PMID- 18164920 OWN - NLM STAT- MEDLINE DCOM- 20080205 LR - 20221207 IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 29 Suppl DP - 2007 TI - 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. PG - 2536-46 LID - 10.1016/j.clinthera.2007.12.002 [doi] AB - 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 >or=30% and >or=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. FAU - Kajdasz, Daniel K AU - Kajdasz DK AD - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. kaidasz_daniel_k@lilly.com FAU - Iyengar, Smriti AU - Iyengar S FAU - Desaiah, Durisala AU - Desaiah D FAU - Backonja, Misha-Miroslav AU - Backonja MM FAU - Farrar, John T AU - Farrar JT FAU - Fishbain, David A AU - Fishbain DA FAU - Jensen, Troels S AU - Jensen TS FAU - Rowbotham, Michael C AU - Rowbotham MC FAU - Sang, Christine N AU - Sang CN FAU - Ziegler, Dan AU - Ziegler D FAU - McQuay, Henry J AU - McQuay HJ LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Adrenergic Uptake Inhibitors) RN - 0 (Serotonin Uptake Inhibitors) RN - 0 (Thiophenes) RN - 9044SC542W (Duloxetine Hydrochloride) SB - IM MH - Adrenergic Uptake Inhibitors/*therapeutic use MH - Adult MH - Aged MH - Diabetic Neuropathies/*drug therapy MH - Double-Blind Method MH - Duloxetine Hydrochloride MH - Female MH - Humans MH - Male MH - Middle Aged MH - Neuralgia/*drug therapy MH - Peripheral Nervous System Diseases/*drug therapy MH - Selective Serotonin Reuptake Inhibitors/*therapeutic use MH - Thiophenes/*therapeutic use EDAT- 2008/01/26 09:00 MHDA- 2008/02/06 09:00 CRDT- 2008/01/26 09:00 PHST- 2007/09/19 00:00 [accepted] PHST- 2008/01/26 09:00 [pubmed] PHST- 2008/02/06 09:00 [medline] PHST- 2008/01/26 09:00 [entrez] AID - S0149-2918(07)00370-0 [pii] AID - 10.1016/j.clinthera.2007.12.002 [doi] PST - ppublish SO - Clin Ther. 2007;29 Suppl:2536-46. doi: 10.1016/j.clinthera.2007.12.002.