Bonds DE, Miller ME, Bergenstal RM, Buse JB, Byington RP, Cutler JA, Dudl
RJ, Ismail-Beigi F, Kimel AR, Hoogwerf B, Horowitz KR, Savage PJ, Seaquist
ER, Simmons DL, Sivitz WI, Speril-Hillen JM, Sweeney ME.
The association between symptomatic, severe hypoglycaemia and mortality
in type 2 diabetes: retrospective epidemiological analysis of the ACCORD
study.
BMJ. 2010 Jan 8;340:b4909.
PubMed PMID: 20061358.
カテゴリー: 治療
研究デザイン: ランダム化比較試験,後ろ向き疫学解析 資金源: This study was supported by grants from the NationalHeart, Lung, and Blood Institute (N01-HC-95178, N01-HC-95179,N01-HC-95180, N01-HC-95181, N01-HC-95182, N01-HC-95183, N01-HC-95184,IAA-Y1-HC-9035, and IAA-Y1-HC-1010); by other components ofthe National Institutes of Health, including the National Instituteof Diabetes and Digestive and Kidney Diseases, the NationalInstitute on Aging, and the National Eye Institute; by the Centersfor Disease Control and Prevention; and by General ClinicalResearch Centers. The following companies provided study medications,equipment, or supplies: Abbott Laboratories, Amylin Pharmaceuticals,AstraZeneca, Bayer HealthCare, Closer Healthcare, GlaxoSmithKline,King Pharmaceuticals, Merck, Novartis, Novo Nordisk, Omron Healthcare,Sanofi-Aventis, and Schering-Plough. 利益相反: RMB receives research grant support and/oris a member of a scientific advisory board for the followingcompanies: Amylin Pharmaceuticals, Abbott Diabetes Care, Bayer,Eli Lilly, Intuity Medical, LifeScan, Mannkind, Medtronic-Minimed,National Institutes of Health, Novo Nordisk, ResMed, Roche,Sanofi-Aventis, Valeritas, and UnitedHealth Group. All the aboveactivities are performed under contract with the non-profitPark Nicollet Institute and the International Diabetes Center,Minneapolis, MN, USA. RMB receives no personal compensationfor any of these activities. He also inherited Merck stock.JBB is a shareholder of Insulet. Under contracts with his employer,JBB has been an investigator, consultant, or speaker for AmylinPharmaceuticals, Bayhill Therapeutics, Becton, Dickinson andCompany Research Laboratories, Bristol-Myers Squibb, Dexcom,Eli Lilly, GlaxoSmithKline, Intekrin, Intuity Medical, Johnson& Johnson, MannKind, Medtronic, Merck, MicroIslet, Novartis,Novo Nordisk, Osiris, Pfizer, Roche, Sanofi-Aventis, TransitionTherapeutics, and Wyeth. BH is a full-time employee of LillyUSA (Endocrine), Indianapolis, IN, USA. ERS has been reimbursedby Pfizer for participating in the review of applications forvisiting professorships and has been a paid consultant for Merck.WIS receives research funds from GlaxoSmithKline and has beenreimbursed by Merck as a consultant at a Global Experts Forum.The remaining authors declare no competing interests.
ACCORD研究における死亡者数は460名.
年間粗死亡率は標準血糖コントロール群が1.14%,集中血糖コントロール群が1.42%だった.
死亡者のうち,451人は死亡前に予定されていたスケジュールで受診し,重度の低血糖のエピソードを経験したかどうか明らかになっていた.
集中治療群が標準群よりも多く,HA(15.9% vs 5.0%),HMA(10.3% VS 3.4%)を経験していた.
研究期間中に703人の患者がHMAを経験した.
ACCORD研究で死亡した人の原因は,心血管疾患(1.7% vs 1.3%),癌と心血管疾患以外の原因(1.0% vs 0.7%)が集中治療群と標準治療群の間に違いがあったものである.
集中治療群の死亡率上昇は,これらが原因と考えるのが妥当か.
ACCORD研究の元論文(NEJM 2008;358:2545)のTable 2をみると,集中治療群で多かった特に多かった(20%以上差があった)処方は,Repaglinide(50.2% vs 17.7%,32.5%差),Thiazolidinedione(91.7%
vs 58.3%,33.4%差),Any insulin(77.3% vs 55.4%,21.9%差),Any bolus insulin(55.3%
vs 35.0%,20.3%差)であり,これらの薬剤が低血糖とは独立して死亡率を上げた可能性もある(詳細はこちら).