Table 3. Summary of findings from trials assessing efficacy of nalmefene in the treatment of adult alcohol dependence.
| Outcome | 6-mo Follow-Up | 1-y Follow-Up | ||
|---|---|---|---|---|
| Number of Studies | RR/MD/SMD (95% CI) | Number of Studies | RR/MD/SMD (95% CI) | |
| Health outcomes | ||||
| Mortality (RR) | 4 | 0.39 (0.08; 2.01) (F) | 1 | 0.98 (0.04; 23.95) (F) |
| Accidents or injuries | — | Not available | — | Not available |
| QoL: SF−36 physical component summary score (MD) | 3 | 0.85 (−0.32; 2.01) (R) | — | Not available |
| QoL: SF−36 mental component summary score (MD) | 3 | 1.01 (−1.33; 3.34) (R) | — | Not available |
| Somatic alcoholism complications | — | Not available | — | Not available |
| Alcohol consumption outcomes | ||||
| Monthly number of HDDs (MD) | 5 | −1.65 (−2.41; −0.89) (F) | 1 | −1.60 (−2.85; −0.35) (F) |
| Total alcohol consumption (SMD) | 5 | −0.20 (−0.30; −0.10) (F) | 1 | −0.13 (−0.36; 0.1) (F) |
| Response (RR) | 3 | 0.99 (0.88; 1.12) (R) | 1 | 1.1 (0.99; 1.21) (F) |
| Complete abstinence | — | Not available | — | Not available |
| DrInC score (SMD) | 5 | −0.12 (−0.22; −0.02) (F) | — | Not available |
| Clinical Global Impression–Severity score (MD) | 3 | −0.25 (−0.38; −0.13) (F) | 1 | −0.20 (−0.44; 0.04) (F) |
| Alcohol Dependence Scale score (SMD) | 4 | −0.11 (−0.21; −0.01) (F) | — | Not available |
| Biological outcomes | ||||
| γ-Glutamyltransferase (MD) | 1 | −38.2 (−75.74; −0.66) (F) | — | Not available |
| Alanine-aminotransferase (MD) | 1 | −14.5 (−23.69; −5.31) (F) | — | Not available |
| Mean corpuscular volume (MD) | 1 | −0.20 (−1.29; 0.89) (F) | — | Not available |
| Carbohydrate-deficient transferrin (SMD) | 4 | −0.08 (−0.20; 0.05) (R) | 1 | −0.19 (−0.42; 0.05) (F) |
| Treatment safety outcomes | ||||
| Adverse events (RR) | 4 | 1.18 (1.11; 1.24) (F) | 1 | 1.20 (1.05; 1.36) (F) |
| Serious adverse events (RR) | 4 | 0.89 (0.55; 1.43) (F) | 1 | 1.39 (0.66; 2.94) (F) |
| Withdrawal from the study (RR) | 4 | 1.27 (1.01; 1.59) (R) | 1 | 1.20 (0.94; 1.53) (F) |
| Withdrawal from the study for safety reasons (RR) | 4 | 3.65 (2.02; 6.63) (R) | 1 | 7.01 (1.72; 28.63) (F) |
All outcomes are presented at both 6 mo and 1 y as they were reported in the different studies. Efficiency indexes are presented with their 95 confidence intervals. Bold values are statistically significant.
F, fixed effect model; QoL, quality of life; R, random effect model.