Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. Issue 9 (18th May 2014)

• Record Type: Journal Article
• Authors: Irving, G.; Tanenberg, R. J.; Raskin, J.; Risser, R. C.; Malcolm, S.
• Is Part Of: International journal of clinical practice. Volume 68:Issue 9(2014)
• Page Start: 1130
• Page End: 1140
• Publication Date: 2014-05-18
• Subjects: Clinical medicine -- Periodicals; Medicine -- Periodicals; 610.5
• DOI: 10.1111/ijcp.12452
• Languages: English
• ISSNs: 1368-5031

Abstract

<abstract abstract-type="main" id="ijcp12452-abs-0001"> <title>Summary</title> <sec id="ijcp12452-sec-0001" sec-type="section"> <title>Objective</title> <p>The safety and tolerability of three treatments for diabetic peripheral neuropathic pain (DPNP) were compared.</p> </sec> <sec id="ijcp12452-sec-0002" sec-type="section"> <title>Methods</title> <p>A 12‐week, randomized, open‐label study confirming the non‐inferiority of duloxetine (<italic>N</italic> = 138) vs. pregabalin (<italic>N</italic> = 134) and the combination of duloxetine plus gabapentin (<italic>N</italic> = 135) as the primary outcome was previously published. Patients had an inadequate pain response to a stable dose of gabapentin (≥ 900 mg/day) for ≥ 5 weeks prior to study enrolment. Data from that study were assessed in this current analysis for a detailed report of safety and tolerability.</p> </sec> <sec id="ijcp12452-sec-0003" sec-type="section"> <title>Results</title> <p>Completion rates did not differ significantly between the groups. Discontinuation because of adverse events was significantly greater in the duloxetine (19.6%) vs. pregabalin group (10.4%; p<italic> = </italic>0.04); no differences emerged between the duloxetine vs. duloxetine plus gabapentin (13.3%) groups (p = 0.19) or pregabalin vs. duloxetine plus gabapentin groups (p = 0.57). Adverse event rates varied: nausea, insomnia, hyperhidrosis and decreased appetite were reported significantly more often in patients treated with duloxetine vs. patients treated with pregabalin (each p ≤ 0.01); insomnia significantly more in patients treated with duloxetine vs. duloxetine plus gabapentin (p = 0.01); peripheral oedema significantly more in patients treated with pregabalin vs. duloxetine and duloxetine plus gabapentin (p ≤ 0.001 each) and nausea, hyperhidrosis, decreased appetite and vomiting significantly more in patients treated with duloxetine plus gabapentin vs. pregabalin (each p ≤ 0.05). At end‐point, weight change differed significantly among treatment groups: patients in the pregabalin group on average gained weight (1.0 ± 0.04 kg); while, patients in the duloxetine and duloxetine plus gabapentin groups on average lost weight (−2.39 ± 0.04 and −1.06 ± 0.04 kg, respectively) (pregabalin vs. duloxetine, p ≤ 0.001; pregabalin vs. duloxetine plus gabapentin, p ≤ 0.001; duloxetine vs. duloxetine plus gabapentin, p<italic> = </italic>0.01).</p> </sec> <sec id="ijcp12452-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Duloxetine, pregabalin and duloxetine plus gabapentin were generally safe and tolerable for the treatment of DPNP.</p> </sec> </abstract>