Duloxetine in the treatment of chronic pain due to fibromyalgia and diabetic neuropathy

Figures & data

Table 1 Somatic and psychological manifestations of pain¹

Physical attributes	Psychologic attributes
Hypertension	Anxiety
Tachycardia	Depression
Diaphoresis	Fear
Mydriasis	Anger
Pallor	Insomnia
Gastrointestinal distress

Table 2 Efficacy of duloxetine in treating pain in fibromyalgia patients

Study duration	Study
	Arnold et al^Citation31		Arnold et al^Citation32			Russell et al^Citation34								Chappell^Citation33		Chappell et al^Citation35
						3 months				6 months				6 months		12 months
Baseline demographics
Percentage female	89		100			94.8								93.3		95.7
Mean age (years)	49		49.6			51								50.5		49
Treatment group	DLX 120 mg	PBO	DLX 60 mg	DLX 120 mg	PBO	DLX 20 mg	DLX 60 mg	DLX 120 mg	PBO	DLX 20 mg	DLX 60 mg	DLX 120 mg	PBO	DLX 60/120 mg	PBO	DLX 60 mg	DLX 120 mg
n	104	103	118	116	120	79	150	147	144	49	97	95	84	162	168	104	203
Outcome measure (change from baseline ± SE)
FIQ total score	−13.46 (1.82)	−7.93 (1.73)	−16.72 (1.53)	−16.81 (1.54)	−8.35 (1.53)	−14.60 (1.83)*	−15.41 (1.40)*	−14.50 (1.38)*	−10.05 (1.42)	−14.77 (1.88)	−12.28 (1.44)	−13.86 (1.41)	−10.42 (1.46)	−7.96 (1.35)	−5.81 (1.29)	−0.69 (1.82)	3.49 (1.34)*
Mean tender point pain threshold	0.29 (0.07)	−0.04 (0.07)	0.22 (0.08)	0.39 (0.08)	0.06 (0.08)	0.51 (0.11)	0.52 (0.08)	0.42 (0.08)	0.33 (0.08)	0.54 (0.12)	0.52 (0.09)	0.54 (0.09)	0.42 (0.09)	0.40 (0.09)	0.18 (0.08)	0.58 (0.11)	0.32 (0.08)*
Brief pain inventory
Average pain	−1.83 (0.24)	−0.94 (0.23)	−2.39 (0.22)	−2.40 (0.22)	−1.16 (0.21)	−1.92 (0.27)	−1.99 (0.2)*	−2.31 (0.20)*	−1.39 (0.20)	−2.22 (0.28)*	−1.98 (0.21)*	−2.26 (0.21)*	−1.43 (0.21)	−1.62 (0.20)	−1.13 (0.19)	−0.37 (0.26)	−0.16 (0.19)
Worst pain	–	–	−2.53 (0.25)	−2.37 (0.25)	−1.35 (0.24)	–	–	–	–	–	–	−	–	−1.75 (0.22)	−1.25 (0.21)	−0.53 (0.28)	−0.18 (0.21)
Least pain	–	–	−1.77 (0.20)	−1.76 (0.20)	−0.58 (0.20)	–	–	–	–	–	–	–	–	−1.22 (0.19)	−0.73 (0.18)	−0.12 (0.26)	0.21 (0.19)
CGI-S	−0.72 (0.12)	−0.39 (0.12)	−0.84 (0.10)	−0.84 (0.10)	−0.44 (0.10)	−0.96 (0.12)	−1.06 (0.10)*	−1.10 (0.09)*	0.70 (0.10)	−0.97 (0.13)*	−1.07 (0.10)*	−1.14 (0.10)*	−0.66 (0.10	−0.57 (0.09)	−0.28 (0.08)	−0.23 (0.11)	−0.04 (0.08)
PGI-I	3.02 (0.17)	3.53 (0.17)	3.11 (1.77)	3.06 (1.73)	3.71 (1.5)	2.85 (0.17)*	3.04 (−0.13)*	2.89 (0.13)*	3.39 (0.13)	2.79 (0.17)*	3.08 (0.13)	2.93 (0.13)*	3.37 (0.13)	3.43 (0.13)	3.72 (0.12)	2.19 (0.15)	2.65 (0.11)*

* Notes: Results were statistically significant (P < 0.05) versus placebo.

Abbreviations: SE, standard error; DLX, duloxetine; PBO, placebo; FIQ, Fibromyalgia Impact Questionnaire; CGI-I, Clinical Global Impressions of Severity; PGI-I, Patient’s Global Impressions of Improvement.

Table 3 Efficacy of duloxetine in treating neuropathic pain

Study duration	Study
	Goldstein et al^Citation36				Wernicki et al^Citation38			Raskin et al^Citation37
	12 weeks				12 weeks			12 weeks
Demographics
Percentage female	38.5				38.9			53.4
Mean age (years)	60.1				60.7			58.8
Treatment group	DLX 20 mg	DLX 60 mg	DLX 120 mg	PBO	DLX 60 mg	DLX 120 mg	PBO	DLX 60 mg	DLX 120 mg	PBO
n	115	114	113	115	114	112	108	116	116	116
Outcome measure (change from baseline ± SE)
24-hour average pain	−2.36 (0.21)	−2.89 (0.22)	−3.24 (0.23)	−1.91 (0.22)	−2.72 (0.22)*	−2.84 (0.23)*	−1.39 (0.23)	−2.50 (0.18)*	−2.47 (0.18)*	−1.60 (0.18)
24-hour worst pain	−2.78 (0.23)	−3.31 (0.24)*	−3.72 (0.24)*	−2.09(0.24)	−3.21 (0.25)*	−3.39 (0.26)*	−1.94 (0.25)	−2.97 (0.20)*	−2.84 (0.20)*	−2.03 (0.20)
Brief pain inventory
Average pain	−2.25 (0.21)	−2.81 (0.21)*	−3.07 (0.22)*	−2.04 (0.21)	−2.66 (0.23)*	−3.05 (0.24)*	−1.48 (0.23)	−2.65 (0.19)*	−2.62 (0.19)*	−1.82 (0.19)
Worst pain	–	–	–	–	−3.33 (0.27)*	−3.50 (0.28)*	−1.98 (0.28)	−3.00 (0.22)	−3.09 (0.22)*	−2.20 (0.22)
Least pain	–	–	–	–	−1.88 (0.22)*	−2.30 (0.22)*	−0.86 (0.22)	−1.98 (0.18)*	−1.86 (0.18)*	−1.17 (0.18)
CGI -S	−1.28 (0.11)*	−1.42 (0.12)*	−1.7 (0.12)*	−0.83 (0.12)	−1.37 (0.11)*	−1.47 (0.12)*	−0.98 (0.12)	−1.42 (0.09)*	−1.40 (0.10)*	−0.93 (0.09)
PGI -I	2.68 (0.12)	2.21 (0.12)*	2.24 (0.12)*	2.91 (0.12)	2.61 (1.44)*	2.40 (1.29)*	3.17 (1.44)	2.50 (0.10)*	2.54 (0.10)*	3.04 (0.10)

* Note: Results were statistically significant (P < 0.05) versus placebo.

Abbreviations: DLX, duloxetine; PBO, placebo; FIQ, Fibromyalgia Impact Questionnaire; CGI-I, Clinical Global Impressions of Severity; PGI-I, Patient’s Global Impressions of Improvement; SE, standard error.

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