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Duloxetine Appears Safe for Hypertensive Patients With Diabetic Neuropathic Pain

By Jerry Ingram

ORLANDO, FL -- May 18, 2005 -- Duloxetine appears to be safe for patients suffering from diabetic neuropathic pain even when they are hypertensive, researchers say. Michael J. Robinson, MD, presented the findings here May 12^th at the 2005 American Geriatrics Society Annual Scientific Meeting.

"We know that studies have shown duloxetine to be safe and effective for treating diabetic peripheral neuropathic pain. Many patients with diabetes are predisposed to hypertension – the most common comorbidity – so our study looked at safety when that comorbidity is present," explained Dr. Robinson, who is a clinical investigator with Eli Lilly and Company in Indianapolis, Indiana, United States. "We found that safety is not impacted by the presence of hypertension in this population."

For this investigation, Dr. Robinson and colleagues pooled data from two double-blind, placebo-controlled studies of patients diagnosed with diabetic peripheral neuropathic pain. They randomized 568 patients to duloxetine (20 mg daily, 60 mg daily, or 60 mg twice daily) and 223 patients to placebo.

Patients were treated for 12 to 13 weeks with investigators performing assessment of safety data, discontinuation rates, adverse events, and any changes in vital signs. The most common comorbidities were hypertension, hypercholesterolemia, gastroesophageal reflux disease, and erectile dysfunction.

Investigators found no significant difference in terms of dropout rates due to adverse events between patients with and without hypertension (13.5% and 14.5%, respectively). Most importantly, hypertensive patients treated with duloxetine had sitting blood pressure rates similar to those in the placebo group (-9.3 mmHg for the duloxetine-treated group compared with -8.4 mmHg in the placebo group; P = .639).

The researchers concluded that duloxetine produces marginal changes in blood pressure for hyptertensive patients in this population.


[Presentation title: Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain: Safety and Tolerability in Patients with Baseline Comorbid Conditions.]

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