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Journal Club

Journal Club. Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; on behalf of the NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.

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Journal Club

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  1. Journal Club Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; on behalf of the NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Oct 22. [Epub ahead of print] The IDF Global Guideline on Pregnancy and Diabetes The IDF Oral Health for People With Diabetes Guideline The IDF Guidelines on Self-Monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes 20th World Diabetes Congress , Montreal, Canada, Oct 18-22, 2009. 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 2009年10月29日　8:30-8:55 ８階　医局

  2. LEAD: Liraglutide Effect and Action in Diabetes. All studies 26 weeks’ duration (LEAD 3=52 weeks); all RCT; all with double dummy except LEAD 5 vs. glargine. Studies NN2211-1436, -1572, -1573 and -1697 presented as Marre et al. Diabetes 2008;57(Suppl. 1):A4 (LEAD 1); Nauck et al. Diabetes 2008;57(Suppl. 1):A150 (LEAD 2); Garber et al, The Lancet, accepted for publication (LEAD 3); Russell-Jones et al. Diabetes 2008;57(Suppl. 1):A159 (LEAD 5).

  3. Orlistat works by inhibiting gastric and pancreatic lipases, the enzymes that break down triglycerides in the intestine. 中外製薬の開発中止で、日本での発売の目処すら立っていなかった抗肥満薬オルリスタット（Orlistat）ですが、大正製薬が開発に名乗りを上げた。 抗肥満薬「orlistat」製剤の日本における開発及び販売に関する契約締結について　　（大正製薬プレスリリース 2009年1月13日）http://www.taisho.co.jp/company/release/2009/2009011301.pdf 　今回大正製薬が開発・販売権を取得したのは、中外製薬が開発を中止したロシュ社の医療用医薬品の『ゼニカル』（オルリスタット120mg）ではなく、米国で発売されているGSK社のOTC版の『alli』（オルリスタット60ｍｇ）で、薬事日報などではリアップのようにダイレクトスイッチとして開発されるのではないかと伝えている。（発売には最低でも4～5年かかるでしょうが）

  4. Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark (Prof A Astrup MD); Obesity Unit, Karolinska University Hospital, Huddinge, Sweden (Prof S Rossner MD); Department of Endocrinology, Diabetology and Metabolism, Antwerp University Hospital, Antwerp, Belgium (Prof L Van Gaal MD); Obesity Research Unit, Department of Psychiatry, Helsinki University Central Hospital, Helsinki, Finland (Prof A Rissanen MD); Department of Medicine, Kuopio University Hospital, Kuopio, Finland (Prof L Niskanen MD); Department of Medicine, EB FlevoResearch, Almere, Netherlands (M Al Hakim MD); Department of Biostatistics (J Madsen PhD) and Medical and Science (M F Rasmussen PhD), Novo Nordisk A/S, Bagsvaerd, Denmark; and Department of Human Nutrition, University of Glasgow, Glasgow Royal Infi rmary, Glasgow, UK (Prof M E J Lean MD) www.thelancet.com Published online October 23, 2009 DOI:10.1016/S0140-6736(09)61375-1

  5. Background and Aim The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. This study is registered with ClinicalTrials.gov, number NCT00422058.

  6. Method We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18–65 years of age, body-mass index 30–40 kg/m2) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1・2 mg, 1・8 mg, 2・4 mg, or 3・0 mg, n=90–95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-defi cit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed.

  7. Liraglutide 1.8mg/day in US 0.9mg/day in Japan for DM Tx

  8. Results Participants on liraglutide lost significantly more weight than did those on placebo (p=0・003 for liraglutide 1・2 mg and p<0・0001 for liraglutide 1・8–3・0 mg) and orlistat (p=0・003 for liraglutide 2・4 mg and p<0・0001 for liraglutide 3・0 mg). Mean weight loss with liraglutide 1・2–3・0 mg was 4・8 kg, 5・5 kg, 6・3 kg, and 7・2 kg compared with 2・8 kg with placebo and 4・1 kg with orlistat, and was 2・1 kg (95% CI 0・6–3・6) to 4・4 kg (2・9–6・0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3・0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84–96% reduction) with 1・8–3・0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment.

  9. Conclusion Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. Funding Novo Nordisk A/S, Bagsvaerd, Denmark.

  10. Message Liraglutide（GLP-1アナログ製剤）の減量作用はOrlistatを遥に凌駕している！

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