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

Table 5

Serious adverse events in the double-blind treatment phases of studies 1 through 4.

Study 𝑛 (%)	Patients experiencing ≥1 SAE				SAEs
	DLX 40 mg QD; (𝑁=85)	DLX 60 mg QD; (𝑁=430)	PLB; (𝑁=506)	DLX 40 mg QD	DLX 60 mg QD	PLB
Study 1 [20]; DLX 60 mg QD (𝑛=114); PLB (𝑛=115)	NA	3 (2.6)	4 (3.5)	NA	Exhaustion; hypertension; left hip fracture; prostatic abscess; urinary tract infection; acute urinary retention	Accidental drowning; strangulated right inguinal hernia; hyperglycemia; chest pain
Study 2 [20]; DLX 60 mg QD (𝑛=114); PLB (𝑛=108)	NA	4 (3.5)	7 (6.5)	NA	Congestive heart failure; coronary artery stenosis; hip fracture; prostate cancer	Heart block; fatigue; obesity; cancer to left side of the neck; COPD; diabetic ulcer; hypertension
Study 3 [20]; DLX 60 mg QD (𝑛=116); PLB (𝑛=116)	NA	4 (3.5)	4 (3.5)	NA	Atrial fibrillation; cholecystitis; DM; nephrolithiasis	Anemia; cerebrovascular accident; chest pain; COPD; dyspnea; melaena; pneumonia
Study 4 [16]; DLX 40 mg QD (𝑛=85); DLX 60 mg QD (𝑛=86); PLB (𝑛=167)	3 (3.5)	2 (2.3)	6 (3.6)	Alcohol poisoning; contusion; ulna fracture; hypoglycemia	Epiglottitis; radiculopathy; self injurious behavior	Abnormal hepatic function; bacterial arthritis; osteomyelitis; sepsis; tuberculous pleurisy; back injury; pathological fracture; cerebral infarction; facial palsy; hemiparesis; thalamus hemorrhage; acute renal failure

COPD: chronic obstructive pulmonary disease; DLX: duloxetine; DM: diabetes mellitus; NA: not applicable; PLB: placebo; QD: once daily; SAE: serious adverse event.