Pregabalin treatment for peripheral neuropathic pain: A review of safety data from randomized controlled trials conducted in Japan and in the west

Drug Safety

Volumn 35, Issue 10, 2012, Pages 793-806

  Ogawa, Setsuro ^a   Satoh, Jo ^b   Arakawa, Akio ^c   Yoshiyama, Tamotsu ^c   Suzuki, Makoto ^c  

^a SURUGADAI NIHON UNIVERSITY HOSPITAL   (Japan)

^b IWATE MEDICAL UNIVERSITY   (Japan)

^c PFIZER INC   (United States)

Author keywords

Diabetic neuropathies; Dizziness; Neuropathic pain; Postherpetic neuralgia; Pregabalin; Randomised controlled trials; Somnolence

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; PLACEBO; PREGABALIN;

BLURRED VISION; CONSTIPATION; DIABETIC PERIPHERAL NEUROPATHY; DISEASE SEVERITY; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG EXCRETION; DRUG SAFETY; ETHNICITY; FACE EDEMA; FATIGUE; GAIT DISORDER; GLUCOSE BLOOD LEVEL; HEADACHE; HEALTH HAZARD; HUMAN; JAPAN; NAUSEA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; POSTHERPETIC NEURALGIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SOMNOLENCE; THIRST; TREATMENT DURATION; TREATMENT INDICATION; WEIGHT GAIN; XEROSTOMIA;

ANALGESICS; ASIAN CONTINENTAL ANCESTRY GROUP; DIABETIC NEUROPATHIES; DOSE-RESPONSE RELATIONSHIP, DRUG; EUROPEAN CONTINENTAL ANCESTRY GROUP; GAMMA-AMINOBUTYRIC ACID; HUMANS; JAPAN; NEURALGIA; NEURALGIA, POSTHERPETIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84866105435     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11632660-000000000-00000     Document Type: Review

References (35)

1. Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia 2004; 45 Suppl. 6: 13-8
2. European Medicines Agency. European Public Assessment Report (EPAR) for Lyrica [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/ document-library/EPAR-Summary-for-the-public/human/000546/WC5000 46603.pdf [Accessed 2011 Apr 27]
3. Pfizer Inc. Highlights of prescribing information [online]. Available from URL: http://www.pfizer.com/files/prod ucts/uspi-lyrica.pdf [Accessed 2011 Jan]
4. Bockbrader HN, Radulovic LL, Posvar EL, et al. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol 2010 Aug; 50 (8): 941-50
5. Brodie MJ, Wilson EA, Wesche DL, et al. Pregabalin drug interaction studies: lack of effect on the pharmacokinetics of carbamazepine, phenytoin, lamotrigine, and valproate in patients with partial epilepsy. Epilepsia 2005 Sep; 46 (9): 1407-13
6. Ogawa S, Suzuki M, Arakawa A, et al. Long-term efficacy and safety of pregabalin in patients with postherpetic neuralgia: results of a 52-week, open-label, flexible-dose study. Masui 2010 Aug; 59 (8): 961-70
7. 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 Jan; 28 (1): 109-16
8. News Blaze. Pfizer's Lyrica® (Pregabalin) capsules CV receives approval for treatment of peripheral neuropathic pain in Japan [online]. Available from URL: http://news blaze.com/story/2010102814380200001.pnw/ topstory.html [Accessed 2011 May 17]
9. Opstelten W, Mauritz JW, de Wit NJ, et al. Herpes zoster and postherpetic neuralgia: incidence and risk indicators using a general practice research database. Fam Pract 2002 Oct; 19 (5): 471-5
10. Gialloreti LE, Merito M, Pezzotti P, et al. Epidemiology and economic burden of herpes zoster and post-herpetic neuralgia in Italy: a retrospective, population-based study. BMC Infect Dis 2010 Aug 3; 10: 230
11. Sampathkumar P, Drage LA, Martin DP. Herpes zoster (shingles) and postherpetic neuralgia. Mayo Clin Proc 2009 Mar; 84 (3): 274-80
12. Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain 2002 Nov-Dec; 18 (6): 350-4
13. Kazuo H, Kazunori H, Keiichi N. Bridging the gap between pain research and treatment-update review: postherpetic neuralgia: diagnosis and treatment. Pain Clinic 2004; 25 (2): 158-65
14. Ziegler D. Treatment of diabetic neuropathy and neuropathic pain: how far have we come? Diabetes Care 2008 Feb; 31 Suppl. 2: S255-61
15. Kawano M, Omori Y, Katayama S, et al. A questionnaire for neurological symptoms in patients with diabetes: cross-sectional multicenter study in Saitama Prefecture, Japan. Diabetes Res Clin Pract 2001 Oct; 54 (1): 41-7
16. Ogawa S, Suzuki M, Arakawa A, et al. Evaluation of the efficacy and safety of pregabalin in the treatment of post-herpetic neuralgia: a randomized, double-blind, multicen-ter, placebo-controlled study. J Japan Soc Pain Clin 2010; 17 (2): 141-52
17. van Seventer R, Feister HA, Young Jr JP, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin 2006 Feb; 22 (2): 375-84
18. Tolle T, Freynhagen R, Versavel M, et al. Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: a randomized, double-blind study. Eur J Pain 2008 Feb; 12 (2): 203-13
19. Zaccara G, Gangemi P, Perucca P, et al. The adverse event profile of pregabalin: a systematic review and meta-analysis of randomized controlled trials. Epilepsia 2011 Apr; 52 (4): 826-36
20. Stommel M, Schoenborn CA. Variations in BMI and prevalence of health risks in diverse racial and ethnic populations. Obesity (Silver Spring) 2010 Sep; 18 (9): 1821-6
21. World Health Organization. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet 2004 Jan 10; 363 (9403): 157-63
22. Freynhagen R, Strojek K, Griesing T, et al. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible-and fixed-dose regimens. Pain 2005 Jun; 115 (3): 254-63
23. Sabatowski R, Galvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain 2004 May; 109 (1-2): 26-35
24. Dworkin RH, Corbin AE, Young Jr JP, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2003 Apr 22; 60 (8): 1274-83
25. Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005 Apr; 6 (4): 253-60
26. Lesser H, Sharma U, LaMoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 2004 Dec 14; 63 (11): 2104-10
27. Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004 Aug; 110 (3): 628-38
28. Arezzo JC, Rosenstock J, Lamoreaux L, et al. Efficacy and safety of pregabalin 600 mg/d for treating painful diabetic peripheral neuropathy: a double-blind placebo-controlled trial. BMC Neurol 2008 Sep 16; 8: 33
29. Semel D, Murphy TK, Zlateva G, et al. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies. BMC Fam Pract 2010; 11: 85
30. Sharma U, Griesing T, Emir B, et al. Time to onset of neuropathic pain reduction: a retrospective analysis of data from nine controlled trials of pregabalin for painful diabetic peripheral neuropathy and postherpetic neuralgia. Am J Ther 2010 Nov-Dec; 17 (6): 577-85
31. Freeman R, Durso-Decruz E, Emir B. Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care 2008 Jul; 31 (7): 1448-54
32. Pfizer Inc. Protocol A0081071: a randomized double-blind, placebo-controlled, parallel-group, multi-center trial of pregabalin versus placebo in the treatment of neuropathic pain associated with diabetic peripheral neuropathy [online]. Available from URL: http://www.clinicalstudyresults. org/documents/company-study-3972-0.pdf [Accessed 2011 May 17]
33. Pfizer Inc. Protocol A0081030: a 14 week, double-blind, randomized, placebo-controlled, multi-center study to evaluate the safety and efficacy of pregabalin (150 mg-600 mg day) using a flexible, optimized dose schedule in patients with painful diabetic peripheral neuropathy (DPN) [online]. Available from URL: http://www.clinicalstudyresults.org/doc uments/company-study-2504-0. pdf [Accessed 2011 May 17]
34. Seino Y, Nanjo K, Tajima N, et al. Report of the Committee on the Classification and Diagnostic Criteria of Diabetes Mellitus. J Diabet Invest 2010; 1 (5): 212-28
35. Satoh J, Yagihashi S, Baba M, et al. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a phase III double-blind placebo-controlled trial. J Diabet Invest 2011; 2 (6): 457-63