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Progression of glucose-lowering diabetes therapy in TECOS.

ABSTRACT: Aims:TECOS was a randomized, double-blind, placebo-controlled trial assessing the impact of sitagliptin vs. placebo on cardiovascular outcomes when added to usual care in patients with type 2 diabetes. We report the use of concomitant diabetes medications and the risk for progression to insulin during follow-up. Materials and Methods:TECOS enrolled 14 671 participants with HbA1c 6.5%-8.0% on monotherapy with metformin, pioglitazone, sulfonylurea (SU), or dual therapy with two oral agents or insulin with or without metformin. Subsequent diabetes management was by the participant's usual care physician. Time to initiation of insulin and risk of hypoglycaemia were estimated using Cox proportional hazards models. Results:The most common glucose-lowering regimens at baseline were metformin monotherapy (30.2%), SU monotherapy (8.5%), metformin/SU therapy (35.1%), and insulin with or without metformin (13.9% and 8.6%, respectively). Over a median 3.0 years' follow-up, diabetes therapy was intensified in 25.2% of participants (sitagliptin 22.0%, placebo 28.3%). Medications most commonly added were SU (8.3%) or insulin (8.8%). Insulin initiation in the usual care setting occurred at mean (standard deviation) HbA1c of 8.5 (1.5)%. Sitagliptin did not impact rates of severe hypoglycaemia, but delayed progression to insulin when added to metformin or metformin/SU regimens. Conclusion:Consistent with the trial's pragmatic design, TECOS participants underwent typical progression of diabetes medications. Sitagliptin was associated with lower HbA1c, without increased risk for severe hypoglycaemia and was associated with delayed progression to insulin when added to metformin with or without SU.

SUBMITTER: Bethel MA

PROVIDER: S-EPMC6354756 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Progression of glucose-lowering diabetes therapy in TECOS.

Bethel M Angelyn MA Engel Samuel S SS Stevens Susanna R SR Lokhnygina Yuliya Y Ding Jie J Josse Robert G RG Alvarsson Michael M Hramiak Irene I Green Jennifer B JB Peterson Eric D ED Holman Rury R RR

Endocrinology, diabetes & metabolism 20181222 1

<h4>Aims</h4>TECOS was a randomized, double-blind, placebo-controlled trial assessing the impact of sitagliptin vs. placebo on cardiovascular outcomes when added to usual care in patients with type 2 diabetes. We report the use of concomitant diabetes medications and the risk for progression to insulin during follow-up.<h4>Materials and methods</h4>TECOS enrolled 14 671 participants with HbA1c 6.5%-8.0% on monotherapy with metformin, pioglitazone, sulfonylurea (SU), or dual therapy with two oral ...[more]

PMID: 30815579

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Project description:Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors.In this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up.At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001).As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)

Project description:BACKGROUND:Glucose-lowering therapy (GLT) should be individualized in older patients with type 2 diabetes (T2D) according to their health status and their life expectancy. This study aimed at assessing the inappropriateness of GLT prescribing and the one-year mortality rate in geriatric patients with T2D. METHODS:Retrospective cohort study of consecutive inpatients with T2D admitted to a geriatric ward of a Belgian university hospital. Inclusion criteria were age???75?years, T2D with GLT before admission, and HbA1c measurement during the hospital stay. Comorbidities and geriatric syndromes were collected. GLT agents were classified into hypoglycaemic and non-hypoglycaemic ones, and their dosages were expressed in daily defined dose (DDD). Health status (intermediate or poor) and GLT appropriateness (appropriate, overtreatment, undertreatment) were assessed according to the 2019 Endocrine Society guideline on diabetes treatment in older adults, in which GLT overtreatment requires the presence of hypoglycaemic therapy. One-year mortality was determined using the National Registry of vital status, and its associated factors were analysed using multivariable Cox' regression. RESULTS:The 318 geriatric patients with T2D (median age 84?years; 46% female) were in intermediate (33%) or poor health (67%). These two groups reached similar low HbA1c values (median 6.9%) with similar GLT regimens. GLT overtreatment was frequent (57%) irrespectively of the geriatric features. One-year mortality rate was high (38.5%) and associated in multivariate analysis with poor health status (HR: 1.59, p?=?0.033), malnutrition (HR: 1.67, p?=?0.006) and GLT overtreatment (HR: 1.73, p?=?0.023). Patients with GLT overtreatment had a higher mortality rate (44.5%). CONCLUSIONS:GLT overtreatment was present in more than half of these geriatric patients. Many of them were in poor health status and died within one-year. Special attention should be paid to individualisation of the HbA1c goals in the geriatric patients with diabetes, and to GLT de-intensification in those being over-treated.

Project description:ObjectiveTo estimate the contemporary prevalence of intensive glucose-lowering therapy among US adults with diabetes and model the number of hypoglycemia-related emergency department (ED) visits and hospitalizations that are attributable to such intensive treatment.Patients and methodsUS adults with diabetes and glycated hemoglobin (HbA1c) levels less than 7.0% who were included in the National Health and Nutrition Examination Survey (NHANES) between 2011 and 2014. Participants were categorized as clinically complex if 75 years or older or with 2 or more activities of daily living limitations, end-stage renal disease, or 3 or more chronic conditions. Intensive treatment was defined as any glucose-lowering medications with HbA1c levels of 5.6% or less or 2 or more with HbA1c levels of 5.7% to 6.4%. First, we quantified the proportion of clinically complex and intensively treated individuals in the NHANES population. Then, we modeled the attributable hypoglycemia-related ED visits/hospitalizations over a 2-year period based on published data for event risk.ResultsAlmost half (48.8% [10,719,057 of 21,980,034]) of US adults with diabetes (representing 10.7 million US adults) had HbA1c levels less than 7.0%. Among them, 32.3% (3,466,713 of 10,719,057) were clinically complex, and 21.6% (2,309,556 of 10,719,057) were intensively treated, with no difference by clinical complexity. Over a 2-year period, we estimated 31,511 hospitalizations and 30,954 ED visits for hypoglycemia in this population; of these, 4774 (95% CI, 954-9714) hospitalizations and 4804 (95% CI, 862-9851) ED visits were attributable to intensive treatment.ConclusionIntensive glucose-lowering therapy, particularly among vulnerable clinically complex adults, is strongly discouraged because it may lead to hypoglycemia. However, intensive treatment was equally prevalent among US adults, irrespective of clinical complexity. Over a 2-year period, an estimated 9578 hospitalizations and ED visits for hypoglycemia could be attributed to intensive diabetes treatment, particularly among clinically complex patients. Patients at risk for hypoglycemia may benefit from treatment deintensification to reduce hypoglycemia risk and treatment burden.

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Progression of glucose-lowering diabetes therapy in TECOS.

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Progression of glucose-lowering diabetes therapy in TECOS.

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