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Abordaje de los problemas de alcohol: de las intervenciones
breves a los tratamientos farmacológicos
Dr Antoni Gual
REUNION DE LA RED DE TRASTORNOS ADICTIVOS
HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA
6 DE MARZO DE 2015
Conflicts of interest
Interest Name of organisation
Current roles and affiliations
Addictions Unit, Psychiatry Dept, Neurosciences Institute, Hospital Clinic, University of Barcelona; IDIBAPS; RTA; Vice President of INEBRIA, President of EUFAS
Grants Lundbeck, D&A Pharma, FP7, SANCO
Honoraria Lundbeck, D&A Pharma, Servier, Lilly, Abbvie
Advisory board/consultant
Lundbeck, D&A Pharma, Socidrogalcohol (Alcohol Clinical Guidelines) 2013
Alcohol-attributable mortality (2004)
• Premature deaths are defined as deaths in the age
group between 15 and 64 years of age.
Men Women Total
% of premature deaths 13,9% 7,7% 11,9% 95% CI 8,1 – 19,2% 3,1 – 12,1% 6,5 – 16,9%
Number of premature deaths 94.500 25.000 119.500
95% CI 55.500 – 130.500 10.500 – 40.000 66.000 – 170.500
Proportion One in 7 One in 13 One in 8
Alcohol-attributable premature deaths in the EU 2004 by sex and main causes
DetrimentaleffectsMen
#sWomen
#sMen
%Women
%
Cancer 17,358 8,668 15.9% 30.7%
Cardiovasculardisease
(otherthanIschemicheart
disease)7,914 3,127 7.2% 11.1%
Mentalandneurologicaldisorders
10,868 2,330 9.9% 8.3%
Livercirrhosis 28,449 10,508 26.0% 37.2%
Unintentionalinjury 24,912 1,795 22.8% 6.4%
Intentionalinjury 16,562 1,167 15.1% 4.1%
Otherdetrimental 3,455 637 3.2% 2.3%
Totaldetrimental 109,517 28,232 100.0% 100.0%
Beneficialeffects
Ischemicheartdisease 14,736 1,800 97.8% 61.1%
Otherbeneficial 330 1,147 2.2% 38.9%
Totalbeneficial 15,065 2,947 100.0% 100.0%
Alcohol-attributable Alcohol-attributable (net) Heavy drinking Alcohol dependence
Men 16,1% 13,9% 11,1% 10,7%
Women 8,5% 7,7% 5,3% 3,7%
Total 13,6% 11,8% 9,2% 8,4%
Men Women Total
25
20
15
10
5
0
Per
cen
tage
of
dea
ths
Heavy drinking accounts for 78 % of the net burden
Rehm et al. 2012. Alcohol consumption, alcohol dependence, and attributable burden of disease
Alcohol-attributable deaths for people 15 to 64 years of age
Alcohol dependence incurs an enormous financial burden on society
Total = €155.8 billion
€21.4
€6.3
€45.2
€11.3
€17.6
€18.8
€15.1
€7.5
€12.6
HealthTreatment/preventionMortalityAbsenteeismUnemploymentCrime - policeCrime - defensiveCrime - damageTraffic accident damage
Breakdown of costs, in billions, attributable to alcohol-related problems in the EU in 2010
Rehm et al, 2012 Social costs defined as costs to society, i.e., all costs arising from alcohol consumption that are not borne exclusively by the drinker, such as spending on the drinks
Alcohol-attributable harm to others
• Harm to others includes three major items, with different prevalence: – transport injuries – physical violence or homicide – babies born with low birth weight due to the mother’s drinking
(FASD)
• In the EU in 2004, the harm to others caused by alcohol consumption included – 7,710 deaths, – 191,151 potential years of life lost due to premature mortality – 27,410 years of life lost due to disability – 218,560 DALYs
• Overall, the above numbers are clear underestimates.
Prevalence of Alcohol Dependence (AD) and access to treatment. Data from the APC study
AD diagnosis by GP
Patients visited by the GP 13,003
Patients identified as alcohol dependent 5.1% (663)
Patients who received professional help 21.8% (n=145)
• Six EU countries • GPs interviewed about
patients seen in a given day • Patients interviewed with
standardized questionnaires when they exit consultation
Rehm J, et al. Ann Fam Med. 2015.
The double gap
Patients with AUD in PHC
settings
Risky drinkers offered brief
advice to reduce
Alcohol dependent offered treatment
1st GAP
Screening or early identification?
• Screening: Strategy used in a population to identify an unrecognised disease in individuals without signs or symptoms.
• Targeted screening: Screening limited to selected population (because of high risk or high vulnerability)
• Early identification: Evaluation of patients in whom signs of alcohol playing a negative role in a case history are present
The AUDIT-C
1. How often do you have a drink containing alcohol?
2. How many standard drinks containing alcohol do you have on a typical day when drinking?
3. How often do you have six or more drinks on one occasion
0) Never 1) Less than monthly 2) Monthly
3) Weekly 4) Daily or almost daily
The AUDIT-C
1. How often do you have a drink containing alcohol?
2. How many standard drinks containing alcohol do you have on a typical day when drinking?
3. How often do you have six or more drinks on one occasion
0) Never 1) Less than monthly 2) Monthly
3) Weekly 4) Daily or almost daily
Cut off point for Hazardous drinking:
• 4 or more in women • 5 or more in men
Isn’t this a brief intervention?
What is a Brief Intervention?
It usually consists of a package involving:
• information on drinking risk levels,
• the status of the patient’s own drinking in relation to those levels,
• encouragement to cut down and set a date for doing so
• and perhaps a few simple hints on how cutting down might best be achieved
Heather, N., 2010
What is the evidence ?
1. Do brief interventions work? Efficacy studies.
2. Do brief interventions work in the real world of primary care? Effectiveness trials.
3. Are they cost-effective? Cost-effectiveness studies.
4. What factors promote widespread adoption of brief interventions into routine practice? Implementation trials.
5. Wider roll-out work: Demonstration studies.
O’Donnell et al, 2014
1. Efficacy studies
• 23 trials
• Best evidence for 10-15 min BIs and multicontacts
• Compared to controls:
• Consumption decreased by 3,6 drinks per week from baseline
• Heavy drinking episodes reduced by 12%
• 11% reported drinking below recommended limits
Jonas et al, 2012
2. Effectiveness trials
• 24 systematic reviews
• Brief alcohol interventions are effective when delivered in primary healthcare
• Brief alcohol intervention equally effective across different countries and different health care systems
• Insuficient evidence in young and older adults
• Optimum length, frequency and content unknown
O’Donnell et al, 2013
3. Cost-effectiveness studies
Agnus et al, 2014, Unpublished
3. Cost-effectiveness studies Cost-effective Highly cost-effective Cost-saving
Bulgaria Estonia Romania
Croatia Latvia Lithuania Hungary Slovakia Poland Czech Republic Germany Italy Finland
Portugal Malta Cyprus Greece Spain France Austria Belgium Ireland Luxembourg Sweden Netherlands Denmark United Kingdom
Agnus et al, 2014, Unpublished
4. Implementation trials
• Cluster randomized factorial trial
• 120 PHC practices in 5 countries
• Objective: to test three strategies that might increase implementation of EIBI for excessive alcohol consumption in PHC:
– Training and support (Education)
– Financial incentives (Money)
– E-Brief Intervention (Time)
Keurhorst et al, 2013
4
8
12
16
20
24
28
Baseline Week 1-4 Week 5-8 Week 9-12 Follow-up
TS-
TS+
FR-
FR+
eBI-
eBI+
125%*** > FR-
69%*** > TS-
Anderson et al, 2014, Submitted
4
8
12
16
20
24
28
32
Baseline Week 1-4 Week 5-8 Week 9-12 Follow-up
TSFR-
TSFR+
TSeBI-
TSeBI+
FReBI-
FReBI+
TSFReBI-
TSFReBI+
280%*** > TSFR-
Anderson et al, 2014, Submitted
Implementation trials
1. Two hours of training led to more interventions being delivered.
2. Modest financial reimbursement led to more interventions being delivered. Work optimally when fine-tuned to country-specific contexts
3. A combination of training and support and financial reimbursement led to more interventions being delivered than either strategy alone
Anderson et al, 2014, Submitted
5. Demonstration studies: screening in PHC in Catalonia
Colom et al, 2014. Data on file
0
10
20
30
40
50
60
70
2005 2006 2007 2008 2009 2010 2011
Lleida
Tarragona
Barcelona
Girona
MetropolitanaSud
MetropolitanaNord
Caralunyacentral
AltPirineu
Terresdel'Ebre
Total
Health areas in Catalonia
When do opportunistic BIs become motivational?
• Ask for permission to Assess consumption with a brief screening tool
• Ask for permission to give Advise to patients to reduce their consumption
• Agree on individual goals through negotiation
• Assist patients with acquiring the motivations, self-help skills, or supports needed for behaviour change using MI microskills
• Offer to Arrange follow-up
25
A Brief Intervention is..
A short advice given by a health
professional to a patient
But a Brief Motivational Intervention
is
A short conversation between a health
professional and a patient
Two different MBI approaches
Assessment feedback
• Feedback of assessment as the primary means of structuring the conversation and as the basis to elicit change talk
Conversational style
• Series of conversational exercises expected to be helpful in eliciting change talk on relevant material
McCambridge J, 2002
Why do MBI work?
• Life events (raise awareness)
• Assessment (raise awareness)
• Internal discrepancies (importance)
• Taking steps - planning (confidence)
The double gap
Patients with AUD in PHC
settings
Risky drinkers offered brief
advice to reduce
Alcohol dependent offered treatment
1st GAP 2nd GAP
• Avoid withdrawal signs
• Treat comorbid conditions (mental & physical)
• Accept and understand his disease
• Reduce his desire & craving for alcohol
• Reduce the priming effects of alcohol if drinking
• Promote abstinence or reduction of alcohol
• Improve coping skills
• Improve quality of life
TREATMENT: Group of therapeutic processes
designed to help the patient to:
H
S
S
S
S
S
H
H
S - pSychosocial H - pHarmacological
H
H S
S
Pharmacological treatments
70
Alcohol related problems
Pharmacological interventions
70
Alcohol related problems
Pharmacological interventions
Widening the scope of pharmacological treatments
• Classical approach: Abstinence oriented (disulfiram*, acamprosate*, naltrexone*, topiramate)
• Substitution therapy: BZD, sodyum oxibate, baclofen
• Reduction approach: nalmefene*, naltrexone, topiramate, gabapentine.
* Registered indication
Target of Pharmacological treatments
Goal Example
Decrease craving Acamprosate
Decrease priming Nalmefene
Decrease impulsivity Topiramate
Aversive reaction Disulfiram
51
Jonas, D. E., Amick, H. R., Feltner, C., et al (2014). Pharmacotherapy for
adults with alcohol use disorders in outpatient settings: a systematic review
and meta-analysis. Jama, 311(18), 1889–900. doi:10.1001/jama.2014.3628
Abstinence Oriented Pharmacological treatments
Other drugs for abstinence oriented treatments
Baclofen • Very controversial
• Ongoing research just about to be published
• High doses likely to be effective
Sodyum Oxibate • Registered in Austria and Italy
• Efficacy stablished for withdrawal
• Main trials finished but not published yet
Reduced drinking
Pharmacological treatments
• Nalmefene
• Naltrexone?
• Topiramate?
• Gabapentin?
Topiramato vs placebo a las 14 semanas
Pivotal Nalmefene RCTs
HDD: change from baseline in the 6-month studies
– patients with at least high DRL at baseline and randomisation
23 HDDs
11 HDDs
23 HDDs
10 HDDs
Difference: -3.7 HDDs, p=0.0010
Difference: -2.7 HDDs, p=0.0253
ESENSE 2 ESENSE 1
van den Brink et al. Alcohol Alcohol 2013;48(5):570–578; Data on file
MMRM (OC) FAS estimates and SE; *p<0.05, **p<0.01, ***p0.001; MMRM=mixed-effect model repeated measure; OC=observed cases; FAS=full analysis set; SE=standard error
TAC: change from baseline in the 6-month studies
– patients with at least high DRL at baseline and randomisation
113 g/day
43 g/day
102 g/day
44 g/day
Difference: -18.3 g/day, p<0.0001
Difference: -10.3 g/day, p=0.0404
ESENSE 2 ESENSE 1
MMRM (OC) FAS estimates and SE; *p<0.05, **p<0.01, ***p<0.001; MMRM=mixed-effect model repeated measure; OC=observed cases; FAS=full analysis set; SE=standard error van den Brink et al. Alcohol Alcohol 2013;48(5):570–578; Data on file
Putting the efficacy of psychiatric and general medicine
medication into perspective: review of meta-analyses
Leucht et al. Br J Psychiatry 2012;200:97–106
Nalmefene
standardised effect size range
Standardized effect size (Cohen’s d)
Nalmefene1 HDDs TAC
ESENSE 1 0.37 0.46
ESENSE 2 0.27 0.25
Alcohol
treatment2,3 0.12 to 0.33
Antidepressants4 0.24 to 0.35
Antipsychotics4 0.30 to 0.53
1. Data on file; 2. Kranzler & Van Kirk. Alcohol Clin Exp Res 2001;25:1335–1341;
3. NICE. CG115. Alcohol dependence and harmful alcohol use: appendix 17d – pharmacological interventions forest plot. 2011;
4. Leucht et al. Br J Psychiatry 2012;200:97–106
Psychosocial treatments
The confrontational model
• Review of four decades of treatment outcome research.
• A large body of trials found no therapeutic effect relative to control or comparison treatment conditions.
• Several have reported harmful effects including increased drop-out, elevated and more rapid relapse.
• This pattern is consistent across a variety of confrontational techniques tested.
• In sum, there is not and never has been a scientific evidence base for the use of confrontational therapies.
WR. Miller, W. White; 2007
Motivational Interviewing
• New golden standard for the psychological approach to addictive behaviours
• Radical change:
– external confrontation as a technique vs internal confrontation as a goal
– Patient centered
– Spirit: partnership, compassion, evocation and acceptance
WR. Miller, S. Rollnick; 2012
Summary
• Statistically significant, modest but robust effect: Odds ratio = 1.55
• Effective: HIV viral load, dental outcomes, death rate, body weight, alcohol and tobacco use, sedentary behavior, self-monitoring, confidence in change, and approach to treatment.
• Not particularly effective: eating disorder and some medical outcomes
Lundahl et al, 2013
Patient-Centered Care (PCC)
‘Providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions.’
Institute of Medicine, 2001
“No decision about me, without me.”
Defining attributes of PCC:
• Holistic
• Individualized
• Respectful
• Empowering
Morgan and Yoder (2012)
Clinicians and patients should discuss:
• ambivalence toward change;
• patient goals (eg, abstinence vs decreasing drinking vs no change);
• preference for group based or individual psychosocial treatment
• differences in the privacy and cost of the various options
• medication treatments
Shared decision making
• Helping patients better understand
their medical conditions;
• Providing information about benefits
and adverse effects of treatment
options;
• Supporting patients while they clarify
their values and preferences;
• Providing support while patients
implement their decisions
• working with family and caregivers
when patients have impaired
decisional capacities
• Double gap: identification and treatment rates are very low
• BIs efficacy and effectiveness established but implementation is difficult
• Pharmacological treatments have widened their scope
• Pychosocial treatment remains the basis of a good clinical approach to AUDs.
Final remarks
Abordaje de los problemas de alcohol: de las intervenciones breves a los tratamientos
farmacológicos
Dr Antoni Gual
REUNION DE LA RED DE TRASTORNOS ADICTIVOS
HOSPITAL REGIONAL UNIVERSITARIO DE MALAGA
6 DE MARZO DE 2015
MUCHAS GRACIAS !!!