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Table 2 Summary of demographics and baseline characteristics (safety analysis set)

From: Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study

Parameter

Capsaicin 8% patch (30 min) + SOC

(n = 156)

Capsaicin 8% patch (60 min) + SOC (n = 157)

SOC

(n = 155)

Sex, n (%)

 Male

74 (47.4)

79 (50.3)

71 (45.8)

 Female

82 (52.6)

78 (49.7)

84 (54.2)

Ethnicity, n (%)

 Caucasian

154 (98.7)

155 (98.7)

154 (99.4)

 Other

2 (1.3)

2 (1.3)

1 (0.6)

Age, years

 Mean [SD]

60.9 [10.9]

61.0 [10.3]

59.1 [10.3]

Weight, kg

 Mean [SD]

86.6 [14.5]

86.7 [16.4]

89.6 [17.6]

Height, cm

 Mean [SD]

169.7 [8.9]

169.7 [9.0]

169.3 [10.9]

Body mass index, kg/m2

 Mean [SD]

30.1 [4.6]

30.1 [5.0]

31.2 [5.0]

Duration of PDPN, years

 Mean [SD]

4.1 [3.7]

4.4 [3.9]

4.4 [3.6]

Pain medications before baseline, n (%)

 Overall

70 (44.9)

71 (45.2)

79 (51.0)

 Analgesicsa

56 (35.9)

54 (34.4)

59 (38.1)

 Antiepileptics

44 (28.2)

49 (31.2)

52 (33.5)

 Psycholeptics

22 (14.1)

19 (12.1)

24 (15.5)

 Anti-inflammatory/antirheumatic products

14 (9.0)

12 (7.6)

17 (11.0)

 Topical joint/muscular pain productsb

14 (9.0)

11 (7.0)

15 (9.7)

Baseline average pain score (BPI-DN question 5)

 Mean [SD]

5.6 [1.3]

5.6 [1.4]

5.5 [1.3]

Baseline Norfolk QOL-DN score

 Mean [SD]

42.8 [19.5]

40.6 [18.3]

41.0 [18.5]

Baseline UENS total score

 Mean [SD]

17.0 [7.4]

16.5 [7.0]

15.6 [6.2]

HbA1c at screening

 Mean, % [SD]

7.3 [1.0]

7.4 [1.0]

7.4 [1.0]

 Mean, mmol/mol [SD]

56.6 [10.8]

57.5 [10.8]

57.6 [11.4]

  1. BPI-DN Brief pain inventory diabetic neuropathy, HbA1c glycosylated haemoglobin of A1c, PDPN painful diabetic peripheral neuropathy, QOL-DN Quality-of-life questionnaire for diabetic neuropathy, SD standard deviation, SOC standard of care
  2. aAnalgesics were categorised by analgesics, anilides, natural opium alkaloids, other analgesics and antipyretics, other opioids, pyrazolones and salicylic acid and derivatives
  3. bAnti-inflammatory preparations, non-steroidals for topical use, preparations with salicylic acid derivatives