A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: Efficacy and tolerability in a double-blind, randomized, controlled clinical trial

Diabetes Research and Clinical Practice

Volumn 97, Issue 3, 2012, Pages 438-445

  Sandercock, David ^a   Cramer, Marilou ^b   Biton, Victor ^c   Cowles, Verne E ^b  

^a North San Antonio Healthcare   (United States)

^b Pharmacokinetics Depomed Inc   (United States)

^c Clinical Trials Inc   (United States)

Author keywords

Diabetic peripheral neuropathy; Gabapentin; Gastroretentive; Once daily

Indexed keywords

GABAPENTIN; INSULIN; METFORMIN; ORAL ANTIDIABETIC AGENT; PLACEBO; SULFONYLUREA DERIVATIVE;

ADULT; ARTICLE; BLURRED VISION; CONTROLLED STUDY; DIABETES MELLITUS; DIABETIC NEUROPATHY; DIABETIC PATIENT; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; FALLING; FEMALE; FOLLOW UP; HUMAN; HYPESTHESIA; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; MUSCLE WEAKNESS; NAUSEA; PAIN ASSESSMENT; PAINFUL DIABETIC PERIPHERAL NEUROPATHY; RANDOMIZED CONTROLLED TRIAL; RECIPIENT; SCORING SYSTEM; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP INTERFERENCE SCORE; SOMNOLENCE; TREMOR; URINE INCONTINENCE;

AGED; ALGORITHMS; AMINES; ANALGESICS; CHEMISTRY, PHARMACEUTICAL; CYCLOHEXANECARBOXYLIC ACIDS; DIABETIC NEUROPATHIES; DOUBLE-BLIND METHOD; DRUG TOXICITY; FEMALE; GAMMA-AMINOBUTYRIC ACID; GASTRIC EMPTYING; HUMANS; MALE; MIDDLE AGED; PLACEBOS; TREATMENT OUTCOME;

EID: 84866534485     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2012.03.010     Document Type: Article

References (25)

1. Boulton A.J. Treatment of symptomatic diabetic neuropathy. Diabetes Metab Res Rev 2003, 19(Suppl. 1):S16-S21.
2. Barbano R., Hart-Gouleau S., Pennella-Vaughan J., Dworkin R.H. Pharmacotherapy of painful diabetic neuropathy. Curr Pain Headache Rep 2003, 7:169-177.
3. Crofford O.B. Diabetes control and complications. Annu Rev Med 1995, 46:267-279.
4. Chen H., Lamer T.J., Rho R.H., Marshall K.A., Sitzman B.T., Ghazi S.M., et al. Contemporary management of neuropathic pain for the primary care physician. Mayo Clin Proc 2004, 79:1533-1545.
5. Attal N., Cruccu G., Baron R., Haanpaa M., Hansson P., Jensen T.S. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol 2010, 17:1113-1123.
6. Bril V., England J., Franklin G.M., Backonja M., Cohen J., Del Toro D. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. PM R 2011, 3(4):345-352.
7. Backonja M., Beydoun A., Edwards K.R., Schwartz S.L., Fonseca V., Hes M., et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA 1998, 280:1831-1836.
8. Backonja M., Glanzman R.L. Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials. Clin Ther 2003, 25:81-104.
9. Rosenstock J., Tuchman M., LaMoreaux L., Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004, 110:628-638.
10. Richter R.W., Portenoy R., Sharma U., LaMoreaux L., Bockbrader H., Knapp L.E. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005, 6:253-260.
11. Lesser H., Sharma U., LaMoreaux L., Poole R.M. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology 2004, 63:2104-2110.
12. Schwartz S., Fonseca V., Berner B., Cramer M., Chiang Y.K., Lewin A. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care 2006, 29:759-764.
13. Fourcroy J.L., Berner B., Chiang Y.K., Cramer M., Rowe L., Shore N. Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women. Antimicrob Agents Chemother 2005, 49:4137-4143.
14. Stewart B.H., Kugler A.R., Thompson P.R., Bockbrader H.N. A saturable transport mechanism in the intestinal absorption of gabapentin is the underlying cause of the lack of proportionality between increasing dose and drug levels in plasma. Pharm Res 1993, 10:276-281.
15. Chen C., Cowles V.E., Hou E. Pharmacokinetics of gabapentin in a novel gastric-retentive extended-release formulation: comparison with an immediate-release formulation and the effect of dose escalation and food. J Clin Pharmacol 2010, 51:346-358.
16. Gordi T., Hou E., Kasichayanula S., Berner B. Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive-extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in healthy subjects. Clin Ther 2008, 30:909-916.
17. Farrar J.T., Young J.P., LaMorequx L., Werth J.L., Poole R.M. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158.
18. Backonja M.M., Galer B.S. Pain assessment and evaluation of patients who have neuropathic pain. Neurol Clin 1998, 16:775-790.
19. Irving G., Jensen M., Cramer M., Wu J., Chiang Y.K., Tark M., et al. Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial. Clin J Pain 2008, 25:185-192.
20. Wallace M.S., Irving G., Cowles V.E. Gabapentin extended-release tablets for the treatment of patients with postherpetic neuralgia: a randomized, double-blind, placebo-controlled, multicentre study. Clin Drug Invest 2010, 30:765-776.
21. Belgrade M.J. Following the clues to neuropathic pain. Distribution and other leads reveal the cause and the treatment approach. Postgrad Med 1999, 106:127-140.
22. Odrcich M., Bailey J.M., Cahill C.M., Gilron I. Chronobiological characteristics of painful diabetic neuropathy and postherpetic neuralgia: diurnal pain variation and effects of analgesic therapy. Pain 2006, 120:207-212.
23. Unruh A.M. Gender variations in clinical pain experience. Pain 1996, 65:123-167.
24. Keefe F.J., Affleck G., France C.R., Emery C.F., Waters S., Caldwell D.S., et al. Gender differences in pain, coping, and mood in individuals having osteoarthritic knee pain: a within-day analysis. Pain 2004, 110:571-577.
25. Fletcher C.V., Acosta E.P., Strykowski J.M. Gender differences in human pharmacokinetics and pharmacodynamics. J Adolesc Health 1994, 15:619-629.