Review of Evidences
Contemporary sedentary lifestyle and behavioral trends coupled with increased life expectancy profoundly have influenced the rise in type 2 diabetes and its complications in last four decades. Both micro-vascular and macro-vascular complications contribute to death and disability in type 2 diabetes and both are associated with elevated blood glucose levels. Thus, glycemic control remains a crucial first step for reducing the risk of these complications.
There is a plethora of evidence to suggest that intensive therapy with the goal of achieving euglycemia should be implemented as early as possible in patients with either type 1 or type 2 diabetes. Additionally, it is generally agreed that the Glycosylated hemoglobin (HbA1c) goal should be <7%. The Diabetes Control and Complications Trial (DCCT) and the Stockholm Diabetes Intervention Study (SDIS) showed that intensive therapy significantly reduced the incidence and progression of micro-vascular complications in patients with type 1 diabetes.[1,2] The United Kingdom Prospective Diabetes Study (UKPDS) and the Kumamoto study determined that stricter glycemic control could be useful in delaying the onset and progression of diabetic micro-vascular and possibly the macro-vascular complications as well in patients with type 2 diabetes.[3,4]
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While the need for intensive management is clear and while so many therapeutic advances have been made, are we actually reaching these target HbA1c levels in clinical practice? The answer is a clear no as evidenced by numerous epidemiological studies showing that majority of patients in real life clinical setting, at any given point of time, are not on glycemic target. Risk of hypoglycemia is a reason often cited for not achieving the glycemic goals. This argument can actually be backed with evidences from the same studies that demonstrated reduced risk of complication with intensive glycemic control. The DCCT reported a three-fold increase in severe hypoglycemia with intensive versus conventional therapy during the trial.[5] In fact, a continuous curvilinear relation between glycemic control and incidence of hypoglycemia has been observed in DCCT [Figure 1].[1] The SDIS showed a 2.5 times greater incidence of severe hypoglycemia among intensively treated patients.[2] Similarly, for patients with type 2 diabetes, it was observed in the UKPDS study that the proportion of patients with one or more major, or any, hypoglycemic episode in a year was significantly higher in the intensive group than in the conventional group [Figure 2]. By intention-to-treat analyses, major hypoglycemic episodes occurred with Chlorpropamide (1.0%), Glibenclamide (1.4%), Insulin (1.8%), and diet (0.7%) and any hypoglycemic episodes in 16, 21, 28 and 10%, respectively.[3] A continuous curvilinear relation between glycemic control and incidence of hypoglycemia, similar to that observed in DCCT, has also been observed in a meta-analysis of 11 sponsored randomized trials comparing Insulin Glargine and Insulin Neutral Protamine Hagedorn (NPH) in patients with type 1 or type 2 diabetes.[6]
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The risk of hypoglycemia increases with absolute or relative insulin excess (caused by exogenous insulin or agents that increase insulin secretion) or compromised glucose regulation.[7] In the earlier stages of type-2 diabetes when glucose counter-regulatory responses are still functional, hypoglycemia is less common than in patients with type 1 diabetes. However, since progressive β-cell failure is a key patho-physiological feature of type 2 diabetes, the characteristics of disease and frequency of hypoglycemic episodes eventually approach that of type 1 diabetes.[8]
The clinical implications of hypoglycemia stems from the fact that it has been considered as the most important limiting factor in the glycemic management of patients with diabetes and a significant barrier in terms of adherence to medication and achievement of the life-long goal to attain euglycemia. It has further been suggested that the presence (or fear) of hypoglycemia can limit the aggressiveness of drug therapy to achieve reduction of micro-and macro-vascular complications, decrease adherence to diet and reduce patients’ willingness to take medications as directed. Additionally, hypoglycemia causes recurrent morbidity in many patients with type 2 diabetes, worsens their quality of life and is sometimes fatal. It also impairs defenses against subsequent hypoglycemia because of autonomic failure (Hypoglycemia Associated Autonomic Failure) and has even been causally linked to neuro-cognitive deterioration and detrimental changes in cardiac electro-physiology. Attempts have been made to quantify the economic burden of hypoglycemia as well, though this varies from country to country as estimates will be affected by factors such as the prevalence of hypoglycemia; classifications of hypoglycemic events; patient characteristics; knowledge and attitudes to hypoglycemic events; and varying quality and implementation of care across different healthcare systems.[7,9]
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