Severe hypoglycemia, CV events share ‘bidirectional relationship’
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Adults with type 2 diabetes are at increased risk for severe hypoglycemia after a cardiovascular event and also are at increased risks for cardiovascular events following severe hypoglycemia, indicating a bidirectional relationship between severe hypoglycemia and CV events for this population, according to findings published in Diabetes Care.
“Our study helps to better recognize those with type 2 diabetes at high dual risk of severe hypoglycemia and CV events. This is of high clinical importance, as they need special attention. On the one hand, one needs to deal with the complex comorbidities, on the other hand one has to reconsider the often high doses or even the use of insulin therapy, as there might be now alternate treatment options,” Eberhard Standl, MD, PhD, chairman and professor of medicine at the Diabetes Research Group e.V. at Munich Helmholtz Centre in Neuherberg, Germany, and colleagues wrote. “A striking new finding was the confirmation of the equivalence between those with severe hypoglycemia first and those with CV event first — bidirectional relationship between CV events and severe hypoglycemia."
Standl and colleagues analyzed data on the number of severe hypoglycemic events and CV events, including MI, stroke, all-cause mortality, CV death, acute coronary syndrome hospitalization and heart failure hospitalization, at baseline, 1 week, 2 months, 6 months and 12 months as well as at semiannual visits over 3.2 years of median follow-up time from 14,752 adults with type 2 diabetes who participated in the EXSCEL trial. The trial compared a 2 mg weekly dose of exenatide with placebo via random assignment.
Participants who took exenatide (Bydureon, AstraZeneca) experienced 1.6 severe hypoglycemia events per 100 patient-years and those who took placebo experienced 1.8 severe hypoglycemic events per 100 patient-years, according to the researchers, who noted that “severe hypoglycemic events were relatively uncommon and not associated with once-weekly exenatide therapy.” In total, 466 participants experienced a severe hypoglycemic event (mean age, 63 years; 38.8% women) while the remaining 14,286 did not experience such an event (mean age, 62 years; 38% women).
Following a severe hypoglycemic event, HRs were 1.6 (95% CI, 1.11-2.3) for CV death, 1.83 (95% CI, 1.38-2.42) for all-cause mortality and 2.09 (95% CI, 1.37-3.17) for heart failure hospitalization, compared with no hypoglycemic event.
The researchers also found that the HRs for a severe hypoglycemic event were 2.04 following MI or stroke (95% CI, 1.42-2.93), 2.02 following MI alone (95% CI, 1.35-3.01), 2.3 following stroke alone (95% CI, 1.25-4.23), 3.24 following hospitalization for HF (95% CI, 1.98-5.3) and 2 following hospitalization for acute coronary syndrome (95% CI, 1.39-2.9).
The researchers further noted that these “elevated hazards … were approximately constant over time.”
“Our results based on the largest sample of people with type 2 diabetes at dual risk for severe hypoglycemia and CV events seem to suggest a new treatment algorithm of first singling out the minority of those at high dual risk of both CV and severe hypoglycemic events and providing them with the appropriate complex care,” Standl said. “For the others, diabetes therapy and personalized treatment targets should not be unduly compromised to assure the best possible outcome longer term.” – by Phil Neuffer
For more information:
Eberhard Standl, MD, PhD, can be reached at eberhard.standl@lrz.uni-muenchen.de.
Disclosures: Amylin Pharmaceuticals funded the EXSCEL trial. Standl reports he has received personal fees from Bayer, Berlin Chemie, Boehringer Ingelheim, Menarini, Merck Serono, Novartis, Novo Nordisk and Sanofi. Please see the study for all other authors’ relevant financial disclosures.
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