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Table 1 Direct (nalmefene versus placebo and naltrexone versus placebo) and indirect (nalmefene versus naltrexone) meta-analyses concerning change from baseline in quantity of drinking

From: Evaluation in alcohol use disorders – insights from the nalmefene experience

Studies Abstinence criterion Consumption criterion Soyka et al. analysis Analysis of complete data
Quantity of drinking Quantity of drinking
SMD [95 % CI] SMD [95 % CI]
CPH-101-0801a No more than 14 days At least 18 heavy drinking days in the last 12 weeks −0.48 [−0.87; −0.09] −0.21 [−0.46; 0.03]
ESENSE 1a [3] No more than 14 days At least 40 g alcohol/day for men and 20 g alcohol/day for women and ≥6 heavy drinking days in the last 4 weeks −0.46 [−0.74; −0.17] −0.35 [−0.56; −0.14]
ESENSE 2a [2] No more than 14 days At least 40 g alcohol/day for men and 20 g alcohol/day for women and ≥6 heavy drinking days in the last 4 weeks −0.25 [−0.52; 0.02] −0.15 [−0.34; 0.04]
SENSEa [4] No more than 14 days >6 heavy drinking days in the last 4 weeks −0.36 [−0.76; 0.03] −0.12 [−0.34; 0.1]
Nalmefene versus placebo, direct comparison, fixed-effect model −0.37 [−0.53; −0.21] −0.21 [−0.31; −0.10]
Anton (1999) [45] At least 5 days 5 or more drinks per day in the last 30 days −0.35 [−0.69; −0.01] −0.35 [−0.69; −0.01]
Balldin (2003) [46] No more than 14 days At least 20 heavy drinking days in the last 60 days 0.01 [−0.35; 0.37] 0.01 [−0.35; 0.37]
Anton (2005) [47] At least 5 days Average consumption of at least 5 standard drinks per day for men and 4 for women in the past 90 days −0.18 [−0.49; 0.13] −0.18 [−0.49; 0.13]
Kranzler (2000) [48] At least 3 days and no longer than 28 days Not specific 0.02 [−0.33; 0.37] 0.02 [−0.33; 0.37]
O’Malley (2008) [49] At least 4 days and no more than 30 days More than 14 drinks (women) or 21 drinks (men) per week and at least 2 heavy drinking days during a 30-day period within the 90 days prior to baseline. 0.08 [−0.39; 0.55] 0.08 [−0.39; 0.55]
Naltrexone versus placebo, direct comparison, fixed-effect model −0.11 [−0.27; 0.05] −0.11 [−0.27; 0.05]
Nalmefene versus Naltrexone, indirect comparison, fixed-effect model −0.26 [−0.04; −0.49] −0.10 [−0.29; 0.10]
Heterogeneity in the network I2 = 0 %. Q = 5.9. p = 0.65 I2 = 0 %. Q = 6.4. p = 0.50
  1. aFor those studies. Soyka et al. report results obtained in the subgroup analyses (patients concerned by the market approval) while this precaution was not taken in the naltrexone trials. Results based upon this dataset are presented in the ‘Soyka et al. analysis’ column. Results based upon the complete nalmefene studies are reported in the ‘Analysis of complete data’ columns
  2. All analyses were performed using the frequentist approach, which is implemented in R in the netmeta library. Details about two important inclusion criteria of the included studies (abstinence and previous consumption) are given to be informative about the similarity assumption that is necessary to interpret results of indirect comparisons