Changes in clinically important hematologic and clinical chemistry parameters in G6PD-deficient malaria patients after receiving dapsone
| Laboratory parameter . | Dapsone G6PD deficient (n = 119)* . | Control group (n = 366) . | Adjusted difference (95% CI)† . |
|---|---|---|---|
| Hemoglobin | |||
| Lowest value, g/dL | 7.20 ± 1.50 | 8.64 ± 1.41 | −1.04 (−1.29, −0.79) |
| Maximum decrease from pretreatment, g/dL | −2.64 ± 1.58 | −1.37 ± 1.06 | −1.46 (−1.76, −1.15) |
| Maximum decrease from pretreatment, % | −26.0 ± 13.9 | −13.2 ± 9.9 | −13.9 (−16.8, −11.0) |
| Maximum decrease from day 1 value, g/dL | −2.08 ± 0.46 | −0.56 ± 1.47 | −1.61 (−1.91, −1.30) |
| Day 7 value, g/dL | 7.50 ± 1.57 | 9.76 ± 1.48 | −1.80 (−2.08, −1.51) |
| Reticulocytes, % | |||
| Highest value | 6.4 ± 6.6 | 2.3 ± 2.5 | 1.4 (0.5-2.3) |
| Maximum increase from pretreatment | 4.9 ± 6.3 | 1.2 ± 2.3 | 1.4 (0.5-2.3) |
| White blood count, ×109/L | |||
| Highest value | 13.9 ± 5.9 | 11.8 ± 4.5 | 2.3 (1.1-3.5) |
| Maximum increase from pretreatment | 4.0 ± 5.8 | 2.9 ± 4.1 | 1.7 (0.5-2.9) |
| Unconjugated bilirubin, μmol/L | |||
| Highest value | 12.9 ± 14.3 | 4.1 ± 5.5 | 5.0 (2.3-7.8) |
| Maximum increase from pretreatment | 4.4 ± 13.7 | −1.1 ± 7.3 | 4.4 (1.0-7.9) |
| Laboratory parameter . | Dapsone G6PD deficient (n = 119)* . | Control group (n = 366) . | Adjusted difference (95% CI)† . |
|---|---|---|---|
| Hemoglobin | |||
| Lowest value, g/dL | 7.20 ± 1.50 | 8.64 ± 1.41 | −1.04 (−1.29, −0.79) |
| Maximum decrease from pretreatment, g/dL | −2.64 ± 1.58 | −1.37 ± 1.06 | −1.46 (−1.76, −1.15) |
| Maximum decrease from pretreatment, % | −26.0 ± 13.9 | −13.2 ± 9.9 | −13.9 (−16.8, −11.0) |
| Maximum decrease from day 1 value, g/dL | −2.08 ± 0.46 | −0.56 ± 1.47 | −1.61 (−1.91, −1.30) |
| Day 7 value, g/dL | 7.50 ± 1.57 | 9.76 ± 1.48 | −1.80 (−2.08, −1.51) |
| Reticulocytes, % | |||
| Highest value | 6.4 ± 6.6 | 2.3 ± 2.5 | 1.4 (0.5-2.3) |
| Maximum increase from pretreatment | 4.9 ± 6.3 | 1.2 ± 2.3 | 1.4 (0.5-2.3) |
| White blood count, ×109/L | |||
| Highest value | 13.9 ± 5.9 | 11.8 ± 4.5 | 2.3 (1.1-3.5) |
| Maximum increase from pretreatment | 4.0 ± 5.8 | 2.9 ± 4.1 | 1.7 (0.5-2.9) |
| Unconjugated bilirubin, μmol/L | |||
| Highest value | 12.9 ± 14.3 | 4.1 ± 5.5 | 5.0 (2.3-7.8) |
| Maximum increase from pretreatment | 4.4 ± 13.7 | −1.1 ± 7.3 | 4.4 (1.0-7.9) |
Values are mean ± SD except where indicated otherwise. The control group received artemether-lumefantrine. Changes from pretreatment were defined as maximum decrease (or minimum increase) for hemoglobin and hematocrit and as maximum increase (or minimum decrease) for other parameters.
Total of 95 G6PD-deficient hemizygous male plus 24 G6PD-deficient homozygous female patients.
Difference between treatment groups adjusted for sex, center, age, weight, pretreatment hemoglobin, and G6PD status. For dapsone subjects, a term was also fitted for study (trial 005 or 006).