Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study

Abstract

To evaluate the efficacy and safety of 6 weeks of venlafaxine extended-release (ER) (75 mg and 150-225 mg) treatment in patients with painful diabetic neuropathy. This multicenter, double-blind, randomized, placebo-controlled study included 244 adult outpatients with metabolically stable type 1 or 2 diabetes with painful diabetic neuropathy. Primary efficacy measures were scores on the daily 100 mm Visual Analog Pain Intensity (VAS-PI) and Pain Relief (VAS-PR) scales. Secondary efficacy measures included the Clinical Global Impressions-Severity of Illness and the Clinical Global Impressions-Improvement, Patient Global Rating of Pain Relief, and percentage of patients achieving 50% reduction in pain intensity. Baseline pain intensity was 68.7 mm (moderately severe). At week 6, the percentage reduction from baseline in VAS-PI was 27% (placebo), 32% (75 mg), and 50% (150-225 mg; P < 0.001 vs placebo). Mean VAS-PR scores in the 150-225 mg group were significantly greater than placebo at week 6 (44 vs 60 mm; P < 0.001). The number needed to treat (NNT) for 50% pain intensity reduction with venlafaxine ER 150-225 mg was 4.5 at week 6. Nausea and somnolence were the most common treatment-emergent adverse events. Seven patients on venlafaxine had clinically important ECG changes during treatment. Venlafaxine ER appears effective and safe in relieving pain associated with diabetic neuropathy. NNT values for higher dose venlafaxine ER are comparable to those of tricyclic antidepressants and the anticonvulsant gabapentin.

Diabetic Neuropathy: A Position Statement by the American Diabetes Association

“…Venlafaxine, a selective norepinephrine and serotonin reuptake inhibitor, in doses between 150 and 225 mg/day has shown some effectiveness in the treatment of painful DSPN (126,127). Both venlafaxine and duloxetine (see above) inhibit the reuptake of serotonin and norepinephrine without the muscarinic, histaminic, and adrenergic side effects that accompany the use of the tricyclic agents (98)(99)(100)102).…”

“…However, the level of evidence for pain reduction associated with DSPN is higher with duloxetine (see above). Venlafaxine may lower the seizure threshold, and gradual tapering is recommended to avoid the emergence of adverse events upon discontinuation (126,127).…”

Peripheral Neuropathy in Ovarian Cancer

“…It is a serotonin, norepinephrine, and dopamine reuptake inhibitor. A moderate effect of pain relief was found compared with placebo (Rowbotham et al, 2004). Venlafaxine XR 75 mg daily may be increased to 150 mg daily.…”

Antidepressant Drug Use in Patients with Diabetes Mellitus Type 1 - The Effect of Medication on Mental Problems and Glycemic Control

“…A small, but statistically significant increase in fasting glycemia was found when using duloxetine in comparison with placebo. [Fava, 2004] Venlafaxine [Kunz, 2000;Rowbotham, 2004] as well as duloxetine [Goldstein, 2005;Raskin, 2005] …”