Impact of Istradefylline on Levodopa Dose Escalation in Parkinson's Disease: ISTRA ADJUST PD Study, a Multicenter, Open-Label, Randomized, Parallel-Group Controlled Study

被引：7

作者：

Hatano, Taku ^{[1
]}

Sengoku, Renpei ^{[2
]}

Nagayama, Hiroshi ^{[3
]}

Yanagisawa, Naotake ^{[4
,5
]}

Yoritaka, Asako ^{[6
]}

Suzuki, Keisuke ^{[7
]}

Nishikawa, Noriko ^{[1
]}

Mukai, Yohei ^{[8
]}

Nomura, Kyoichi ^{[9
]}

Yoshida, Norihito ^{[10
]}

Seki, Morinobu ^{[11
]}

Matsukawa, Miho Kawabe ^{[12
]}

Terashi, Hiroo ^{[13
]}

Kimura, Katsuo ^{[14
]}

Tashiro, Jun ^{[15
]}

Hirano, Shigeki ^{[16
]}

Murakami, Hidetomo ^{[17
]}

Joki, Hideto ^{[18
,27
]}

Uchiyama, Tsuyoshi ^{[19
]}

Shimura, Hideki ^{[20
,28
]}

Ogaki, Kotaro ^{[21
]}

Fukae, Jiro ^{[22
]}

Tsuboi, Yoshio ^{[23
]}

Takahashi, Kazushi ^{[24
]}

Yamamoto, Toshimasa ^{[25
]}

Kaida, Kenichi ^{[10
]}

Ihara, Ryoko ^{[12
]}

Kanemaru, Kazutomi ^{[12
]}

Kano, Osamu ^{[26
]}

机构：

[1] Juntendo Univ, Fac Med, Dept Neurol, 2-1-1 Hongo,Bunkyo Ku, Tokyo 1138421, Japan

[2] Jikei Univ, Sch Med, Daisan Hosp, Dept Neurol, Tokyo, Japan

[3] Nippon Med Sch, Dept Neurol, Tokyo, Japan

[4] Juntendo Univ, Med Technol Innovat Ctr, Tokyo, Japan

[5] Juntendo Clin Res & Trial Ctr, Tokyo, Japan

[6] Juntendo Univ, Koshigaya Hosp, Dept Neurol, Saitama, Japan

[7] Dokkyo Med Univ, Dept Neurol, Tochigi, Japan

[8] Natl Ctr Neurol & Psychiat, Dept Neurol, Tokyo, Japan

[9] Higashimatsuyama Municipal Hosp, Dept Neurol, Saitama, Japan

[10] Saitama Med Univ, Saitama Med Ctr, Dept Neurol, Saitama, Japan

[11] Keio Univ, Sch Med, Dept Neurol, Tokyo, Japan

[12] Tokyo Metropolitan Inst Geriatr & Gerontol, Dept Neurol, Tokyo, Japan

[13] Tokyo Med Univ, Dept Neurol, Tokyo, Japan

[14] Yokohama City Univ Med Ctr, Dept Neurol, Yokohama, Japan

[15] Sapporo Parkinson MS Neurol Clin, Sapporo, Hokkaido, Japan

[16] Chiba Univ, Grad Sch Med, Dept Neurol, Chiba, Japan

[17] Jikei Univ, Sch Med, Dept Neurol, Tokyo, Japan

[18] Yokohama City Univ, Grad Sch Med, Dept Neurol & Stroke Med, Yokohama, Japan

[19] Seirei Hamamatsu Gen Hosp, Dept Neurol, Hamamatsu, Japan

[20] Juntendo Tokyo Koto Geriatr Med Ctr, Dept Neurol, Tokyo, Japan

[21] Juntendo Univ, Urayasu Hosp, Dept Neurol, Chiba, Japan

[22] Juntendo Univ Nerima Hosp, Dept Neurol, Tokyo, Japan

[23] Fukuoka Univ, Dept Neurol, Fukuoka, Japan

[24] Tokyo Metropolitan Neurol Hosp, Dept Neurol, Tokyo, Japan

[25] Saitama Med Univ, Dept Neurol, Saitama, Japan

[26] Toho Univ, Fac Med, Dept Neurol, Tokyo, Japan

[27] Natl Hosp Org Yokohama Med Ctr, Dept Neurol, Yokohama, Kanagawa, Japan

[28] Juntendo Univ Koshigaya Hosp, Dept Neurol, Koshigaya, Japan

来源：

NEUROLOGY AND THERAPY | 2024年 / 13卷 / 02期

关键词：

Adenosine A(2A) receptor antagonist; Istradefylline; Levodopa; Levodopa dose; Parkinson's disease; ANTAGONIST ISTRADEFYLLINE; ADENOSINE; EFFICACY; DYSKINESIA; SLEEPINESS; DISORDERS;

D O I：

10.1007/s40120-023-00574-6

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Introduction: A higher levodopa dose is a risk factor for motor complications in Parkinson's disease (PD). Istradefylline (IST) is used as adjunctive treatment to levodopa in PD patients with off episodes, but its impact on levodopa dose titration remains unclear. The objective of this study was to investigate the effect of IST on levodopa dose escalation in PD patients with wearing-off. Methods: This was a multicenter, open-label, randomized, parallel-group controlled study (ISTRA ADJUST PD) in which PD patients experiencing wearing-off (n = 114) who were receiving levodopa 300-400 mg/day were randomized to receive IST or no IST (control). Levodopa dose was escalated according to clinical severity. The primary endpoint was cumulative additional levodopa dose, and secondary endpoints were changes in symptom rating scales, motor activity determined by a wearable device, and safety outcomes. Results: The cumulative additional levodopa dose throughout 37 weeks and dose increase over 36 weeks were significantly lower in the IST group than in the control group (both p < 0.0001). The Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I and device-evaluated motor activities improved significantly from baseline to 36 weeks in the IST group only (all p < 0.05). Other secondary endpoints were comparable between the groups. Adverse drug reactions (ADRs) occurred in 28.8% and 13.2% of patients in the IST and control groups, respectively, with no serious ADRs in either group. Conclusion: IST treatment reduced levodopa dose escalation in PD patients, resulting in less cumulative levodopa use. Adjunctive IST may improve motor function more objectively than increased levodopa dose in patients with PD.

引用

页码：323 / 338

页数：16

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