VIVITROL and counseling may help your appropriate patients with alcohol dependence1
The efficacy of VIVITROL in the treatment of alcohol dependence was evaluated in a 24-week, placebo-controlled, multicenter, double-blind, randomized trial of alcohol dependent (DSM-IV criteria) outpatients2
Patients met the DSM-IV criteria for alcohol dependence and had a minimum of 2 episodes of heavy drinking per week in the 30 days before screening. Heavy drinking was defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women.
A total of 627 outpatients were randomized to receive VIVITROL 380 mg (n=208), extended-release naltrexone (XR-NTX) 190 mg (n=210), or placebo (n=209).
Participants received an intramuscular (IM) injection every 4 weeks in an outpatient setting for a total of 6 injections over 24 weeks, along with psychosocial support every other week. 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. Only data for VIVITROL 380 mg and placebo are presented here.
PRIMARY ENDPOINT2
The primary endpoint was the event rate of heavy drinking over the 24 weeks of treatment, defined as the number of heavy drinking days divided by the number of days at risk for heavy drinking.
*17 patients abstained 7 days prior to treatment.
†19 patients abstained 7 days prior to treatment.
Please see below for study limitations.
Demographics and clinical baseline characteristics2
|
VIVITROL 380 mg
(n=205)‡
|
Placebo
(n=209)
|
Mean age in years§ |
45.0 (±10.1) |
44.7 (±10.8) |
White |
172 (83.9%) |
180 (86.1%) |
Mean weight in kg§ |
84.2 (±20.7) |
81.6 (±17.0) |
Employed ≥20 hours/week |
144 (70.2%) |
151 (72.2%) |
Other drug use |
|
Current smoker§ |
99 (48.3%) |
88 (42.1%) |
Antidepressants |
62 (30.2%) |
61 (29.2%) |
Drinking behavior |
|
Abstinence goal |
90.0 (43.9%) |
90.0 (43.1%) |
Abstinence for 7 days before
randomization
|
17 (8.3%) |
19 (9.1%) |
Self-help group attendance§ |
24 (11.7%) |
23 (11.0%) |
Mean % heavy drinking in
30 days before randomization
|
64.0% (±25.9) |
65.2% (±24.8) |
‡Three of 208 patients did not receive their first injection based on investigator decision.
§P<0.05 (significant difference between men and women in the overall study population [N=624]).
Data are mean (SD) or number (%).
STUDY LIMITATIONS2
- 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
Heavy drinking days were significantly reduced for patients treated with VIVITROL and counseling vs placebo2
The primary endpoint was the event rate of heavy drinking over the 24 weeks of treatment, defined as the number of heavy drinking days divided by the number of days at risk for heavy drinking.2
In a subset of patients in the pivotal trial able to abstain completely from drinking 7 days prior to treatment, drinking days and heavy drinking days were reduced1
In a subset|| of patients able to abstain from drinking alcohol completely during the 7 days prior to initiation of outpatient therapy, a reduction in the number of drinking days and heavy drinking days was observed vs placebo1
Patients should not be actively drinking at the time of initial VIVITROL administration.1
Median heavy drinking days: ≥7-day abstinent subset (n=53) over 6 months1,3
Greater reduction in the number of any drinking days in a subset|| of patients who abstained from drinking 1 week before treatment1
Median any drinking days per month: ≥7-day abstinent subset (n=53)1,3
At baseline, the median 7-day abstinent patient had 15.2 drinking days and 15.2 abstinent days per average month (30.4 days).
||A predefined subpopulation of lead-in abstinent patients (n=53, or 8% of the total study population), defined as those who reported no drinking during the 7 consecutive days prior to the first injection.1
¶Psychosocial support was defined as biweekly counseling.1
A subset of patients in the pivotal trial able to abstain completely from drinking 7 days prior to treatment were more likely to maintain complete abstinence with VIVITROL vs placebo1
Patients maintaining complete abstinence (%): ≥7-day abstinent subset (n=53)2,3
A greater proportion of patients with a 7-day lead-in abstinence on VIVITROL maintained abstinence throughout the 6-month study period vs those on placebo.1
#Psychosocial support was defined as bi-weekly counseling.1
STUDY LIMITATIONS1,2
- Due to the small numbers, this analysis should be interpreted with caution
- The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation
- Secondary data analysis; no adjustments were made for multiple comparisons
- Only data for VIVITROL 380 mg and placebo are presented here
Adverse reactions in alcohol dependence pivotal trial
Treatment-emergent adverse reactions that occurred in ≥5% of patients with alcohol dependence treated with VIVITROL and that occurred more frequently in the VIVITROL group vs the placebo group1
|
VIVITROL 380 mg
(n=205)
|
Placebo
(n=214)
|
Any ISR |
69% |
50% |
Injection site tenderness |
45% |
39% |
Injection site induration |
35% |
8% |
Nausea |
33% |
11% |
Headache |
25% |
18% |
Asthenic conditions |
23% |
12% |
Injection site pain |
17% |
7% |
Other ISR (primarily nodules, swelling) |
15% |
4% |
Insomnia, sleep disorder |
14% |
12% |
Vomiting NOS |
14% |
6% |
Anorexia, appetite decreased NOS,
appetite disorder NOS
|
14% |
3% |
Diarrhea |
13% |
10% |
Dizziness, syncope |
13% |
4% |
Anxiety |
12% |
8% |
Arthralgia, arthritis, joint stiffness |
12% |
5% |
Pharyngitis |
11% |
11% |
Abdominal pain |
11% |
8% |
Injection site pruritus |
10% |
0% |
Depression |
8% |
4% |
Muscle cramps |
8% |
1% |
Injection site ecchymosis |
7% |
5% |
Back pain, back stiffness |
6% |
5% |
Rash |
6% |
4% |
Dry mouth |
5% |
4% |
Somnolence, sedation |
4% |
1% |
Please see the complete list of adverse reactions in the VIVITROL Prescribing Information.
Discontinuation rates due to adverse events1
ISR=injection site reaction; NOS=not otherwise specified.
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.