ACAD
Me he leído las conclusiones por curiosidad para poner a prueba mi capacidad propia de lectura de implícitos en este tipo de informes (los antiguos amarines ya entenderán el por qué).
No conozco el fármaco ni lo he leído todo, que conste; tendría que hacer una lectura completa para apreciar el tono positivo o negativo, pero el resumen del informe dice sencillamente que las ventajas son mínimas frente a los riesgos, por lo que la conclusión lógica sería que no se aprobara.
The mean difference in change from baseline on the SAPS-PD for pimavanserin-treated patients in the 6 -week trial was 3.1 points (p=0.001) better than the change for placebo-treated patients; this represents an improvement in the measured psychotic symptoms of 23.1% over placebo. Linking the change in rating scales of psychosis to
the CGI, Leucht finds that a 22-34% improvement in scales that measure psychotic symptoms correlates to a CGI score of “minimally improved” (Leucht, et al., 2006). Thus, the highly statistically significant treatment difference from placebo demonstrated in the single positive clinical trial (ACP-103-020) appears quite modest, on average, although the benefit received by some patients was more than minimal (see Figure 2). In any case, the benefit observed in this trial must be weighed against the potential harms of the drug.
The observed risk for serious adverse events including death in the 6-week, placebo-controlled trial (PDP6) population for the development of pimavanserin is 2.38 (95% CI 1.00 to 5.73, p=0.05) for 34 mg vs. placebo. SAEs occurred in 16/202 (7.9%) patients taking pimavanserin 34 mg versus 8/231 (3.5%) placebo treated patients in the PDP6 population. No individual SAE appeared to dominate this difference and there was
no unifying pathological mechanism or premonitory signal. In the long-term PDP open-
label treatment population, there were 51 deaths among 459 treated patients with PDP (11.1%).
