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

Table 6

LSMean changes in heart rate and blood pressure during 12-week treatment with duloxetine 40 and 60 mg QD versus placebo in placebo-controlled studies in patients with DPNP.

Measure, mean change (SD)	Study 1^a		Study 2		Study 3		Study 4^c
	DLX 60 mg QD (𝑛=87)	PLB (𝑛=88)	DLX 60 mg QD (𝑛=114)	PLB (𝑛=107)	DLX 60 mg QD (𝑛=114)	PLB (𝑛=114)	DLX 40/60 mg QD (𝑛=160)	PLB (𝑛=159)
Heart rate, bpm	2.49^∗ (0.95)	−0.59 (0.95)	−0.35^b (10.41)	−0.99 (9.53)	0.47 (9.02)	−0.82 (10.97)	3.2^d	−2.1^e
Systolic blood Pressure, mm Hg	−1.57 (1.41)	−3.50 (1.40)	−0.18 (16.33)	−0.50 (14.27)	−2.24 (14.06)	−2.89 (16.13)	0.7	−2.1
Diastolic blood Pressure, mm Hg	2.52^∗∗∗ (0.87)	−1.84 (0.86)	−0.29 (8.99)	−0.34 (8.82)	−0.74 (9.01)	−0.58 (9.79)	1.4	−1.8

^∗𝑃≤.05 versus placebo; ^∗∗∗𝑃≤.001 versus placebo
^aValues presented are LSMean change (SE)
^b𝑛=113 ^cno measure of distribution and no statistical comparison of the treatment group available
^d𝑛=161 ^e𝑛=158
bpm: beats per minute; DLX: duloxetine; LSMean: least-squares mean; 𝑛: number of patients; PLB: placebo; QD: once daily; SD: standard deviation; SE: standard error.