Health-related quality of life associated with daytime and nocturnal hypoglycaemic events: a time trade-off survey in five countries

London, ON
Health and Quality of Life Outcomes (Impact Factor: 2.1). 06/2013; 11(1):90. DOI: 10.1186/1477-7525-11-90
Source: PubMed

ABSTRACT Background
Hypoglycaemic events, particularly nocturnal, affect health-related quality of life (HRQoL) via acute symptoms, altered behaviour and fear of future events. We examined the respective disutility associated with a single event of daytime, nocturnal, severe and non-severe hypoglycaemia.

Representative samples were taken from Canada, Germany, Sweden, the United States and the United Kingdom. Individuals completed an internet-based questionnaire designed to quantify the HRQoL associated with different diabetes- and/or hypoglycaemia-related health states. HRQoL was measured on a utility scale: 1 (perfect health) to 0 (death) using the time trade-off method. Three populations were studied: 8286 respondents from the general population; 551 people with type 1 diabetes; and 1603 with type 2 diabetes. Respondents traded life expectancy for improved health states and evaluated the health states of well-controlled diabetes and diabetes with non-severe/severe and daytime/nocturnal hypoglycaemic events.

In the general population, non-severe nocturnal hypoglycaemic events were associated with a 0.007 disutility compared with 0.004 for non-severe daytime episodes, equivalent to a significant 63% increase in negative impact. Severe daytime and nocturnal events were associated with a 0.057 and a 0.062 disutility, respectively, which were not significantly different.

This study applies an established health economic methodology to derive disutilities associated with hypoglycaemia stratified by onset time and severity using a large multinational population. It reveals substantial individual and cumulative detrimental effects of hypoglycaemic events – particularly nocturnal – on HRQoL, reinforcing the clinical imperative of avoiding hypoglycaemia.

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    ABSTRACT: Introduction This study aimed to assess the costs and benefits of three alternative second-line treatment strategies for Swedish patients with type 2 diabetes mellitus (T2DM) who fail to reach glycated hemoglobin (HbA1c) ≤ 7% with metformin treatment alone: glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and neutral protamine Hagedorn (NPH) insulin. Methods A previously developed cohort model for T2DM was applied over a 35-year time horizon. Data on T2DM patients on metformin monotherapy with HbA1c > 7% were collected from the Swedish National Diabetes Register. Treatment effects were taken from published studies. Costs and effects were discounted at 3% per annum, and the analysis was conducted from a societal perspective. The robustness of the results was evaluated using one-way and probabilistic sensitivity analyses. Results Treatment with GLP-1 agonists was associated with a discounted incremental benefit of 0.10 and 0.25 quality-adjusted life years (QALYs) and higher discounted costs of Swedish Krona (SEK) 34,865 and SEK 40,802 compared with DPP-4 inhibitors and NPH insulin, respectively. Assuming willingness-to-pay (WTP) of SEK 500,000 per QALY, treatment strategy with GLP-1 agonists was a cost-effective option with incremental cost-effectiveness ratios of SEK 353,172 and SEK 160,618 per QALY gained versus DPP-4 inhibitors and NPH insulin, respectively. The results were most sensitive to incidence rate of moderate/major hypoglycemia and disutilities associated with insulin treatment, body mass index (BMI), and hypoglycemia. Conclusion Assuming a WTP of SEK 500,000 per QALY, treatment strategy with GLP-1 agonists is a cost-effective strategy in comparison to DPP-4 inhibitors and NPH insulin among T2DM patients inadequately controlled with metformin alone in a Swedish setting.
    Diabetes Therapy 09/2014; 5(2):591-607. DOI:10.1007/s13300-014-0080-0
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    Journal of Medical Economics 08/2014; DOI:10.3111/13696998.2014.959590
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    ABSTRACT: Glycemic control remains the major therapeutic objective to prevent or delay the onset and progression of complications related to diabetes mellitus. Insulin therapy represents a cornerstone in the treatment of diabetes and has been used widely for achieving glycemic goals. Nevertheless, a large portion of the population with diabetes does not meet the internationally agreed glycemic targets. Moreover, insulin treatment, especially if intensive, may be associated with emergency room visits and hospitalization due to hypoglycemic events. Therefore, fear of hypoglycemia or hypoglycemic events represents the main barriers to the attainment of glycemic targets. The burden associated with multiple daily injections also remains a significant obstacle to initiating and maintaining insulin therapy. The most attractive insulin treatment approach should meet the patients' preference, rather than demanding patients to change or adapt their lifestyle. Insulin degludec/insulin aspart (IDegAsp) is a new combination, formulated with ultra-long-acting insulin degludec and rapid-acting insulin aspart, with peculiar pharmacological features, clinical efficacy, safety, and tolerability. IDegAsp provides similar, noninferior glycemic control to a standard basal-bolus regimen in patients with type 1 diabetes mellitus, with additional benefits of significantly lower episodes of hypoglycemia (particularly nocturnal) and fewer daily insulin injections. Moreover, although treatment strategy and patients' viewpoint are different in type 1 and type 2 diabetes, trial results suggest that IDegAsp may be an appropriate and reasonable option for initiating insulin therapy in patients with type 2 diabetes inadequately controlled on maximal doses of conventional oral agents. This paper will discuss the role of IDegAsp combination as a novel treatment option in diabetic patients.
    Vascular Health and Risk Management 08/2014; 10:465-475. DOI:10.2147/VHRM.S40097

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