NEJM Audio Summary - May 24, 2012

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0:56|"Aspirin for Preventing the Recurrence of Venous Thromboembolism" by Cecilia Becattini. From University of Perugia, Italy. About 20% of patients with venous thrombosis or embolism but no defined risk factors have a recurrence within the first 2 years after stopping anticoagulation therapy. This study assessed the clinical benefit of aspirin for the prevention of recurrence after a course of treatment with vitamin K antagonists in patients with unprovoked venous thromboembolism. Venous thromboembolism recurred in 28 of the 205 patients who received aspirin and in 43 of the 197 patients who received placebo (6.6% vs. 11.2% per year). During a median treatment period of 23.9 months, 23 patients taking aspirin and 39 taking placebo had a recurrence (5.9% vs. 11.0% per year). One patient in each treatment group had a major bleeding episode. Aspirin reduced the risk of recurrence when given to patients with unprovoked venous thromboembolism who had discontinued anticoagulant treatment, with no apparent increase in the risk of major bleeding.
2:13| Richard Becker, from Duke University Medical Center, Durham, North Carolina, writes in the editorial that the findings of this study are compelling and may signal an important step in the evolution of care; however, confirmatory studies will be required to establish a role in daily clinical practice for the use of aspirin among patients who are at high risk for bleeding due to anticoagulant therapy or for whom ongoing investigations identify and subsequently validate a clinical or biomarker-based profile associated with a low risk of recurring venous thromboembolism.

これをきっかけに循環器学会のHPを覗いて見ました。いつのまにか、ガイドラインが充実しています。呼吸器学会みたいに「買ってね」というのじゃないのが嬉しい。

NEJM Audio Summary - May 17, 2012

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0:54| "Warfarin and Aspirin in Patients with Heart Failure and Sinus Rhythm", by  Shunichi Homma, from Columbia University Medical Center, New York. Patients with heart failure and sinus rhythm benefit from anticoagulation. This trial assessed whether warfarin or aspirin is a better treatment for patients with a reduced left ventricular ejection fraction (LVEF) who were in sinus rhythm. The rates of the primary outcome which was the first event of ischemic stroke, intracerebral hemorrhage, or death from any cause were 7.47 events per 100 patient-years in the warfarin group and 7.93 in the aspirin group. Thus, there was no significant overall difference between the two treatments. In a time-varying analysis, the hazard ratio changed over time, slightly favoring warfarin over aspirin by the fourth year of follow-up, but this finding was only marginally significant. Warfarin, as compared with aspirin, was associated with a significant reduction in the rate of ischemic stroke throughout the follow-up period (0.72 events per 100 patient-years vs. 1.36 ). The rate of major hemorrhage was 1.78 events per 100 patient-years in the warfarin group as compared with 0.87 in the aspirin group. Among patients with reduced LVEF who were in sinus rhythm, there was no significant overall difference in the primary outcome between treatment with warfarin and treatment with aspirin. A reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage. The choice between warfarin and aspirin should be individualized.
2:47| In editorial, John Eikelboom from McMaster University, Hamilton, Ontario, Canada, writes that the results of this trial are consistent with those of three previous smaller randomized, controlled trials in showing that warfarin anticoagulant therapy, as compared with aspirin, is not associated with a reduction in mortality among patients with heart failure. This trial provides clear evidence that anticoagulant therapy prevents stroke, probably embolic stroke, in patients with heart failure who have severe systolic dysfunction, but the rates of stroke are too low to justify the routine clinical use of warfarin in most patients with heart failure, in light of the increase in the risk of bleeding.

内容は2月に行われた国際脳卒中学会で発表されたもの。著者の本間俊一教授はこのような方。

NEJM Audio Summary - May 10, 2012

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0:41| "Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma" by Antonio Palumbo, from the University of Turin, Italy.
Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This study compared melphalan–prednisone–lenalidomide induction followed by lenalidomide maintenance (MPR-R) with melphalan–prednisone–lenalidomide (MPR) or melphalan–prednisone (MP) followed by placebo in patients 65 years of age or older with newly diagnosed multiple myeloma.  The median progression-free survival was significantly longer with MPR-R (31 months) than with MPR (14 months) or MP (13 months). Response rates were superior with MPR-R and MPR (77% and 68%, respectively, vs. 50% with MP). After induction therapy, a landmark analysis showed a 66% reduction in the rate of progression with MPR-R  that was age-independent. MPR-R significantly prolonged progression-free survival in patients with newly diagnosed multiple myeloma who were ineligible for transplantation, with the greatest benefit observed in patients 65 to 75 years of age. 

多発性骨髄腫、クリニックで診療していると、ともすると鑑別診断からこぼれ落ちそうになる疾患だ。その治療に関し、サリドマイド誘導体の「レナリドミド」の有効性が話題になっている。日本でも薬価収載され、１日25㎎、１ヶ月に21日間服用し7日間休薬するスケジュールの場合、１ヶ月のレナリドミドの費用は、8,861円×５カプセル×21日 ＝ 930,405円で、１割負担で 93,040円となります。治療したくとも放置せざるを得ない患者さんの存在が懸念されます。

NEJM Audio Summary - May 3, 2012

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0:48| "Strategies of Radioiodine Ablation in Patients with Low-Risk Thyroid Cancer",
by Martin Schlumberger, from Institut de Cancérologie Gustave Roussy, Villejuif, France. This trial compared two thyrotropin-stimulation methods and two 131I doses for postoperative ablation in patients with low-risk thyroid cancer.  In the 684 patients with data that could be evaluated, ultrasonography of the neck was normal in 652 (95%), and the stimulated thyroglobulin level was 1.0 ng per milliliter or less in 621 of the 652 patients (95%) without detectable thyroglobulin antibodies. Thyroid ablation was complete in 631 of the 684 patients (92%). The ablation rate was equivalent between the 131I doses and between the thyrotropin-stimulation methods. The use of recombinant human thyrotropin and low-dos(1.1 GBq) postoperative radioiodine ablation may be sufficient for the management of low-risk thyroid cancer.
4:40| "Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement", by Susheel Kodali, from Columbia University Medical Center and New York Presbyterian Hospital, New York. This study provides 2-year data from the PARTNER trial, in which patients with aortic stenosis received transcatheter aortic-valve replacement (TAVR) or surgical replacement. The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90) and at 2 years were 33.9% in the TAVR group and 35.0% in the surgery group. The frequency of all strokes during follow-up did not differ significantly between the two groups. At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR, and even mild paravalvular regurgitation was associated with increased late mortality. This 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality.

今回からCMEの指定のある記事の部分を取り上げることにする。

NEJM Audio Summary - April 26, 2012

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0:49| "Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes", by Philip Schauer from Cleveland Clinic, Cleveland, Ohio.
This randomized controlled study of 150 obese patients with type 2 diabetes determined the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The proportion of patients with the primary end point,  which was glycated hemoglobin level of 6% or less 12 months after treatment, was 12% in the medical-therapy group versus 42% in the gastric-bypass group and 37% in the sleeve-gastrectomy group. Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5% in the medical-therapy group, 6.4% in the gastric-bypass group, and 6.6% in the sleeve-gastrectomy group. Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (−29.4 kg and −25.1 kg, respectively) than in the medical-therapy group (−5.4 kg). In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results.
1:44| "Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes", by Geltrude Mingrone from Università Cattolica S. Cuore, Rome.
This trial compared the efficacy of two types of bariatric surgery (gastric bypass and biliopancreatic diversion) with conventional medical therapy in severely obese patients with type 2 diabetes. At 2 years, diabetes remission had occurred in no patients in the medical-therapy group versus 75% in the gastric-bypass group and 95% in the biliopancreatic-diversion group. Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline glycated hemoglobin level (8.65%) had decreased in all groups, but patients in the two surgical groups had the greatest degree of improvement (average glycated hemoglobin levels, 7.69% in the medical-therapy group, 6.35% in the gastric-bypass group, and 4.95% in the biliopancreatic-diversion group).  In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures.
2:42| In editorial Paul Zimmet from the Baker IDI Heart and Diabetes Institute, Melbourne, Australia, writes that these studies are likely to have a major effect on future diabetes treatment. Nevertheless, more studies are needed, particularly those that may provide better prediction of success and the expected duration of remission and long-term complications. Meanwhile, the success of various types of bariatric surgery suggests that they should not be seen as a last resort. Such procedures might well be considered earlier in the treatment of obese patients with type 2 diabetes.

「肥満手術」って、肥満症が異常に多い彼の国での話かと思いきや、先進国の中では、むしろ日本が異常に少ないのだそうだ。（参照："Metabolic/Bariatric Surgery Worldwide 2008"[PDF]）そして、そんな我が国でも2010年に日本肥満症治療学会で「日本における高度肥満症に対する安全で卓越した外科治療のためのステートメント2010」[PDF]なんてもんが公開されていた。考えようによっては、効くかどうかわからないダイエット商品よりも、手術の質が担保されれば、手術のほうが倫理的と言えるかもしれないが…