日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較

Translated title of the contribution: Comparison of efficacy and safety of mirtazapine versus fluvoxamine in Japanese and Caucasian patients with major depressive disorder

Joep Schoemaker, Mitsukuni Murasaki, Mutsuo Miyake, Anja Heukels, Joel Gailledreau, Hein Fennema, Ad Sitsen

Research output: Contribution to journalArticleScientificpeer-review

Abstract

A randomized, double-blind, 6 -week, multi-center trial was conducted with flexible doses of mirtazapine (15-45 mg/day) and fluvoxamine (50-150 mg/day) in patients suffering from major depressive disorder in Japan and Europe. The primary objective was to establish noninferiority of mirtazapine compared to fluvoxamine at endpoint using a margin of 2 points on the total score of the first 17 items of Hamilton Depression Rating Scale (HAMD17) . Secondary objective was to compare the safety profile of both drugs in Japanese and Caucasian patients.
In total 402 patients (20-73 years) were randomized and treated: 199 on mirtazapine (96 Japanese and 103 Caucasian patients) and 203 on fluvoxamine (98 Japanese and 105 Caucasian patients). The mean daily dose taken by subjects on mirtazapine was 21 mg (Japanese: 19 mg, Caucasians: 23 mg); the mean daily dose taken by subjects on fluvoxamine was 79 mg (Japanese: 79 mg. Caucasians: 78 mg).
A clinically significant decrease in the average HAMD17 total score was observed both in the mirtazapine (-14.3) and fluvoxamine (-13.6) group (-13.8 on mirtazapine and -11.7 on fluvoxamine in Japanese patients, -14.4 on mirtazapine and -15.1 on fluvoxamine in Caucasian patients). Overall the -0.7 points difference in HAMD17 total score change from baseline in favor
of mirtazapine was not statistically signtflcant, but allowed a conclusion of non-inferiority.
There was a tendency for Japanese patients to respond slightly better to mirtazapine, and for Caucasian patients to respond slightly better to fluvoxamine, and the herewith presumed treatment-by-region interaction was statistically significant (P = 0.075) and a possible result of random variation.
Mirtazapine was characterized with a faster onset of action as compared to fluvoxamine.
Both drugs were generally well tolerated. Mirtazapine was associated with a higher frequency of somnolence in Japanese patients, whereas fluvoxamine was associated with a higher incidence of nausea in both Japanese and Caucasian patients.
In conclusion, mirtazapine was shown to be non-inferior to fluvoxamine in the treatment of major depressive disorder. Both drugs were well tolerated with some adverse events being almost exclusively reported in Japanese patients and some in Caucasian patients.
Original languageOther
Pages (from-to)339-355
JournalJapanese Journal of Clinical Psychopharmacology
Volume13
Issue number2
Publication statusPublished - 2010
Externally publishedYes

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Fluvoxamine
Major Depressive Disorder
mirtazapine
Pharmaceutical Preparations

Cite this

Schoemaker, J., Murasaki, M., Miyake, M., Heukels, A., Gailledreau, J., Fennema, H., & Sitsen, A. (2010). 日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較. Japanese Journal of Clinical Psychopharmacology, 13(2), 339-355.
Schoemaker, Joep ; Murasaki, Mitsukuni ; Miyake, Mutsuo ; Heukels, Anja ; Gailledreau, Joel ; Fennema, Hein ; Sitsen, Ad. / 日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較. In: Japanese Journal of Clinical Psychopharmacology. 2010 ; Vol. 13, No. 2. pp. 339-355.
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abstract = "A randomized, double-blind, 6 -week, multi-center trial was conducted with flexible doses of mirtazapine (15-45 mg/day) and fluvoxamine (50-150 mg/day) in patients suffering from major depressive disorder in Japan and Europe. The primary objective was to establish noninferiority of mirtazapine compared to fluvoxamine at endpoint using a margin of 2 points on the total score of the first 17 items of Hamilton Depression Rating Scale (HAMD17) . Secondary objective was to compare the safety profile of both drugs in Japanese and Caucasian patients.In total 402 patients (20-73 years) were randomized and treated: 199 on mirtazapine (96 Japanese and 103 Caucasian patients) and 203 on fluvoxamine (98 Japanese and 105 Caucasian patients). The mean daily dose taken by subjects on mirtazapine was 21 mg (Japanese: 19 mg, Caucasians: 23 mg); the mean daily dose taken by subjects on fluvoxamine was 79 mg (Japanese: 79 mg. Caucasians: 78 mg).A clinically significant decrease in the average HAMD17 total score was observed both in the mirtazapine (-14.3) and fluvoxamine (-13.6) group (-13.8 on mirtazapine and -11.7 on fluvoxamine in Japanese patients, -14.4 on mirtazapine and -15.1 on fluvoxamine in Caucasian patients). Overall the -0.7 points difference in HAMD17 total score change from baseline in favorof mirtazapine was not statistically signtflcant, but allowed a conclusion of non-inferiority.There was a tendency for Japanese patients to respond slightly better to mirtazapine, and for Caucasian patients to respond slightly better to fluvoxamine, and the herewith presumed treatment-by-region interaction was statistically significant (P = 0.075) and a possible result of random variation.Mirtazapine was characterized with a faster onset of action as compared to fluvoxamine.Both drugs were generally well tolerated. Mirtazapine was associated with a higher frequency of somnolence in Japanese patients, whereas fluvoxamine was associated with a higher incidence of nausea in both Japanese and Caucasian patients.In conclusion, mirtazapine was shown to be non-inferior to fluvoxamine in the treatment of major depressive disorder. Both drugs were well tolerated with some adverse events being almost exclusively reported in Japanese patients and some in Caucasian patients.",
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Schoemaker, J, Murasaki, M, Miyake, M, Heukels, A, Gailledreau, J, Fennema, H & Sitsen, A 2010, '日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較', Japanese Journal of Clinical Psychopharmacology, vol. 13, no. 2, pp. 339-355.

日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較. / Schoemaker, Joep; Murasaki, Mitsukuni; Miyake, Mutsuo; Heukels, Anja; Gailledreau, Joel; Fennema, Hein; Sitsen, Ad.

In: Japanese Journal of Clinical Psychopharmacology, Vol. 13, No. 2, 2010, p. 339-355.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - 日本人及び白人大うつ病患者におけるmirtazapineと fluvoxamineの有効性及び安全性の比較

AU - Schoemaker, Joep

AU - Murasaki, Mitsukuni

AU - Miyake, Mutsuo

AU - Heukels, Anja

AU - Gailledreau, Joel

AU - Fennema, Hein

AU - Sitsen, Ad

PY - 2010

Y1 - 2010

N2 - A randomized, double-blind, 6 -week, multi-center trial was conducted with flexible doses of mirtazapine (15-45 mg/day) and fluvoxamine (50-150 mg/day) in patients suffering from major depressive disorder in Japan and Europe. The primary objective was to establish noninferiority of mirtazapine compared to fluvoxamine at endpoint using a margin of 2 points on the total score of the first 17 items of Hamilton Depression Rating Scale (HAMD17) . Secondary objective was to compare the safety profile of both drugs in Japanese and Caucasian patients.In total 402 patients (20-73 years) were randomized and treated: 199 on mirtazapine (96 Japanese and 103 Caucasian patients) and 203 on fluvoxamine (98 Japanese and 105 Caucasian patients). The mean daily dose taken by subjects on mirtazapine was 21 mg (Japanese: 19 mg, Caucasians: 23 mg); the mean daily dose taken by subjects on fluvoxamine was 79 mg (Japanese: 79 mg. Caucasians: 78 mg).A clinically significant decrease in the average HAMD17 total score was observed both in the mirtazapine (-14.3) and fluvoxamine (-13.6) group (-13.8 on mirtazapine and -11.7 on fluvoxamine in Japanese patients, -14.4 on mirtazapine and -15.1 on fluvoxamine in Caucasian patients). Overall the -0.7 points difference in HAMD17 total score change from baseline in favorof mirtazapine was not statistically signtflcant, but allowed a conclusion of non-inferiority.There was a tendency for Japanese patients to respond slightly better to mirtazapine, and for Caucasian patients to respond slightly better to fluvoxamine, and the herewith presumed treatment-by-region interaction was statistically significant (P = 0.075) and a possible result of random variation.Mirtazapine was characterized with a faster onset of action as compared to fluvoxamine.Both drugs were generally well tolerated. Mirtazapine was associated with a higher frequency of somnolence in Japanese patients, whereas fluvoxamine was associated with a higher incidence of nausea in both Japanese and Caucasian patients.In conclusion, mirtazapine was shown to be non-inferior to fluvoxamine in the treatment of major depressive disorder. Both drugs were well tolerated with some adverse events being almost exclusively reported in Japanese patients and some in Caucasian patients.

AB - A randomized, double-blind, 6 -week, multi-center trial was conducted with flexible doses of mirtazapine (15-45 mg/day) and fluvoxamine (50-150 mg/day) in patients suffering from major depressive disorder in Japan and Europe. The primary objective was to establish noninferiority of mirtazapine compared to fluvoxamine at endpoint using a margin of 2 points on the total score of the first 17 items of Hamilton Depression Rating Scale (HAMD17) . Secondary objective was to compare the safety profile of both drugs in Japanese and Caucasian patients.In total 402 patients (20-73 years) were randomized and treated: 199 on mirtazapine (96 Japanese and 103 Caucasian patients) and 203 on fluvoxamine (98 Japanese and 105 Caucasian patients). The mean daily dose taken by subjects on mirtazapine was 21 mg (Japanese: 19 mg, Caucasians: 23 mg); the mean daily dose taken by subjects on fluvoxamine was 79 mg (Japanese: 79 mg. Caucasians: 78 mg).A clinically significant decrease in the average HAMD17 total score was observed both in the mirtazapine (-14.3) and fluvoxamine (-13.6) group (-13.8 on mirtazapine and -11.7 on fluvoxamine in Japanese patients, -14.4 on mirtazapine and -15.1 on fluvoxamine in Caucasian patients). Overall the -0.7 points difference in HAMD17 total score change from baseline in favorof mirtazapine was not statistically signtflcant, but allowed a conclusion of non-inferiority.There was a tendency for Japanese patients to respond slightly better to mirtazapine, and for Caucasian patients to respond slightly better to fluvoxamine, and the herewith presumed treatment-by-region interaction was statistically significant (P = 0.075) and a possible result of random variation.Mirtazapine was characterized with a faster onset of action as compared to fluvoxamine.Both drugs were generally well tolerated. Mirtazapine was associated with a higher frequency of somnolence in Japanese patients, whereas fluvoxamine was associated with a higher incidence of nausea in both Japanese and Caucasian patients.In conclusion, mirtazapine was shown to be non-inferior to fluvoxamine in the treatment of major depressive disorder. Both drugs were well tolerated with some adverse events being almost exclusively reported in Japanese patients and some in Caucasian patients.

M3 - Article

VL - 13

SP - 339

EP - 355

JO - Japanese Journal of Clinical Psychopharmacology

JF - Japanese Journal of Clinical Psychopharmacology

IS - 2

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