Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain: Evidence-Based Findings from Post Hoc Analysis of Three Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Studies

• Published in: Clinical therapeutics 2007, Vol.29 (11), p.2536-2546
• Main Authors: Kajdasz, Daniel K., PhD, Iyengar, Smriti, PhD, Desaiah, Durisala, PhD, Backonja, Misha-Miroslav, MD, Farrar, John T., MD, MSCE, PhD, Fishbain, David A., MD, Jensen, Troels S., MD, Rowbotham, Michael C., MD, Sang, Christine N., MD, MPh, Ziegler, Dan, MD, MRCP, PhD, FRCPE, McQuay, Henry J., MD, FRCA, FRCP
• Format: Article
• Language: English
• Subjects: Adrenergic Uptake Inhibitors - therapeutic use; Adult; Aged; Clinical trials; Diabetes; Diabetic Neuropathies - drug therapy; Diabetic neuropathy; diabetic peripheral neuropathic pain; Double-Blind Method; Drug dosages; duloxetine; Duloxetine Hydrochloride; Female; Humans; Internal Medicine; Laboratories; Male; Medical Education; Mental depression; Middle Aged; Neuralgia - drug therapy; Neurology; neuropathy; NNH; NNT; Pain; Peripheral Nervous System Diseases - drug therapy; Serotonin Uptake Inhibitors - therapeutic use; Systematic review; Thiophenes - therapeutic use
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2007.12.002

Abstract Objective: This post hoc analysis was aimed to summarize the efficacy and tolerability of duloxetine as represented by number needed to treat (NNT) and number needed to harm (NNH) to provide a clinically useful assessment of the position of duloxetine among current agents used to treat diabetic peripheral neuropathic pain (DPNP). Methods: Data were pooled from three 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in which patients received 60 mg duloxetine either QD or BID or placebo. NNT was calculated based on rates of response (defined as ≥30% and ≥50% reductions from baseline in the weekly mean of the 24-hour average pain severity scores); NNH was calculated based on rates of discontinuation due to adverse events (AEs). Results: Patients receiving duloxetine 60 mg QD and 60 mg BID had NNTs (95% CI) of 5.2 (3.8-8.3) and 4.9 (3.6-7.6), respectively, based on last observation carried forward; NNTs of 5.3 (3.8-8.3) for 60 mg QD and 5.7 (4.1-9.7) for 60 mg BID were obtained based on baseline observations carried forward. The NNHs (95% CI) based on discontinuation due to AEs were 17.5 (10.2-58.8) in the duloxetine 60-mg QD group and 8.8 (6.3-14.7) in the 60-mg BID group. Conclusion: These post hoc results suggest that duloxetine was effective and well tolerated for the management of DPNP and further support the importance of duloxetine as a treatment option for clinicians and patients to assist with the management of DPNP.