Tapentadol Prolonged Release Reduces the Severe Chronic Ischaemic Pain and Improves the Quality of Life in Patients with Type 2 Diabetes

Table 2

Doses per day of tapentadol PR, pain intensity, quality of sleep, and quality of life at different time intervals between examinations in patients with diabetes and PVD.

	Baseline	V2	V3	V4
Time intervals	0	33.3 ± 8.8	65.6 ± 11.1	96.8 ± 11.0
Tapentadol PR (mg)	104.0 ± 20.0	200.0 ± 28.9	196.0 ± 35.1	186.4 ± 56.0
NRS	7.9 ± 1.2	5.7 ± 1.9	3.9 ± 2.1	2.8 ± 2.3	<0.01
NRS responders ()
Number of patients ≥ 30%	—	12	21	22
Number of patients ≥ 50%	—	3	13	19
Quality of sleep° (%)					<0.01^§
Very disturbed	32	20	16	12
Frequent awakenings	68	36	0	4
Good	0	44	76	28
Deep	0	0	8	56
Presence of constipation° (%)	8	20	12	12	NS
DN4	4.0 ± 1.2	2.9 ± 1.3	1.8 ± 1.3	1.2 ± 1.5	<0.01
SF12
PCS-12	27.1 ± 5.3	29.5 ± 6.1	43.8 ± 11.2	49.1 ± 10.8	<0.01
MCS-12	28.8 ± 9.4	36.2 ± 10.2	43.8 ± 11.2	49.1 ± 10.8	<0.01
Adverse events	0	0	0	0

Values are mean ± SD. NRS: numeric pain intensity scale from 0 to 10. Responders: patients who had recorded a reduction in the NRS score of at least 30% and 50% from the baseline level measured. DN4: diagnostic neuropathic pain questionnaire. Quality of sleep was assessed on four-point scale: deep, good, frequent awakenings, and very disturbed. SF-12 summary scores (Physical Component Summary: PCS-12 and Mental Component Summary: MCS-12) also range from 0 to 100. Friedman’s test. °Test McNemar. ^§Sleep quality and constipation have been assessed comparing each medical examination to baseline values.