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Effects of intensive glucose lowering in type 2 diabetes.
, et al. · 2008
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📉 Lavora su: Stabilità nel tempo · lente Traiettoria · il corpo nel tempo
tocca anche 🛡️ Protezione d'organo💊 Terapia
RCT (prova forte)
La domandaNel diabete di tipo 2 ad alto rischio cardiovascolare, un controllo glicemico intensivo (target HbA1c <6,0%) riduce gli eventi cardiovascolari?
Cosa hanno trovatoRCT (ACCORD), 10.251 pazienti (eta media 62,2 anni; HbA1c mediana basale 8,1%; 38% donne; 35% con pregresso evento CV) randomizzati a terapia intensiva (target HbA1c <6,0%) vs standard (7,0-7,9%). A 1 anno HbA1c mediana 6,4% (intensivo) vs 7,5% (standard). Esito primario (IMA non fatale, ictus non fatale o morte cardiovascolare): 352 vs 371 eventi, HR 0,90 (IC 95% 0,78-1,04; P=0,16), non significativo. Mortalita totale: 257 (intensivo) vs 203 (standard), HR 1,22 (IC 95% 1,01-1,46; P=0,04): mortalita aumentata nel braccio intensivo. Ipoglicemia richiedente assistenza e aumento di peso >10 kg piu frequenti con la terapia intensiva (P<0,001). Il braccio intensivo e stato interrotto dopo una media di 3,5 anni per l'eccesso di mortalita.
Cosa significa per teRiguarda il tipo 2 ad alto rischio cardiovascolare. Spingere l'HbA1c verso valori quasi normali non ha ridotto gli eventi cardiovascolari e ha aumentato la mortalita e le ipoglicemie gravi: piu basso non e automaticamente meglio. Il target glicemico va individualizzato dal diabetologo in base a eta, durata di malattia e rischio di ipoglicemia. Prova forte (grande RCT interrotto per danno).
Abstract (in lingua originale)
BACKGROUND: 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 had 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, 257 patients 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 3.5 years 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.gov number, NCT00000620.)
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Come leggerlo: è uno studio scientifico peer-reviewed. Le evidenze aiutano a capire i trend, ma un singolo studio non è una prescrizione: parlane col tuo diabetologo prima di cambiare dieta o terapia.