Care of patients with diabetes mellitus is kept to a minimum the risk of microvascular and macrovascular complications, maintaining normal blood pressure, lipid profile and blood glucose.
Glycemic control is to maintain glycosylated hemoglobin (HbA1c) between normal limitted, because we know that good glycemic control reduces the long-term risk of microvascular complications in both types of diabetes, 1 and 2. Researchers at ADVANCE and ACCORD studies examined the effect of glycemic control on the evolution of patients with type 2 diabetes and macrovascular and microvascular disease. Both studies failed to demonstrate that good glycemic control is associated with reduced cardiovascular risk.
Reports of a potential increase in mortality rates associated with intensive glycemic control resulted in a debate on the recommendations for the treatment of type 2 diabetes, specifically aiming to establish an optimal HbA1c. Researchers have suggested that in diabetics, hypoglycemia is a possible increased risk of mortality. Because intensive glycemic control increases the risk of hypoglycemia, with some drugs than with others, it is important to assess the risks associated with the various schemes to lower blood sugar. In two meta-analysis, researchers pooled data from several major works and concluded that intensive glycemic control has a positive effect on cardiovascular outcomes. However, these meta-analysis were limited by the limitations of clinical trials analyzed.
In this retrospective cohort study, the objective was to evaluate the association between mortality from all causes and HbA1c in type 2 diabetic patients seen at primary care and establish the existence of any apparent association that was independent of treatment regimen diabetes.
Test of HbA1c of approximately 7.5% was associated with lower mortality from all causes and a lower progression to disease events of the great vessels. An increase or decrease the lower value of HbA1c was associated with increased risk of adverse outcomes. The lower pattern is the association of risk was sufficiently similar in both treatment groups as to suggest that the risk of mortality for HbA1c was independent of treatment regimen. On the other hand, observed that the risk of mortality in two cohorts of treatment was different, showing that treatment with insulin was associated with higher mortality. This pattern of association remained consistent with time-dependent HbA1c as a covariate. The results, say, support the evidence of the ACCORD study. In this study, the results showed that mortality increased (RR 1.22, 95% CI 1.01 -1 46) in patients with cardiovascular disease or had at least two risk factors for cardiovascular disease or atherosclerosis severe and HbA1c 7.5%, subject to intensive glycemic control (target HbA1c <6.0% vs. 7.0 -7 * 9%). However, these data are in contradiction with the monitoring data from the UK Prospective Diabetes Study (UKPDS) showed that intensive treatment was associated with a reduced risk for all outcomes related to diabetes. However, less than 15% of UKPDS patients achieved an HbA1c level below 6.5%.
The results of the initial phase of the UKPDS randomization showed a significant reduction in relative risk of myocardial infarction of 14% for every 1% reduction HbA1c.Los results of this analysis confirmed a weak association between HbA1c and reduced risk of sick pictures of the great vessels, with HbA1c values above 7.5%, but, unlike the results of the UKPDS, we found an increased mortality to a level of HbA1c less than 6.5 % in patients with and without large vessel disease recorded.
THE ADVANCE study evaluated the effects of intensive control of blood pressure and blood sugar (HbA1c HbA1c <7.5%) on micro and macrovascular complications in patients treated with oral hypoglycemic regimens. After an average of 5 years of follow up, a good glycemic control was associated with less frequent microvascular events, but not macrovascular events. Improved glycemic control was not associated with higher mortality. The difference between the observations of the ADVANCE study and this work could be partly due to statistical power issues, a low cardiovascular risk profile in the ADVANCE study or, as the authors, their results are not representative.
Both the ACCORD study and the Veterans Affairs study raised reservations about the safety for patients with type 2 diabetes receiving intensive insulin therapy. Moreover, the study’s researchers EDIC (Epidemiology of Diabetes Interventions and Complications) of patients with type 1 diabetes reported cardiovascular benefits in patients with intensive glycemic control, but not in those with evidence of less than 6.5% HbA1c . The mechanisms that could explain this finding is unknown. The first reports of the ACCORD trial were unable to identify the causes of death among both groups studied, mortality rates were higher for the extreme values of HbA1c, regardless of treatment regimen and some cardiovascular risk factors. The decrease in survival in patients achieving low percentages of the average HbA1c could be related to hypoglycemia, a common complication of intensive control of blood glucose. In this study, patients with severe hipooglucemia mortality was 3 times higher than those who did not experience severe hypoglycemia, both in patients treated conventionally and intensively. Moreover, in the Veterans Affairs study, the occurrence of more than 1 episode of severe hypoglycemia was associated with an increase of 88% of the risk of sudden death.
Hypoglycemia is associated with different consequences. For example, a relationship between the manifestations of sympathomimetic (adrenergic) or hypokalemic of hypoglycemia and the onset of cardiac arrhythmia, including long QT syndrome in diabetic patients with established cardiovascular disease. Intensive glycemic control associated with hypoglycemia may enhance the variability of glucose, which contributes to oxidative stress and vascular inflammation. This result may predispose to atherosclerotic plaque destabilization and vascular disfuncióln.
The lower survival in the group treated with insulin may be that insulin may increase the risk of mortality in patients with type 2 diabetes. Margolis et al. reported that the use of insulin is associated with an increased risk of serious ischemic cardiac complications. One possible explanation, as it is derived from an evaluation conducted diabetics undergoing coronary bypass surgery is that the insulin-treated patients were older and had more comorbidities as well as a longer duration of diabetes patients in group treated with oral hypoglycemic agents. In this study, the reference frequency of comorbidities such as renal failure was greater in those who used insulin. There was no evidence to support the idea that insulin has a direct toxic effect in patients with type 2 diabetes without cardiovascular disease or autonomic, however, this disorder has been reported the existence of a link between insulin use and progression and mortality of cancer.
The authors state that differences between cohorts at baseline could have affected the results. Compared with patients in group 1, more patients in group 2 had experienced a prior cardiovascular table and had a creatinine greater than 1.50 mg/100 ml. Tables previous cardiovascular and renal initial cardiovascular risk factors that herald poor outcomes in patients with atherosclerosis or diabetes. However, when we excluded patients without documented the large vessels, the Cox analysis showed that those treated with insulin had an increased risk of macrovascular disease progression than patients treated with oral agents combined.
In this study, adjustments were made for different morbidities between cohorts and gave a detailed sensitivity analysis comparing the two cohorts, as the adjustment of duration of diabetes. The differences in survival and the frame rate of disease of large vessels between the cohorts persisted under all conditions of analysis. For the authors, another plausible idea is that the causes of death and the underlying pathology in the extreme values of HbA1c were of different categories among the study’s limitations CPRD mentions that collects data from routine practice, therefore Some data is lost, there may be imperfections in encoding and HbA1c determinations are not standardized.
The normal range of HbA1c vary among centers and biochemical determinations could have been done with different periodicity. By using techniques such as linear interpolation of values, the authors measured the total exposure to the risk parameters unreliable. The variability in the frequency of the measurement of HbA1c could have created a bias. However, the bias was tested by three different methods and findings remain the same. Moreover, the study was not randomized. Although standardized when possible confounding factors recognized, it is possible that some effects have not yet been detected. Also you may not have appeared other confounding factors because other variables that might have been important were not recorded or included in the model. In addition, HbA1c groups differed systematically, although the survival models may have taken account of some of these differences.
As for the details of the cause of death, they were considered too imprecise to be informed and in this study. No data are available to characterize ethnic origin. Other limitations are that its not made a separate analysis of cases to assess the duration of response or the effect of severe hypoglycemia in mortality due to insufficient data. One possible source of confusion was the difference in prescription rates for cardiovascular prophylaxis in deciles of HbA1c. Although these data are not shown, the researchers concluded that patients with higher HbA1c received less treatment for cardiovascular prophylaxis.
The decision by the authors to include cases of dual membership cohort is an argument that can influence litigation for and against. Although this factor could have introduced bias into the study, the authors made a sensitivity analysis by introducing an indicator covariance members of both groups for the parameter of insulin regimen. These data, therefore, still need to be interpreted with caution. However, the large number of patients represents what actually took place in clinical practice. Given these limitations, the authors say, “We believe that the resultant force of our evidence suggests that this association is reliable, although these findings need further confirmation.” “Our study, together with evidence of ACCORD, could have important implications care of people with type 2 diabetes. Both in our data and the ACCORD study findings, these results are applicable to type 1 diabetic patients is unclear and needs to be investigated. “These data imply that for a broad range of HbA1c, combined oral treatment is safe with respect to mortality from all causes and pictures of the great vessels, but for insulin-based therapy, it is desirable to establish tighter limits. This involvement does not mean that there is unquestionable value in achieving the current glycemic targets to reduce microvascular disease. Still require more research and evaluation of overall risk assessment to determine whether intensification of glycemic control by insulin therapy increases the risk of death in the dibéticos. The findings suggest that it may be necessary to revise the guidelines for diabetes and include a definition of a minimum value of HbA1c.
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Tags: diabetes, diabetes type II, diabetics, drugs, medicine, obesity
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