Baseline risk characterization of early versus later adopters of long-acting paliperidone palmitate formulations.

Autor: Fife D; Department of Epidemiology, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Fortin S; Department of Epidemiology, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Qiu H; Department of Epidemiology, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Yamazaki M; Department of Epidemiology, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Najarian D; Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA., Voss EA; Department of Epidemiology, Janssen Research & Development, LLC, Titusville, New Jersey, USA.
Jazyk: angličtina
Zdroj: Neuropsychopharmacology reports [Neuropsychopharmacol Rep] 2022 Sep; Vol. 42 (3), pp. 347-351. Date of Electronic Publication: 2022 Jun 01.
DOI: 10.1002/npr2.12260
Abstrakt: Early Post-Marketing Phase Vigilance (EPPV) is a unique system that encourages reporting of serious adverse reactions for medications newly introduced to Japan. When a once-monthly paliperidone palmitate formulation (PP1M) was introduced in Japan in 2013, EPPV detected a signal of increased mortality, but this signal was not subsequently confirmed. To clarify whether that signal reflected increased adverse event reporting or an atypically high baseline mortality risk among early adopters of PP1M, we evaluated the baseline risk characteristics of early, mid, and later adopters of PP1M in a Japanese database and did a similar evaluation of PP1M and the three-monthly formulation (PP3M) in two US databases. In Japan, early adopters compared with later adopters were older (mean 39.16 vs 33.70 years) but had a lower proportion of male patients (32.0% vs 44.44%), and a lower mean number of antipsychotic medications (distinct active medical substances) other than paliperidone (2.62 vs 2.85). In the United States, the baseline characteristics of early adopters of PP1M and PP3M did not suggest higher mortality risk than later adopters. These results offer no convincing evidence that the unconfirmed early signal of increased mortality with PP1M was due to increased baseline mortality risk among early adopters.
(© 2022 Janssen Research & Development, LLC. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsychopharmacology.)
Databáze: MEDLINE
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