Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE)

被引：49

作者：

Punthakee, Zubin ^{[1
,2
]}

Gerstein, Hertzel C. ^{[1
,2
]}

Bosch, Jackie ^{[1
,2
]}

Tyrwhitt, Jessica ^{[1
,2
]}

Jung, Hyejung ^{[1
,2
]}

Lee, Shun Fu ^{[1
,2
]}

Lonn, Eva ^{[1
,2
]}

Marsden, Tamara ^{[1
,2
]}

McKelvie, Robert ^{[1
,2
]}

McQueen, Matthew J. ^{[1
,2
]}

Morillo, Carlos A. ^{[1
,2
]}

Yusuf, Salim ^{[1
,2
]}

Dagenais, Gilles R. ^{[3
]}

Diaz, Rafael ^{[4
]}

Maggioni, Aldo P. ^{[5
]}

Probstfield, Jeffrey ^{[6
]}

Ramachandran, Ambady ^{[7
]}

Riddle, Matthew C. ^{[8
]}

Ryden, Lars E. ^{[9
]}

Badings, Erik A. ^{[10
]}

Birkeland, Kare I. ^{[11
,12
]}

Cardona, Ernesto ^{[13
]}

Commerford, Patrick ^{[14
]}

Davies, Melanie ^{[15
]}

Fodor, J. George ^{[16
]}

Gomis, Ramon ^{[17
]}

Hanefeld, Markolf ^{[18
]}

Hildebrandt, Per ^{[19
]}

Kacerovsky-Bielesz, Gertrud ^{[20
]}

Keltai, Matyas ^{[21
]}

Lanas, Fernando ^{[22
]}

Lewis, Basil S. ^{[23
]}

Lopez-Jaramillo, Patricio ^{[24
,25
]}

Marin-Neto, Jose ^{[26
]}

Marre, Michel ^{[27
]}

Mendoza, Ivan ^{[28
]}

Pan, Chang Yu ^{[29
]}

Pirags, Valdis ^{[30
]}

Rosenstock, Julio ^{[31
]}

Spinas, Giatgen A. ^{[32
]}

Sreenan, Seamus ^{[33
]}

Syvanne, Mikko ^{[34
]}

Yale, Jean-Francois ^{[35
]}

机构：

[1] Populat Hlth Res Inst, Hamilton, ON, Canada

[2] McMaster Univ, Hamilton, ON, Canada

[3] Inst Univ Cardiol & Pneumol Quebec, Quebec City, PQ, Canada

[4] Estudios Clin Latino Amer, Rosario, Argentina

[5] Assoc Nazl Med Cardiol Osped, Res Ctr, Florence, Italy

[6] Univ Washington, Seattle, WA 98195 USA

[7] India Diabet Res Fdn, Chennai, Tamil Nadu, India

[8] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[9] Karolinska Inst, Dept Med K2, Cardiol Unit, Stockholm, Sweden

[10] Deventer Hosp, Dept Cardiol Res, Deventer, Netherlands

[11] Oslo Univ Hosp, Oslo, Norway

[12] Univ Oslo, Oslo, Norway

[13] Univ Guadalajara, Guadalajara 44430, Jalisco, Mexico

[14] Univ Cape Town, ZA-7925 Cape Town, South Africa

[15] Univ Leicester, Diabet Res Ctr, Leicester, Leics, England

[16] Univ Ottawa, Inst Heart, Ottawa, ON, Canada

[17] Inst Investc Biomed August Pi & Sunyer, Barcelona, Spain

[18] GWT TUD GmbH, Studyctr Prof Hanefeld, Dresden, Germany

[19] Frederiksberg Univ Hosp, Dept Cardiol & Endocrinol, Frederiksberg, Denmark

[20] Hanusch Krankenhaus Diabet Ambulanz, Mauerbach, Austria

[21] Semmelweis Univ, Hungarian Inst Cardiol, H-1085 Budapest, Hungary

[22] Univ La Frontera, Temuco, Chile

[23] Lady Davis Carmel Med Ctr, Haifa, Israel

[24] Fdn Oftalmol Santander FOSCAL, Bucaramanga, Colombia

[25] Univ Santander, Bucaramanga, Colombia

[26] Univ Sao Paulo, Fac Med Riberirao Preto, Ribeirao Preto, Brazil

[27] Grp Hosp Bichat Claude Bernad, AP HP, Paris, France

[28] Urol San Roman, Caracas, Venezuela

[29] Chinese Peoples Liberat Army Gen Hosp, Beijing 100853, Peoples R China

[30] Pauls Stradins Clin Univ Hosp, Ctr Endocrinol, Riga, Latvia

[31] Dallas Diabet & Endocrine Ctr Med City, Dallas, TX USA

[32] Univ Zurich Hosp, CH-8091 Zurich, Switzerland

[33] Connolly Hosp Blanchardstown, Diabet 3U, Dublin, Ireland

[34] Finnish Heart Assoc, Helsinki, Finland

[35] McGill Univ, Montreal, PQ, Canada

来源：

DIABETES CARE | 2016年 / 39卷 / 05期

关键词：

N-3; FATTY-ACIDS; ATRIAL-FIBRILLATION; GLUCOSE CONTROL; CLINICAL-TRIAL; BASAL INSULIN; FOLLOW-UP; DYSGLYCEMIA; DISEASE; PREVENTION;

D O I：

10.2337/dc15-1676

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high-cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years. RESEARCH DESIGN AND METHODS Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA(1c) persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94-1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97-1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88-1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88-1.09]; P = 0.68) or other outcomes. CONCLUSIONS During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.

引用

页码：709 / 716

页数：8

共 18 条

[1] n-3 polyunsaturated fatty acids and atrial fibrillation in patients with chronic heart failure: the GISSI-HF trial [J].