Table 1.
Serious cardiovascular adverse events and mortality associated with severe hypoglycemia in randomized controlled trials evaluating the effects of intensive or standard therapy in individuals with type 2 diabetes.
| Study | Population | HbA1c (intensive: standard/conventional group) | Incidence of Severe Hypoglycemia (intensive:standard/conventional group) | Overall hypoglycemiaglycemia Findings | hypoglycemiaglycemia-Related Intensive Group Findings | hypoglycemiaglycemia-Related Standard/Conventional Group Findings | ||
|---|---|---|---|---|---|---|---|---|
| DCCT/EDIC | 1441 T1DM patients | 7% | 9% | 65% | 35% | Increased hypoglycemia events. | ||
| UKPDS | 5102 T2DM patients | 7% | 7.9% | 1.1% | 0.7% | Low number of severe hypoglycemia events reported. | ||
| ACCORD | 10,251 T2DM patients- 62 y.o | 6.4% | 7.5% | 16.2% | 5.1% | Increased severe hypoglycemia events. Increased mortality with increased severe hypoglycemia. | Relatively increased mortality with severe hypoglycemia. | |
| ADVANCE | 11,140 T2DM patients- 66 y.o, | 6.5% | 7.3% | 2.7% | 1.5% | Increased cardiovascular adverse events with severe hypoglycemia. Decreased macrovascular and increased microvascular events with minor hypoglycemia. No dose response or temporal relation. | Increased hypoglycemia events. | Relatively increased mortality associated with severe hypoglycemia. |
| VADT | 1791 T2DM- 60 y.o, | 6.9% | 8.4% | 8.5% | 3.1% | Increased severe hypoglycemia events. Severe adverse cardiac events and mortality associated with severe hypoglycemia. | Relatively increased risk of mortality in standard/conventional group following severe hypoglycemia. | |
| Origin | 12,537 T2DM and pre-T2DM- 63 y.o, | 6.2% | 6.5% | 1.0% | 0.3% | Severe hypoglycemia-increased cardiovascular and total mortality | Increased severe and non-severe hypoglycemia events. | Increased relative risk of composite CV outcome, mortality, CV mortality and arrhythmic mortality |
| NICE-SUGAR | 6026 critically ill, ICU inpatients | 6.9% | 0.5% | Increased mortality with moderate hypoglycemia. Further increased mortality with severe hypoglycemia. | Increased severe hypoglycemia in standard group | |||
| ET2DS | 1066 T2DM patients- 68 y.o | 7.4% | Hypoglycemia associated with increased macrovascular, myocardial infarction and all adverse coronary heart events. | |||||