高齢者低テストステロン群ホルモン補充療法は副事象イベント増大させた

内科開業医のお勉強日記から、「TOMトライアル中断：高齢者低テストステロン群ホルモン補充療法は副事象イベント増大させた」の引用です。

http://intmed.exblog.jp/10902794/

65歳以上の血中テストステロン値低値で、運動能に限界のあるひとたちの下肢筋力（log-press strength)はプラセボよりテストステロン治療群で強くなる。しかし、このトライアルはテストステロン群の心臓副事象増加にて中断された。

Adverse Events Associated with Testosterone Administration
Published at www.nejm.org June 30, 2010 (10.1056/NEJMoa1000485)

平均74歳、209名の男性で、高血圧・糖尿病・高脂血症、肥満存在
テストステロン群が有意に心臓、呼吸器、皮膚疾患増加
特に、心臓関連副事象がテストステロン群　23例、プラセボ　5例であり、6ヶ月治療期間を通して心血管疾患関連副事象リスク増加傾向は不変。
leg-press strengthは改善

確かにサルコペニアの治療として男性ホルモンは筋力を増強させますが、この研究結果を見る限り、筋力増強目的でテストステロンを使用することはできませんね。

現状ではサルコペニアに対しては、レジスタンストレーニングがメインで、あとはBCAAを併用する程度でしょう。ビタミンDも副作用が怖いので、正常範囲の方に使用する気はしませんね。

ABSTRACT

Background Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.

Methods Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.

Results A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load.

Conclusions In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.