Severe Hypoglycemia and Risks of Vascular Events and Death

Zoungas, Sophia; Patel, Anushka; Chalmers, John; Galan, Bastiaan E. de; Li, Qiang; Billot, Laurent; Woodward, Mark; Ninomiya, Toshiharu; Neal, Bruce; MacMahon, Stephen; Grobbee, Diederick E.; Kengne, André Pascal; Marre, Michel; Heller, Simon

doi:10.1056/nejmoa1003795

Cited by 1,288 publications

(1,079 citation statements)

References 29 publications

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“…ACCORD did not evaluate a direct effect of hypoglycaemia on risk of cardiovascular death or determine a definite reason for increased cardiovascular death among patients treated intensively. By contrast, the ADVANCE study found higher risk in patients who had an episode of severe hypoglycaemia for vascular events, cardiovascular death and death from any cause – and speculated such hypoglycaemia episodes could be only markers for susceptibility; any causative contribution of hypoglycaemia to risk of cardiovascular events remains uncertain 1, 13. More recent results from the SAVOR‐TIMI 53 study in patients with T2DM and renal impairment have shown an increase in hypoglycaemia and major cardiovascular events in patients with moderate but not severe renal impairment, potentially attributable to higher rates of concomitant medication use in the moderately impaired group 14…”

Section: Discussionmentioning

confidence: 99%

“…The ADVANCE investigators highlighted the potential contribution of confounding to their reported association13; however, a recent meta‐analysis which included data on six large observational studies involving >900 000 patients used a statistical approach – bias analysis – to show that confounding as a result of comorbid severe illness was unlikely to explain the whole association 5. The authors concluded that there was, in fact, a strong likelihood of a direct relationship between hypoglycaemic episodes and subsequent cardiovascular events.…”

Section: Discussionmentioning

confidence: 99%

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Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial

Heller

Bergenstal

White

et al. 2017

Diabetes Obesity Metabolism

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AimsTo investigate relationships between glycated haemoglobin (HbA1c) and reported hypoglycaemia and risk of major adverse cardiovascular events (MACE).MethodsThe EXAMINE trial randomized 5380 patients with type 2 diabetes (T2DM) and a recent acute coronary syndrome (ACS) event, in 49 countries, to double‐blind treatment with alogliptin or placebo in addition to standard of care. We used Cox proportional hazards models to analyse relationships among MACE, HbA1c levels and hypoglycaemic events.ResultsPatients randomized to alogliptin achieved lower HbA1c levels than the placebo group in all baseline HbA1c categories without differences in hypoglycaemia rates. No systematic change was found in MACE rates according to baseline HbA1c (P interaction = 0.971) or HbA1c category at 1 month. Patients in the combined treatment groups (n = 5380) who experienced serious hypoglycaemia (n = 34) had higher MACE rates than those who did not (35.3% vs 11.4%, adjusted hazard ratio [HR] 2.42, 95% confidence interval [CI] 1.27–4.60; P = .007), although the association was less strong when analysing only events after the hypoglycaemic event (adjusted HR 1.60, 95% CI 0.80, 3.20).ConclusionsThere were no relationships between baseline HbA1c levels or HbA1c levels after 1 month of treatment and the risk of MACE. Alogliptin improved glycaemic control without increasing hypoglycaemia. Reported events of hypoglycaemia and serious hypoglycaemia were associated with MACE. These data underscore the safety of alogliptin in improving glycaemic control in T2DM post‐ACS. Further study of hypoglycaemia as an independent risk factor for MACE in patients with T2DM and coronary disease is needed.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial

Heller

Bergenstal

White

et al. 2017

Diabetes Obesity Metabolism

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“…Similarly, hypoglycaemia may be life-threatening [4,5]. While hyperglycaemia is the characteristic feature of diabetes [3], patients with diabetes may also be susceptible to hypoglycaemia due to the nature of the disease [4] and treatment [6].…”

Section: Introductionmentioning

confidence: 99%

Blood glucose monitoring in type 2 diabetes – Nepalese patients’ opinions and experiences

Sapkota

Brien

Aslani

2017

Global Health Action

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Background: Blood glucose monitoring forms a vital component of diabetes care. Monitoring conducted at home using glucometers, and in laboratories by professionals, are two common methods of blood glucose monitoring in clinical practice. Objective: To investigate Nepalese patients’ perceptions and practices of blood glucose monitoring in diabetes. Methods: In-depth interviews were conducted with 48 Nepalese participants with type 2 diabetes in Sydney and Kathmandu. The interviews were audio-recorded, transcribed verbatim and thematically analysed. Results: In Australia, most participants perceived home monitoring as useful; and both home and laboratory monitoring were conducted at fairly regular intervals. In Nepal, only a small number conducted home monitoring and the laboratory method formed the primary method of day-to-day monitoring. The laboratory method was preferred due to easy access to laboratories, lack of faith in glucometers and perceptions that home monitoring is costlier. However, overall monitoring was irregular in Nepal. In addition to the healthcare system which enabled cheaper self-monitoring in Australia, Nepalese in Australia also tended to have a better understanding about the purpose of home monitoring. Conclusions: This study has highlighted the disparity in perceptions and practices related to blood glucose monitoring. Understanding the importance of blood glucose monitoring and access to affordable resources are critical facilitators for conducting regular monitoring. Both patient and health-system factors play a key role in ensuring continued diabetes monitoring and management.

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“…We screened 1273 citations and included 17 studies with a total of 1498358 participants in the meta-analysis (Bonds et al, 2010, Chiba et al, 2015, Duckworth et al, 2011, Hsu et al, 2013, Origin Trial Investigators et al, 2013, Johnston et al, 2012, Johnston et al, 2011, Khunti et al, 2015, Majumdar et al, 2013, McCoy et al, 2012, Rajpathak et al, 2015, Rathmann et al, 2013, Signorovitch et al, 2013, Zhao et al, 2012, Zoungas et al, 2010. The flow chart of the study selection in shown in the supplementary eFigure.…”

Section: Resultsmentioning

confidence: 99%

Meta-analysis: Association between hypoglycaemia and serious adverse events in older patients

Mattishent

Loke

2016

Journal of Diabetes and its Complications

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Aims:We aimed to conduct a meta-analysis of serious adverse events (macro-and micro-vascular events, falls and fractures, death) associated with hypoglycaemia in older patients. Methods:We searched MEDLINE and EMBASE spanning a ten-year period up to March 2015 (with automated PubMed updates to October 2015). We selected observational studies reporting on hypoglycaemia and associated serious adverse events, and conducted a meta-analysis. We assessed study validity based on ascertainment of hypoglycaemia, adverse events and adjustment for confounders. Conclusion:Our meta-analysis raises major concerns about a range of serious adverse events associated with hypoglycaemia. Clinicians should prioritize individualized therapy and closer monitoring strategies to avoid hypoglycaemia in susceptible older patients.

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Severe Hypoglycemia and Risks of Vascular Events and Death

Cited by 1,288 publications

References 29 publications

Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial

Relationship of glycated haemoglobin and reported hypoglycaemia to cardiovascular outcomes in patients with type 2 diabetes and recent acute coronary syndrome events: The EXAMINE trial

Blood glucose monitoring in type 2 diabetes – Nepalese patients’ opinions and experiences

Meta-analysis: Association between hypoglycaemia and serious adverse events in older patients

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