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Diabetic Peripheral Neuropathic PainThe efficacy of CYMBALTA for the management of neuropathic pain associated withdiabetic peripheral neuropathy was established in 2 randomised, 12-week, double-blind,placebo-controlled, fixed-dose studies in adult patients having diabetic peripheralneuropathic pain for at least 6 months The design of the two studies is summarised inTable 2.Table 2: Study Design of Clinical Trials Supporting Efficacy of Duloxetine in theTreatment of DPNPStudy Code Design Duration ofTreatmentHMAW-AcuteParallel, double-blind,randomised, placebocontrolledTreatment andDose12 Weeks DLX 20 mg QDDLX 60 mg QDDLX 60 mg BIDPBOHMAVa- AcuteParallel, double-blind,randomised, placebocontrolled12 weeks (plus 1week taper)52-week extensionDLX 60 mg QDDLX 60 mg BIDPBOBID = twice daily; QD = once daily; DLX = duloxetine; PBO = placeboPatients enrolled had Type I or II diabetes mellitus with a diagnosis of painful distalsymmetrical sensorimotor polyneuropathy for at least 6 months. The patients had abaseline pain score of ≥4 on an 11-point scale ranging from 0 (no pain) to 10 (worstpossible pain). Patients were permitted up to 4 g of paracetamol per day as needed forpain, in addition to CYMBALTA. Patients recorded their pain daily in a diary.Both studies compared duloxetine 60 mg once daily or 60 mg twice daily with placebo;one study additionally compared duloxetine 20 mg with placebo. A total of 457 patients(342 Cymbalta, 115 placebo) were enrolled in study HMAW-acute and a total of 334patients (226 Cymbalta, 108 placebo) were enrolled in study HMAVa-acute.The weekly average of the 24-hour average pain severity was the primary efficacymeasure for the assessment of duloxetine’s effectiveness in the treatment of DPNP.Duloxetine 60 mg once daily and duloxetine 60 mg twice daily were both statisticallysignificantly superior to placebo as assessed by the reduction from baseline in theprimary efficacy measure, 24-hour average pain severity, as shown in Table 3. Inaddition, duloxetine 60 mg once daily and duloxetine 60 mg twice daily were statisticallysignificant to placebo as assessed by response rate (whether measured by at least a 30%reduction or at least a 50% reduction in pain score from baseline). Evidence of efficacyfrom the primary efficacy measure is confirmed by comprehensive results from thesecondary pain and DPNP symptom measures.The secondary efficacy measures that supported the use of CYMBALTA in the treatmentof DPNP were: weekly averages of night pain and 24-hour worst pain from the dailyCymbalta PI Nov 2012 v8.0 6
diary, Brief Pain Inventory Severity and Interference (BPI Severity and Interference),Clinical Global Impressions of Severity (CGI-Severity), Patient Global Impression ofImprovement (PGI-Improvement) scale, and Sensory portion of the Short-form McGillpain questionnaire. In addition, measures of mood were employed in both placebocontrolledstudies to demonstrate changes of pain uncontaminated by duloxetine’s effecton mood.Table 3 Summary of Primary Efficacy in 12 week placebo controlled studiesStudy HMAVa-acute 1 Study HMAW-acute 2PBOn=106DLX60QDn=110DLX60BIDn=111PBOn=111DLX20QDn=111DLX60QDn=112 DLX60BIDn=109Mean Baseline 5.85 6.12 6.21 5.73 5.84 6.01 5.85Mean Change -1.39 -2.72P
Page 1 and 2: CYMBALTA ®(duloxetine hydrochlorid
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