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

2019 ◽  
Vol 8 (4) ◽  
pp. 471 ◽  
Author(s):  
Pablo Barrio ◽  
Carlos Roncero ◽  
Lluisa Ortega ◽  
Josep Guardia ◽  
Lara Yuguero ◽  
...  

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.

2005 ◽  
Vol 23 (1) ◽  
pp. 27-64 ◽  
Author(s):  
Marilyn S. Sommers

In both the clinical and research settings, nurses assess patterns of alcohol consumption to screen for risk of adverse events or to determine the health consequences of drinking. The purposes of this critical review are to explore issues and controversies surrounding the measurement of alcohol consumption and to critique the existing literature relevant to the research and clinical arenas. An electronic literature search was completed to identify research articles addressing human studies from 1995 through 2004 related to alcohol consumption. Key words included alcohol drinking (subheadings blood, metabolism, psychology, and urine), standard drink, problem drinking, heavy drinking, and ethanol analysis (subheadings blood, urine, and chemistry). The results were in two primary content areas: self-reported alcohol consumption and assessment of consumption by using biological markers.Self-reported alcohol consumption can be quantified in a variety of ways, such as ounces of ethanol per day, standard drinks per day, drinking occurrences per month, heavy drinking occasions per month, and frequency of perceived drunkenness. The choice of measure depends on setting (clinical vs. research), the role of the variable under study, the capabilities and demographics of the study population, the study design, and the resources available to collect alcohol consumption data.A variety of biologic instruments are used to assess alcohol consumption, each with sensitivities and specificities that vary by age, gender, and possibly by ethnicity/race. Previous work has focused on the white, male, alcohol-dependent population and non-alcohol-dependent male controls. Some urgency exists to expand the biometrics of alcohol use to minority and older populations as well as to women across the life span.


2016 ◽  
Vol 33 (S1) ◽  
pp. S12-S13
Author(s):  
K. Mann

IntroductionTreatment of alcohol dependent patients is moderately successful but it only reaches about 10% of the population in need. A new harm reduction strategy aims at abstinence in the long run but claims to benefit patients already early on by reducing their alcohol consumption.ObjectivesA brief outline of the debate on abstinence versus controlled drinking will be followed reporting several RCTs striving for reduced drinking in alcohol dependent patients.AimsThe participant will find guidance whether and how to treat patients following this new approach.ResultsStudies testing behavioural treatments and counselling (MATCH, UKATT) indicate that a reduction over time is possible. Using nalmefene (a mu and delta opioid antagonist and a partial agonist) RCTs with more than 2500 patients were performed showing a benefit over placebo. On this basis the EMA approved this drug for the reduction of alcohol consumption in alcohol dependent patients. Other compounds such as naltrexone showed similar effects in smaller trials but are not approved for reduction. More studies testing further compounds are underway.ConclusionsThis new approach has the potential to lower the barriers which to date prevent many patients from accepting treatment for their alcohol problems. Two research questions warrant further study: (1) does the reduction in alcohol consumption translate into health and other benefits, and (2) are there specific subgroups of patients who benefit more than others. Preliminary answers will be given in the lecture.Disclosure of interestThe author has not supplied his declaration of competing interest.


2020 ◽  
Author(s):  
Eva Jane LLopis ◽  
Peter Anderson ◽  
Marina Piazza ◽  
Amy O'Donnell ◽  
Antoni Gual ◽  
...  

Abstract Background : While primary health care-based prevention and management of heavy drinking is clinically effective and cost-effective, it remains poorly implemented in routine practice. Systematic reviews and multi-country studies have demonstrated the ability of training and support programmes for healthcare professionals to increase primary health care-based measurement and brief advice activity to reduce heavy drinking. However, gains have been only modest and short term at best. WHO studies have concluded that a more effective uptake could be achieved by embedding primary health care activity within broader municipal-based support. Methods : A quasi-experimental study will compare primary health care-based prevention and management of heavy drinking in three intervention municipal areas from Colombia, Mexico and Peru with three comparator municipal areas from the same countries. In the implementation municipal areas, primary health care units will receive training embedded within ongoing supportive municipal action over an 18-month implementation test period. In the comparator municipal areas, half the units will receive training, and the other half will continue with practice as usual. The primary outcome is the proportion of the adult population (aged 18+ years) registered with the unit that has their alcohol consumption measured. Return-on-investment analyses and full process evaluation will be undertaken, coupled with an analysis of potential contextual, financial and political-economy influencing factors. Discussion : This multi-country study will test the extent to which embedding primary health care-based prevention and management of heavy drinking within supportive municipal action leads to improved scale-up of more patients having their alcohol consumption measured, and subsequently receiving appropriate advice and treatment.


2019 ◽  
Author(s):  
Sean Lund ◽  
Taylor Courtney ◽  
Gavin Williams

Isoprenoids are a large class of natural products with wide-ranging applications. Synthetic biology approaches to the manufacture of isoprenoids and their new-to-nature derivatives are limited due to the provision in Nature of just two hemiterpene building blocks for isoprenoid biosynthesis. To address this limitation, artificial chemo-enzymatic pathways such as the alcohol-dependent hemiterpene pathway (ADH) serve to leverage consecutive kinases to convert exogenous alcohols to pyrophosphates that could be coupled to downstream isoprenoid biosynthesis. To be successful, each kinase in this pathway should be permissive of a broad range of substrates. For the first time, we have probed the promiscuity of the second enzyme in the ADH pathway, isopentenyl phosphate kinase from Thermoplasma acidophilum, towards a broad range of acceptor monophosphates. Subsequently, we evaluate the suitability of this enzyme to provide non-natural pyrophosphates and provide a critical first step in characterizing the rate limiting steps in the artificial ADH pathway.<br>


2020 ◽  
Vol 132 (6) ◽  
pp. 1970-1976
Author(s):  
Ashwin G. Ramayya ◽  
H. Isaac Chen ◽  
Paul J. Marcotte ◽  
Steven Brem ◽  
Eric L. Zager ◽  
...  

OBJECTIVEAlthough it is known that intersurgeon variability in offering elective surgery can have major consequences for patient morbidity and healthcare spending, data addressing variability within neurosurgery are scarce. The authors performed a prospective peer review study of randomly selected neurosurgery cases in order to assess the extent of consensus regarding the decision to offer elective surgery among attending neurosurgeons across one large academic institution.METHODSAll consecutive patients who had undergone standard inpatient surgical interventions of 1 of 4 types (craniotomy for tumor [CFT], nonacute redo CFT, first-time spine surgery with/without instrumentation, and nonacute redo spine surgery with/without instrumentation) during the period 2015–2017 were retrospectively enrolled (n = 9156 patient surgeries, n = 80 randomly selected individual cases, n = 20 index cases of each type randomly selected for review). The selected cases were scored by attending neurosurgeons using a need for surgery (NFS) score based on clinical data (patient demographics, preoperative notes, radiology reports, and operative notes; n = 616 independent case reviews). Attending neurosurgeon reviewers were blinded as to performing provider and surgical outcome. Aggregate NFS scores across various categories were measured. The authors employed a repeated-measures mixed ANOVA model with autoregressive variance structure to compute omnibus statistical tests across the various surgery types. Interrater reliability (IRR) was measured using Cohen’s kappa based on binary NFS scores.RESULTSOverall, the authors found that most of the neurosurgical procedures studied were rated as “indicated” by blinded attending neurosurgeons (mean NFS = 88.3, all p values < 0.001) with greater agreement among neurosurgeon raters than expected by chance (IRR = 81.78%, p = 0.016). Redo surgery had lower NFS scores and IRR scores than first-time surgery, both for craniotomy and spine surgery (ANOVA, all p values < 0.01). Spine surgeries with fusion had lower NFS scores than spine surgeries without fusion procedures (p < 0.01).CONCLUSIONSThere was general agreement among neurosurgeons in terms of indication for surgery; however, revision surgery of all types and spine surgery with fusion procedures had the lowest amount of decision consensus. These results should guide efforts aimed at reducing unnecessary variability in surgical practice with the goal of effective allocation of healthcare resources to advance the value paradigm in neurosurgery.


2021 ◽  
pp. 1-9
Author(s):  
Victoire Leroy ◽  
Yaohua Chen ◽  
Naiara Demnitz ◽  
Florence Pasquier ◽  
Pierre Krolak-Salmon ◽  
...  

Background: Falls are a major health problem in older persons but are still under-diagnosed and challenging to prevent. Current guidelines do not target high-risk populations, especially people living with dementia. In France, people with neurocognitive disorders are mainly referred to memory clinics (MCs). Objective: We aimed to survey the routine practice of physicians working in MCs regarding fall risk assessment. Methods: We conducted a cross-sectional survey in France from January to May 2019 among physicians working in MCs, through an anonymous online questionnaire: twenty-seven questions about the physician’s background and their practice of fall risk assessment, especially use of clinical and paraclinical tools. We compared the results according to the age and the specialty of the physician. Results: We obtained 171 responses with a majority of women (60%) and geriatricians (78%). All age classes and all French regions were represented. Most of respondents (98.8%) stated that they address gait and/or falls in outpatient clinic and 95.9%in day hospitals. When asked about how they assess fall risk, fall history (83%) and gait examination (68.4%) were the most widely used, while orthostatic hypotension (24%) and clinical standardized tests (25.7%) were less common. Among standardized tests, One-leg Balance, Timed Up and Go Test, and gait speed measurements were the most used. Geriatricians had more complete fall risk assessment than neurologists (e.g., 56%versus 13%for use of standardized tests, p <  0.0001). Conclusion: Almost all physicians addressed the question of fall in MC, but practices are widely heterogeneous. Further investigations are needed to standardize fall risk assessment in MCs.


2021 ◽  
pp. 1-11
Author(s):  
Chang Liu ◽  
Murat Yücel ◽  
Chao Suo ◽  
Mike E. Le Pelley ◽  
Jeggan Tiego ◽  
...  

Background: To date, there has been little investigation on how motivational and cognitive mechanisms interact to influence problematic drinking behaviours. Towards this aim, the current study examined whether reward-related attentional capture is associated with reward, fear (relief), and habit drinking motives, and further, whether it interacts with these motives in relation to problematic drinking patterns. Methods: Ninety participants (mean age = 34.8 years, SD = 9.1, 54% male) who reported having consumed alcohol in the past month completed an online visual search task that measured reward-related attentional capture as well as the Habit Reward Fear Scale, a measure of drinking motives. Participants also completed measures of psychological distress, impulsivity, compulsive drinking, and consumption items of Alcohol Use Disorders Identification Test. Regression analyses examined the associations between motives for alcohol consumption and reward-related attentional capture, as well as the associations between reward-related attentional capture, motives, and their interaction, with alcohol consumption and problems. Results: Greater reward-related attentional capture was associated with greater reward motives. Further, reward-related attentional capture also interacted with fear motives in relation to alcohol consumption. Follow-up analyses showed that this interaction was driven by greater fear motives being associated with heavier drinking among those with lower reward-related attentional capture (i.e., “goal-trackers”). Conclusion: These findings have implications for understanding how cognition may interact with motives in association with problematic drinking. Specifically, the findings highlight different potential pathways to problematic drinking according to an individual’s cognitive-motivational profile and may inform tailored interventions to target profile-specific mechanisms. Finally, these findings offer support for contemporary models of addiction that view excessive goal-directed behaviour under negative affect as a critical contributor to addictive behaviours.


2018 ◽  
Vol 41 (2) ◽  
pp. e177-e184 ◽  
Author(s):  
Helen-Maria Vasiliadis ◽  
Marie-Christine Payette ◽  
Djamal Berbiche ◽  
Sébastien Grenier ◽  
Carol Hudon

AbstractBackgroundThe effect of alcohol consumption on cognitive decline is not clear. We aimed to study the association between alcohol consumption and cognitive functioning controlling for functional heath status.MethodsA total of 1610 older adults with a score ≥26 on the Mini-Mental State Examination (MMSE) were followed to assess the change in scores at the 3-year follow-up. Information on alcohol consumption as well as socio-demographic, lifestyle, psychosocial and clinical factors, as well as health service use were assessed at baseline and 3-year follow-up interviews. Linear mixed models with repeated measures were used stratifying by functional status.ResultsClose to 73% reported consuming alcohol in the past 6 months, of which 11% were heavy drinkers (≥11 and ≥16 drinks for women and men). A significant decrease in MMSE scores was observed in low functioning non-drinkers (−1.48; 95% CI: −2.06, −0.89) and light to moderate drinkers (−0.99; 95% CI: −1.54, −0.44) and high functioning non-drinkers (−0.51; 95% CI: −0.91, −0.10).ConclusionsAlcohol consumption did not contribute to cognitive decline. Cognitive decline was greater in individuals reporting low functional status. Research should focus on the interaction between changing patterns of alcohol consumption and social participation in individuals with low and high functioning status.


2017 ◽  
Vol 41 (S1) ◽  
pp. s866-s866
Author(s):  
M. Juncal Ruiz ◽  
O. Porta Olivares ◽  
L. Sánchez Blanco ◽  
R. Landera Rodríguez ◽  
M. Gómez Revuelta ◽  
...  

IntroductionAlcohol consumption represents a significant factor for mortality in the world: 6.3% in men and 1.1% in women. Alcohol use disorder is also very common: 5.4% in men and 1.5% in women. Despite its high frequency and the seriousness of this disorder, only 8% of all alcohol-dependents are ever treated. One potentially interesting treatment option is oriented toward reducing alcohol intake.AimsTo describe one case who has improved his alcohol consumption after starting treatment with nalmefene, an opioid receptor antagonist related to naltrexone.MethodsA 35-year-old male with alcohol use disorder since 2001 came to our consult in November 2015. He was in trouble with his family and he had a liver failure. We offer a new treatment option with nalmefene 18 mg to reduce alcohol consumption.ResultsBefore to start nalmefene he drank 21 drinks/week. Six-month later, he decreased alcohol intake until 5 drinks/week with better family relationship and liver function. After starting nalmefene he complained of nausea, so we recommend to take the middle of the pill for next 7 days. After this time he returned to take one pill with good tolerance and no more side effects or withdrawal syndrome.ConclusionsNalmefene appears to be effective and safe in reducing heavy drinking and in preventing alcohol withdrawal syndrome due to its opioid receptor antagonism. This case suggests nalmefene is a potential option to help patients, who do not want or cannot get the abstinence, in reducing their alcohol consumption.Disclosure of interestThe authors have not supplied their declaration of competing interest.


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