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投稿日:2008-09-29 Mon
9月25日号にはSpecial articleが掲載されています。これは9月2日のweb版に先行発表されたものです。これも全文が無料で読めます。では早速、タイトルから。
Analyses of Cancer Data from Three Ezetimibe Trials
Analyses 分析
Trials 試験
本文に入りましょう。
Background Five years of statin therapy lowers low-density lipoprotein (LDL) cholesterol substantially and, over a 5-year period, results in reductions in the incidence of cardiovascular events. The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial (ClinicalTrials.gov number, NCT00092677 [ClinicalTrials.gov] ) has raised the hypothesis that adding ezetimibe to statin therapy for larger LDL cholesterol reductions might increase the incidence of cancer.
substantially 大幅に
results in ~に帰着する、~に結果としてもたらす
raised the hypothesis 仮説を立てる、仮説を提起する
Methods We compared the results of a hypothesis-generating analysis of the incidence of cancer in the SEAS trial of ezetimibe plus simvastatin in 1873 patients (mean follow-up after ezetimibe or matching placebo was begun, 4.1 years) with a hypothesis-testing analysis of cancer data from the two large ongoing trials of this regimen: the Study of Heart and Renal Protection (SHARP) (NCT00125593 [ClinicalTrials.gov] ) with 9264 patients (mean follow-up, 2.7 years) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) (NCT00202878 [ClinicalTrials.gov] ), currently with 11,353 patients (mean follow-up, 1.0 year).
hypothesis-generating 仮説生成型の、仮説を惹起する
generateは生み出す、生成するという意味です。
hypothesis-testing 仮説検証型の
前のと対になっています。
ongoing 現在進行中の
Results In the SEAS trial, assignment to ezetimibe was associated with an increase in any new onset of cancer (101 patients in the active-treatment group vs. 65 in the control group) from several cancer sites. In SHARP and IMPROVE-IT combined, there was no overall excess of cancer (313 active-treatment vs. 326 control; risk ratio, 0.96; 95% confidence interval, 0.82 to 1.12; P=0.61) and no significant excess at any particular site. Among patients assigned to ezetimibe, there were more, albeit not significantly more, deaths from cancer (97, vs. 72 in the control group; P=0.07), but there were also fewer, although not significantly fewer, other cases of cancer (216, vs. 254 in the control group; P=0.08). There was no evidence of a trend in the risk ratio for incidence of or death from cancer with increasing duration of follow-up.
assignment 割付
overall 総
assigned to ~に割り付けられた
もうおなじみですね。
albeit ....にもかかわらず
althoughという意味です。あまり見かけない語かも。
Conclusions The available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer. Follow-up of longer duration will permit the balance of risks and benefits to be determined more reliably.
available 利用可能な、得られる
the balance of risks and benefits リスクと利益のバランス
日本語で言うところの「メリット、デメリット」です。
今週号掲載の原著論文はこれで全部です。いかがですか。
NEJMのサイトはThe New England Journal of Medecineで見られます。abstractは無料で閲覧できますから、どうぞ。
抄録の日本語版はこちらへ。
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