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Title: Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)
Authors: Punthakee, Zubin
Gerstein, Hertzel C.
Bosch Pagans, Jordi
Tyrwhitt, Jessica
Jung, Hyejung
Lee, Shun Fu
Lonn, Eva
Marsden, Tamara
McKelvie, Robert
McQueen, Matthew J.
Morillo, Carlos
Yusuf, Shazzid
Dagenais, Gilles
Diaz, Rafael
Maggioni, Aldo P.
Probstfield, Jeffrey
Ramachandran, Ambady
Riddle, Matthew C.
Rydén, Lars
Badings, Erik
Birkeland, Kare
Cardona Munoz, Ernesto G.
Commerford, Patrick
Davies, Melanie
Fodor, George J.
Gomis, Ramon
Hanefeld, Markolf
Hildebrandt, Per
Kacerovsky Bielesz, Gertrud
Keltai, Matyas
Lanas, Fernando
Lewis, Basil S.
López Jaramillo, Patricio
Marin Neto, Jose Antonio
Marre, Michel
Mendoza, Ivan
Pan, Chun yue
Pirags, Valdis
Rosenstock, Julio
Spinas, Giatgen A.
Sreenan, Seamus
Syvänne, Mikko
Yale, Jean Francois
ORIGIN Trial Investigators
Issue Date: May-2016
Abstract: 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 HbA1c 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.
Description: 8 p.
ISBN: 0149-5992
ISSN: 1935-5548
Appears in Collections:DCABA. Artículos de Investigación

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