Adjusted mean difference between G6PD genotypes in the maximum change from pretreatment values for clinically important laboratory parameters in malaria patients receiving dapsone or AL
| Parameter . | Dapsone . | Artemether-lumefantrine . | ||||||
|---|---|---|---|---|---|---|---|---|
| G6PD deficient vs G6PD normal . | G6PD deficient vs heterozygous . | Heterozygous vs G6PD normal . | Analysis of variance P* . | G6PD deficient vs G6PD normal . | G6PD deficient vs heterozygous . | Heterozygous vs G6PD normal . | Analysis of variance P* . | |
| Hemoglobin, g/dL | −1.34 (−1.15, −1.52) | −0.91 (−0.68, −1.14) | −0.43 (−0.27, −0.58) | < .001 | 0.06 (0.41, −0.29) | −0.02 (0.47, −0.51) | 0.08 (0.44, −0.28) | .863 |
| Hematocrit, % | −3.8 (−3.2, −4.4) | −2.8 (−2.0, −3.5) | −1.0 (−0.5, −1.5) | < .001 | −0.2 (1.1, −1.5) | 0.7 (2.4, −1.1) | −0.9 (0.4, −2.1) | .400 |
| Reticulocytes, % | 2.4 (1.7-3.1) | 1.0 (0.1-2.0) | 1.4 (0.8-2.0) | < .001 | 0.1 (−0.8, 0.9) | 0.2 (−1.0, 1.3) | −0.1 (−0.9, 0.7) | .956 |
| WBC ×109/L | 1.4 (0.6-2.3) | 0.3 (−0.8, 1.4) | 1.1 (0.4-1.8) | < .001 | 1.0 (−0.4, 2.5) | −0.2 (−2.2, 1.9) | 1.2 (−0.3, 2.7) | .129 |
| Unconj bil, μmol/L | 6.8 (3.8-9.8) | 6.8 (2.8-10.7) | 0.0 (−2.7, 2.8) | < .001 | −2.3 (−6.3, 1.8) | 3.1 (−2.6, 8.7) | −5.3 (−9.5, −1.2) | .028 |
| Platelets ×109/L | −27.4 (−55.0, 0.1) | −43.3 (−78.5, −8.1) | 15.8 (−7.6, 39.2) | .053 | 18.0 (−35.1, 71.1) | −81.3 (−155.2, −7.4) | 99.4 (44.9-153.8) | .002 |
| ALT, IU/L | −4.3 (−18.0, 9.4) | −5.7 (−23.2, 11.8) | 1.4 (−10.3, 13.1) | .796 | −0.2 (−15.3, 15.0) | −2.2 (−23.3, 18.8) | 2.1 (−13.4, 17.6) | .966 |
| AST, IU/L | 6.3 (−14.2, 26.8) | −7.4 (−33.7, 18.9) | 13.7 (−3.9, 31.4) | .273 | 6.3 (−15.2, 27.9) | 1.5 (−28.6, 31.5) | 4.9 (−17.3, 27.0) | .782 |
| Parameter . | Dapsone . | Artemether-lumefantrine . | ||||||
|---|---|---|---|---|---|---|---|---|
| G6PD deficient vs G6PD normal . | G6PD deficient vs heterozygous . | Heterozygous vs G6PD normal . | Analysis of variance P* . | G6PD deficient vs G6PD normal . | G6PD deficient vs heterozygous . | Heterozygous vs G6PD normal . | Analysis of variance P* . | |
| Hemoglobin, g/dL | −1.34 (−1.15, −1.52) | −0.91 (−0.68, −1.14) | −0.43 (−0.27, −0.58) | < .001 | 0.06 (0.41, −0.29) | −0.02 (0.47, −0.51) | 0.08 (0.44, −0.28) | .863 |
| Hematocrit, % | −3.8 (−3.2, −4.4) | −2.8 (−2.0, −3.5) | −1.0 (−0.5, −1.5) | < .001 | −0.2 (1.1, −1.5) | 0.7 (2.4, −1.1) | −0.9 (0.4, −2.1) | .400 |
| Reticulocytes, % | 2.4 (1.7-3.1) | 1.0 (0.1-2.0) | 1.4 (0.8-2.0) | < .001 | 0.1 (−0.8, 0.9) | 0.2 (−1.0, 1.3) | −0.1 (−0.9, 0.7) | .956 |
| WBC ×109/L | 1.4 (0.6-2.3) | 0.3 (−0.8, 1.4) | 1.1 (0.4-1.8) | < .001 | 1.0 (−0.4, 2.5) | −0.2 (−2.2, 1.9) | 1.2 (−0.3, 2.7) | .129 |
| Unconj bil, μmol/L | 6.8 (3.8-9.8) | 6.8 (2.8-10.7) | 0.0 (−2.7, 2.8) | < .001 | −2.3 (−6.3, 1.8) | 3.1 (−2.6, 8.7) | −5.3 (−9.5, −1.2) | .028 |
| Platelets ×109/L | −27.4 (−55.0, 0.1) | −43.3 (−78.5, −8.1) | 15.8 (−7.6, 39.2) | .053 | 18.0 (−35.1, 71.1) | −81.3 (−155.2, −7.4) | 99.4 (44.9-153.8) | .002 |
| ALT, IU/L | −4.3 (−18.0, 9.4) | −5.7 (−23.2, 11.8) | 1.4 (−10.3, 13.1) | .796 | −0.2 (−15.3, 15.0) | −2.2 (−23.3, 18.8) | 2.1 (−13.4, 17.6) | .966 |
| AST, IU/L | 6.3 (−14.2, 26.8) | −7.4 (−33.7, 18.9) | 13.7 (−3.9, 31.4) | .273 | 6.3 (−15.2, 27.9) | 1.5 (−28.6, 31.5) | 4.9 (−17.3, 27.0) | .782 |
Values are the adjusted mean difference between G6PD genotypes in the maximum change from pre-treatment values (95% CI). In this analysis, each treatment group was compared separately. For hemoglobin and hematocrit, the adjusted mean change is for the maximum decrease (or minimum increase) vs pretreatment values. For all other parameters it is the maximum increase (or minimum decrease) vs pretreatment.
ALT indicates alanine aminotransferase; AST, aspartate aminotransferase; Unconj bil, unconjugated bilirubin; and WBC, white blood cell.
Analysis of variance model included terms for sex, center, age, weight, pretreatment hemoglobin, and G6PD status. For dapsone subjects, a term was also fitted for study (trial 005 or 006).