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Closing	
  the	
  treatment	
  gap	
  in	
  alcohol	
  
dependence	
  :	
  the	
  role	
  of	
  nalmefene	
  
Dr	
  Antoni...
Conflicts	
  of	
  interest	
  
Interest	
   Name	
  of	
  organisa/on	
  
Current	
  roles	
  and	
  
affilia/ons	
  
Addic;...
Index	
  
•  Burden	
  of	
  disease	
  
•  The	
  first	
  gap:	
  role	
  of	
  Brief	
  Interven;ons	
  
•  The	
  secon...
Index	
  
•  Burden	
  of	
  disease	
  
•  The	
  first	
  gap:	
  role	
  of	
  Brief	
  Interven;ons	
  
•  The	
  secon...
Prevalence	
  of	
  Alcohol	
  Dependence	
  (AD)	
  and	
  
access	
  to	
  treatment.	
  Data	
  from	
  the	
  APC	
  s...
Treatmentgap*(%)
Kohn et al. Bull World Health Organ 2004;82:858–866
Treatment gap in alcohol dependence
6
*Treatment gap=...
The	
  double	
  gap	
  
Pa;ents	
  with	
  
AUD	
  in	
  PHC	
  
sebngs	
  
Risky	
  drinkers	
  
offered	
  brief	
  
adv...
Symptoms of depression and alcohol dependence frequently
overlap1,2
8
1. Boden JM, et al. Addiction 2011;106:906-914. 2. W...
Symptom overlap between alcohol dependence and anxiety
disorders1
1. Brady, et al. Am J Psychiatry . 2007;164(2):217-221. ...
20%-30% of psychiatric patients are also alcohol dependent1
Lifetime prevalence of psychiatric disorders and co-occurrent ...
Screening	
  or	
  early	
  iden;fica;on?	
  
•  Screening:	
  Strategy	
  used	
  in	
  a	
  popula;on	
  to	
  iden;fy	
 ...
The	
  AUDIT-­‐C	
  
1.	
  How	
  ofen	
  do	
  you	
  have	
  a	
  drink	
  containing	
  
alcohol?	
  
2.	
  How	
  many...
The	
  AUDIT-­‐C	
  
1.	
  How	
  ofen	
  do	
  you	
  have	
  a	
  drink	
  containing	
  
alcohol?	
  
2.	
  How	
  many...
•  No	
  standard	
  defini/on	
  –	
  can	
  range	
  from	
  a	
  short	
  conversa/on	
  to	
  a	
  number	
  of	
  
str...
Brief	
  Interven;on:	
  Level	
  1	
  
Raistrick	
  et	
  al.	
  Review	
  of	
  the	
  effec;veness	
  of	
  treatment	
 ...
Index	
  
•  Burden	
  of	
  disease	
  
•  The	
  first	
  gap:	
  role	
  of	
  Brief	
  Interven;ons	
  
•  The	
  secon...
The	
  double	
  gap	
  
Pa;ents	
  with	
  
AUD	
  in	
  PHC	
  
sebngs	
  
Risky	
  drinkers	
  
offered	
  brief	
  
adv...
Nalmefene blocks
the µ-opioid receptor3
Nalmefene modulates
the κ-opioid receptor3
2.9%
3.0%
3.1%
4.2%
5.7%
5.9%
5.9%
6.5%...
Pa;ents’	
  treatment	
  goal	
  preference	
  
UKATT: 742 patients seeking help for
alcohol problems1
Canada: 106 patient...
Benefits	
  of	
  reduc;on:	
  reducing	
  consump;on	
  by	
  a	
  constant	
  amount	
  	
  
translates	
  to	
  a	
  hig...
 
	
  
	
  
	
  
	
  
	
  
	
  
	
  
	
  
‘…For	
  all	
  people	
  who	
  
misuse	
  alcohol,	
  offer	
  
interven7ons	
 ...
The	
  double	
  gap	
  
Pa;ents	
  with	
  
AUD	
  in	
  PHC	
  
sebngs	
  
Risky	
  drinkers	
  
offered	
  brief	
  
adv...
Pa;ents	
  with	
  
AUD	
  in	
  PHC	
  
sebngs	
  
Risky	
  drinkers	
  
offered	
  brief	
  
advice	
  to	
  reduce	
  
A...
Which	
  are	
  the	
  clinical	
  characteris;cs	
  
of	
  those	
  pa;ents?	
  
a.  Demographic	
  characteris;cs	
  
b....
Alcohol dependence is typically a progressive disease1,2
References >
EARLY-STAGE
Ability to function:
Most likely functio...
Some	
  prac;cal	
  examples.	
  
•  Jesús M. 49 años, broker
•  Maria R. 35 años, housewife
•  Juana F. 26 años, student
Some	
  prac;cal	
  examples.	
  
Jesús M. 49 years.
•  Married, 2 sons, works as a broker at an insurance
company
•  Mode...
Some	
  prac;cal	
  examples.	
  
Maria R. 35 years
•  Married, a daughter 7 years old. Housewife.
•  No somathic diseases...
Some	
  prac;cal	
  examples.	
  
Juana F. 26 years.
•  Last year in a Business school. Lives with her
parents.
•  Gets dr...
•  Mild to moderate AUD
•  Socially stable
•  Psychological distress (anxiety/
depression that may or may not be linked
to...
Index	
  
•  Burden	
  of	
  disease	
  
•  The	
  first	
  gap:	
  role	
  of	
  Brief	
  Interven;ons	
  
•  The	
  secon...
Alcohol	
  use	
  Abs;nence	
  	
  	
  -­‐	
  	
  low	
  risk	
  	
  -­‐	
  	
  hazardous	
  use	
  -­‐	
  harmful	
  use	...
Alcohol	
  use	
  Abs;nence	
  	
  	
  -­‐	
  	
  low	
  risk	
  	
  -­‐	
  	
  hazardous	
  use	
  -­‐	
  harmful	
  use	...
Widening	
  the	
  scope	
  of	
  
pharmacological	
  treatments	
  
•  Classical	
  approach:	
  Abs;nence	
  oriented	
 ...
Nalmefene – What it does!
•  Nalmefene diminishes
the reinforcing effects
of alcohol, helping the
patient to reduce
drinki...
Nalmefene indication
Nalmefene Summary of Product Characteristics, 2012
•  Nalmefene is indicated for the reduction of alc...
Mann et al. Biol Psychiatry 2013;73(8):706–713;
Gual et al. Eur Neuropsychopharmacol 2013;
van den Brink et al. Poster at ...
HDD: change from baseline in the 6-month studies
– patients with at least high DRL at baseline and randomisation
23	
  HDD...
TAC: change from baseline in the 6-month studies
– patients with at least high DRL at baseline and randomisation
113	
  g/...
Onset of action
37th	
  RSA	
  &	
  17th	
  ISBRA	
  
	
  
JUNE	
  21-­‐25,	
  2014;	
  BELLEVUE,	
  
WASHINGTON	
  
	
  
Index	
  
•  Burden	
  of	
  disease	
  
•  The	
  first	
  gap:	
  role	
  of	
  Brief	
  Interven;ons	
  
•  The	
  secon...
Basic	
  psychosocial	
  strategies	
  	
  
•  Monitor	
  alcohol	
  consump;on	
  
– TLFB	
  
– Apps	
  
•  Mo;va;onal	
 ...
Timeline	
  
followback	
  
•  Retrospec;ve	
  
assessment	
  of	
  drinking	
  
behaviour.	
  
•  Reliable	
  and	
  vali...
Avoid a confrontational approach
•  Review of four decades of treatment outcome research.
•  A large body of trials found ...
Mo;va;onal	
  Interviewing	
  
•  New	
  golden	
  standard	
  for	
  the	
  psychological	
  
approach	
  to	
  addic;ve	...
B	
  
R	
  
E	
  N	
  
D	
  
A	
  
BRENDA
Biopsychosocial
evaluation
Report to the
patient on
assessment
Empathetic
unders...
Brief	
  Interven/on:	
  Level	
  2	
  	
  
Raistrick	
  et	
  al.	
  Review	
  of	
  the	
  effec;veness	
  of	
  treatmen...
•  AUD are a brain disease and a public health problem
•  AUD are underdiagnosed (First Gap)
•  Patients who do not respon...
Closing	
  the	
  treatment	
  gap	
  in	
  alcohol	
  
dependence	
  :	
  the	
  role	
  of	
  nalmefene	
  
Dr	
  Antoni...
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Closing the treatment gap in alcohol dependence thessalonika 2015

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Lecture on the treatment gap (underdiagnose & undertreatment) of alcohol use disorders. Presented at the 5th Conference of the Greek Psychiatric society in Thessalonika, march 21st, 2015.

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Closing the treatment gap in alcohol dependence thessalonika 2015

  1. 1. Closing  the  treatment  gap  in  alcohol   dependence  :  the  role  of  nalmefene   Dr  Antoni  Gual   tgual@clinic.cat   Υπό την αιγίδα 19–21 Μαρτίου 2015 Θεσσαλονίκη THE MET HOTEL 5 o ΜΕ ∆ΙΕΘΝΗ ΣΥΜΜΕΤΟΧΗ ΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΥΓΕΙΑ ΣΥΝΕΔΡΙΟ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΙΑΤΡΙΚΗ ΠΕΡΙΘΑΛΨΗ Προκαταρκτικό πρόγραμμα
  2. 2. Conflicts  of  interest   Interest   Name  of  organisa/on   Current  roles  and   affilia/ons   Addic;ons  Unit,  Psychiatry  Dept,   Neurosciences  Ins;tute,  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  
  3. 3. Index   •  Burden  of  disease   •  The  first  gap:  role  of  Brief  Interven;ons   •  The  second  gap:  need  for  a  reduc;on   approach   •  The  second  gap:  the  role  of  nalmefene   •  Framing  Nalmefene  within  a  psychosocial   support  strategy   •  Summary  
  4. 4. Index   •  Burden  of  disease   •  The  first  gap:  role  of  Brief  Interven;ons   •  The  second  gap:  need  for  a  reduc;on   approach   •  The  second  gap:  the  role  of  nalmefene   •  Framing  Nalmefene  within  a  psychosocial   support  strategy   •  Summary  
  5. 5. Prevalence  of  Alcohol  Dependence  (AD)  and   access  to  treatment.  Data  from  the  APC  study   AD  diagnosis  by  GP   Pa;ents  visited  by  the  GP   13,003   Pa;ents  iden;fied  as  alcohol  dependent   5.1%    (663)   Pa/ents  who  received  professional  help   21.8%  (n=145)   •  Six  EU  countries   •  GPs  interviewed  about   pa;ents  seen  in  a  given  day   •  Pa;ents  interviewed  with   standardized  ques;onnaires   when  they  exit  consulta;on   Rehm  J,  et  al.  Ann  Fam  Med.  2015.  
  6. 6. Treatmentgap*(%) Kohn et al. Bull World Health Organ 2004;82:858–866 Treatment gap in alcohol dependence 6 *Treatment gap=difference between number of people needing treatment for mental illness and number of people receiving treatment Alcohol abuse and dependence have the widest treatment gap among all mental disorders – less than 10% of patients with alcohol abuse and dependence are treated
  7. 7. The  double  gap   Pa;ents  with   AUD  in  PHC   sebngs   Risky  drinkers   offered  brief   advice  to  reduce   Alcohol  dependent   offered  treatment   1st GAP
  8. 8. Symptoms of depression and alcohol dependence frequently overlap1,2 8 1. Boden JM, et al. Addiction 2011;106:906-914. 2. Watts M. B J Nursing. 2008;17(11):696-699 . 3. Shivani R, et al. Alcohol Research & Health. 2002;26:90-98
  9. 9. Symptom overlap between alcohol dependence and anxiety disorders1 1. Brady, et al. Am J Psychiatry . 2007;164(2):217-221. 2.. DSM-IV. American Psychiatric Association. 1994. 3. Shivani, et al. Alcohol Research Health 2002;26(2),90-98. 4. The ICD-10 Classification of Mental and behavioral disorders - Clinical Description and diagnostic guidelines. WHO 1992
  10. 10. 20%-30% of psychiatric patients are also alcohol dependent1 Lifetime prevalence of psychiatric disorders and co-occurrent alcohol dependence1,2 31% Comorbid alcohol dependence 21% 21% Comorbid alcohol dependence 26% Anxiety disorder Mood disorder Lifetime prevalence of psychiatric disorder2 Lifetime prevalence of co-occurrent alcohol dependence and psychiatric disorder1 12% 24% 7% 28% 6% 30% 17% 26% 4% 28% GAD Phobia PTSD Major depressive disorder Bipolar disorder 1. Kessler et al. American Journal of Orthopsychiatry 1996; 66(1): 17-31 2. National Comorbidity Survey Replication NCS-R. Lifetime prevalences estimates www.hcp.med.harvard.edu/ncs/index.php
  11. 11. Screening  or  early  iden;fica;on?   •  Screening:  Strategy  used  in  a  popula;on  to  iden;fy   an  unrecognised  disease  in  individuals  without  signs   or  symptoms.   •  Targeted  screening:  Screening  limited  to  selected   popula;on  (because  of  high  risk  or  high  vulnerability)   •  Early  iden/fica/on:  Evalua;on  of  pa;ents  in  whom   signs  of  alcohol  playing  a  nega;ve  role  in  a  case   history  are  present    
  12. 12. The  AUDIT-­‐C   1.  How  ofen  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  ofen  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  
  13. 13. The  AUDIT-­‐C   1.  How  ofen  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  ofen  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
  14. 14. •  No  standard  defini/on  –  can  range  from  a  short  conversa/on  to  a  number  of   structured  sessions1-­‐5   •  Brief  Interven;ons  are  carried  out  in  general  community  sebngs  (primarily   used  in  primary  care  clinics)  and  are  delivered  by  HCPs  (Health  Care   Professionals)   •  Includes  the  giving  of  informa;on  and  advice   •  Encouragement  to  the  pa;ents  to  consider  the  posi;ves  and  nega;ves  of  their   drinking  behaviour   •  Offers  support  to  pa;ents  if  they  do  decide  that  they  want  to  cut  down   •  Is  ;mely  and  opportunis;c   Brief  interven;on:  Overview   1.  Raistrick  et  al.  Na;onal  Treatment  Agency  for  Substance  Misuse,  2006,  p79;  2.  Scobsh  Intercollegiate  Guidelines  Network,  2003;  3.  NICE  public  health  guidance  24:   Alcohol-­‐use  disorders:  preven;ng  harmful  drinking.  June  2010;  4.  NICE  guidance  CG115:  Alcohol  dependence  and  harmful  alcohol  use  (CG115).  February  2011;  5.   WHO.  Am  J  Public  Health  1996;86:948-­‐55  
  15. 15. Brief  Interven;on:  Level  1   Raistrick  et  al.  Review  of  the  effec;veness  of  treatment  for  alcohol  problems,  2006     1.  Some  assessment  of  alcohol  use   2.  Feddback  on  the  screening  assessment  (clinical   findings  plus  compare  to  the  general   popula;on?   3.  Some  clear  advise  on  how  to  cut  down  (or  stop   drinking)  
  16. 16. Index   •  Burden  of  disease   •  The  first  gap:  role  of  Brief  Interven;ons   •  The  second  gap:  need  for  a  reduc/on   approach   •  The  second  gap:  the  role  of  nalmefene   •  Framing  Nalmefene  within  a  psychosocial   support  strategy   •  Summary  
  17. 17. The  double  gap   Pa;ents  with   AUD  in  PHC   sebngs   Risky  drinkers   offered  brief   advice  to  reduce   Alcohol  dependent   offered  abs;nence   oriented  treatment   1st GAP 2nd GAP
  18. 18. Nalmefene blocks the µ-opioid receptor3 Nalmefene modulates the κ-opioid receptor3 2.9% 3.0% 3.1% 4.2% 5.7% 5.9% 5.9% 6.5% 8.1% 8.4% 8.6% 8.9% 10.6% 30.3% 49.5% 0 10 20 30 40 50 60 Treatment would not help Other barriers No openings in a programme Did not want others to find out Did not have time No programme having type of treatment Did not feel need for treatment No transportation/inconvenient Thought could handle without treatment Health coverage did not cover cost Social stigma Did not know where to go for treatment Might have negative effect on job No health coverage & could not afford cost Not ready to stop using Percentage of patients Reasons  given  for  not  receiving  alcohol  treatment  in  the  past  year  by  persons  who   needed  treatment  and  who  perceived  a  need  for  it:  2009  to  2012   Survey  of  approx.  67500  interviewed  persons  in  the  US   SAMHSA.  Results  from  the  2012  Na;onal  Survey  on  Drug  Use  and  Health,  2013   Why    does  the  gap  exist?  
  19. 19. Pa;ents’  treatment  goal  preference   UKATT: 742 patients seeking help for alcohol problems1 Canada: 106 patients with chronic alcoholism2 1. Heather et al. Alcohol Alcohol 2010;45(2):128–135; 2. Hodgins et al. Addict Behav 1997;22(2):247–255 54% 46% 0 20 40 60 80 100 Abstinence Alcohol reduction Percentageofpatients(%) Treatment preference 46% 44% 9% 0 20 40 60 80 100 Abstinence Moderate drinking Unsure Percentageofpatients(%) Treatment preference
  20. 20. Benefits  of  reduc;on:  reducing  consump;on  by  a  constant  amount     translates  to  a  higher  reduc;on  in  mortality  if  the  reduc;on  is  at  higher   levels   •  Reduc;on  of  36  g/day  (3  drinks)  from   a  baseline  of  60  g/day  corresponds  to   reduced  mortality  risk  of  38  per   10,000     •  Reduc;on  of  36  g/day  from  a  baseline   of  96  g/day  corresponds  to  reduced   mortality  risk  of  119  per  10,000     It’s  the  heavy  drinking  day   that  leads  to  harm!!   Men   Women   Riskofdeath(%) 0   20   40   60   80   100   Alcohol  consump;on  (g/day)   18   12   4   0   16   8   10   2   14   6   Rehm et al. Addiction 2011;106(Suppl 1):11–19; Rehm & Roerke. Alcohol Alcohol 2013;48:509–513 Lifetime risk of death due to alcohol-related injury
  21. 21.                   ‘…For  all  people  who   misuse  alcohol,  offer   interven7ons  to  promote   abs7nence  or  moderate   drinking  as  appropriate’   ‘...For  harmful  drinking  or   mild  dependence,   without  significant   comorbidity,  and  if  there   is  adequate  social   support,  consider  a   moderate  level  of   drinking  as  the  goal  of   treatment’   NICE.  Clinical  guideline  115,  2011   ‘…it’s best to determine individual goals with each patient. Some patients may not be willing to endorse abstinence as a goal, especially at first. If a patient with alcohol dependence agrees to reduce drinking substantially, it’s best to engage him or her in that goal while continuing to note that abstinence remains the optimal outcome.’ NIAAA.     Helping  Pa;ents  Who  Drink  Too  Much,  2007   “In case an alcohol-dependent patient is not able or willing to become abstinent immediately, a clinically significantly reduced alcohol intake with subsequent harm reduction is also a valid, although only intermediate, treatment goal, since it is recognised that there is a clear medical need in these patients as well.” EMA.  Guideline  on  the  development  of  medicinal  products,  2010         Reduc;on  is  included  in  several  interna;onal  guidelines,  either  as  an  intermediate  goal,  or  for  those  pa;ent  that  cannot  accept  or  achieve  abs;nence,  as  an  acceptable  treatment  goal  in  itself                                       16  countries  in  EU  have  guidelines  for  treatment  of  alcohol  dependence,  and  10  out  of  these   countries  have  guidelines  that  recommend  both  abs;nence  and  reduc;on.   14  countries  in  EU,  do  not  have  any  guidelines  for  treatment  of  alcohol  dependence,  but  a   clinical  prac;ce,  and  12  out  of  these  countries  recommend  both  abs;nence  and  reduc;on  in   their  clinical  prac;ce.     Reduc;on  accepted  as  a  treatment  op;on  by  26/30  European  countries     Reduc;on  of  alcohol  consump;on  is  endorsed  by   interna;onal  guidelines    
  22. 22. The  double  gap   Pa;ents  with   AUD  in  PHC   sebngs   Risky  drinkers   offered  brief   advice  to  reduce   Alcohol  dependent   offered  abs;nence   oriented  treatment   2nd GAP
  23. 23. Pa;ents  with   AUD  in  PHC   sebngs   Risky  drinkers   offered  brief   advice  to  reduce   Alcohol  dependent   offered  abs;nence   oriented  treatment   Which  are  the  clinical  characteris;cs   of  those  pa;ents?  
  24. 24. Which  are  the  clinical  characteris;cs   of  those  pa;ents?   a.  Demographic  characteris;cs   b.  Clinical  status   c.  Level  of  mo;va;on   d.  Pa;ent  goals  
  25. 25. Alcohol dependence is typically a progressive disease1,2 References > EARLY-STAGE Ability to function: Most likely functional (e.g. employed, in a relationship) Ability to function: Likely non-functional DEPENDENCE MID-STAGE DEPENDENCE LATE-STAGE Health consequences: Minimal/not life-threatening Anxiety, depressive symptoms Elevated liver enzymes Hypertension Health consequences: Severe/possibly life-threatening Liver cirrhosis Stroke Social consequences: Family conflict, neglect Inability to concentrate on job, absenteeism Social consequences: Divorce, spouse/child abuse Job loss, chronic unemployment, deviant behaviour DEPENDENCE 1.  Burge et al. Am Fam Physician. 1999 59(2): 361-370 2.  Edwards & Gross. BMJ 1976; 1: 1058-1061 Ability to function: Marginally functional (e.g. employed in non-demanding job, problems in marriage or relationship) Health consequences: More severe health consequences, already carrying alcohol-related medical history eg. depression, obesity, visits to hospital, withdrawal symptoms (tremor,anxiety), sleep disorders, clinical signs of liver deficiency (oedema, portal hypertension, coagulation disorder), injuries (driving, other accidents) ischemic encephalopathy, heart hypertophy Social consequences: Significant loss of social interaction, irritability, difficulty to follow team rules, occasionally violent (eg. when provoked, have gone to football match or lost patience by kid’s behaviour). Financial problems, legal problems (eg. due to debts, car accident, caught drunk when driving, violence)
  26. 26. Some  prac;cal  examples.   •  Jesús M. 49 años, broker •  Maria R. 35 años, housewife •  Juana F. 26 años, student
  27. 27. Some  prac;cal  examples.   Jesús M. 49 years. •  Married, 2 sons, works as a broker at an insurance company •  Moderate hypertension. Smoker 1 pack/day •  Drinks with clients (6 beers) and also after dinner at home (3 whiskies). •  Comes under his wifes’ pressure. He is worried with hypertension since his father died from a CVD. •  Has tried unsuccessfully to reduce his drinking. He does not want to stop drinking with clients but thinks he should stop drinking at nights.
  28. 28. Some  prac;cal  examples.   Maria R. 35 years •  Married, a daughter 7 years old. Housewife. •  No somathic diseases. Depression treated with sertraline since 2 years. •  Drinks alone, above 1 liter of wine daily. Refers moderate depression and anxiety symptoms. •  Ready to stop drinking initially, but wants to drink moderately at family events (because of social pressure) at a later stage.
  29. 29. Some  prac;cal  examples.   Juana F. 26 years. •  Last year in a Business school. Lives with her parents. •  Gets drunk on weekends. Abstainer the rest of the week. •  Decreased academic performance, low mood and difficulties with parents. •  Worried because of her sexual behaviour when drunk. •  Wants to avoid drunkeness on weekends, but thinks a bit of drinking is essential when meeting with friends in order to overcome her social phobia.
  30. 30. •  Mild to moderate AUD •  Socially stable •  Psychological distress (anxiety/ depression that may or may not be linked to alcohol intake) •  Desire to reduce their drinking to avoid problems •  Desire not to stop drinking completely What  do  those  cases  have  in  common?  
  31. 31. Index   •  Burden  of  disease   •  The  first  gap:  role  of  Brief  Interven;ons   •  The  second  gap:  need  for  a  reduc;on   approach   •  The  second  gap:  the  role  of  nalmefene   •  Framing  Nalmefene  within  a  psychosocial   support  strategy   •  Summary  
  32. 32. Alcohol  use  Abs;nence      -­‐    low  risk    -­‐    hazardous  use  -­‐  harmful  use  -­‐-­‐    dependence   Alcohol  related  problems   Recommended  psychosocial  interven;ons   Primary  preven;on      -­‐-­‐      Brief  interven;ons    -­‐-­‐  Specialized  treatment   Pharmacological   interven/ons  
  33. 33. Alcohol  use  Abs;nence      -­‐    low  risk    -­‐    hazardous  use  -­‐  harmful  use  -­‐-­‐    dependence   Alcohol  related  problems   Recommended  psychosocial  interven;ons   Primary  preven;on      -­‐-­‐      Brief  interven;ons    -­‐-­‐  Specialized  treatment   Pharmacological   interven/ons  
  34. 34. Widening  the  scope  of   pharmacological  treatments   •  Classical  approach:  Abs;nence  oriented   (disulfiram*,  acamprosate*,  naltrexone*,   topiramate)   •  Subs;tu;on  therapy:  BZD,  sodium  oxibate,   baclofen   •  Reduc;on  approach:  nalmefene*,  naltrexone,   topiramate,  gabapen;ne.   *  Registered  indica;on  
  35. 35. Nalmefene – What it does! •  Nalmefene diminishes the reinforcing effects of alcohol, helping the patient to reduce drinking possibly by modulating cortico- mesolimbic functions. Nalmefene Summary of Product Characteristics; Nalmefene European Public Assessment Report, 2012; Clapp et al. Alcohol Res Health 2008;31(4):310–339 Prefrontal cortex Nucleus accumbens Amygdala Ventral tegmental area Hippocampus Nalmefene Areas in the brain affected by alcohol, including the mesolimbic dopamine system
  36. 36. Nalmefene indication Nalmefene Summary of Product Characteristics, 2012 •  Nalmefene is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification •  Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption •  Nalmefene should be initiated only in patients who continue to have a high DRL two weeks after initial assessment
  37. 37. Mann et al. Biol Psychiatry 2013;73(8):706–713; Gual et al. Eur Neuropsychopharmacol 2013; van den Brink et al. Poster at Research Society on Alcoholism 2012; Data on file Living with someone: 65–86% (65–85%) Higher education: 24–40% (23–32%) Employed: 54–63% (61–64%) Gender: 62–78% (67–77%) men Age: 44–53 yrs (44–52 yrs) Family history: 36–62% (49–61%) Years since onset: 11–15 yrs (11–14 yrs) Not previously treated: 59–78% (60–70%) Number of patients: 854 (1,997) High and very high drinking-risk levels at baseline and randomisation – demographics* Numbers in ()=total sample *No significant differences between placebo and nalmefene arms; Data show range of the means from individual studies
  38. 38. 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  es;mates  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  
  39. 39. 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  es;mates  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  
  40. 40. Onset of action 37th  RSA  &  17th  ISBRA     JUNE  21-­‐25,  2014;  BELLEVUE,   WASHINGTON    
  41. 41. Index   •  Burden  of  disease   •  The  first  gap:  role  of  Brief  Interven;ons   •  The  second  gap:  need  for  a  reduc;on   approach   •  The  second  gap:  the  role  of  nalmefene   •  Framing  Nalmefene  within  a  psychosocial   support  strategy   •  Summary  
  42. 42. Basic  psychosocial  strategies     •  Monitor  alcohol  consump;on   – TLFB   – Apps   •  Mo;va;onal  approach  
  43. 43. Timeline   followback   •  Retrospec;ve   assessment  of  drinking   behaviour.   •  Reliable  and  valid  for  a   variety  of  popula;ons   for  ;me  frames  of  up   to  one  year.   (Sobell  &  Sobell,  1992,  1996)      
  44. 44. Avoid a confrontational approach •  Review of four decades of treatment outcome research. •  A large body of trials found no therapeutic effect of confrontational strategies 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
  45. 45. Mo;va;onal  Interviewing   •  New  golden  standard  for  the  psychological   approach  to  addic;ve  behaviours   •  Radical  change:     – external  confronta;on  as  a  technique    vs  internal   confronta;on  as  a  goal   – Pa;ent  centered   – Spirit:  partnership,  compassion,  evoca;on  and   acceptance   WR. Miller, S. Rollnick; 2012
  46. 46. B   R   E  N   D   A   BRENDA Biopsychosocial evaluation Report to the patient on assessment Empathetic understanding of the patient’s problem Needs expressed by the patient that should be addressed Direct advice on how to meet those needs Assessing response/ behaviour of the patient to advice and adjusting treatment recommendations Clinical  management  –  BRENDA  
  47. 47. Brief  Interven/on:  Level  2     Raistrick  et  al.  Review  of  the  effec;veness  of  treatment  for  alcohol  problems,  2006     Structured, motivation enhancing intervention, as opposed to just screening and brief advice: 1.  Careful History 2.  Clinical Examination 3.  Laboratory testing 4.  Detailed and repeated review of drink diaries 5.  Motivational approach
  48. 48. •  AUD are a brain disease and a public health problem •  AUD are underdiagnosed (First Gap) •  Patients who do not respond to BI should be offered more intensive treatments, including a reduction approach (Second Gap) •  Reduction of alcohol consumption is a feasible goal with nalmefene – efficacy is evident immediately and maintained up to 1 year The ‘as-needed’ dosing, and the reduction goal are well accepted and empower the patient •  Nalmefene must be prescribed within a psychosocial support strategy that is based on motivational principles and monitors alcohol consumption carefully Summary and conclusions
  49. 49. Closing  the  treatment  gap  in  alcohol   dependence  :  the  role  of  nalmefene   Dr  Antoni  Gual   tgual@clinic.cat   Υπό την αιγίδα Γ΄ Ψυχιατρικής Κλινικής ΑΠΘ Τµήµατος Ιατρικής ΑΠΘ 19–21 Μαρτίου 2015 Θεσσαλονίκη THE MET HOTEL 5 o ΜΕ ∆ΙΕΘΝΗ ΣΥΜΜΕΤΟΧΗ ΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΥΓΕΙΑ ΣΥΝΕΔΡΙΟ ΒΙΟΨΥΧΟΚΟΙΝΩΝΙΚΗΣ ΠΡΟΣΕΓΓΙΣΗΣ ΣΤΗΝ ΙΑΤΡΙΚΗ ΠΕΡΙΘΑΛΨΗ Προκαταρκτικό πρόγραμμα Thanks for your attention !!! Moltes gracies !!! Σας ευχαριστώ για την προσοχή σας !!!  

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