Who Receives Nalmefene and How Does It Work in the Real World? A Single-Arm, Phase IV Study of Nalmefene in Alcohol Dependent Outpatients: Baseline and 1-Month Results

Barrio, Pablo; Ortega, Lluïsa; Guardia, Josep; Roncero, Carlos; Yuguero, Lara; Gual, Antoni

doi:10.1007/s40261-017-0590-4

Cited by 15 publications

(7 citation statements)

References 42 publications

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“…Se incluyeron 110 pacientes en total de 4 centros de la región española de Cataluña entre 2015 y 2016. Los resultados completos del estudio de fase 4 están disponibles en otra publicación (Barrio, Ortega, Guardia, Roncero, Yuguero y Gual, 2018). La tabla 1 muestras las diferencias entre este estudio y el ensayo de fase 3 de nalmefeno respecto de los variables basales del estudio principal.…”

Section: Resultsunclassified

Una comparación entre los estudios de fase 3 y un estudio de fase 4 de nalmefeno en el trastorno por uso de alcohol. ¿Existen diferencias?

et al. 2018

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Concerns regarding the external validity of phase-III trials are common to many medical disciplines, with relevant discrepancies found between experimental and clinical samples in some diseases such as hypertension. The aim of this study was to compare the samples included in the pivotal, phase-III clinical trials of nalmefene with that of a recently conducted phase-IV trial. Baseline characteristics of the studies were compared through univariate analysis. Significant differences were found in the percentage of low-risk drinkers included. Differences were also found in the prescription and intake pattern of nalmefene, as well as in the rate of psychiatric and addictive comorbidities, which were much higher in the phase-IV study. These data suggest that in the field of alcohol use disorders there are also relevant differences between experimental and clinical samples, a fact that reinforces the need for phase-III trials to be balanced with observational, phase-IV trials.

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Section: Resultsunclassified

Una comparación entre los estudios de fase 3 y un estudio de fase 4 de nalmefeno en el trastorno por uso de alcohol. ¿Existen diferencias?

et al. 2018

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“…A full description of the methods has been described elsewhere [5]. As a summary, this was an observational, multisite, single-arm, phase-IV study, conducted among adult alcohol-dependent outpatients taking nalmefene for the first time.…”

Section: Methodsmentioning

confidence: 99%

“…Baseline and one month results [5] suggested nalmefene was effective in reducing alcohol consumption. They also showed that it was well-tolerated with no serious adverse events, and the satisfaction with the drug of both professionals and patients was high.…”

Section: Introductionmentioning

confidence: 99%

The More You Take It, the Better It Works: Six-Month Results of a Nalmefene Phase-IV Trial

Barrio

Roncero

Ortega

et al. 2019

JCM

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Background: Alcohol use disorders remain a major health problem. Reduced drinking has been increasingly recognized as a valuable alternative to abstinence. Nalmefene has shown in previous, experimental studies to be a useful tool to aid reduced drinking. However, more data from routine practice settings are needed in order to obtain evidence with high external validity. The aim of this study was to conduct a single-arm phase-IV study with alcohol-dependent outpatients starting with nalmefene for the first time. Here, we present the main effectiveness analysis, scheduled at six months. Methods: This was an observational, multisite, single-arm, phase-IV study conducted among adult alcohol-dependent outpatients who received nalmefene for the first time. The study consisted of four visits: Baseline, 1 month, 6 months, and 12 months. At each visit, drinking variables were obtained from the time-line follow-back regarding the previous month. Satisfaction with medication was also assessed from both patients and professionals with the Medication Satisfaction Questionnaire. A repeated measures mixed model was performed for effective analysis regarding drinking outcomes (reduction in total alcohol consumption and the number of heavy drinking days). Regression analyses were performed in order to find predictors of responses to nalmefene. Results: From a total of 110 patients included, 63 reported data at the six-month visit. On average, patients took nalmefene 69% of days during the month previous to the 6-month assessment. Compared to the one month results, the number of heavy drinking days and total alcohol consumption increased. Still, they were significantly lower than baseline values (outcome evolution over time was from 13.5 to 6.8 to 9.4 days/month, and from 169 to 79 to 116 units/month). A total of 23 patients were considered medication responders. The number of days of taking nalmefene was significantly associated in the regression analysis. Satisfaction was globally high for both professionals and patients and, overall, nalmefene was well-tolerated with no serious adverse events reported. Conclusion: The data provided by this phase-IV study suggest that nalmefene is an effective, well-tolerated treatment for alcohol-dependence in real world, clinical settings.

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“…Nalmefen wirkt als selektiver Opioidrezeptorligand mit antagonistischer Aktivität am μ- und δ-Rezeptor und mit partieller agonistischer Aktivität am κ-Rezeptor trinkmengenreduzierend bei Alkoholabhängigkeit 18 19 . Ob die Wirkung am κ-Rezeptor (und die mögliche Reduktion anxiogener, anhedoner Symptome) darüber hinaus einen klinisch relevanten Zusatznutzen vermittelt, ist offen.…”

Section: Rückfallprophylaktische Pharmakotherapieunclassified

Rückfallprophylaxe bei Alkoholabhängigkeit

Koopmann¹

2020

PSYCH up2date

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Da bei alkoholabhängigen Patienten psychiatrische und somatische Folgeerkrankungen auftreten, kommt nach der Akutbehandlung in Form einer qualifizierten Entzugsbehandlung der Postakutbehandlung inklusive einer psycho-, sozio- und pharmakotherapeutischen Rückfallprophylaxe zur dauerhaften Aufrechterhaltung der Abstinenz eine wichtige Rolle zu. Dieser Beitrag zeigt die therapeutischen Bausteine der Rückfallprophylaxe.

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Who Receives Nalmefene and How Does It Work in the Real World? A Single-Arm, Phase IV Study of Nalmefene in Alcohol Dependent Outpatients: Baseline and 1-Month Results

Abstract: The data provided by this phase IV study suggest nalmefene is an effective, well-tolerated treatment for alcohol dependence in real-world, clinical settings.

Cited by 15 publications

References 42 publications

Una comparación entre los estudios de fase 3 y un estudio de fase 4 de nalmefeno en el trastorno por uso de alcohol. ¿Existen diferencias?

Una comparación entre los estudios de fase 3 y un estudio de fase 4 de nalmefeno en el trastorno por uso de alcohol. ¿Existen diferencias?

The More You Take It, the Better It Works: Six-Month Results of a Nalmefene Phase-IV Trial

Rückfallprophylaxe bei Alkoholabhängigkeit

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