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Update on Alcohol, Other Drugs, and Health

Update on Alcohol, Other Drugs, and Health. January–February 2009. Studies on Interventions & Assessments. Topiramate Shows Potential for Treatment of Alcohol Dependence. Baltieri DA, et al.  Addiction. 2008;103(12):2035–2044. Summary by Peter D. Friedmann, MD, MPH. Objectives/Methods.

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Update on Alcohol, Other Drugs, and Health

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  1. Update on Alcohol, Other Drugs, and Health January–February 2009 www.aodhealth.org

  2. Studies on Interventions & Assessments www.aodhealth.org

  3. Topiramate Shows Potential for Treatment of Alcohol Dependence Baltieri DA, et al. Addiction. 2008;103(12):2035–2044. Summary by Peter D. Friedmann, MD, MPH www.aodhealth.org

  4. Objectives/Methods • This study compares topiramate with naltrexone and placebo for the treatment of alcohol dependence. • In a 12-week controlled trial following a 1-week detoxification period, Brazilian investigators randomized 155 adults with alcohol dependence to receive either topiramate (TITRATED to 300 mg per day), naltrexone (50 mg per day), or placebo. www.aodhealth.org

  5. Results • Outcome event rates for topiramate, naltrexone, and placebo, respectively, were • 7.8*, 5.7, and 5.0 weeks for time to first relapse. • 8.2*, 6.6, and 5.6 weeks for cumulative abstinence. • 3.4*, 5.0, and 5.9 weeks for mean weeks of heavy drinking. • The percentage of patients remaining continuously abstinent were • 67%*, 53%, and 43% at 4 weeks. • 62%*, 41%, and 32% at 8 weeks. • 46%, 29%, and 28% at 12 weeks. • Side-effects did not differ between groups. *p<.05 compared with placebo. www.aodhealth.org

  6. Comments • Safe effective medications are essential to bringing treatment for alcohol use disorders into mainstream practice. • Evidence for disulfiram, naltrexone, and acamprosate has been mixed, limiting their adoption by physicians. • These results suggest topiramate is superior to placebo, and may show benefit over naltrexone, in improving outcomes among patients with alcohol dependence, a result that warrants larger comparative trials. www.aodhealth.org

  7. Antiretroviral Therapy Has Equal Benefit for Injection Drug Users and Nonusers Wood E, et al. JAMA. 2008;300(5):550–554. Summary by Julia H. Arnsten, MD, MPH www.aodhealth.org

  8. Objectives/Methods • To determine the effect of intravenous drug use (IDU) on long-term outcomes among patients receiving highly active antiretroviral therapy (HAART), investigators compared survival rates in 3116 HIV-infected persons who initiated HAART between 1996 and 2006. • Median duration of follow-up was 5.3 years for patients with IDU and 4.3 years for patients with no IDU. www.aodhealth.org

  9. Results • Two hundred thirty-two of 915 patients with IDU and 390 of 2201 patients with no IDU died over the study period (crude mortality rate, 20%). • All-cause mortality rates were similar for patients with and without IDU (26.5% and 21.6%, respectively) and remained similar after adjusting for age, sex, baseline AIDS diagnosis/CD4 cell count, adherence, and physician experience (hazard ratio [HR], 1.09). • In analyses of non-accidental causes of death, the HR for mortality between patients with IDU and those with no IDU was 1.06 adjusted for the same characteristics. www.aodhealth.org

  10. Comments • Injection drug use was not associated with decreased survival among HIV-infected patients initiating HAART in this study. • The impact of past versus ongoing drug use was not assessed, and the study included only subjects receiving HAART, which patients with IDU are less likely to initiate. www.aodhealth.org

  11. Social Reinforcement and Stepped Counseling Combined with Medication May Improve Abstinence in Patients with Alcohol Dependence Neto D, et al. Alcohol Alcohol. 2008;43(6):661–668. Summary by Nicolas Bertholet, MD, MSc www.aodhealth.org

  12. Objectives/Methods To decrease relapse rates, researchers at 2 Portuguese alcohol treatment centers randomized 209 patients with alcohol dependence to 1 of 2 treatment groups and compared results: • treatment as usual (TAU), which included • detoxification • individual counseling • medication • sequential combined treatment (SCT), including • social reinforcement (enlisting an adult close to the patient to be co-responsible for his or her treatment) • individual and family counseling • medication www.aodhealth.org

  13. Results • Among the 64% of subjects who completed 6-month follow-up, 78% in the SCT group were abstinent compared with 59% in TAU group (p<0.01). • Mean time to first relapse was 150 days in the SCT group compared with 123 days in the TAU group (p<0.01). • The maximum duration of continuous abstinence was 130 days in the SCT group compared with 111 days in the TAU group (p<0.05). www.aodhealth.org

  14. Comments • Although SCT showed promise, these results should be interpreted with caution because: • Subjects agreed to take disulfiram prior to randomization. • Loss to follow-up was high. • Therapists were selected according to the model (SCT or TAU) they were already delivering in their clinical practices. www.aodhealth.org

  15. Does Opioid Agonist Treatment Impact HIV-infected Patients' Use of Antiretroviral Therapy? Roux P, et al. Addiction. 2008;103(11):1828–1836. Summary by Jeffrey H. Samet, MD, MA, MPH www.aodhealth.org

  16. Objectives/Methods • To determine whether opioid agonist treatment (OAT) with methadone or buprenorphine improves adherence to antiretroviral therapy (ART), researchers studied its impact on opioid dependence in 276 individuals in France who had become HIV-infected through drug use. • Patients were assessed at 6-month intervals (1558 visits), starting from their first ART prescription, and were categorized with regard to current report of injection drug use (IDU) and current receipt of OAT. • Outcomes were self-reported ART adherence and HIV viral load suppression. www.aodhealth.org

  17. Results • Using logistic regression analysis and adjusting for alcohol consumption, depression, and ART side effects, • adherence to ART was comparable between IDU-negative patients receiving OAT and IDU-negative patients who did not receive OAT. • IDU-positive patients receiving OAT or not receiving OAT had a 2- and 3-fold risk, respectively, of non-adherence to ART. • viral suppression was associated with duration of IDU-negative status among patients receiving OAT. www.aodhealth.org

  18. Comments • Cessation of IDU improves ART adherence and HIV-related outcomes. Methadone and buprenorphine treatment can help decrease IDU. • These findings highlight the importance of providing substance use treatment as part of HIV care and strongly suggest the benefit of OAT in countries with IDU-driven HIV epidemics that are now scaling up ART use. www.aodhealth.org

  19. Mertens JR, et al. Drug Alcohol Depend. 2008;98(1–2):45–53.Summary by Alexander Y. Walley, MD, MSc Primary Care Integrated with Substance Abuse Treatment and Ongoing Primary Care Utilization are Associated with Remission at 5 Years www.aodhealth.org

  20. Objectives/Methods • A 2001 randomized controlled trial among patients with substance use disorders (N=598) demonstrated that substance abuse treatment integrated with primary care increased abstinence at 6 months for patients with substance abuse-related medical conditions (SAMCs) but not for patients without SAMCs. • In an extended observational study using the same sample, researchers assessed whether the original integrated care intervention combined with ongoing primary care was associated with abstinence at 5-year follow-up. www.aodhealth.org

  21. Results • Older age, increased medical problem severity, and assignment to the integrated care model in the original study were associated with abstinence at 5 years. • Among subjects with SAMCs at baseline in the original study (n=458), ongoing primary care utilization (2–10 visits versus 0–1 visits) was associated with abstinence at 5 years. www.aodhealth.org

  22. Comments • Integrated care increased abstinence from substance use regardless of SAMC status—an effect not apparent in the original trial—and increased abstinence among patients with SAMCs who had greater primary care engagement. • These findings support efforts to integrate substance abuse treatment with primary care and to manage substance use disorders as chronic diseases. www.aodhealth.org

  23. Ernst DB, et al.Ann Fam Med. 2008; 6(5):435–440.Summary by Peter D. Friedmann, MD, MPH Confidence and Judgment Are Important For Medical Management of Alcohol Dependence www.aodhealth.org

  24. Objectives/Methods • This secondary analysis of the COMBINE study, a randomized controlled trial that measured the efficacy of pharmacotherapy combined with psychosocial treatments, including Medical Management (MM),* in the treatment of alcohol dependence, examined the influence of patient and clinician factors on drinking outcomes among 1162 patients randomized to receive MM plus naltrexone and/or acamprosate from 37 clinicians. *Nine brief structured outpatient sessions provided by a health care professional. www.aodhealth.org

  25. Results • Clinicians’ ability to convey confidence in the treatment and to be flexible in delivering the intervention predicted better drinking outcomes. • Among patients, number of visits and better perception of the relationship with the clinician predicted better drinking outcomes. • Patient satisfaction with MM also predicted increased abstinence and clinical improvement. www.aodhealth.org

  26. Comments • This analysis implies that clinician confidence, skill, and judgment improve outcomes in patients receiving MM for alcohol dependence. • Blind adherence to MM treatment guidelines will not optimize management of alcohol dependence in primary care settings. • Greater emphasis on substance use disorders at all stages of medical education and training is needed to improve clinician confidence, skill, and judgment in identifying and managing these disorders. www.aodhealth.org

  27. Studies of Health Outcomes www.aodhealth.org

  28. Unhealthy Alcohol Use Is Associated with Medication Nonadherence Bryson CL, et al. Ann Intern Med. 2008;149(11):795–804. Summary by Richard Saitz, MD, MPH www.aodhealth.org www.aodhealth.org 28

  29. Objectives/Methods To determine the effect of unhealthy alcohol use on adherence to prescription medication, investigators performed a secondary analysis of data from a randomized trial conducted in general medicine clinics at 7 Veterans Affairs Medical Centers. The 22,670 patients in the analysis had been prescribed either a statin, oral hypoglycemic agents, or antihypertensive medications and had completed a 3 question screening test* for alcohol consumption. Based on screening scores, patients were categorized as nondrinkers, low-level drinkers, or as having mild, moderate, or severe unhealthy alcohol use. *The Alcohol Use Disorders Identification Test—Consumption. www.aodhealth.org www.aodhealth.org 29

  30. Results More severe unhealthy alcohol use was significantly associated with lower adherence* to both statin and antihypertensive medications. In adjusted analyses, adherence at 1 year was: 66% for nondrinkers 63% for those with mild unhealthy use 58% for those with moderate unhealthy use 55% for those with severe unhealthy use. Despite a similar trend, screening scores were not significantly associated with adherence to oral hypoglycemic medication. *Defined as having medication available during at least 80% of the observation period based on pharmacy refill records. www.aodhealth.org www.aodhealth.org 30

  31. Comments Patients may not take prescribed medicines when they drink to avoid possible interactions and adverse effects or they may forget to take their medication due to changes in priorities or cognition. This study underscores the value of alcohol screening not only because it identifies a risky health behavior but also because it may help clinicians manage chronic medical conditions by improving adherence to medications. www.aodhealth.org www.aodhealth.org 31

  32. Britton A, et al. J Epidemiol Community Health. 2008;62(10):905–908.Summary by Richard Saitz, MD, MPH Possible Cardioprotection from Moderate Drinking Limited to People with Other Unhealthy Behaviors www.aodhealth.org

  33. Objectives/Methods • Moderate drinking* has been shown to reduce the risk of myocardial infarction (MI), but whether this benefit is dependent on other health behaviors is unknown. • In a prospective study, researchers in England followed 9655 middle-aged adult civil servants without evidence of MI at baseline for a median of 17 years. • Subjects were characterized according to alcohol use and “unhealthy behavior” (limited or no exercise, poor diet, and/or smoking). *<1–8 or 9 standard [14 g] US drinks per week. www.aodhealth.org

  34. Results • In analyses adjusted for age, sex, and socio-economic status, moderate alcohol use (compared with no use or heavier use) had no effect on the incidence of coronary heart disease or MI among people reporting regular physical activity and daily fruit and vegetable consumption who did not smoke. • Moderate use was associated with half the risk of coronary heart disease among people with 2 or 3 unhealthy behaviors. • Analyses adjusted for diabetes, angina, hyper-tension, and cardiovascular medication use yielded similar results. www.aodhealth.org

  35. Comments • These results suggest moderate alcohol consumption has no benefit in nonsmokers who eat fruits and vegetables and exercise. • Limitations: • Investigators assessed drinking at only 1 point in time. • Adjustment variables were limited. • Important subgroups were small (e.g., there were only 8 coronary heart disease events among healthy nondrinkers). www.aodhealth.org

  36. Pain and the Nonmedical Use of Prescription Opioids Novak SP, et al. Drug Alcohol Depend. 2009;100(1–2):63–70. Summary by David A. Fiellin, MD www.aodhealth.org

  37. Objectives/Methods • Prescription opioid abuse and dependence are increasing. • Researchers analyzed demographic, psychiatric, and substance use data from 42,734 US adults* to determine whether nonmedical use of prescription opioids is driven by untreated pain. • Respondents answered questions regarding: • past-year nonmedical use of prescription opioids. • the extent to which pain interfered with activities of daily living (i.e., low, moderate, high interference). *Participants in the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). www.aodhealth.org

  38. Results • Past-year rate of nonmedical use of prescription opioids was 1.8%. Of these individuals, 20% met criteria for opioid abuse/dependence. • Pain was positively associated with an increased probability of nonmedical use and prescription opioid abuse/dependence. • Within each level of pain, the odds of past-year nonmedical use and abuse /dependence were significantly higher for those with unhealthy alcohol use. www.aodhealth.org

  39. Comments • Although limited by a cross-sectional design that prevents drawing a direct casual relationship, these results support existing evidence regarding the association between inadequately treated pain and the rise in nonmedical use of prescription opioids. • Clinicians should: • screen for inappropriate use of prescription opioids in all patients with pain. • monitor for evidence of abuse/dependence in those who are taking opioids. • be aware that unhealthy alcohol use increases the likelihood of nonmedical use of prescription opioids. www.aodhealth.org

  40. Fan AZ. J Clin Endocrinol Metab. 2008;93(10):3833–3828.Summary by R. Curtis Ellison, MD Drinking in Excess of US Guidelines and Heavy Episodic Drinking May Increase Risk for Metabolic Syndrome www.aodhealth.org

  41. Objectives/Methods • To examine the association between alcohol consumption and the Metabolic Syndrome (MS), researchers analyzed data from the 1999–2002 National Health and Nutrition Examination Survey. • The sub-sample included current drinkers aged 20–84 years with no cardiovascular disease and for whom complete data on MS and drinking existed (n=1529). • Metabolic syndrome was defined as having 3 of the following: www.aodhealth.org

  42. Results • In logistic regression models controlling for demographics, family history of cardiovascular disease, diabetes, and lifestyle factors, risk of MS increased with: • daily alcohol consumption exceeding US dietary guidelines* (odds ratio [OR], 1.60). • heavy episodic drinking† ≥1 time per week (OR, 1.51). • In analyses of individual metabolic abnormalities, drinking in excess of dietary guidelines was associated with: *Consuming >1 drink per drinking day for women and >2 drinks per drinking day for men. †Consuming 5 or more drinks per day. www.aodhealth.org

  43. Limitations/Comments • This paper presents prevalence ORs for certain levels of drinking among subjects who have varying components of MS rather than measuring the risk of MS according to drinking pattern. • Due to the cross-sectional design of this study, whether drinking alcohol leads to, or is the result of, MS cannot be clearly defined. • Prospective studies that include nondrinkers, and in which drinking patterns are assessed prior to the development of MS, would help elucidate the relationship between alcohol consumption and MS. www.aodhealth.org

  44. Beulens JW, et al. Diabetologia. 2008;51(9):1631–1638.Summary by R. Curtis Ellison, MD Does Moderate Alcohol Consumption Reduce Microvascular Complications of Type 1 Diabetes? www.aodhealth.org 44

  45. Objectives/Methods This cross-sectional study investigated the association between moderate alcohol consumption and risk for microvascular complications including retinopathy, neuropathy, and nephropathy (macroalbuminuria >200 μg/min). The sample included 1857 patients with type 1 diabetes participating in the EURODIAB Prospective Complications Study. Follow-up was at 7 years following baseline examination. www.aodhealth.org 45

  46. Results • Researchers identified 304 cases of proliferative retinopathy, 660 cases of neuropathy, and 157 cases of nephropathy. • Alcohol consumption was associated with risk of microvascular complications in a U-shaped fashion: • Moderate consumers (30–70 g per week) had a lower risk for proliferative retinopathy (odds ratio [OR], 0.60), neuropathy (OR, 0.61), and macroalbuminuria (OR, 0.36) in multivariable adjusted models. • Drinking frequency was significantly inversely associated with risk of neuropathy, with a similar trend visible for proliferative retinopathy and macroalbuminuria. www.aodhealth.org 46

  47. Results (cont’d) • Results were similar when excluding patients who had been advised to drink less alcohol because of their health. • The relation was most pronounced in consumers of wine versus beer, while consumption of distilled spirits was associated with an increased risk of microvascular complications. www.aodhealth.org 47

  48. Comments Results indicate that the risk for microvascular complications in people with type 1 diabetes may be markedly reduced by moderate alcohol intake, especially for consumers of wine. The relative importance of drinking frequency and quantity consumed per drinking day could not be determined in this study, however, because too little variation in drinks per drinking day existed to draw valid conclusions. www.aodhealth.org 48

  49. Does Heavy Alcohol Intake Increase the Risk for Cardiovascular and Cerebrovascular Disease? Hvidtfeldt UA, et al. Alcohol Clin Exp Res. 2008;32(11);1920–1924. Summary by Kevin L. Kraemer, MD, MSc www.aodhealth.org

  50. Objectives/Methods • To assess the effect of heavy alcohol intake on cardiovascular and cerebrovascular disease, researchers analyzed data from 13,814 men and 3563 women presenting to 5 Copenhagen outpatient alcohol treatment clinics between 1954 and 1992. • Demographic data, average drinks per day (22 for men and 16 for women), and duration of heavy alcohol use (14 years for men and 9 years for women) were recorded at registration. • Danish national databases were used to identify death or hospitalization from cardiovascular or cerebrovascular disease from 1977 through 2001. • Age-, sex-, and time-adjusted standardized incidence ratios (SIRs) were calculated as the ratio of observed to expected events. www.aodhealth.org

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