Short course of low-dose pregabalin is effective for the treatment of restless leg syndrome in patients with cirrhosis: A pilot study.

BACKGROUND AND AIM: Restless leg syndrome (RLS) is common in patients with cirrhosis, but its treatment in such patients remains unclear. This pilot study assessed the clinical effectiveness of intravenous iron and a 6-week course of low-dose (75 mg/day) pregabalin for the treatment of RLS in patients with cirrhosis. METHODS: It was a prospective, interventional study that included adult patients with cirrhosis and RLS. The participants underwent serum ferritin measurement. Patients with low serum ferritin (< 75 µg/dL) were treated with intravenous iron. Those with normal ferritin levels and those with low levels whose RLS symptoms failed to respond to iron replacement were treated with oral pregabalin, initially 75 mg/day for 6 weeks, followed by 150 mg/day for 6 weeks if there was no response. Recurrence of symptoms was assessed at 6-12 weeks after stopping pregabalin. RESULTS: Of the 50 patients (male patients 52%; median age 48 [interquartile range: 21-65] years; median Child-Pugh-Turcotte score 8 [5-13] and median Model for End-Stage Liver disease score 17 [12-20]) studied, 29 (58%) had low ferritin; of them, 14 (48%) responded to intravenous iron alone. Eleven of 15 (38%) patients with low ferritin and nonresponse to iron, and 16 of 21 (76%) with normal ferritin levels had a response with low-dose pregabalin. Of the nine nonresponders who received 150 mg/day of pregabalin, four had to discontinue it because of adverse effects. CONCLUSION: A short course of low-dose (75 mg/day) pregabalin was effective (82%) in alleviating RLS in patients with cirrhosis. (CTRI/2019/02/017642).