期刊
ENDOCRINE JOURNAL
卷 65, 期 3, 页码 359-371出版社
JAPAN ENDOCRINE SOC
DOI: 10.1507/endocrj.EJ17-0276
关键词
Metyrosine; Catecholamines; Pheochromocytoma; Paraganalioma; Multi-center clinical trial
资金
- Ono Pharmaceutical Co., Ltd. (Osaka, Japan)
To assess the efficacy, safety, and pharmacokinetics of metyrosine (an inhibitor of catecholamine synthesis) in patients with pheochromocytoma/paraganglioma (PPGL), we conducted a prospective, multi-center, open-label study at 11 sites in Japan. We recruited PPGL patients aged >= 12 years requiring preoperative or chronic treatment, receiving alpha-blocker treatment, having baseline urinary metanephrine (uMN) or normetanephrine (uNMN) levels >= 3 times the upper limit of normal values, and having symptoms associated with excess catecholamine. Metyrosine treatment was started at 500 mg/day and modified according to dose-adjustment criteria up to 4,000 mg/day. The main outcome measure was the proportion of patients who achieved at least 50% reduction in uMN or uNMN levels from baseline. Sixteen patients (11 males/5 females) aged 12-86 years participated. After 12 weeks of treatment and at the last evaluation of efficacy, the primary endpoint was achieved in 31.3% of all patients, including 66.7% of those under preoperative treatment and 23.1% of those under chronic treatment. Sedation, anemia, and death were reported in 1 patient each as serious adverse drug reactions during the 24-week treatment. Metyrosine was shown to be tolerated and to relieve symptoms by reducing excess catecholamine in PPGL patients under both preoperative and chronic treatment.
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