TOPIRAMATE FOR THE TREATMENT OF PERIPHERAL DIABETIC NEUROPATHY- CANADIAN CLINICAL EXPERIENCE
Author(s)
Hwang P1, Brock I2 , 1Janssen-Ortho Inc, Toronto, ON, Canada; 2Research One International, Lachine, QC, Canada
OBJECTIVE: The complexity of peripheral diabetic neuropathy (PDN) and the highly variable effects of individual drugs mean that clinicians continue to seek alternatives for their patients. The objective of this study was to evaluate and describe the use of topiramate for PDN in Canadian clinical practice. METHODS: Retrospective review of 100 patient charts using physician interview. Physicians were asked to include the 4 most recent patients that met the following criteria: 1) diagnosis of PDN; 2) topiramate started > 6 months prior to review date to allow an adequate trial time for drug therapy; 3) no concomitant gabapentin use. RESULTS: Patient characteristics: 8% Type 1 diabetes, 92% Type 2; mean age 55.4 years; 45% male; 85% Caucasian; 61% with medical conditions other than diabetes /PDN requiring drug therapy. Pain distribution: foot/toe 91%, calf 29%, finger/hand 28%, thigh 19%. Pain quality: burning 55%, tingling 47%, pins and needles 30%, aching 23%, sharp 19%, cramping 17%, jabbing 17%, shooting 17%. Topiramate therapy: mean duration 14.4 months; mean total daily dose 136mg. 98% were current users. Patients had PDN for 21.5 months on average prior to starting topiramate therapy. Topiramate was used as monotherapy in 79%. In 59% topiramate was the first-line drug. 24% experienced topiramate-related adverse effects (AEs); most common: dizziness 29%, somnolence 21%, nausea 17%, and numbness 13%. Actions taken for AEs: none (71%), dose reduction (17%), slower titration (13%), treatment with another drug (4%). According to physician assessment, 64% (95%CI 46, 82) were "very much improved" or "much improved" for pain, 49% (95%CI 30, 68) for physical activity, and 51% (95%CI 33, 70) for sleep. CONCLUSIONS: Under conditions of routine clinical care, topiramate was effective in relieving pain and improving physical activity and sleep in patients with PDN. Most patients tolerated the drug long-term with no discontinuation of therapy resulting from AEs.
Conference/Value in Health Info
2003-11, ISPOR Europe 2003, Barcelona, Spain
Value in Health, Vol. 6, No. 6 (November/December 2003)
Code
PPN1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Systemic Disorders/Conditions