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Effect of combination of atomoxetine and oxybutynin for Japanese patients with obstructive sleep apnea syndrome
(Effect of combination treatment of atomoxetine and oxybutynin for Japanese patients with obstructive sleep apnea syndrome)

Effect of combination treatment of atomoxetine and oxybutynin

18

Atomoxetine + Oxybutynin first group: total 9 (1 exclusion) male 7 female 2 (1 exclusion), age 49-65 No-med first group: total 9 male 8 female 1, age 47-65

Consent obtained :18 Enrollment:18 ATO + OXY first group: 9 (exclude 1) ATO + OXY 8 to No medicine(med) 8 No med first group: 9 No med 9 to ATO + OXY 9 Analysis: ATO + OXY first group 8 , no med first group 9

Mild adverse events: 1case (vomiting)

Primary endpoints: AHI ( No significant difference) Secondary endpoints: lowest SPO2 value (no significant difference), minimum SPO2 time (no significant difference) sleep architecture (REM sleep p<0.0001, sleep efficiency p=0.02)

Contrary to previous reports, ATO and OXY combined therapy did not significantly improve AHI in Japanese OSA. Sleep architecture showed significant changes, which could be attributed to differences in the metabolic capacity of Asians for ATO.

Oct. 26, 2022

Oct. 02, 2022

https://pubmed.ncbi.nlm.nih.gov/36184258/

No

no plan

https://jrct.niph.go.jp/latest-detail/jRCTs031200046

Sakao Seiichiro

Chiba University Hospital

1-8-1 Inohana Chuo-ku Chiba-city Chiba, Japan

jirotera@chiba-u.jp

Sakao Seiichiro

Chiba university hospital

1-8-1 Inohana Chuo-ku Chiba-city Chiba, Japan

+81-43-222-7171

sakaos@faculty.chiba-u.jp

Complete

June. 06, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

1. Patients diagnosed with OSA who have a treatment history or are undergoing treatment for OSA
2. Patients aged between 20 and 70 years
3. Written informed consent

1. Patients with central apnea superior to obstructive apnea
2. Patients with drug allergy to atomoxetine and oxybutynin
3. Patients with severe liver function, cardiac function, renal function, pulmonary function disorder
4. Patients with severe central nervous system disease
5. Patients with bipolar disorder or psychotic disorder
6. Patients who have already taken MAO inhibitors or drugs equivalent to atomoxetine or oxybutynin
7. Pregnant women
8. Lactating women
9. Patients who are difficult to keep supine position during sleep
10. Patients who have a history of angle-closure glaucoma, history of paralytic ileus, history of pheochromocytoma, history of benign prostatic hyperplasia, history of urinary retention, history of myasthenia gravis
11. Patients with severe hyperthyroidism, ulcerative colitis, tachyarrhythmia, prolonged QT syndrome, seizures, cerebrovascular disorder
12. Patients judged to be ineligible

Both

Obstructive sleep apnea

Take atomoxetine and oxybutynin 30 minutes before falling asleep and perform PSG test

OSA AHI

Difference in average value of AHI

SpO2 minimum difference, SpO2 drop time difference, Differences in sleeping stage

+81-43-226-2616

Mar. 18, 2020

none