Table 1

Efficacy (% resolution of incontinence) and discontinuation data included into the economic model

% Resolution of incontinence (<1 episode/24 hrs)

W2

W8

W12

W12|W8

W12|~W8


Placebo

20,99%

34,66%

27,84%

80,33%

14,16%

Fesoterodine 4 mg

30,41%

50,00%

43,67%

87,34%

21,05%

Fesoterodine 8 mg

40,59%a

55,38%a

50,21%

90,65%

24,20%

Tolterodine

29,23%

49,47%

38,18%

77,17%

13,04%

Solifenacin 5 mgc

31,49%

51,99%

41,76%

80,33%d

21,24%

Solifenacin 10 mge

32,11%a

53,01%a

42,58%

80,33%d

21,66%b


Other data

% Nocturia (> = 2 episodes/night) % of patients with nocturia at baseline without nocturia at W12

Constipation


Placebo

54,34%

1,99%

Fesoterodine 4 mg

55,56%

4,15%

Fesoterodine 8 mg

55,90%

6,01%

Tolterodine

57,69%

2,76%

Solifenacin 5 mg

54,34%i

3,53%j

Solifenacin 10 mg

88,72%j

7,72%j


Discontinuation

W2

W8

W12

W24f

W52f


Placebo

100%

92,84%

90,64%

79,32%

59,27%

Fesoterodine 4 mg

100%

92,67%g

equal to placebo data h

Fesoterodine 8 mg

--

--

equal to placebo data h

Tolterodine

100%

95,76%

equal to placebo data h

Solifenacin 5 mg

100%

94,06%

equal to placebo data h

Solifenacin 10 mg

--

--

equal to placebo data h


The symbol "|" denotes conditional response rates; the response at week 12 given response at week 8. The symbol "~" denotes non-response; no-response at week 12 given no-response at week 8

Source: Fesoterodine phase III trials, except when a different source is described [17,18].

a - values not used in the decision tree; only used to calculate conditional response rates

b - conditional response rates estimated by applying the W8 low dose: high dose response ratio to the W12|~W2(~W8) non-titrating response rate

c - equal to 1,5 times the placebo rates [29]

d - conditional response equal to placebo rate

e - equal to 1,5294 times the placebo rates [29]

f - W24 and W52 values were extrapolated from clinical trial data using an exponential decay curve fitted to W2, W8, and W12 discontinuation values

g - discontinuation rate of fesoterodine 4 mg at W8 in the trial data was greater than that of placebo at W12, therefore this value was set equal to the W12 rate.

h - discontinuation rates at week 12 were found to be not statistically significant for any treatment [30], therefore the values are equal to placebo discontinuation

i - relative rates from published literature [42]; solifenacin 5 mg not found to be significantly different than placebo; solifenacin 10 mg 63.28% higher than placebo

j - relative rates from published literature [29]; solifenacin 5 mg 1,778 times placebo; solifenacin 10 mg 3,889 times higher than placebo

Arlandis-Guzman et al. BMC Urology 2011 11:9   doi:10.1186/1471-2490-11-9

Open Data