Abstract
This study has been performed in diabetic type 2 patients with pain due to peripheral artery disease (PAD) in order to evaluate the efficacy and tolerability of tapentadol prolonged release (PR). Methods. 25 patients with type 2 diabetes (13 F and 12 M) were admitted in the study. The evaluation of the analgesic efficacy of tapentadol PR was based on both the assessment of the intensity of the pain (NRS scale from 0 to 10) and the nature of the pain (DN4 questionnaire) and on assessment of the patient's quality of life and state of health (SF-12 Health Survey). Study duration was 3 months: a baseline visit and follow-up included visits after 1 week, 1 month, 2 months, and 3 months. Results. At the beginning of the study, the mean intensity of the pain was 7.88 ± 1.17 on the NRS scale and at visit 2 it reduced in a statistically significant way; at the end of the treatment with tapentadol PR, the mean intensity was 2.84 points on the NRS scale. Conclusion. In type 2 diabetic patients with chronic severe pain due to PAD, tapentadol PR reduced pain intensity, improving the quality of life.
Highlights
According to WHO definition, diabetes mellitus is a chronic disease that appears when a deficit in the secretion of insulin by the pancreatic cells or an insulin resistance occurs [1]
9 patients were being treated with insulin, 10 with metformin, 1 with insulin and metformin, 1 with GLP-1 agonist, and, 2 patients were being treated by diet only
The 3-month study was completed by all 25 subjects; treatment was suspended in 2 cases due to complete regression of the pain, and in another case, due to a switch to morphine
Summary
According to WHO definition, diabetes mellitus is a chronic disease that appears when a deficit in the secretion of insulin by the pancreatic cells or an insulin resistance occurs [1]. According to the International Diabetic Foot study group, a diabetic foot is defined as a foot with anatomicalfunctional alterations caused by peripheral artery disease (PAD) and/or distal symmetrical neuropathy. Neuropathy and arteriopathy often appear in the same patient and are capable of generating a significant worsening of the patient’s prognosis and quality of life and chronic complex pain [3,4,5]. Diabetic neuropathy is frequent and affects up to 50% of patients with types 1 and 2 diabetes [3, 4]; it is a condition that is often severe and disabling and characterised by the presence of neuropathic pain.
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