Mirogabalin: A New Drug For Neuropathy

Today's post from medivizor.com (see link below) looks at a new drug designed to treat neuropathic symptoms. It looks as though it may be a possible substitute for Lyrica (pregabalin) but with less side-effects and that has to be a good thing considering the bad press that pregabalin gets. As so often, the article is aimed at diabetics with neuropathy but if it's a possible substitute for pregabalin, then it will be prescribed for many people with neuropathy from other causes. The problem is, there has only been one small study on humans to date and whether the conclusions drawn are enough to convince you or not, there needs to be more research, especially on the effects on the various major forms and causes of neuropathy. Pregabalin, for instance, is issued to some neuropathy patients and is not recommended for others, depending on the cause of the nerve damage - clarity and evidence are essential.

Mirogabalin: a potential new drug to treat pain in diabetics with peripheral neuropathy
Posted by Medivizor on Jul 10, 2015 in Diabetes mellitus

In a nutshell

This study examined whether mirogabalin is safe and effective in diabetics with peripheral neuropathy. 

Some background

Chronic high blood glucose levels can lead to damage to blood vessels in patients with diabetes. This can result in various complications, such as eye disease, kidney disease and diabetic neuropathy. Diabetic neuropathy is a condition in which the nervous system becomes injured. Approximately 50% of diabetics who have neuropathy experience peripheral neuropathic pain (PNP – chronic pain in legs and arms). PNP can result in depression, anxiety and sleep disorders.

Pregabalin (Lyrica) is a drug currently used to treat PNP, however it is poorly tolerated. In addition, 50% of patients require pregabalin along with another drug in order to achieve pain relief. Mirogabalin is a similar drug to pregabalin, but is believed to have fewer side effects. Its use in treating PNP is currently being investigated.

Methods & findings

This study aimed to determine the safety and most effective dose of mirogabalin.

This study involved 452 diabetic patients divided into 7 groups. One group of patients received a placebo (a substance with no therapeutic effect). 5 groups received mirogabalin at different doses (5, 10, 15, 20 or 30 mg per day). One group received 300 mg pregabalin daily. Participants received the drug or placebo for 5 weeks.

Participants recorded their pain score at the start of the study and throughout the study. All participants had an average daily pain score greater than 4 (maximum score of 11). Mirogabalin had a clinically significant effect if it reduced the daily pain score by 1.

In comparison to the placebo group, participants receiving mirogabalin had a greater decrease in pain. This decrease was greater with a higher dose (pain score difference of -0.53 for 10 mg vs. -1.01 for 30 mg). This decrease was also greater than participants using pregabalin (pain score difference of -0.05 for pregabalin compared to placebo).

61% of participants experienced side effects. 9.4% experienced mild to moderate dizziness, while 6.1% experienced headaches.

The bottom line

This study concluded that 30 mg of mirogabalin reduces pain in diabetics with PNP and is well-tolerated. 

The fine print

This study only assessed the effects of mirogabalin over 5 weeks. It is not known whether mirogabalin is safe or effective for long-term use. As some participants experienced side effects, this drug may not be suitable for all patients. The author received funding from Daiichi Sankyo, the company who developed the drug.

Published By :
Diabetes Care

Date :

Sep 17, 2014

Original Title :

Efficacy and Safety of Mirogabalin (DS-5565) for the Treatment of Diabetic Peripheral Neuropathic Pain: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Adaptive Proof-of-Concept Phase 2 Study.

https://medivizor.com/blog/SampleLibrary/diabetes-mellitus/mirogabalin-a-potential-new-drug-to-treat-pain-in-diabetics-with-peripheral-neuropathy/