  symptoms (n = 49)                  improve UPDRS
                                                                                         scores by 48%
                                                                                         (tremors are
                                                                                         improved mostly)
                                                                                         and daily living
                                                                                         ability by 43%, and
                                                                                         may decrease the
                                                                                         dose of levodopa
                                                                                         and increase its
                                                                                         duration of effect
            Rascol et al.,   Multi-national  Multicenter,   Patients with early  Piribedil   UPDRS III   After 7 months,   I
            2006 [39]                 randomized,   PD (n = 401)  monotherapy    score as the last   UPDRS III scores
                                      double-blind,          (150 – 300 mg/day,    observation on   were improved
                                      placebo-               n = 197)       monotherapy over  (−4.9 points) in
                                      controlled             Placebo group    7 months was the   the piribedil group,
                                      clinical trial         (n = 204)      primary outcome  and exacerbated
                                      (REGAIN)                                           in the placebo
                                                                                         group (+2.6 points;
                                                                                         P<0.0001), and the
                                                                                         response rateb in
                                                                                         the piribedil group
                                                                                         was also higher
                                                                                         than that in the
                                                                                         placebo (42% vs.
                                                                                         14%, P < 0.001)
                                                                                                       (Cont’d...)


            Volume 2 Issue 1 (2023)                         5                          https://doi.org/10.36922/an.290
   42   43   44   45   46   47   48   49   50   51   52