Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2?
Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who...
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Sociedad Médica de Santiago
2009
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oai:scielo:S0034-988720090011000202010-01-13Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2?Rivera M,SolangeUribe-San Martín,ReinaldoBelmar N,NicolásPérez l,AlfonsoEpidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who laid either established cardiovascular disease or additional cardiovascular risk factors. Methods: In this randomized study 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. Results: At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). Conclusions: As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.govnumber, NCT00000620.).info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.137 n.11 20092009-11-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009001100020es10.4067/S0034-98872009001100020 |
| institution |
Scielo Chile |
| collection |
Scielo Chile |
| language |
Spanish / Castilian |
| description |
Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who laid either established cardiovascular disease or additional cardiovascular risk factors. Methods: In this randomized study 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. Results: At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001). Conclusions: As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.govnumber, NCT00000620.). |
| author |
Rivera M,Solange Uribe-San Martín,Reinaldo Belmar N,Nicolás Pérez l,Alfonso |
| spellingShingle |
Rivera M,Solange Uribe-San Martín,Reinaldo Belmar N,Nicolás Pérez l,Alfonso Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| author_facet |
Rivera M,Solange Uribe-San Martín,Reinaldo Belmar N,Nicolás Pérez l,Alfonso |
| author_sort |
Rivera M,Solange |
| title |
Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| title_short |
Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| title_full |
Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| title_fullStr |
Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| title_full_unstemmed |
Análisis crítico de un artículo: El tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| title_sort |
análisis crítico de un artículo: el tratamiento hipoglicemiante intensivo ¿reduce los eventos cardiovasculares o la mortalidad en diabéticos tipo 2? |
| publisher |
Sociedad Médica de Santiago |
| publishDate |
2009 |
| url |
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872009001100020 |
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