Table 3.
Summary analysis of mean (± s.e. mean) changes of plasma dofetilide concentration vs change in QTc relationship.
Change in slope from day 1 (ms/ng ml−1) | |||||
---|---|---|---|---|---|
Dofetilide 1 mg dosing group | Day 1 slope | Day 5 | Day 10 | Day 17 | Day 24 |
Cont | 14.2 ± 1.7 | −5.2 ± 1.3 | −5.6 ± 1.2 | −5.4 ± 1.5 | −5.8 ± 1.5 |
Intermittent⋆ | 16.1 ± 1.8 | −0.8 ± 0.6 | −0.7 ± 0.9 | −0.2 ± 1.1 | −1.4 ± 1.1 |
Mean difference in change in slope | 4.4 | 4.9 | 5.2 | 4.4 | |
95% confidence interval of difference | 1.3, 7.4 | 1.6, 8.2 | 1.1, 9.2 | 0.4, 8.4 | |
P value between treatments | 0.011 | 0.008 | 0.023 | 0.037 |
Slope of plasma concentration vs change in QTc not calculated for one subject in intermittent dofetilide group since data were not amenable to regression analysis. Only QTc data for this subject was analysed and tabulated
Cont = continuously, twice daily oral doses of dofetilide 1 mg (all values n = 8); Int = intermittently, single oral doses of dofetilide 1 mg (n =7).