Source: Ned Tijdschr Geneeskd  |  Posted 5 years ago

By Maria Bishop
BOSTON, MA -- June 28, 2006 -- The antidepressant duloxetine is safe for the long-term management of diabetic peripheral neuropathic pain (DPNP), according to a study presented here at the Endocrine Society's 88[^]th[] Annual Meeting (ENDO 2006).

The leading cause of damage to the peripheral nerves in the United States is diabetes. Approximately 30% to 60% of diabetics develop long-term complications of peripheral neuropathy, and 10% to 20% of these patients experience pain. A patient with DPNP will typically present with burning or stinging feet, which are usually worse at night.
Researchers led by Joel Raskin, MD, FRCPC, medical fellow, Lilly Research Laboratories, Eli Lilly Canada, Scarborough, Ontario, Canada, compared the use of duloxetine (60 mg twice daily) against routine care of acetylsalicylic acid, gabapentin and paracetamol using pooled data from three 52-week trials. In each of the trials, adult patients who completed a randomized, double-blind, placebo-controlled acute therapy period of 12 to 13 weeks were then randomized into extension studies to receive either duloxetine (60 mg twice daily) (n = 580) or routine care (n = 287).

Safety assessments were based on measurements of neuropathy, nephropathy and retinopathy progression; discontinuation due to adverse events; treatment-emergent adverse events; vital signs; ECGs; and laboratory assessments.

Thirteen (4.5%) routine care and 56 (9.7%) duloxetine-treated patients discontinued treatment due to adverse events and 10 (1.2%) patients discontinued due to death (5 [1.7%] routine-care-treated, 5 [0.9%] duloxetine-treated).

Serious adverse events reported by 1% or more of routine care-treated patients were as follows: myocardial infarction (2.4%), pneumonia (2.1%), congestive cardiac failure (1.7%), cerebrovascular accident (1.4%), and cellulitis (1%), and by 1% or more of duloxetine-treated patients was myocardial infarction (1.6%). Statistically significant therapy-group differences were observed in fasting glucose (mean change: -0.64 mmol/L [routine-care], 0.67 mmol/L [duloxetine]), HbA1c (mean change: 0.002 [routine-care], 0.005 [duloxetine]), high density lipoprotein cholesterol (mean change: -0.078 mmol/L [routine-care], -0.014 mmol/L [duloxetine]), diastolic blood pressure (mean change: -0.15 mm/Hg [routine-care], 1.38 mmHg [duloxetine]), and pulse (mean change: -1.29 bpm [routine-care], 1.52 bpm [duloxetine]). Duloxetine did not appear to adversely affect eye or nerve function.

According to the research team, the lack of significant cardiovascular changes with duloxetine compared with routine care suggests that patients with diabetes mellitus do not require more intensive treatment of their cardiovascular status when treated with duloxetine than they require for their underlying diabetes.

The team concluded from these pooled results that duloxetine is safe in the long-term management of DPNP.

This study was supported by Eli Lilly Canada, Scarborough, Ontario, Canada.

[Presentation title: Duloxetine in the Long-Term Management of Diabetic Peripheral Neuropathic Pain: Results from Three Clinical Trials. Abstract 660]