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Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial.
Diabet Med 2011; 28(1):109-16DM

Abstract

AIMS

To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients.

METHODS

A randomized, double-blind, placebo-controlled, multicentre 14 week clinical trial was conducted. Japanese patients with diabetic peripheral neuropathy (n = 317) were randomized to receive placebo or pregabalin at 300 or 600 mg/day. The primary efficacy measure was a change of mean pain score from baseline to end-point from patients' daily pain diaries.

RESULTS

Significant reductions in pain were observed in patients treated with pregabalin at 300 and 600 mg/day vs. placebo (P < 0.05). Improvements in weekly pain scores were observed as early as week 1 and were sustained throughout the study period (300 and 600 mg/day difference from placebo at study end-point, -0.63 and -0.74, respectively). Pregabalin produced significant improvements in weekly sleep interference scores, the short-form McGill Pain Questionnaire, the Medical Outcomes Study-Sleep Scale, the 36-item Short-Form Health Survey scale, and the Patient and Clinical Global Impression of Change. Patient impressions of numbness, pain and paraesthesia were also significantly improved. Regarding treatment responders, 29.1 and 35.6% of patients treated with 300 and 600 mg/day, respectively, reported ≥ 50% improvement in mean pain scores (vs. 21.5% for placebo). Pregabalin was well tolerated; somnolence (26%), dizziness (24%), peripheral oedema (13%) and weight gain (11%) were the most common adverse events and generally were reported as mild to moderate.

CONCLUSIONS

Pregabalin was effective in reducing pain and improving sleep disturbances due to pain, and was well tolerated in Japanese patients with painful DPN.

Authors+Show Affiliations

Division of Diabetes and Metabolism, Department of Internal Medicine, Iwate Medical University School of Medicine, Morioka, Iwate, Japan. jsatoh@iwate-med.ac.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21166852

Citation

Satoh, J, et al. "Efficacy and Safety of Pregabalin for Treating Neuropathic Pain Associated With Diabetic Peripheral Neuropathy: a 14 Week, Randomized, Double-blind, Placebo-controlled Trial." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 28, no. 1, 2011, pp. 109-16.
Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabet Med. 2011;28(1):109-16.
Satoh, J., Yagihashi, S., Baba, M., Suzuki, M., Arakawa, A., Yoshiyama, T., & Shoji, S. (2011). Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. Diabetic Medicine : a Journal of the British Diabetic Association, 28(1), pp. 109-16. doi:10.1111/j.1464-5491.2010.03152.x.
Satoh J, et al. Efficacy and Safety of Pregabalin for Treating Neuropathic Pain Associated With Diabetic Peripheral Neuropathy: a 14 Week, Randomized, Double-blind, Placebo-controlled Trial. Diabet Med. 2011;28(1):109-16. PubMed PMID: 21166852.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of pregabalin for treating neuropathic pain associated with diabetic peripheral neuropathy: a 14 week, randomized, double-blind, placebo-controlled trial. AU - Satoh,J, AU - Yagihashi,S, AU - Baba,M, AU - Suzuki,M, AU - Arakawa,A, AU - Yoshiyama,T, AU - Shoji,S, PY - 2010/12/21/entrez PY - 2010/12/21/pubmed PY - 2011/5/10/medline SP - 109 EP - 16 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 28 IS - 1 N2 - AIMS: To evaluate the efficacy, safety and pharmacokinetics of pregabalin in treating neuropathic pain associated with diabetic peripheral neuropathy in Japanese patients. METHODS: A randomized, double-blind, placebo-controlled, multicentre 14 week clinical trial was conducted. Japanese patients with diabetic peripheral neuropathy (n = 317) were randomized to receive placebo or pregabalin at 300 or 600 mg/day. The primary efficacy measure was a change of mean pain score from baseline to end-point from patients' daily pain diaries. RESULTS: Significant reductions in pain were observed in patients treated with pregabalin at 300 and 600 mg/day vs. placebo (P < 0.05). Improvements in weekly pain scores were observed as early as week 1 and were sustained throughout the study period (300 and 600 mg/day difference from placebo at study end-point, -0.63 and -0.74, respectively). Pregabalin produced significant improvements in weekly sleep interference scores, the short-form McGill Pain Questionnaire, the Medical Outcomes Study-Sleep Scale, the 36-item Short-Form Health Survey scale, and the Patient and Clinical Global Impression of Change. Patient impressions of numbness, pain and paraesthesia were also significantly improved. Regarding treatment responders, 29.1 and 35.6% of patients treated with 300 and 600 mg/day, respectively, reported ≥ 50% improvement in mean pain scores (vs. 21.5% for placebo). Pregabalin was well tolerated; somnolence (26%), dizziness (24%), peripheral oedema (13%) and weight gain (11%) were the most common adverse events and generally were reported as mild to moderate. CONCLUSIONS: Pregabalin was effective in reducing pain and improving sleep disturbances due to pain, and was well tolerated in Japanese patients with painful DPN. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/21166852/Efficacy_and_safety_of_pregabalin_for_treating_neuropathic_pain_associated_with_diabetic_peripheral_neuropathy:_a_14_week_randomized_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1111/j.1464-5491.2010.03152.x DB - PRIME DP - Unbound Medicine ER -