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Drugs Similar in Efficacy for Neuropathic Pain in Diabetes. Diabetes Care

Amitriptyline, duloxetine, and pregabalin reduce pain; differ in sleep quality, adverse effects

 — In the treatment of patients with chronic diabetic peripheral neuropathic pain (DPNP), there are no significant differences in pain-relief efficacy between amitriptyline, duloxetine, and pregabalin; however, pregabalin improves sleep continuity and duloxetine improves daytime functioning, according to research published online Sept. 18 in Diabetes Care.

Julia Boyle, Ph.D., of the University of Surrey in the United Kingdom, and colleagues conducted a randomized, double-blind, parallel-group study involving 83 type 1 and type 2 diabetes patients with chronic DPNP who were treated with a placebo run-in followed by 14 days of lower-dose therapy, then 14 days of higher-dose therapy, with either amitriptyline, duloxetine, or pregabalin. The authors sought to evaluate the impact of these medications on pain, polysomnographic sleep, daytime functioning, and quality of life.

The researchers found that all three medications improved pain compared with placebo, but no statistically significant between-group difference was observed. Pregabalin was associated with improved sleep continuity, while duloxetine increased wake and reduced total sleep time. Despite its negative effect on sleep, duloxetine improved central nervous system arousal and performance on sensory motor tasks. Pregabalin was associated with a significantly higher number of adverse events compared with the other drugs.

”In conclusion, amitriptyline, duloxetine, and pregabalin were equally effective analgesic medications in patients with DPNP. Daytime function was relatively unaffected by drug treatment, and all three drugs were well tolerated,” the authors write. ”In this short, 28-day dosing study, there was no evidence of improved quality of life (Short Form 36) even with the sleep enhancement observed with pregabalin.”

The study was funded by an investigator-led research grant awarded by Pfizer; two authors disclosed potential financial conflicts of interest.

 

See abstract

Randomized, Placebo-Controlled Comparison of Amitriptyline, Duloxetine, and Pregabalin in Patients With Chronic Diabetic Peripheral Neuropathic Pain
Impact on pain, polysomnographic sleep, daytime functioning, and quality of life

    Julia Boyle, PHD1,
    Malin E.V. Eriksson, PHD1,
    Laura Gribble, PHD1,
    Ravi Gouni, MD2,
    Sigurd Johnsen, PHD1,
    David V. Coppini, MD3 and
    David Kerr, MD2

    1Surrey Clinical Research Centre, Institute of Biosciences and Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, U.K.
    2Department of Diabetes and Endocrinology, Royal Bournemouth Hospital, Dorset, U.K.
    3Department of Diabetes and Endocrinology, Poole Hospital Foundation Trust, Dorset, U.K.

 Abstract

OBJECTIVE Chronic diabetic peripheral neuropathic pain (DPNP) is difficult to treat, with treatment regimens often inadequate at controlling pain and limited by side effects and drug tolerance. Secondary parameters, such as quality of sleep and mood, may also be important for successful DPNP management. The objectives of this study were to compare the analgesic efficacy of pregabalin, amitriptyline, and duloxetine, and their effect on polysomnographic sleep, daytime functioning, and quality of life in patients with DPNP.

RESEARCH DESIGN AND METHODS This was a double-blind, randomized, parallel group investigation of type 1 and 2 diabetic subjects with DPNP. Each treatment group had a single-blind, 8-day, placebo run-in followed by 14 days of lower-dose and 14 days of higher-dose medication. At the end of each dose titration period, subjective pain, sleep, and daytime functioning were assessed during a 2-day residential period.

RESULTS All medications reduced pain when compared with placebo, but no one treatment was superior to any other. For sleep, pregabalin improved sleep continuity (P < 0.001), whereas duloxetine increased wake and reduced total sleep time (P < 0.01 and P < 0.001). Despite negative effects on sleep, duloxetine enhanced central nervous system arousal and performance on sensory motor tasks. There were no significant safety findings; however, there was a significantly higher number of adverse events in the pregabalin treatment group.

CONCLUSIONS There was no significant difference in analgesic efficacy between amitriptyline, duloxetine, and pregabalin. However, there were significant differences in the secondary parameters, which may be of relevance when deciding the optimal treatment for DPNP.

From ADA

Nyhetsinfo Diabetes Care Sept 2012

www red DiabetoogNytt

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