Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

Table 1

Studies of duloxetine 40 mg QD and/or 60 mg QD in the management of DPNP.

Study	Location	Number of patients	Duration and design	Treatments	Primary outcome measure
1 [13]	USA, Canada, Puerto Rico, Argentina	457	12 weeks, double blind	Duloxetine 20 mg QD	Mean change from baseline to endpoint on weekly mean of 24-hour Average Pain Severity rating
				Duloxetine 60 mg QD
				Duloxetine 60 mg BID
				Placebo
2 [14]	USA, Puerto Rico	334	12 weeks, double blind	Duloxetine 60 mg QD	Mean change from baseline to endpoint on weekly mean of 24-hour Average Pain Severity rating
				Duloxetine 60 mg BID
				Placebo
3 [15]	Canada, Croatia, Hungary, Poland, Germany, Russian Federation	348	12 weeks, double blind	Duloxetine 60 mg QD	Mean change from baseline to endpoint on weekly mean of 24-hour Average Pain Severity rating
				Duloxetine 60 mg BID
				Placebo
4 [16]	Japan	338	12 weeks, double blind	40 mg QD duloxetine	Mean change from baseline to endpoint on weekly mean of 24-hour Average Pain Severity rating
				60 mg QD Duloxetine
				Placebo
5 [17]	Brazil, France, Germany, Italy	216	8 weeks, open label	Duloxetine 60 mg QD	NA
		184	26 weeks, open label 60 mg MOE	Duloxetine 60 mg QD	Non-inferiority test of a 1-sided 97.5% CI of the change from baseline to endpoint on the 24-hour Average Pain Severity rating
				Duloxetine 120 mg QD

Abbreviations: BID: twice daily; CI: confidence interval; DPNP: diabetic peripheral neuropathic pain; MOE: maintenance of effect; NA: not applicable; QD: once daily.