baclofenwiki-blog

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Baclofen moduliert die kardiovaskulären Reaktionen auf Schlüsselreize bei alkoholabhängigen Personen (Human Psychopharmacology Clinical and Experimental, 2020)

Baclofen modulates cardiovascular responses to appetitive cues in treatment-seeking alcohol use disorder individuals (Human Psychopharmacology Clinical and Experimental, 2020) Autoren: Warren B. Logge, Andrew J. Baillie, Paul S. Haber & Kirsten C. Morley (pp, 15.02.2020)

Struktur des Inhalts

1 Abstract im englischen Original

1.0.1 OBJECTIVE:

1.0.2 METHODS:

1.0.3 RESULTS:

1.0.4 CONCLUSION:

Abstract im englischen Original

OBJECTIVE:

To assess whether baclofen-treated alcohol dependent participants show different subjective and psychophysiological responses to appetitive cues during an alcohol cue reactivity task compared to placebo, and whether these responses are associated with prospective drinking outcomes.

METHODS:

Forty-two alcohol dependent participants (placebo: n = 12, low-dose baclofen [30 mg/day] n = 18, high-dose baclofen [75 mg/day]: n = 12) completed an alcohol cue reactivity task, whereby water and alcohol beverage cues were presented, with subsequent recovery periods, and subjective alcohol craving and psychophysiological indices (skin conductance; cardiovascular measures: heart rate, high-frequency heart rate variability) were recorded.

RESULTS:

High-dose baclofen-treated participants showed both overall cue reactivity to water and alcohol cues and greater recovery effects during recovery periods, revealed by high-frequency heart rate variability, when compared to low-dose- and placebo-treated participants. There were no medication effects on subjective craving. In high-dose baclofen participants only, there was a predictive effect of lower baseline heart rate variability and fewer post-test percentage of heavy drinking days.

CONCLUSION:

There was a dose-specific rescuing effect of high-dose baclofen on the dynamic modulation of cardiovascular responses to eliciting cues. Investigation of treatment responses using psychophysiological techniques may elucidate baclofen’s mechanisms of action, and identify subgroups amenable to treatment.

Link zum englischen Abstract Link zum frei zugänglichen englischen Volltext

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Baclofen und Alkoholabhängigkeit: Durchbruch oder "nur" ein großer weißer Elefant? (Alcohol and Alcoholism, 2020)

Baclofen and Alcohol Use Disorders: Breakthrough or Great White Elephant? (Alcohol and Alcoholism, 2020) Autoren: Alain Braillon, Florian Naudet, Ioana A. Cristea & Joel Lexchin (pp, 11.01.2020)

Abstract im englischen Original

On 23 October 2018, the French drug agency granted Ethypharm, a French corporation, marketing authorization for baclofen in the treatment of alcohol use disorders (AUD). This is most unusual as applications for therapeutic improvements almost always proceed through a centralized process at the European Medicines Agency (EMA) and cover the entire European Union. Here, we recount the history of baclofen for AUD in France.

Link zu den bibliographischen Angaben auf PubMed Volltext auf Anfrage

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Die Zulassung von Baclofen bei Alkoholmissbrauch in Frankreich: Aus der US-Perspektive betrachtet (Alcohol and Alcoholism, 2020)

Approval of Baclofen for Alcohol Use Disorders in France: A Perspective From the United States (Alcohol and Alcoholism, 2020) Autor: James C. Garbutt (pp, 11.01.2020)

Abstract im englischen Original

The recent approval of baclofen for the treatment of alcohol use disorders (AUDs) in France is notable as baclofen is now the sixth chemical entity (disulfiram, calcium carbamide, naltrexone, acamprosate, nalmefene and baclofen) to obtain approval by a government agency as a medication for AUDs. The approval noted that baclofen is indicated ‘. . . following failure of other available medical treatments in adults with alcohol dependence and high-risk alcohol consumption (>60 g/day for men or >40 g/day for women)’ and that dose should not exceed 80 mg/day. This can be viewed as a positive sign that the scientific understanding of AUDs continues to advance, and we are at the point where pharmacology is being brought into the clinic. However, this approval also brings up questions—Is there sufficient evidence of efficacy and safety for baclofen to merit approval at this time? Do we have any understanding of who should receive baclofen? What are the prospects for approval of baclofen in the USA?

Link zu den bibliographischen Angaben auf PubMed Volltext auf Anfrage

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Frankreich erteilt eine Zulassung für Baclofen bei Alkoholabhängigkeit (Alcohol and Alcoholism, 2020)

France Grants an Approval to Baclofen for Alcohol Dependence (Alcohol and Alcoholism, 2020) Autoren: Benjamin Rolland, Nicolas Simon, Nicolas Franchitto & Henri-Jean Aubin (pp, 11.01.2020)

Abstract im englischen Original

In October 2018, France became the first country to officially approve baclofen for alcohol dependence. The French Medicines Agency (ANSM) granted a marketing authorization for baclofen, following the request of the French pharmaceutical company Ethypharm. The approval has been given for ‘supporting drinking reduction in alcohol dependence after failure of other approved drugs’. The maximum authorized dose is 80 mg per day. However, it is also stated in the approval that the ‘doses should be progressively increased to reach an optimal posology adjusted to each patient’.

Link zu den bibliographischen Angaben auf PubMed Volltext auf Anfrage

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Die Diagnose und Behandlung der Alkoholkonsumstörung bei Patienten mit Leberkrankheit: Licht und Schatten (Neurotherapeutics, 2020)

Diagnosis and Management of Alcohol Use Disorder in Patients with Liver Disease: Lights and Shadows (Neurotherapeutics, 2020) Autoren: Giovanni Addolorato, Gabriele A. Vassallo, Antonio Mirijello & Antonio Gasbarrini (pp, 11.01.2020)

Abstract im englischen Original

Alcohol use disorder is themost common cause of advanced liver disease in theWestern world. Diagnosis of alcohol use disorder can be difficult because patients with liver disease tend to deny alcohol intake for the fear of being excluded from treatment and because available biomarkers of alcohol intake have poor specificity in these patients. Alcohol abstinence is the cornerstone of the therapy in these patients. However, pharmacological treatments for alcohol use disorders have not been formally tested in patients with advanced liver disease, except for baclofen. Psychosocial intervention became crucial in these patients considering the limited pharmacological choice. However, psychosocial approach and an appropriate team to manage these patients are not still well defined. In this review, we critically discuss the diagnosis and the management of alcohol use disorder in patients with liver disease.

Link zum englischen Abstract Volltext auf Anfrage

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Die Capture-Recapture-Methode zur Schätzung der Inzidenz von Off-Label-Verschreibungen am Beispiel von Baclofen für die Alkoholkonsumstörung in Frankreich (Clinical Pharmacology, 2019)

A capture-recapture method for estimating the incidence of off-label prescriptions: the example of baclofen for alcohol use disorder in France (Clinical Pharmacology, 2019) Autoren: Marine Auffret, Benjamin Rolland, Hélène Béhal, Julien Labreuche, Emilie Jouanjus, Régis Bordet,  Sophie Gautier (pp, 11.01.2020)

Abstract im englischen Original

The local/regional incidence of off-label prescriptions can be difficult to estimate. Capture-recapture models can be used to indirectly estimate population sizes. Here, we used a capture-recapture model to estimate the number of patients treated off-label with baclofen for alcohol use disorder in northern France in 2013. Three capture sources were used: (i) the active case file at the region’s largest Addiction Unit, (ii) the regional pharmacovigilance centre, and (iii) a sample of community pharmacies. After between-source overlaps had been identified, we used a log-linear model to produced eight estimates. Two models displayed the best goodness-of-fit, with estimates [95% confidence interval] of 1123 [714-2162] and 2180 [1598-2870] subjects, respectively. These two values are in line with a previous estimate of 1624 patients, based on an analysis of the French national health insurance database in 2013. Capture-recapture methods can be usefully applied to estimate the prevalence of OLPs in a specific geographical area, when direct counting is not feasible or the estimate through claim database is not possible.

Link zum englischen Abstract Volltext auf Anfrage

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Titriertes Baclofen bei risikoreichem Alkoholkonsum: Eine randomisierte, plazebokontrollierte, ambulante Studie mit einjähriger Nachbeobachtung (Addiction, 2019)

Titrated baclofen for high-risk alcohol consumption: A randomized placebo-controlled trial in outpatients with one-year follow up (Addiction, 2019) Autoren: L. Rigal, S. Sidorkiewicz, J. M. Tréluyer, E. Perrodeau, C. Le Jeunne, R. Porcher & P. Jaury (pp, 11.01.2020)

Struktur des Inhalts

1 Abstract im englischen Original

1.0.1 BACKGROUND AND AIMS:

1.0.2 DESIGN:

1.0.3 SETTING:

1.0.4 PARTICIPANTS:

1.0.5 INTERVENTION AND COMPARATOR:

1.0.6 MEASUREMENTS:

1.0.7 FINDINGS:

1.0.8 CONCLUSION:

Abstract im englischen Original

BACKGROUND AND AIMS:

Baclofen is a promising drug for treating patients with alcohol-related disorders. Nevertheless, the first randomized clinical trials (mainly with target doses), reported inconsistent efficacy, possibly because of the effective dose widely varying between patients. The Bacloville study aimed to test the efficacy of titrated baclofen for achieving low-risk alcohol consumption.

DESIGN:

12-month multicenter pragmatic double-blind randomized clinical trial from June 2012 to June 2014.

SETTING:

62 French primary care centers.

PARTICIPANTS:

Outpatients with high-risk alcohol consumption (>40 g/day for women and >60 g/day for men).

INTERVENTION AND COMPARATOR:

Patients were randomly assigned (1:1 ratio) to receive titrated baclofen up to 300 mg/day or placebo for 12 months. Switching to open-label baclofen was allowed in cases of perceived inefficacy.

MEASUREMENTS:

The primary outcome defined success as no or low-risk alcohol consumption (≤20 g/day for women and ≤40 g/day for men) during the last month of the one-year follow up, with patients who switched to open-label baclofen classified as failures.

FINDINGS:

320 patients were randomized, 162 to baclofen and 158 to placebo (consumption 129 g/day in both arms). Discontinuation rates were 30% and 34% in the baclofen and placebo arms, respectively, and return rates of the last-month diaries were 42% and 34% respectively. Primary success rates were 57% and 36% in the baclofen and placebo arms, respectively (difference 21 percentage points, 95% CI 8 to 34, p=0.003). When switchers were not classified as failures unless they did fail, the success rates were 62% versus 55% (difference 6 percentage points, 95% CI -7 to 20). Over 12 months, daily consumption differed between both arms (11 g less in the baclofen arm), as did the number of abstinence days (3.3 days more in the baclofen arm). Adverse events were more frequent with baclofen than placebo and were mostly drowsiness, fatigue and insomnia. Serious adverse events occurred in 85 (7 deaths) and 36 (3 deaths) patients with baclofen and placebo, respectively.

CONCLUSION:

Baclofen was more effective than placebo in reducing alcohol consumption to low-risk levels. The number of adverse events and more serious adverse events was greater with baclofen than placebo.

Link zum englischen Abstract Volltext auf Anfrage

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Ein Vergleich zwischen Baclofen und Topiramat bei Alkoholabhängigkeit: Eine prospektive Studie (Indian Journal of Psychiatry, 2019)

Comparison between baclofen and topiramate in alcohol dependence: A prospective study (Indian Journal of Psychiatry, 2019) Autoren: A. Jose, P. Yadav, A. Kapoor & V. P. Mahla (pp, 11.01.2020)

Struktur des Inhalts

1 Abstract im englischen Original

1.0.1 Introduction:

1.0.2 Methodology:

1.0.3 Results:

1.0.4 Conclusion:

Abstract im englischen Original

Introduction:

Baclofen and topiramate are GABAergic drugs, and both have been recommended for the treatment of alcohol dependence as anticraving agent. Several studies have demonstrated the effect of baclofen and topiramate as anticraving, but none has compared them. The main aim of the current study was to assess the baclofen and topiramate as anticraving agent in alcohol dependence during 1 month follow-up.

Methodology:

After 1-week detoxification protocol, 94 patients were randomly assigned to either baclofen (n = 49) or topiramate (n = 45) for 1-month follow-up.  Patients were assessed with clinical institute withdrawal assessment at baseline, and at 1 week, the Addiction Severity Index, ready to change questionnaire at baseline and weekly assessed with Obsessive and Compulsive drinking scale (OCDS) for craving. At every follow-up, adverse effects were also assessed to check tolerability.

Results:

A marked improvement was observed with baclofen in OCDS in each assessment as compared to topiramate. With baclofen, 61.22% of patients became complete abstinence, as compared to 37.78% in topiramate group. Baclofen was better tolerated as 24.49% patients were dropped out in baclofen group as compared to 33.33% in topiramate group.

Conclusion:

Baclofen has better efficacy and tolerability as compared to topiramate.

Link zum englischen Abstract Link zum frei zugänglichen englischen Volltext

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Hemmende Faktoren im somatosensorischen System: Ein integrativer neuropharmakologischer und bildgebender Ansatz (Neuroimage, 2019)

Inhibition in the somatosensory system: An integrative neuropharmacological and neuroimaging approach (Neuroimage, 2019) Autoren: C. Fioravanti, S.D. Kajal, M. Carboni, C. Mazzetti, U. Ziemann & C. Braun (pp, 11.01.2020)

Abstract im englischen Original

The presented study investigates the functional role of GABA in somatosensory processing, using a combined neuropharmacological-neuroimaging approach. Three different GABA agonists (GABAA: alprazolam, ethanol; GABAB: baclofen) were investigated in a double blind cross-over design in 16 male participants, accomplishing a tactile perception task. Somatosensory evoked magnetic fields modulated by GABAR-agonists and placebo were recorded using whole-head magnetoencephalography. Peak latencies and amplitudes of primary (SI) and secondary (SII) somatosensory cortex source activities confirmed the previously reported role of GABA as a modulator of somatosensory processing. Significant inhibitory effects on the latency of SII and on the amplitude of SI and SII were found exclusively for alprazolam, a positive allosteric modulator at GABAA receptors. The GABAB agonist baclofen did not have any modulatory effect. Moreover, we investigated whether the observed effects of alprazolam on the level of SII were explainable by the mere propagation of activity from SI to SII modulated by GABAA receptors, independently from any further GABAA-mediated inhibition in SII. By estimating the transfer function between SI and SII activation under placebo conditions, we were able to predict SII activity for the administration of GABA receptors agonists under the assumption that GABA exclusively acts at the level of SI. By comparing measured and predicted data, we propose a model in which the initial activation of SI is modulated through GABAA receptors and subsequently propagated to SII, without any significant further inhibition. In addition, initial GABAA effects in SI appear to be strongly potentiated with time, selectively in SI but not in SII.

Link zum englischen Abstract Volltext auf Anfrage

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Baclofen für den Alkoholentzug (Cochrane database of systematic reviews, 2019)

Baclofen for alcohol withdrawal (Cochrane database of systematic reviews, 2019) Autoren: Jia Liu, Lu-Ning Wang (pp, 11.01.2020)

Abstract im englischen Original

BACKGROUND: Alcohol withdrawal syndrome (AWS) is a distressing and life-threatening condition that usually affects people who are alcohol dependent when they discontinue or decrease their alcohol consumption. Baclofen shows potential for rapidly reducing symptoms of severe AWS in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane Review first published in 2011 and last updated in 2017.

OBJECTIVES: To assess the efficacy and safety of baclofen for people with AWS.

SEARCH METHODS: We updated our searches of the following databases to June 2019: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, PubMed, Embase, and CINAHL. We also searched registers of ongoing trials. We handsearched the references quoted in the identified trials, and sought information from researchers, pharmaceutical companies, and relevant trial authors about unpublished or uncompleted trials. We placed no restrictions on language.

SELECTION CRITERIA: We included all randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for people with AWS. We excluded uncontrolled, non-randomised, or quasi-randomised trials. We included both parallel group and cross-over studies.

DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane.

MAIN RESULTS: We included four RCTs with 189 randomised participants (one RCT new for this update). None of the included studies reported the primary outcomes of alcohol withdrawal seizures, alcohol withdrawal delirium, or craving. For the comparison of baclofen and placebo (1 study, 31 participants), there was no evidence of a difference in Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores in eight-hour periods from days one to five (very low-quality evidence). For the comparison of baclofen and diazepam (2 studies, 85 participants), there was no evidence of a difference in change from baseline to days 10 to 15 on CIWA-Ar scores (very low-quality evidence, meta-analysis was not performed due to insufficient data). In one study (37 participants), there was no evidence of a difference in participants with at least one adverse event (risk difference (RD) 0.00, 95% confidence interval (CI) -0.10 to 0.10; very low-quality evidence), dropouts (RD 0.00, 95% CI -0.10 to 0.10; very low-quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.10 to 0.10; very low-quality evidence). For the comparison of baclofen and chlordiazepoxide (1 study, 60 participants), there was no evidence of a difference in difference from baseline to nine-day decremental fixed-dose intervention: CIWA-Ar scores (mean difference (MD) 1.00, 95% CI 0.70 to 1.30; very low-quality evidence), global improvement (MD 0.10, 95% CI -0.03 to 0.23; very low-quality evidence), 14/60 participants with adverse events (RD 2.50, 95% CI 0.88 to 7.10; very low-quality of evidence), dropouts (RD 0.00, 95% CI -0.06 to 0.06; very low-quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.06 to 0.06; very low-quality evidence). None of the RCTs provided information on random sequence generation or allocation concealment, therefore, we assessed them at unclear risk of bias. Two RCTs were not of double-blind design and had a high risk of bias in blinding (Addolorato 2006; Girish 2016). One RCT had more than 5% dropouts with high risk of attrition bias (Lyon 2011). We could not assess reporting bias as none of the prepublished protocols were available.

AUTHORS‘ CONCLUSIONS: No conclusions can be drawn about the efficacy and safety of baclofen for the management of alcohol withdrawal because we found insufficient and very low-quality evidence.

Link zum englischen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Medikamente bei Alkoholmissbrauch: Ein Fokus auf klinische Studien (Handbook of Experimental Pharmacology, 2019)

Medication Development for Alcohol Use Disorder: A Focus on Clinical Studies (Handbook of Experimental Pharmacology, 2019) Autoren: Lorenzo Leggio, Daniel E. Falk, Megan L. Ryan, Joanne Fertig & Raye Z. Litten (pp, 11.01.2020)

Abstract im englischen Original

Compared to other medical disorders, including other brain diseases, the number of medications approved for alcohol use disorder (AUD) is very small. Disulfiram, naltrexone (oral and long-acting), and acamprosate are approved by the US Food and Drug Administration (FDA) to treat patients with AUD. These medications are also approved in other countries, including in Europe, where the European Medicines Agency (EMA) also approved nalmefene for AUD. Furthermore, baclofen was recently approved for AUD in France. These approved medications have small effect sizes, which are probably the consequence of the fact that they only work for some patients, yet a personalized approach to match the right medication with the right patient is still in its infancy. Therefore, research is needed to expand the armamentarium of medications that clinicians can use to treat their patients, as well as to better develop personalized approaches. This book chapter reviews other medications, beyond those approved by the FDA, that have shown efficacy in clinical trials, as well as medications which are still in the early stages of evaluation in human studies.

Link zum englischen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Medikamente zur Behandlung der Alkoholabhängigkeit – eine notwendige Stellungnahme zur Stellungnahme der DHS (Suchttherapie, 2019)

Autor: Albrecht Ulmer (pp, 11.01.2020)

In einer Stellungnahme kritisiert der renommierte Suchtmediziner Albrecht Ulmer aus Stuttgart die Einstellung der Deutschen Hauptstelle für Suchtfragen e.V. (DHS) hinsichtlich des Einsatzes von Medikamenten zur Behandlung der Alkoholabhängigkeit.

Abstract

Dass sich die DHS mit der Medikamentösen Behandlung der Alkoholabhängigkeit befasst, ist zu begrüßen. Praktisch alle schweren, chronischen Krankheiten lassen sich in Verlauf und Prognose durch den Einsatz von Medikamenten günstig beeinflussen. Man stelle sich bspw. eine Diabetesbehandlung ohne Medikamente vor. Selbstverständlich könnte man ganz viel durch Gewichtsreduktion, mehr Sport und gesündere Ernährung erreichen. Aber die Realität belehrt uns, wie schwer all das ist, was primär psychologisch ansetzt. Die Erfolge bleiben weit hinter dem zurück, was sich mit dem zusätzlichen Einsatz von Medikamenten erreichen lässt. Insofern bestünde in der Fachwelt kein Zweifel: Auf Medikamente zu verzichten, wäre ein fataler Rückschritt. […] Baclofen sollte nicht, wie in der DHS-Stellungnahme, allein aufgrund widersprüchlicher Studienergebnisse abgetan werden. Angesichts der so fatalen De-facto-Nichtbehandlung vieler Alkoholabhängiger kann man allein versuchen, ob es im individuellen Fall vertragen wird und hilft. Es versagt öfters, aber wenn wir bei einer Reihe von Patienten, die vieles ohne Erfolg durchgemacht haben, dokumentieren können, wie sie sich über Wochen von einem hohen Verbrauch auf Null heruntertrinken und dieser Erfolg anhält, dann erscheint uns das als positiver Ansatz, der weiterentwickelt werden muss. Die Bemerkungen der DHS-Stellungnahme entsprechen dem nicht.

Link zum deutschen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Erfolgreiche Entzugsbehandlung von Gamma-Hydroxybutyrat (GHB) mit Baclofen als eigenständige Therapie: Ein Fallbericht (Journal of Addiction Medicine, 2019)

Successful Management of Gamma-hydroxybutyrate (GHB) Withdrawal Using Baclofen as a standalone Therapy: A Case Report (Journal of Addiction Medicine, 2019) Autoren: Sonia Habibian, Keith Ahamad, Mark McLean & Maria Eugenia Socias (pp, 12.01.2020)

Struktur des Inhalts

1 Abstract im englischen Original

1.0.1 BACKGROUND:

1.0.2 CASE:

1.0.3 CONCLUSION:

Abstract im englischen Original

BACKGROUND:

Gamma-hydroxybutyrate (GHB)-a GABA-B agonist-can lead to a use disorder, and a withdrawal syndrome similar to that of alcohol. At present, evidence is lacking for how to best manage GHB withdrawal, and often clinicians rely on alcohol withdrawal management approaches, using medications like benzodiazepines (BZD). However, BZD doses needed to control GHB withdrawal symptoms are typically much higher than those required for alcohol, posing significant safety risks. Novel approaches include the use of baclofen as an adjunct to BZD, allowing reductions in BZD requirements. While the use of baclofen as monotherapy may result in even greater risk reductions, research to support this approach is limited.

CASE:

We present a case of a 26-year-old female with severe GHB use disorder and history of severe withdrawal symptoms, whose withdrawal was successfully, managed using baclofen alone.

CONCLUSION:

In keeping with other case reports, baclofen appears to have potential to be used in the management of GHB withdrawal. Here, we presented a case of severe GHB withdrawal which was managed solely by baclofen. Clinical research is needed to evaluate baclofen’s potential as a standalone treatment for GHB withdrawal.

Link zum englischen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Aussichten für Pharmakotherapien zur Behandlung von Alkoholkonsumstörungen: ein Update zu den jüngsten Studien am Menschen (Current opinion in Psychiatry, 2019)

Prospects for pharmacotherapies to treat alcohol use disorder: an update on recent human studies (Current opinion in Psychiatry, 2019) Autoren: Mehdi Farokhnia, Brittney D. Browning & Lorenzo Leggio (pp, 11.01.2020)

Abstract im englischen Original

PURPOSE OF REVIEW:

The aim of this study was to provide an update on medication development efforts for alcohol use disorder (AUD) by reviewing recently published (past 2 years) human studies that evaluated medications‘ effects on alcohol-related outcomes.

RECENT FINDINGS:

Forty-five publications were found suitable for this review. A variety of compounds have been tested in the past 2 years as potential pharmacological options for AUD, including medications that act on multiple targets (topiramate, aripiprazole, quetiapine), calcium channels (gabapentin), gamma-Aminobutyric acid receptors (baclofen, diazepam), glutamate receptors (ifenprodil, memantine, glycine), nicotinic acetylcholine receptors (varenicline, mecamylamine), α1 adrenergic receptors (prazosin, doxazosin), neuroendocrine pathways (oxytocin, a vasopressin receptor 1b antagonist, a ghrelin receptor inverse agonist) and others (samidorphan, ibudilast, N-acetylcysteine, citoline). Important findings and limitations regarding the effects of these medications on alcohol-related outcomes are discussed.

SUMMARY:

There is a critical need to increase the armamentarium of medications for AUD. Human laboratory studies may help screen and prioritize promising targets and compounds before running large clinical trials. Given the complexity of AUD and the heterogeneity of afflicted patients, future studies should also investigate potential moderators and predictors of response to each pharmacological intervention.

Link zum englischen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Diagnose und Behandlung der Alkoholabhängigkeit bei Patienten mit alkoholischer Leberkrankheit im Endstadium (Hepatology, 2019)

Diagnosis and Treatment of Alcohol Use Disorder in Patients With End-Stage Alcoholic Liver Disease (Hepatology, 2019) Autoren: Fabio Caputo, Marco Domenicali, Mauro Bernardi (pp, 12.01.2020)

Abstract im englischen Original

Between 14%-30% of the world’s population is affected by alcohol use disorder (AUD), and excessive alcohol consumption represents the most common cause of liver disease in the western world. The clinical picture of alcoholic end-stage liver disease is rendered extremely complex, as manifestations such as alcohol withdrawal syndrome, craving and physical dependence, as well as extrahepatic alcohol-related diseases merge with the complications of advanced cirrhosis. This makes AUD recognition and assessment difficult and its management arduous as many drugs commonly used to treat complications such as alcohol withdrawal syndrome are often contraindicated by the presence of hepatic encephalopathy or hepatorenal syndrome. Reaching and maintaining abstinence represents the mainstay of managing patients with AUD and end-stage liver disease. Psychosocial interventions are an essential component of treatment to reach these goals. However, these interventions alone often prove insufficient in AUD patients and even more frequently in those with end-stage liver disease because of inadequate adherence due to poor functional and physical status. Pharmacological treatments need to be associated, but the available options are greatly limited in end-stage liver disease because many GABA-Ergic drugs can favor the development of hepatic encephalopathy, whereas drugs undergoing extensive liver metabolism should be avoided or used with the greatest caution. Because of these limitations, the management of end-stage AUD is extremely challenging and requires an integrated multidisciplinary approach.

Link zum englischen Abstract Volltext auf Anfrage

Als Reaktion auf diese Veröffentlichung gab es einen Leserbrief von Alain Braillon & Florian Naudet.

Volltext auf Anfrage

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[baclofenwiki-blog]

Pharmakokinetische Daten zur Verabreichung von hochdosiertem Baclofen bei alkoholabhängigen Patienten auf der Intensivstation (Data in Brief, 2019)

Pharmacokinetic data on high dose baclofen administration in unhealthy alcohol user in the ICU (Data in Brief, 2019) Autoren: Mickael Vourc’h, Eric Dailly, Yannick Hourmant, Ronan Bellouard, Pierre-Joachim Mahe, Guillaume Deslandes, Matthieu Grégoire & Karim Asehnoune (pp, 11.01.2020)

Abstract im englischen Original

In the intensive care unit, alcohol intake above the NIAAA recommendations regardless of the existence of an Alcohol Use Disorder (AUD), was associated with an increased risk of death and longer time on ventilator. This rises the hypothesis that unhealthy alcohol use may lead to specific issues when weaning the mechanical ventilation (i.e. agitation or its related complications) regardless of AUD or withdrawal syndrome. Thus, we proposed to use baclofen off-label to avoid agitation. The data presented in this article is related to the research article entitled: „Pharmacokinetics and toxicity of high-dose baclofen in ICU patients“ Vourc’h et al., 2019 Data provided in this submission includes 1) the detailed methods for baclofen assay by mass spectrometric detection, 2) the supplementary population pharmacokinetic analysis presenting observed concentration vs. population or individual predicted concentration (raw data of the latter is also available), and 3) the algorithm for the adaptation of baclofen daily doses according of the renal clearance to assess the risk of toxicity in critically ill patients.

Link zum englischen Abstract Volltext auf Anfrage

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[baclofenwiki-blog]

Pharmakokinetik und Toxizität von hochdosiertem Baclofen bei Patienten auf der Intensivstation (Progress in Neuropsychopharmacology & Biological Psychiatry, 2019)

Pharmacokinetics and toxicity of high-dose baclofen in ICU patients (Progress in Neuropsychopharmacology & Biological Psychiatry, 2019) Autoren: Mickael Vourc’h, Eric Dailly, Yannick Hourmant, Ronan Bellouard, Pierre-Joachim Mahe, Guillaume Deslandes, Matthieu Grégoire, Karim Asehnoune (pp, 12.01.2020)

Struktur des Inhalts

1 Abstract im englischen Original

1.0.1 BACKGROUND:

1.0.2 MATERIALS AND METHODS:

1.0.3 RESULTS:

1.0.4 CONCLUSIONS:

Abstract im englischen Original

BACKGROUND:

High-dose baclofen could prove beneficial in patients with unhealthy alcohol use in intensive care units (ICU). However, the pharmacokinetic properties of baclofen are unknown in this population. Our objectives were to investigate the pharmacokinetics of baclofen and the relationship between baclofen exposure and its toxicity in the ICU.

MATERIALS AND METHODS:

As part of a healthcare quality improvement project, we conducted a prospective, single-center study in a surgical intensive care unit at Nantes University Hospital in order to assess our local protocol of sedation in patients with consumption of alcohol above the recommended limits by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Baclofen pharmacokinetics were investigated by a non-compartment analysis and a population approach in 20 patients under mechanical ventilation. After a baclofen loading dose on day 1, daily doses were divided into 3 intakes adapted to glomerular filtration rate (GFR) and blood samples were withdrawn on day 3 for pharmacokinetic analysis. Baclofen was administered until extubation or tracheostomy and agitation-related events as well as the potential side effects of baclofen were noted.

RESULTS:

In this population, pharmacokinetic parameters [absorption latency time = 0.37 h, absorption constant rate = 2.2 h-1, apparent volume of distribution = 105 L, apparent clearance (l/h) = 13.5 × (GFR/103)0.839] were characterized by modified absorption and the influence of renal function: renal failure significantly increased baclofen exposure (p = .007) and significantly decreased baclofen clearance (p = .007) compared with patients without renal failure. When comparing patients with or without possible signs of baclofen toxicity, no difference was found regarding baclofen exposure (p = .34) and plasma peak concentration (p = .26).

CONCLUSIONS:

The a priori planned algorithm for dose adaptation according to renal clearance appeared to be suitable in our population. Daily administration of 150 mg of baclofen in ICU patients with preserved renal function did not lead to toxic concentrations in the plasma. A dose reduction of approximately 40%, 60% and 70% in patients with mild, moderate and severe renal failure could be suggested.

Link zum englischen Abstract Volltext auf Anfrage

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