A Prospective Flexible-Dose Study of Paliperidone Palmitate in Nonacute But Symptomatic Patients With Schizophrenia Previously Unsuccessfully Treated With Oral Antipsychotic Agents

Abstract

The PALMFlexS study is a pragmatic interventional study compared with randomized controlled trials, conducted in a large, more representative sample of patients with schizophrenia, and designed specifically to mimic real-world clinical situations. The findings support the results from randomized controlled studies. They also demonstrate that a clinically relevant treatment response is possible in patients who are considered to be clinically stable by their physician, supporting the use of flexibly dosed PP in such patients. Clinical trials.gov number: NCT01281527.

Treatment response and tolerability with once-monthly paliperidone palmitate initiated shortly after hospital admission in patients with schizophrenia

“…Comparable PP1M treatment effects have been observed in other pragmatic studies of symptomatic, exacerbated patients and nonacute patients with schizophrenia (Schreiner et al 2014.…”

“…Naturalistic and pragmatic studies, such as the current and other recent studies in acute and nonacute patients with schizophrenia (Schreiner et al 2014, provide valuable information in populations more akin to those encountered in routine clinical practice , by allowing patients with relevant comorbidities, co-medications and substance abuse to be included.…”

Paliperidone Palmitate and Metabolic Syndrome in Patients With Schizophrenia

“…At T2, AEs rate (52.1%) was lower than at T1 and consistent with other findings. 29 Further, there was a statistically significant decrease in DOTES mean scores between T1 and T2. This could be explained by the fact that 15 of 59 patients assessed at T1 did not complete the study, including 7 due to AEs.…”

“…Similarly, a recent unblinded 6-month study on patients with schizophrenia treated with paliperidone flexible-dose reported a ≥7% increase in weight in 15.4% of patients. 29 In a recent study on metabolic parameters in patients treated with PP, occurrences of metabolic AEs trended with greater BMI status. 18 Similarly, in our study correlations between higher scores of BMI at baseline and higher levels of triglycerides after 6 and 12 months of PP treatment emerged.…”

“…For example, a pragmatic interventional study in a large sample of patients of schizophrenia (the PALMFlexS study) found at least 1 AE in 59.7% of patients. 29 The high rates of AEs in our study could be firstly explained by the characteristics of the sample, which included many patients with long-term disease, concurrent medical conditions, many previous antipsychotic treatments and other concomitant drugs throughout the study period. As a matter of fact, in the study of Alphs and colleagues 24 on a group in which many of the patients had a severe and long-term schizophrenia, PP-related AEs were reported in 85.5%.…”