Percentage of Subjects With No Heavy Drinking Days: Evaluation as an Efficacy Endpoint for AlcoholClinical Trials

Abstract

PSNHDD appears to be a clinically informative end point measure, especially when used with a grace period, and is as sensitive as most traditional outcome measures in detecting differences between the medication and placebo groups. Nonetheless, these findings should be replicated in other clinical data sets, particularly with medications that work via different mechanisms.

Continuous Abstinence During Early Alcohol Treatment is Significantly Associated with Positive Treatment Outcomes, Independent of Duration of Abstinence

“…Grace periods, or a priori-defined periods of time during which any drinking is not included into statistical analyses of treatment outcomes, is supported by a recent study from the COMBINE data set that reported heavy drinking during the final 8 weeks of treatment was predictive of drinking at post-treatment follow-up visits (Gueorguieva et al, 2015). Employing grace periods to refine primary outcome analyses in alcohol treatment trials has been endorsed by NIAAA (Falk et al, 2010) and the Food and Drug Administration (FDA) (FDA, 2015), and represents an acknowledgment that it may take time for a medication to begin exerting an effect on drinking patterns or for patients to become stable in their treatment regimen. Additional research that assesses the degree to which early drinking behavior may relate to drinking that occurs after a prespecified grace period would be of great value.…”

Cambio de paradigma en el tratamiento del alcoholismo de baja gravedad

“…Además, estudios recientes han confirmado la relación entre el número de días que el paciente supera dicho límite y la cantidad de consecuencias negativas del consumo de alcohol 10 .…”

“…El estudio COMBINE, efectuado en Estado Unidos 19 , compara diversas modalidades de tratamiento farmacológico y psico-social del alcoholismo y concluye que uno de los indicadores más útiles del resultado del tratamiento es el núme-ro de días de consumo excesivo ("heavy drinking days") que ha tenido el paciente a lo largo de todo el tratamiento, ya que este indicador tiene una buena correlación con la cantidad de consecuencias (relacionadas con el consumo de alcohol) que ha sufrido cada paciente durante el tratamiento e incluso durante su seguimiento posterior 10 . Esta correlación sugiere que si un paciente consigue mantener un consumo de alcohol que no alcance las 5 consumiciones en un día (si es un hombre), 4 si es una mujer, presentaría prácticamente la misma cantidad de consecuencias negativas, (relacionadas con el consumo excesivo de alcohol), que la persona que ha dejado de tomar bebidas alcohólicas.…”

“…There is evidence that some negative consequences are probable above this limit 9 and recent clinical trials have confirmed that drinking over this threshold is associated with negative consequences during treatment and also during follow-up (after treatment has ended) 10 .…”

“…Determinados fár-macos anticomiciales que tienen efectos antiglutamatérgicos y favorecedores de la neurotransmisión GABA podrían ser de Performed in the USA the COMBINE study 19 compares several modalities of alcohol-dependence treatment. It suggests that one of the most useful indicators of treatment outcome is the percentage of heavy drinking days, because this variable shows a good correlation with the number of alcohol-related consequences each patient has suffered (either during treatment or even during the subsequent follow-up) 10 . This correlation suggests that if patients manage to drink fewer than 5 drinks for men (fewer than 4 for women), and do not drink everyday, they will not have more alcohol-related adverse consequences than patients that maintain their sobriety.…”