Mirogabalin: a potential new drug to treat pain in diabetics with peripheral neuropathy

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

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.

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.

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

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.