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Policymaker Summary – Aug. 9, 2016
Pharmacotherapy for Adults With Alcohol Use Disorder in Outpatient Settings
Table of Contents
- Key Issue
- Summary of Evidence From the Systematic Review
- Considerations for Programs and Policies*
- Additional Resources
Medications can be effective in treating alcohol use disorder (AUD) when used in combination with psychosocial interventions. Evidence from epidemiological studies suggests that improving alcohol consumption outcomes (such as reduction in return to drinking or in percentage of drinking days) would likely result in improved health outcomes. However, medications are underutilized in treating AUD, thus providing opportunities for expanding treatment optimization. This is a summary of a systematic review evaluating the efficacy, comparative effectiveness, and adverse effects of medications in adults with AUD. The systematic review included 167 articles published from January 1, 1970, to October 11, 2013.
Alcohol use disorder (AUD) includes harmful use of alcohol, alcohol abuse, and alcohol dependence. In the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), alcohol abuse and alcohol dependence are no longer distinguished and are identified together as AUD. The prevalences of 12-month and lifetime AUD among adults in the United States in 2012 and 2013 were 13.9 percent (32.6 million individuals) and 29.1 percent (64.5 million individuals), respectively.1 Between 2006 and 2010, there were, on average, nearly 85,000 deaths per year related to alcohol consumption in the United States.
Current guidelines by the Veterans Administration, the National Institute on Alcohol Abuse and Alcoholism, and the Substance Abuse and Mental Health Services Administration all recommend that pharmacotherapy be offered as an adjunct to psychosocial therapies (e.g., cognitive behavioral therapy, 12-step programs). However, estimates indicate that fewer than 1 in 3 patients with AUD receives treatment, and fewer than 1 in 10 patients receives pharmacotherapy as part of their treatment. Medications approved by the U.S. Food and Drug Administration for AUD include acamprosate (Campral®, thrice daily), disulfiram (Antabuse®, once daily), oral naltrexone (ReVia®, once daily), and extended-release injectable naltrexone (Vivitrol®, once monthly). In addition, medications such as topiramate have not been approved to treat AUD but have been used or studied as treatment for AUD.
Health care utilization studies* report reduced medical costs among patients treated with AUD medication when compared with patients treated without it.2 A meta-analysis of three health care utilization studies on alcohol dependence reported that total medical costs were $3,649 less among patients on AUD medication than those not on the medication.3
Summary of Evidence From the Systematic Review
- Acamprosate and oral naltrexone improve alcohol consumption outcomes for patients with AUD. Head-to-head trials have not consistently established the superiority of one medication over another. (See Table 1)
- Evidence related to injectable naltrexone is currently limited.
- Evidence from randomized controlled trials does not support the efficacy of disulfiram.
- Disulfiram may be recommended to individuals who have a goal of abstinence but for whom acamprosate and oral naltrexone are not suitable or to individuals who prefer disulfiram and understand its risks.4
- Most studies evaluated medications in combination with a psychosocial cointervention; the potential benefits of using the medications alone are not well established.
- Evidence from randomized controlled trials was insufficient to determine the effectiveness of AUD medications for improving health outcomes (e.g., mortality, quality of life, and function).
- Epidemiological studies consistently related heavy alcohol consumption to an increased risk of serious health problems and suggest that improving alcohol consumption outcomes would likely result in improved health outcomes.
Considerations for Programs and Policies*
Given the underutilization and the effectiveness of pharmacotherapy for AUD, individuals responsible for AUD programs and policies may consider:
- Reducing barriers to access by promoting benefit coverage for oral and injectable prescriptions in combination with psychosocial therapy
- Encouraging patients to use medication adherence programs and educating them about how the medications and psychosocial programs work to treat AUD
- Educating health care providers (physicians, counselors, therapists, etc.) about the effectiveness of available pharmacotherapies in conjunction with psychosocial therapies as recommended by current clinical guidelines
- Providing education to employee assistance program providers and occupational medicine providers to enable them to more effectively support employees with AUD during their treatment
* These studies and considerations were not evaluated in the systematic review but are offered to assist policymakers in applying this evidence.
|Medication||Outcome||N Studiesa||N Subjects||Finding||SOE|
|Note: Studies assessed in this review typically included psychosocial cointerventions in addition to medications.
N = number; SOE = strength of evidence
a This column only includes studies rated as having a low or medium risk of bias that were included in the main analysis; these numbers do not include studies rated as having a high or unclear risk of bias that were included in sensitivity analyses.
b These medications have not been approved by the U.S. Food and Drug Administration as treatment for alcohol dependence, alcohol abuse, or AUD.
|Acamprosate vs. placebo||Return to any drinking||16||4,847||Reduced by acamprosate|
|Return to heavy drinking||7||2,496||No difference|
|Percentage of drinking days||13||4,485||Reduced by acamprosate|
|Disulfiram vs. placebo||Return to any drinking||2||492||No difference|
|Naltrexone 50 mg oral vs. placebo||Return to any drinking||16||2,347||Reduced by naltrexone|
|Return to heavy drinking||19||2,875||Reduced by naltrexone|
|Percentage of drinking days||15||1,992||Reduced by naltrexone|
|Percentage of heavy drinking days||6||521||Reduced by naltrexone|
|Naltrexone injection vs. placebo||Return to any drinking||2||939||No difference|
|Return to heavy drinking||2||615||No difference|
|Percentage of heavy drinking days||2||926||Reduced by naltrexone|
|Topiramateb vs. placebo||Percentage of drinking days||2||521||Reduced by topiramate|
|Percentage of heavy drinking days||2||521||Reduced by topiramate|
|Number of drinks per drinking day||2||521||Reduced by topiramate|
|Other drugsb||The evidence is insufficient to determine the efficacy of other medications because of inconsistency, imprecision, or lack of sufficient studies in the literature (e.g., amitriptyline, aripiprazole, atomoxetine, baclofen, buspirone, citalopram, desipramine, fluoxetine, fluvoxamine, gabapentin, imipramine, olanzapine, ondansetron, paroxetine, quetiapine, varenicline, viloxazine).|
Strength of Evidence Scale
High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect.
Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate.
Low confidence that the evidence reflects the true effect. Further research is likely to change our confidence in the estimate of effect and is likely to change the estimate.
Evidence is either unavailable or does not permit a conclusion.
- Grant BF, Goldstein RB, Saha TD, et al. Epidemiology of DSM-5 alcohol use disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions III. JAMA Psychiatry. 2015 Aug;72(8):757-66. PMID: 26039070.
- Baser O, Chalk M, Rawson R, et al. Alcohol dependence treatments: com- prehensive healthcare costs, utilization outcomes, and pharmacotherapy per- sistence. Am J Manag Care. 2011 Jun;17 Suppl 8;S222-34. PMID: 21761948.
- Hartung DM, McCarty D, Fu R, et al. Extended-release naltrexone for alcohol and opioid dependence: a meta-analysis of healthcare utilization studies. J Subst Abuse Treat. 2014 Aug;47(2):113-21. PMID: 24854219.
- National Institute for Health and Care Excellence. Alcohol Use Disorders: Diagnosis, Assessment and Management of Harmful Drinking and Alcohol Dependence. NICE Guideline No. CG115. London, England: National Institute for Health and Care Excellence; February 2011.
Additional resources on AUD for clinicians and consumers are offered by the National Institute on Alcohol Abuse and Alcoholism.
The information in this summary is based on Jonas DE, Amick HR, Feltner C, Bobashev G, Thomas K, Wines R, Kim MM, Shanahan E, Gass CE, Rowe CJ, Garbutt JC. Pharmacotherapy for Adults With Alcohol-Use Disorders in Outpatient Settings. Comparative Effectiveness Review No. 134. (Prepared by the RTI International–University of North Carolina Evidence-based Practice Center under Contract No. 290-2012-00008-I.) AHRQ Publication No. 14-EHC029-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2014.
This summary was prepared by the John M. Eisenberg Center for Clinical Decisions and Communications Science at Baylor College of Medicine, Houston, TX. It was written by Geetha Achanta, Ph.D., Winifred W. Yu, Ph.D., R.D., Thomas Kosten, M.D., Trudy Millard Krause, Dr.P.H., CPHQ, and Michael Fordis, M.D.