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Background  Previous reports have clearly indicated a significant relationship between hemoglobin (Hb) A 1c  change from one visit to the next and microvascular complications, especially nephropathy (albuminuria and albuminuric chronic kidney disease, CKD). In contrast, data on macrovascular disease are less clear. This study was aimed at examining the association of HbA 1c  variability with cardiovascular disease (CVD) in the large cohort of subjects with type 2 diabetes from the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study.    Methods  Serial (3–5) HbA 1c  values obtained during the 2-year period preceding recruitment, including that obtained at the enrolment, were available from 8,290 subjects from 9 centers (out of 15,773 patients from 19 centers). Average HbA 1c  and HbA 1c  variability were calculated as the intra-individual mean (HbA 1c -MEAN) and standard deviation (HbA 1c -SD), respectively, of 4.52±0.76 values. Prevalent CVD, total and by vascular bed, was assessed from medical history by recording previous documented major acute events. Diabetic retinopathy (DR) was assessed by dilated fundoscopy. CKD was defined based on albuminuria, as measured by immunonephelometry or immunoturbidimetry, and estimated glomerular filtration rate, as calculated from serum creatinine.    Results  HbA 1c -MEAN, but not HbA 1c -SD, was significantly higher ( P <0.0001) in subjects with history of any CVD (n. 2,133, 25.7%) than in those without CVD (n. 6,157, 74.3%). Median and interquartile range were 7.78 (7.04-8.56) and 7.49 (6.81-8.31), respectively, for HbA 1c -MEAN, and 0.47 (0.29-0.75) and 0.46 (0.28-0.73), respectively, for HbA 1c -SD. Logistic regression analyses showed that HbA 1c -MEAN, but not HbA 1c -SD (and independent of it), was a significant correlate of any CVD. Similar findings were observed in subjects with versus those without any coronary or cerebrovascular event or myocardial infarction. Conversely, none of these measures were associated with stroke, whereas both correlated with any lower limb vascular event and HbA 1c -SD alone with ulceration/gangrene. All these associations were independent of known CVD risk factors and microvascular complications (DR and CKD).    Conclusions  In patients with type 2 diabetes, HbA 1c  variability has not a major impact on macrovascular complications, at variance with average HbA 1c , an opposite finding as compared with microvascular disease, and particularly nephropathy.    Trial registration  ClinicalTrials.Gov  NCT00715481

cardiovascular diabetology

Hemoglobin A1c variability as an independent correlate of cardiovascular disease in patients with type 2 diabetes: a cross-sectional analysis of the Renal Insufficiency and Cardiovascular Events (RIACE) Italian Multicenter Study