Duloxetine in the management of diabetic peripheral neuropathic pain

Figures & data

Table 1 Percentage of patients with reduced 24-hour average pain severity in duloxetine DPNP trials

Percent pain reduction	Trial	Treatment				All duloxetine groups significantly different from placebo
		Duloxetine daily dose			Placebo
		20 mg	60 mg	120 mg
≥30%	Raskin et al^Citation33		68.14%	64.04%	43.36%	Yes
	Wernicke et al^Citation35		63%	69%	42%	Yes
≥50%	Raskin et al^Citation33		50%	39%	30%	Unreported
	Goldstein et al^Citation34	41%	49%	52%	26%	Yes
	Wernicke et al^Citation35		43%	53%	27%	Yes

Abbreviation: DPNP, diabetic peripheral neuropathic pain.

Table 2 Treatment-emergent adverse events and serious adverse events seen in duloxetine DPNP trials

Trial	Drug/dose	% patients with ≥1 TEAE,P-value	TEAE more common than placebo	Discontinuation due to AE	% with SAEs,P-value	Listed SAEs	Other significant changes
Raskin et al^Citation33	Placebo	49.1%, −	–	2.6%	3.4%, −	Anemia, cerebrovascular accident, chest pain, chronic obstructive airways, dyspnea, melena, pneumonia
	Duloxetine 60 mg daily	61.2%, P = 0.086	Nausea, somnolence, hyperhidrosis, anorexia	4.3%	3.4%, NS	Atrial fibrillation, cholecystitis, diabetes mellitus, nephrolithiasis	Elevated alkaline phosphatase, transaminases, inorganic phosphorus, fasting glucose, uric acid
	Duloxetine 60 mg bid	62.9%, P = 0.047	Nausea, somnolence, hyperhidrosis, anorexia, vomiting constipation	12.1%	1.7%, NS	Urinary calculi, ventricular extrasystoles	Elevated cholesterol, LDL, alkaline phosphatase, bicarbonate; decreased urea nitrogen; weight loss; increased heart rate; decreased QT interval
Goldstein et al^Citation34	Placebo	NR	–	6.9%	NR	*Chest pain, hyperglycemia
	Duloxetine 20 mg daily	NR		4.3%	NR	*Chest pain, myocardial infarction
	Duloxetine 60 mg daily	NR	Somnolence, constipation	14.0%	NR	*	Decreased sodium, chloride, and ALT; increased alkaline phosphatase; decreased QT interval
	Duloxetine 60 mg bid	NR	Nausea, somnolence, dizziness, constipation, dry mouth, hyperhidrosis, anorexia, weakness	19.5%	NR	*Hyperglycemia, myocardial infarction	Decreased uric acid, chloride, GTT; increase bicarbonate and alkaline phosphatase; decreased QT interval
Wernicke et al^Citation35	Placebo	73.1%, −	–	7.4%	4.6%, −	2nd degree atrioventricular block, carcinoma, chronic obstructive airways disease exacerbation, diabetic ulcer, fatigue, hypertension	CPK elevation
	Duloxetine 60 mg daily	89.5%, P = 0.002	Nausea, dizziness, fatigue, somnolence, diarrhea, hyperhidrosis, dry mouth	14.9%	4.4%, NS	Congestive heart failure, coronary artery stenosis, hip fracture, prostate cancer, hypokalemia, hyponatremia	Increased alkaline phosphatase, inorganic phosphorus, bilirubin, transaminases
	Duloxetine 60 mg bid	85.7%, P = 0.029	Nausea, dizziness, constipation, fatigue, somnolence, insomnia hyperhidrosis, dry mouth, anorexia, asthenia, erectile dysfunction, tremor	17.9%	1.8%, NS	Hypercalcemia, concussion	Decreased chloride, uric acid; increased heart rate

Note:

* Reported as serious adverse events reported in more than 1 patient.

Abbreviations: AE, adverse events; ALT, alanine transaminase; bid, twice daily; CPK, creatine phosphokinase; DPNP, diabetic peripheral neuropathic pain; GTT, glucose tolerance test; LDL, low-density lipoprotein; NR, not reported; SAE, serious adverse events; TEAE, treatment-emergent adverse events.

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