Tiantian Wang1,2,3, Miaofa Ying1, Rui Zhao1, Danyan Zhu4, Lisan Zhang5,6. 1. Department of Pharmacy, Xiasha Campus, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 368 Rd Xiasha, Zhejiang Province, 310016, Hangzhou, China. 2. Institute of Pharmacology and Toxicology, College of Pharmaceutical Science, Zhejiang University, No. 866 Rd Yuhangtang, Zhejiang Province, 310058, Hangzhou, China. 3. Center for Sleep Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Rd East Qingchun, Zhejiang Province, 310016, Hangzhou, China. 4. Institute of Pharmacology and Toxicology, College of Pharmaceutical Science, Zhejiang University, No. 866 Rd Yuhangtang, Zhejiang Province, 310058, Hangzhou, China. zdyzxb@zju.edu.cn. 5. Center for Sleep Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Rd East Qingchun, Zhejiang Province, 310016, Hangzhou, China. zls09@zju.edu.cn. 6. Department of Neurology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, No. 3 Rd East Qingchun, Zhejiang Province, 310016, Hangzhou, China. zls09@zju.edu.cn.
Abstract
PURPOSE: Augmentation is a major complication of long-term pramipexole treatment of restless legs syndrome (RLS). However, there have been no studies on augmentation in Chinese patients with RLS. We therefore investigated the clinical characteristics of augmentation in RLS patients treated with pramipexole in a real-world Chinese setting. METHODS: This study was an observational, retrospective assessment of 103 patients with RLS, who had been continuously treated with pramipexole for at least one month between January 2016 and December 2018 in a tertiary hospital in East China. Demographic data and disease and drug treatment information were collected from electronic medical records and telephone interviews to analyze the rate and clinical features of augmentation. Augmentation was confirmed by Max Planck Institute criteria. Comparisons were made between patients with and without augmentation. RESULTS: Fifteen patients (15%) were classified as having augmentation. Compared to RLS patients without augmentation, more patients with augmentation switched from other dopaminergic drugs (P<0.05) and had a longer duration of RLS symptoms before pramipexole treatment (P<0.05). In addition, patients with augmentation had a longer duration (P<0.05) and higher dosage (P<0.05) of pramipexole than those without augmentation. Augmentation was possibly associated with pramipexole tolerance (P<0.01). CONCLUSION: The augmentation rate of the Chinese RLS patients in our study was 15%. Augmentation may be associated with switching from other dopaminergic drugs, long disease duration before pramipexole use, the dose and duration of pramipexole, and tolerance to pramipexole.
PURPOSE: Augmentation is a major complication of long-term pramipexole treatment of restless legs syndrome (RLS). However, there have been no studies on augmentation in Chinese patients with RLS. We therefore investigated the clinical characteristics of augmentation in RLS patients treated with pramipexole in a real-world Chinese setting. METHODS: This study was an observational, retrospective assessment of 103 patients with RLS, who had been continuously treated with pramipexole for at least one month between January 2016 and December 2018 in a tertiary hospital in East China. Demographic data and disease and drug treatment information were collected from electronic medical records and telephone interviews to analyze the rate and clinical features of augmentation. Augmentation was confirmed by Max Planck Institute criteria. Comparisons were made between patients with and without augmentation. RESULTS: Fifteen patients (15%) were classified as having augmentation. Compared to RLS patients without augmentation, more patients with augmentation switched from other dopaminergic drugs (P<0.05) and had a longer duration of RLS symptoms before pramipexole treatment (P<0.05). In addition, patients with augmentation had a longer duration (P<0.05) and higher dosage (P<0.05) of pramipexole than those without augmentation. Augmentation was possibly associated with pramipexole tolerance (P<0.01). CONCLUSION: The augmentation rate of the Chinese RLS patients in our study was 15%. Augmentation may be associated with switching from other dopaminergic drugs, long disease duration before pramipexole use, the dose and duration of pramipexole, and tolerance to pramipexole.