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Journal Club

Journal Club. Birkmeyer NJ, Dimick JB, Share D, Hawasli A, English WJ, Genaw J, Finks JF, Carlin AM, Birkmeyer JD; Michigan Bariatric Surgery Collaborative. Hospital complication rates with bariatric surgery in Michigan. JAMA. 2010 Jul 28;304(4):435-42.

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Journal Club

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  1. Journal Club Birkmeyer NJ, Dimick JB, Share D, Hawasli A, English WJ, Genaw J, Finks JF, Carlin AM, Birkmeyer JD; Michigan Bariatric Surgery Collaborative. Hospital complication rates with bariatric surgery in Michigan. JAMA. 2010 Jul 28;304(4):435-42. Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. 埼玉医科大学　総合医療センター　内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田　昌文 Matsuda, Masafumi 2010年8月19日　8:30-8:55 ８階　医局

  2. Bariatric Surgery

  3. a reduction in mortality of 23% from 40%! some obese young adults may lose up to 20 years of life expectancy if they do not reduce their weight Department of Surgery, and Center for Healthcare Outcomes and Policy (CHOP) (Drs N. Birkmeyer, Dimick, Finks, and J. Birkmeyer), and Department of Family Medicine (Dr Share), University of Michigan, Ann Arbor; Department of Surgery, St John Hospital and Medical Center, Detroit, Michigan (Dr Hawasli); Department of Surgery, Marquette General Hospital, Marquette, Michigan (Dr English); and Department of Surgery, Henry Ford Hospital, Detroit, Michigan (Drs Genaw and Carlin). Corresponding Author: Nancy J. O. Birkmeyer, PhD, Michigan Surgical Collaborative for Outcomes Research and Evaluation (M-SCORE), Department of Surgery, University of Michigan, 211 N Fourth Ave, Ste 2A and 2B, Ann Arbor, MI 48104 (nbirkmey@umich .edu). JAMA. 2010;304(4):435-442

  4. Background Context Despite the growing popularity of bariatric surgery, there remain concerns about perioperative safety and variation in outcomes across hospitals. Objective To assess complication rates of different bariatric procedures and variability in rates of serious complications across hospitals and according to procedure volume and center of excellence (COE) status.

  5. Methods Design, Setting, and Patients Involving 25 hospitals and 62 surgeons statewide, the Michigan Bariatric Surgery Collaborative (MBSC) administers an externally audited, prospective clinical registry. We evaluated short-term morbidity in 15 275 Michigan patients undergoing 1 of 3 common bariatric procedures between 2006 and 2009. We used multilevel regression models to assess variation in risk-adjusted complication rates across hospitals and the effects of procedure volume and COE designation (by the American College of Surgeons or American Society for Metabolic and Bariatric Surgery) status. Main Outcome Measure Complications occurring within 30 days of surgery.

  6. Adjustable gastric banding Biliopancreatic diversion Roux-en-Y gastric bypass Sleeve gastrectomy Vertical banded gastroplasty with duodenal switch • A meta-analysis from University of California, Los Angeles reports the following weight loss at 36 months • Biliopancreatic diversion - 53 kg • Roux-en-Y gastric bypass (RYGB) - 41 kg • Open - 42 kg • Laparoscopic - 38 kg • Adjustable gastric banding - 35 kg • Vertical banded gastroplasty - 32 kg • Sleeve gastrectomy ?

  7. It is estimated that in 2005, the number of procedures performed in the United States was more than 10 times as great as the number performed in 1994, an increase from approximately 16,200 procedures to 171,000, and the number is still rising. (N Engl J Med 2009; 361:520-521) The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery— have implemented programs for accrediting hospitals as centers of excellence (COE) in bariatric surgery.

  8. The LABS writing group assumes responsibility for the content of this article. Members of the LABS writing group are listed in the Appendix. Address reprint requests to Dr. David R. Flum at the Surgical Outcomes Research Center, Department of Surgery, University of Washington, Box 356410, Seattle, WA 98195-6410 N Engl J Med 2009;361:445-54.

  9. Why COE accreditation by professional organizations or payers might not necessarily identify safer hospitals with bariatric surgery? • First,although COE applications often ask hospitals for rates of specific outcomes ( eg, postoperative venous thromboembolism), such outcomes data are generally not audited for accuracy or completeness and are often loosely defined. • Second, aside from minimum case loads, most requirements for bariatric COE accreditation, including the availability of specific protocols and resources form an aging morbidly obese patients, are easily met by most hospitals with bariatric programs and likely have little bearing on surgical complication rates. • Finally, given the highly competitive market place for bariatric surgery, COE accreditation programs may be attracting hospitals motivated as much by marketing advantage as by the desire to demonstrate and improve their quality.

  10. Results Results Overall,7.3%of patients experienced perioperative complications, most of which were wound problems and other minor complications. Serious complications were most common after gastric bypass (3.6%;95%confidence interval [CI], 3.2%-4.0%), followed by sleeve gastrectomy (2.2%; 95% CI, 1.2%-3.2%), and laparoscopic adjustable gastric band (0.9%; 95% CI, 0.6%-1.1%) procedures (P<.001). Mortality occurred in 0.04% (95% CI, 0.001%-0.13%) of laparoscopic adjustable gastric band, 0 sleeve gastrectomy, and 0.14% (95% CI, 0.08%-0.25%) of the gastric bypass patients. After adjustment for patient characteristics and procedure mix, rates of serious complications varied from1.6% (95%CI,1.3-2.0) to3.5%(95%CI, 2.4-5.0) (risk difference, 1.9;95%CI, 0.08-3.7) across hospitals. Average annual procedure volume was inversely associated with rates of serious complications at both the hospital level (<150cases, 4.1%;95%CI,3.0%-5.1%;150- 299 cases, 2.7%;95%CI, 2.2-3.2; and ≧300 cases, 2.3%;95%CI, 2.0%-2.6%;P=.003) and surgeon level (<100 cases, 3.8%;95%CI, 3.2%-4.5%; 100-249 cases, 2.4%;95% CI, 2.1%-2.8%; ≧ 250 cases, 1.9%;95%CI, 1.4%-2.3%; P=.001). Adjusted rates of serious complications were similar in COE and non-COE hospitals (COE,2.7%;95%CI,2.5%- 3.1%; non-COE, 2.0%; 95% CI, 1.5%-2.4%; P=.41).

  11. Conclusion Conclusions The frequency of serious complications among patients undergoing bariatric surgery in Michigan was relatively low. Rates of serious complications are inversely associated with hospital and surgeon procedure volume, but unrelated to COE accreditation by professional organizations.

  12. Message/Comments FDAが糖尿病の治療で有効と認めている治療の第一は減量手術！ 日本では保険適用もないし一般的ではないが、今後の課題である。 「いい外科医紹介します．．．」

  13. On March 31st 2010, Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave. www.thelancet.com Published online July 30, 2010 DOI:10.1016/S0140-6736(10)60888-4

  14. Novo Nordisk now plans to re-initiate the global phase 3 programme in the first half of 2011 in clinical trials comprising approximately 5,000 patients(June 22, 2010) www.thelancet.com Published online October 23, 2009 DOI:10.1016/S0140-6736(09)61375-1

  15. Lancet 2005; 365: 1389–97

  16. rimonabant In 2006, the European Medicines Agency approved the marketing of rimonabant in Europe. In 2007, however, new contraindications were formulated by the Agency. Also in 2007, the US Food and Drug Administration denied approval in the USA. Reasons for concern were neuropsychiatric side effects, including depression and suicide attempts.

  17. Scripps Translational Science Institute, La Jolla, CA, USA (Prof E J Topol MD); Hopital Lariboisiere, Paris, France (Prof M-G Bousser MD); University of Edinburgh, Edinburgh, UK (Prof K A A Fox MBCh); Brigham and Women’s Hospital and Harvard University, Boston, MA, USA (M A Creager MD); Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Quebec, Canada (Prof J-P Despres MD); Rhode Island Hospital and Brown University, Providence, RI, USA (Prof J D Easton MD); Kerckhoff Klinik, Bad Nauheim, Germany (Prof C W Hamm MD); Centre Hospitalier Universitaire Pitie-Salpetriere, Paris, France (Prof G Montalescot MD); INSERM U-698, Universite Paris 7 and Hopital Bichat, AP-HP, Paris, France (Prof P G Steg MD); University of Rochester, Rochester, NY, USA (Prof T A Pearson MD); Sunnybrook Health Sciences Centre, Toronto, ON, Canada (E Cohen MD); Sanofi -Aventis, Paris, France (C Gaudin MD, B Job MD, J H Murphy MD); and VA Boston Healthcare System, Boston, MA, USA (D L Bhatt MD) Lancet 2010; 376: 517–23

  18. Background Blockade of the endocannabinoid receptor reduces obesity and improves metabolic abnormalities such as triglycerides, HDL cholesterol, and fasting blood glucose. We assessed whether rimonabant would improve major vascular event-free survival

  19. Methods This double-blind, placebo-controlled trial was undertaken in 974 hospitals in 42 countries. 18 695 patients with previously manifest or increased risk of vascular disease were randomly assigned to receive either rimonabant 20 mg (n=9381) or matching placebo (n=9314). Randomisation was stratified by centre, implemented with an independent interactive voice response system, and all study personnel and participants were masked to group assignment. The primary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke, as determined via central adjudication. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00263042.

  20. Follow-up in the trial was prematurely ended on Nov 6, 2008, because of a request by the regulatory agency for cessation of clinical research of rimonabant in Ireland, France, and Germany. At that time, the mean exposure to the drug had been 13・8 months (95% CI 13・6–14・0)

  21. The frequency of serious psychiatric side-effects also differed significantly, occurring in 232 (2・5%) of patients in the rimonabant group compared with 120 (1・3%) in the placebo group (p<0・0001). There were four suicide events in the rimonabant group versus one in the placebo group, and nine versus five patients, respectively, attempted suicide.

  22. A studyshowed that single nucleotide variants in a tyrosine kinase receptor gene (NTRK2) involved in neurotrophic signalling were associated with more than four-fold increased risk of suicide. Furthermore, the clinical benefit of endocannabinoid-1 blockade could have been manifest in patients with a particular gene variant in the endocannabinoid-1 or related pathways.

  23. Results At a mean follow-up of 13・8 months (95% CI 13・6–14・0), the trial was prematurely discontinued because of concerns by health regulatory authorities in three countries about suicide in individuals receiving rimonabant. All randomised participants were analysed. At the close of the trial (Nov 6, 2008), the composite primary endpoint of cardiovascular death, myocardial infarction, or stroke occurred in 364 (3・9%) patients assigned to rimonabant and 375 (4・0%) assigned to placebo (hazard ratio 0・97, 95% CI 0・84–1・12, p=0・68). With rimonabant, gastrointestinal (3038 [33%] vs 2084 [22%]), neuropsychiatric (3028 [32%] vs 1989 [21%]), and serious psychiatric side-effects (232 [2・5%] vs 120 [1・3%]) were significantly increased compared with placebo. Four patients in the rimonabant group and one in the placebo group committed suicide.

  24. Conclusion The premature termination of this trial has important lessons for drug development. A drug that was being marketed for weight loss, but being tested for improving cardiovascular outcomes, induced a level of serious neuropsychiatric effects that was deemed unacceptable by regulatory authorities, and both the drug and the trial were abruptly terminated.

  25. Message Rimonabantはヨーロッパで数年使われていたが、少数例だが自殺が増えるようで販売中止となった。 体重が減ることで心血管障害が予防できるようなこともなかったので当然の処置であろう。 減量の薬物介入はなかなか難しい。

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