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Evidence Based Medicine Pharmacological Treatment of Alcohol Dependence
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Case Presentation 49yo m with HTN, HLP, DM2 presents to clinic for possible medical treatment for his 20 year h/o chronic alcohol use. He drinks about 6- 12pack/day. Denies any legal problems. Retired. Wife recently divorced him secondary to issues that could be related to his alcohol use. He has been sober for a week now “cold turkey.” He has some urges/cravings and His friend from the VFW got medicine that helped him with that. He was wondering if I could prescribe him something similar.
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Question? Can a pharmacotherapy approach (I.e “medical management”) be used to treat alcohol dependence? (I.e. can I try to treat him myself?) Should I refer AND medicate, or just refer?
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Alcohol Background 100,000 deaths annually in US 30% of all traffic fatalities Affect 10% of Americans at some point in their lives 2002 survey of 43,000 adults – prevalence about 12.5%(1) 2006 Survey of 2,397 EM residents (2) – 3.3% daily drinkers – 12.6% increased consumption during residency
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Definition Alcohol Dependence per DSMIV : 3+ – Tolerance – Withdrawal (E) – Substance taken in larger quantities than intended – Persistent desire to cut down or control use (C ) – Time is spent obtaining, using or recovering (G) – Social, occupational or recreational tasks are sacrificed (AG?) – Use continues despite physical and psychological problems (G?)
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Alcohol GABA (stim, sedate, intoxicate) GLUTAMATE (stim, sedate, intoxicate) DOPAMINE (reinforce, reward, craving) OPIATE (reinforce, reward, craving)
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How it works?
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What about medicines? US FDA approval – Disulfiram (antabuse) – Naltrexone (Vivitrol 380mg IM q4week or ReVia 50mg po qday) – Acamprosate(Campral) 666mg to 1g po tid
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Disulfiram (antabuse)
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Disulfiram Data Double blind trial – “core journals” 1 trial 1986 JAMA – VA CoOp study – 605 patients randomized + CBT 250mg disulfiram 1mg disulfiram Nothing
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Disulfiram Data 80% noncompliant – 10% abstinent rate 20% Compliant – 50% abstinent NO difference in time to first drink, abstinent days, patients in the 250mg Disulfiram group did drink less. No difference at 1 year follow up.
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Disulfiram Other studies Author, YrFollow-upDisulfiramAbstinence Gerrein, 197385%, 39% Monitored Unmonitored 40% 7% Azrin, 197690%Monitored90-98% Azrin, 1982100%Monitored73%* Liebson, 197878%Monitored98%
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Disulfiram Summary Works well when patients are compliant. – (i.e not very good for outpt use) Use if goal is zero alcohol use. Warn patients when using other products that may contain alcohol (mouthwash, etc,.)
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Naltrexone Opioid receptor antagonist, can blunt the pleasurable effects and reduce cravings Can’t use in patients taking chronic opiates Hepatotoxicity
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~homotaurine ~GABA (gamma aminobutyric acid) Decrease excitatory glutamergic neurotransmission during alcohol withdrawal, and reduce cravings Usual dose is 666mg po tid Renally cleared so c/i in renal disease. FDA approved in 2004 Acamprosate
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Search Pubmed search – 1996-present RCT, CT ‘naltrexone + alcoholism’ – 1996-present RCT, CT ‘camprosate + alcoholism’ Results: Acamprosate – 1996 Lancet VA study Naltrexone 2001 COMBINE study 2006
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Acamprosate (Whitworth et al, Lancet 1996) Multicenter, DBPCT 448 Adult patients Randomized to – 1998 mg (666mg tid) – Placebo F/u 0, 30, 90, 180, 270 and 360 days Primary Outcome – Time to treatment Failure (relapse or non attendance)
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Acamprosate Results 448 patients – 224 acamprosate arm 94 completed 52 withdrawn, 33 lost to f/u, 31 refused, 15 ill, 2died 6 side effects – 224 placebo arm 85 completed 52 withdrawn, 36 lost to f/u, 32 refused, 11 ill, 1died 4 side effects
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Acamprosate Results At end of study – Day 360 – Abstinent 41/224 (18.3%) abstinent 16/224 (7.1%) abstinent, (p=0.007) – Mean abstinent duration 138.8 days vs 103 days (p=0.012) not significant 11% (1 in 9 NNT) to get abstinent
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2001. Multicenter – RCT 627 Veterans with alcohol dependence – 12months naltrexone 50mg a day – 3monts of naltrexone then placebo 9months – 12months placebo – +Counseling Primary Outcome – Time to relapse (I.e 1 st day of heavy drinking) – Number of drinks/day
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VA - Demographics
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Compliance
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Outcome
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VA Summary Pt population of mainly men (97%), avg 13drinks/day, started drinking regular at 23. Naltrexone 50mg a day + therapy – Not different than placebo in Time to relapse Calendar days drinking
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Naltrexone (Cochrane 2005) 27 RCT 12 weeks of Naltrexone – Decreases relapse 36% – Reduce the chance of returning to drink 13% Faults – short duration, small sizes.
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11sites, 1383 patients, alcohol dependence Excluded patients with other drug use (x/c cannabis) Avg age 44, avg 12drinks/day, 67%men, 40%married 4 days abstinence then -> Randomized (naltrexone 100mg/day, acamprosoate 666mg tid) MM – 9 sessions/16weeks, and at 26,52,68 weeks (0,1,2,4,6,8,10,12,16 week) CBT – alcohol specialist Alcohol use was self reported and verified by level of %CDT (abnormal serum transferrin protein) End Point - % days abstinent, time to >1 heavy drinking days (>5 men >4women)
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COMBINE – arms
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“Good clinical outcome” – – no more than 2days of heavy drinking per week, – (14drinks per week/men 11drink/women) – and without alcohol related problems
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COMBINE SUMMARY Combined therapy - no additive benefit. Acamprosate not statistically beneficial. Naltrexone – %days abstinent 80.6% vs 75.1% = p=.009 – Heavy drinking day (66.2% vs 73.1%) p=0.15 – “Good clinical outcome” – 73.7% vs 58.2%
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Costs Disulfiram – 250mg po qday/month $112.00 ($77.70 CHCS) Naltrexone – 50mg po qday/month $205.00, $18.00 generic (CHCS) – 380mg IM q month. $504.40 (CHCS) Acamprosate – 333mg po tid/month - $150.00 ($30.00 CHCS)
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NMCSD Formulary? We carry all meds but restricted to SARP / Psychiatry
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Summary Disulfiram helpful in a monitored setting Naltrexone data conflicting – Reviews show helpful short term. – VA DBCT – not helpful at 50mg for one year – COMBINE study – benefit at 100mg Camprosate – Benefit with CBI at one year – COMBINE study – showed no benefit
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Follow up Checked labs (LFT, CBC, B12, Folate, TSH) were normal Recommended AA treatment – www.aa.org www.aa.org
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Questions?
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