Clinical Trial Assessing the Efficacy of Gabapentin plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy

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Clinical Trial Assessing the Efficacy of Gabapentin plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy
Key Take-Away: 

Diabetic neuropathy is a type of nerve damage that can occur if you have diabetes. GBP plus complex B and Pregabalin are both competitive treatment drugs for this condition. This study explains the efficacy of gabapentin with B plus complex in comparison with Pregabalin in Diabetic Neuropathy

Painful diabetic neuropathy (PDN) is a prevalent and impairing disorder.

ABSTRACT: 
Background: 

Painful diabetic neuropathy (PDN) is a prevalent and impairing disorder.

The objective of this study was to show the efficacy and safety of gabapentin (GBP) plus complex B vitamins: thiamine (B1) and cyanocobalamine (B12) compared to pregabalin in patients with moderate to severe intensity PDN.

Methods: 

Phase IV, multicenter, randomized, open-label, parallel group, non-inferiority study conducted in Mexico.

Two hundred and seventy patients were evaluated, 147 with GBP/B1/B12 and 123 with PGB, with a 7/10 pain intensity on the Visual Analog Scale (VAS). Five visits (12 weeks) were scheduled. The GBP/B1 (100 mg)/B12 (20 mg) group started with 300 mg at visit 1 to 3600 mg at visit 5. The PGB group started with 75 mg/d at visit 1 to 600 mg/d at visit 5. Different safety and efficacy scales were applied, as well as adverse event assessment.

Results: 

Both drugs showed reduction of pain intensity, without significant statistical difference (P =0.900).

In the GBP/B1/B12 group, an improvement of at least 30% on VAS correlated to a 900 mg/d dose, compared with PGB 300 mg/d. Likewise, occurrence of vertigo was lower in the GBP/B1-B12 group, with a significant statistical difference, P = 0.014.

Conclusion: 

Our study shows that GPB/B1-B12 combination is as effective as PGB. Nonetheless, pain intensity reduction is achieved with 50% of the minimum required gabapentin dose alone (800 to 1600 mg/d) in classic NDD trials.

Our study shows that GPB/B1-B12 combination is as effective as PGB. Nonetheless, pain intensity reduction is achieved with 50% of the minimum required gabapentin dose alone (800 to 1600 mg/d) in classic NDD trials. Less vertigo and dizziness occurrence was also observed in the GBP/B1/B12 group.

J Diabetes Res. 2016; 2016: 4078695

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