Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies

Abstract

Objective:To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW).Methods:We analyzed data from two multinational, double-blind (DB), randomized, controlled phase 3 studies including patients with schizophrenia (DSM-IV-TR) previously stabilized on PP1M/PP3M (open-label [OL] phase). Patients were randomized to PP3M or PP1M (noninferiority study A) and PP3M or placebo (study B) in DB phase. The subgroup analysis included Latin American (Argentina, Brazil, Colombia, Mexico) patients. Primary efficacy endpoints were relapse-free rates (study A) and time-to-relapse (study B).Results:In study A, 63/71 (88.7%) and in study B 38/43 (88.4%) Latin American patients completed the DB phase. In study A, relapse-free percentage was similar in Latin America (PP3M: 97%, PP1M: 100%) and ROW (PP3M: 91%, PP1M: 89%). In study B, median time-to-relapse was not estimable in the Latin American subgroup for either placebo or PP3M groups, nor for the ROW PP3M group; the median time-to-relapse in the ROW placebo group was 395 days. Caregiver burden improved in patients switching from oral antipsychotics (OL baseline) to PP3M/PP1M in DB phase (Involvement Evaluation Questionnaire score mean ± SD change, -9.4±15.16; p < 0.001). Treatment emergent adverse events with PP3M during DB phase were similar in Latin America (study A: 24/34 [70.6%]; study B: 15/21 [71.4%]) and ROW (study A: 318/470 [67.7%]; study B: 84/139 [60.4%]) subgroups.Conclusion:PP3M was efficacious and showed no new safety concerns in patients with schizophrenia from Latin America, corroborating ROW findings.Clinical trial registration:NCT01515423, NCT01529515

Paliperidone 3-Month Injection for Treatment of Schizophrenia: A Narrative Review

“…It is interesting to note that the efficacy of palmitate paliperidone 3-month formulation was noted not only in the American population but was also noted in the Latin American population. A study conducted showed that Latin American patients administered palmitate paliperidone showed no new adverse effects as compared to American patients and patients from all over the world ( 17 ).…”

“…The patients in this study were previously stabilized on the 1-month formulation. The authors found no clinically relevant differences in pharmacokinetic exposures and that PP3M was non-inferior to the 1-month with similar relapse rates ( 17 ). The authors concluded that the PP3M could offer a unique dosing option for relapse prevention in some patients.…”