Factors that impact symptomatic diabetic peripheral neuropathy in placebo-administered patients from two 1-year clinical trials

Diabetes Care

Volumn 30, Issue 10, 2007, Pages 2626-2632

  Tesfaye, Solomon ^a   Tandan, Rup ^b   Bastyr III, Edward J ^c,d   Kles, Keri A ^c   Skljarevski, Vladimir ^c   Price, Karen L ^c  

^a ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^b UNIVERSITY OF VERMONT   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d INDIANA UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RUBOXISTAURIN;

ADULT; ARTICLE; BLOOD GLUCOSE MONITORING; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEMOGRAPHY; DIABETIC NEPHROPATHY; DISEASE COURSE; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; ELECTROPHYSIOLOGY; FEMALE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; NERVE CONDUCTION; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SYMPTOM; TREATMENT OUTCOME;

EID: 35148829421     PISSN: 01495992     EISSN: 01495992     Source Type: Journal    
DOI: 10.2337/dc07-0608     Document Type: Article

References (22)

1. Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O'Brien PC, Melton LJ: The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology 43:817-824, 1993
2. Boulton AJ, Malik RA, Arezzo JC, Sosenko JM: Diabetic somatic neuropathies. Diabetes Care 27:1458-1486, 2004
3. Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977-986, 1993
4. UK Prospective Diabetes Study (UKPDS) Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837-853, 1998
5. Tesfaye S, Chaturvedi N, Eaton SEM, Witte D, Ward JD, Fuller J: Vascular risk factors and diabetic neuropathy. N Engl J Med 352:341-350, 2005
6. Quattrini C, Tesfaye S: Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev 19:S2-S8, 2003
7. Harris M, Eastman R, Cowie C: Symptoms of sensory neuropathy in adults with NIDDM in the U.S. population. Diabetes Care 16:1446-1452, 1993
8. Davies M, Brophy S, Williams R, Taylor A: The prevalence, severity, and impact of painful diabetic peripheral neuropathy in type 2 diabetes. Diabetes Care 29:1518-1522, 2006
9. Bastyr EJ, Price KL, Bril V, MBBQ Study Group: Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther 27:1278-1294, 2005
10. Dyck PJ: Detection, characterization, and staging of polyneuropathy: assessed in diabetics. Muscle Nerve 11:21-32, 1988
11. Olney RK: Clinical trials for polyneuropathy: the role of nerve conduction studies, quantitative sensory testing, and autonomic function testing. J Clin Neurophysiol 15:129-137, 1998
12. Dyck PJ, O'Brien PC, Kosanke JL, Gillen DA, Karnes JL: A 4, 2, and 1 stepping algorithm for quick and accurate estimation of cutaneous sensation threshold. Neurology 43:1508-1512, 1993
13. Muraleedharan V, Shanmugarajah PD, Dodd T, Caddick L, Hardisty C, Scott A, Tesfaye S The diabetes NSF: are targets being met 5 years on? Diabet Med 23 (Suppl. 2):P293, 2006
14. Pambianco G, Costacou T, Ellis D, Becker DJ, Klein R, Orchard TJ: The 30-year natural history of type 1 diabetes complications: the Pittsburgh Epidemiology of Diabetes Complications Study Experience. Diabetes 55:1463-1469, 2006
15. Martin CL, Albers J, Herman WH, Cleary P, Waberski B, Greene DA, Stevens MJ, Feldman EL: Neuropathy among the Diabetes Control and Complications Trial cohort 8 years after trial completion. Diabetes Care 29:340-344, 2006
16. Vinik AI, Bril V, Kempler P, Litchy WJ, Tesfaye S, Price KL, Bastyr EJ, MBBQ Study Group: Treatment of symptomatic diabetic peripheral neuropathy with the protein kinase Cβ-inhibitor ruboxistaurin mesylate during a 1-year, randomized, placebo-controlled, double-blind clinical trial. Clin Ther 27:1164-1180, 2005
17. Tandan R, Skljarevski V, Price KL, Kles KA, Bastyr EJ, Ruboxistaurin Treatment of DPN Study Group: Neuropathy progression in patients with symptomatic diabetic peripheral neuropathy: experience from phase 3 ruboxistaurin clinical trials. Neurology 66 (Suppl. 2):A191, 2006
18. Low PA, Opfer-Gehrking TL, Dyck PJ, Litchy WJ, O'Brien PC: Double-blind, placebo-controlled study of the application of capsaicin cream in chronic distal painful polyneuropathy. Pain 62:163-168, 1995
19. Hrobjartsson A, Gotzsche PC: Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med 256:91-100, 2004
20. Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL: Defining the clinically important difference in pain outcome measures. Pain 88:287-294, 2000
21. England JD, Gronseth GS, Franklin G, Miller RG, Asbury AK, Carter GT, Cohen JA, Fisher MA, Howard JF, Kinsella LJ, Latov N, Lewis RA, Low PA, Sumner AJ: Distal symmetric polyneuropathy: a definition for clinical research: report of the American Academy of Neurology, the American Association of Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 64:199-207, 2005
22. Dyck PJ, O'Brien PC, Litchy WJ, Harper CM, Klein CJ, Dyck PJB: Monotonicity of nerve tests in diabetes: subclinical nerve dysfunction precedes diagnosis of polyneuropathy. Diabetes Care 28:2192-2200, 2005