Extending the Treatment Options in Alcohol Dependence: A Randomized Controlled Study of As-Needed Nalmefene

Mann, Karl; Bladström, Anna; Torup, Lars; Gual, Antoni; Brink, Wim van den

doi:10.1016/j.biopsych.2012.10.020

Cited by 456 publications

(286 citation statements)

References 37 publications

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“…Currently, there are four medications approved by the U.S. Food and Drug Administration (FDA) to treat alcohol dependence: disulfiram, oral naltrexone, a longlasting injectable naltrexone, and acamprosate (Litten et al, 2012). In Europe, nalmefene has been also approved in 2013 (Mann et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Acamprosate Produces Its Anti-Relapse Effects Via Calcium

Spanagel

Vengeliene

Jandeleit³

et al. 2013

Neuropsychopharmacol

126

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Alcoholism is one of the most prevalent neuropsychiatric diseases, having an enormous health and socioeconomic impact. Along with a few other medications, acamprosate (Campral-calcium-bis (N-acetylhomotaurinate)) is clinically used in many countries for relapse prevention. Although there is accumulated evidence suggesting that acamprosate interferes with the glutamate system, the molecular mode of action still remains undefined. Here we show that acamprosate does not interact with proposed glutamate receptor mechanisms. In particular, acamprosate does not interact with NMDA receptors or metabotropic glutamate receptor group I. In three different preclinical animal models of either excessive alcohol drinking, alcohol-seeking, or relapse-like drinking behavior, we demonstrate that N-acetylhomotaurinate by itself is not an active psychotropic molecule. Hence, the sodium salt of N-acetylhomotaurinate (i) is ineffective in alcohol-preferring rats to reduce operant responding for ethanol, (ii) is ineffective in alcohol-seeking rats in a cue-induced reinstatement paradigm, (iii) and is ineffective in rats with an alcohol deprivation effect. Surprisingly, calcium salts produce acamprosatelike effects in all three animal models. We conclude that calcium is the active moiety of acamprosate. Indeed, when translating these findings to the human situation, we found that patients with high plasma calcium levels due to acamprosate treatment showed better primary efficacy parameters such as time to relapse and cumulative abstinence. We conclude that N-acetylhomotaurinate is a biologically inactive molecule and that the effects of acamprosate described in more than 450 published original investigations and clinical trials and 1.5 million treated patients can possibly be attributed to calcium.

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Section: Introductionmentioning

confidence: 99%

Acamprosate Produces Its Anti-Relapse Effects Via Calcium

Spanagel

Vengeliene

Jandeleit³

et al. 2013

Neuropsychopharmacol

126

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“…While most of these treatments take abstinence as main treatment goal, recently interest is growing for a reduction of alcohol use as a valid treatment goal [39,40] . Overall, effect sizes of pharmacological treatments are moderate, i.e., on the same level as antidepressants for depression, and there is no treatment that seems to fit all patients.…”

Section: Pharmacological Interventionsmentioning

confidence: 99%

Addiction specialist's role in liver transplantation procedures for alcoholic liver disease

Dom¹

2015

WJH

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Although liver transplantation (LT) is performed increasingly for patients with end-stage alcoholic liver disease (ALD), the topic remains controversial. Traditionally, the role of an addiction specialist focused on the screening and identification of patients with a high risk on relapse in heavy alcohol use. These patients were in many cases subsequently excluded from a further LT procedure. Recently, awareness is growing that not only screening of patients but also offering treatment, helping patients regain and maintain abstinence is essential, opening up a broader role for the addiction specialist (team) within the whole of the transplant procedure. Within this context, high-risk assessment is proposed to be an indication of increasing addiction treatment intensity, instead of being an exclusion criterion. In this review we present an overview regarding the state of the art on alcohol relapse assessment and treatment in patients with alcohol use disorders, both with and without ALD. Screening, treatment and monitoring is suggested as central roles for the addiction specialist (team) integrated within transplant centers.

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“…Эффективность ле-карственного средства была доказана в двух идентич-ных Европейских клинических исследованиях ESENSE 1 и 2 (продолжительность 24 нед, III фаза) и в иссле-довании SENSE, длившемся 52 нед. В клинических ис-пытаниях участвовали около 2 тысяч пациентов с ал-когольной зависимостью [62][63][64].…”

Section: алкогольная кардиомиопатияunclassified

“…Так, при 6-месячном лечении налмефеном число дней тяжелого пьянства снизилось на 11,6±1,0 дней в ме-сяц (59,6%) с высоко значимой разницей в сравнении с плацебо (р=0,001) 1 , а уменьшение общего средне-го объема потребления чистого алкоголя в день соста-вило 58,3±4,1 г 1 (61,2%),также со статистически значимой разницей с плацебо в пользу Селинкро ® (р<0,0001) 1 [62,63].…”

Section: алкогольная кардиомиопатияunclassified

“…В обоих исследо-ваниях преимущество Селинкро ® наблюдалось уже че-рез 1 мес и сохранялось в течение всего периода ис-следования. Важно, что побочные эффекты налмефе-на носили преходящий характер (продолжались 3-7 дней) и были умеренными, в группах сравнения на-блюдались минимальные серьезные побочные эф-фекты (приводящие к прекращению терапии и выхо-ду из исследований), статистически значимых разли-чий между группами не было [62][63][64]. В 2015 г. пла-нируется регистрация препарата в России.…”

Section: алкогольная кардиомиопатияunclassified

See 1 more Smart Citation

Alcoholic Cardiomyopathy: Basic Aspects of Epidemiology, Pathogenesis and Pharmacotherapy

Yusupova

2014

Racionalʹnaâ farmakoterapiâ v kardiologii

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Extending the Treatment Options in Alcohol Dependence: A Randomized Controlled Study of As-Needed Nalmefene

Cited by 456 publications

References 37 publications

Acamprosate Produces Its Anti-Relapse Effects Via Calcium

Acamprosate Produces Its Anti-Relapse Effects Via Calcium

Addiction specialist's role in liver transplantation procedures for alcoholic liver disease

Alcoholic Cardiomyopathy: Basic Aspects of Epidemiology, Pathogenesis and Pharmacotherapy

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