POST HOC ANALYSES
EARLY TREATMENT RESPONSE IN ALCOHOL DEPENDENCE WITH EXTENDED-RELEASE NALTREXONE1
Evaluating the time to onset of VIVITROL treatment response in alcohol-dependent patients1
Post hoc study design
A post hoc analysis of the alcohol dependence pivotal trial was performed on data from 624 alcohol-dependent patients who were randomly assigned to receive VIVITROL 380 mg, XR-NTX 190 mg, or placebo every 4 weeks for 24 weeks. In addition, patients received 12 counseling sessions. The subanalysis focused on the 30-day period following the first treatment dose and included the subset of the intent-to-treat (ITT) population that received all 6 doses of study treatment and provided sufficient timeline follow-back information without any major protocol violations.1
A total of 208 patients were randomized to the VIVITROL 380 mg group. Three patients did not receive any treatment due to enrollment failures based on investigator decision, leaving 205 patients included in the primary analysis and safety evaluation for the VIVITROL 380 mg group.1,2
Only data for VIVITROL 380 mg and placebo are presented here.
Number of drinks per day through Month 11
The Ciraulo et al post hoc analysis
*Heavy drinking was defined as a self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients.1- Analyses of group tendencies (median, mean) do not reflect the experience of individual patients
STUDY LIMITATIONS1,2
These analyses were based on a post hoc analysis of the clinical trial by Garbutt et al (2005).
This study was not specifically designed to assess the onset of effect of XR-NTX and may have been insufficiently powered for this purpose.
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The study was not designed to answer whether naltrexone may or may not work for women
- The women who participated may not be representative of women with alcohol dependence in the general population, and the number of women studied was small
- Men and women in this study differed on a number of important variables, including the prevalence of smoking and antidepressant use, weight, and commitment to abstinence
- The men and women in this sample may have differed on other variables that may positively influence naltrexone response but were not assessed in this study, such as family history of alcoholism
- Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
- Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
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Patient motivation for change may have affected the response to treatment
- Patients who enroll in clinical studies may be more motivated to change behavior than those who are treated in outpatient settings
- A strong response to counseling, such as occurred in this trial, may be expected to obscure the detection of additional benefit from pharmacotherapy
A post hoc analysis of a subset of patients in the pivotal trial who abstained from drinking alcohol for ≥4 days prior to initiation of treatment3
Post hoc study design
This post hoc analysis was not prespecified and included a small sample size; thus, the results could represent chance findings and should be interpreted with caution. A post hoc analysis of the alcohol dependence pivotal trial was performed on data from 624 alcohol-dependent outpatients who were randomly assigned to receive VIVITROL 380 mg, XR-NTX 190 mg, or placebo every 4 weeks for 24 weeks, along with psychosocial support every other week. In the subanalysis, 82 patients were voluntarily abstinent for ≥4 days prior to treatment initiation. Evaluations occurred weekly for the first 4 weeks and then every 2 weeks for the next 20 weeks until the final visit.
Median heavy drinking† days per month: ≥4-day abstinent subset (n=82)3
- VIVITROL 380 mg with psychosocial support‡ (n=28): 0.2 heavy drinking days
- Placebo with psychosocial support† (n=28): 2.9 heavy drinking days
Median number of days to first heavy drinking event: ≥4-day abstinent subset population (n=82)3,4
†Heavy drinking was defined as a self-report of ≥5 standard drinks consumed on a given day for male patients and ≥4 drinks for female patients.
‡Psychosocial support was defined as biweekly counseling.5
STUDY LIMITATIONS2,3
- Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
- Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
- Analyses of group central tendencies (median, mean) do not reflect the experience of individual patients
VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions, and sudden opioid withdrawal. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose. See Important Safety Information below. See Prescribing Information. Review Medication Guide with your patients.
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LEARN MOREReferences: 1. Ciraulo DA, Dong Q, Silverman BL, Gastfriend DR, Pettinati HM. Early treatment response in alcohol dependence with extended-release naltrexone. J Clin Psychiatry. 2008;69(2):190-195. 2. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625. 3. O’Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27:507-512. 4. Data on file. Alkermes, Inc. Waltham, MA. 5. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021.
§Terms and Conditions
Eligibility for Alkermes-Sponsored Co-pay Savings. This offer is only available to patients 18 years or older, with a prescription consistent with the Prescribing Information and the patient is not enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program.
Additional Terms of Use: This offer is not conditioned on any past, present, or future purchase, including refills. Alkermes reserves the right to rescind, revoke, or amend this offer, program eligibility, and requirements at any time without notice. This offer is limited to one per patient, may not be used with any other offer, is not transferable and may not be sold, purchased or traded, or offered for sale, purchase or trade. Void where prohibited by law. Program Administrator or its designee will have the right upon reasonable prior written notice, during normal business hours, and subject to applicable law, to audit compliance with this program.