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Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program).pdf (1.51 MB)

Vascular complications in patients with type 2 diabetes: prevalence and associated factors in 38 countries (the DISCOVER study program).

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posted on 2019-09-09, 15:04 authored by M Kosiborod, MB Gomes, A Nicolucci, S Pocock, W Rathmann, MV Shestakova, H Watada, I Shimomura, H Chen, J Cid-Ruzafa, P Fenici, N Hammar, F Surmont, F Tang, K Khunti, DISCOVER investigators
BACKGROUND: The global prevalence of type 2 diabetes-related complications is not well described. We assessed prevalence of vascular complications at baseline in DISCOVER (NCT02322762; NCT02226822), a global, prospective, observational study program of 15,992 patients with type 2 diabetes initiating second-line therapy, conducted across 38 countries. METHODS: Patients were recruited from primary and specialist healthcare settings. Data were collected using a standardized case report form. Prevalence estimates of microvascular and macrovascular complications at baseline were assessed overall and by country and region, and were standardized for age and sex. Modified Poisson regression was used to assess factors associated with the prevalence of complications. RESULTS: The median duration of type 2 diabetes was 4.1 years (interquartile range [IQR]: 1.9-7.9 years), and the median glycated hemoglobin (HbA1c) level was 8.0% (IQR: 7.2-9.1%). The crude prevalences of microvascular and macrovascular complications were 18.8% and 12.7%, respectively. Common microvascular complications were peripheral neuropathy (7.7%), chronic kidney disease (5.0%), and albuminuria (4.3%). Common macrovascular complications were coronary artery disease (8.2%), heart failure (3.3%) and stroke (2.2%). The age- and sex-standardized prevalence of microvascular complications was 17.9% (95% confidence interval [CI] 17.3-18.6%), ranging from 14.2% in the Americas to 20.4% in Europe. The age- and sex-standardized prevalence of macrovascular complications was 9.2% (95% CI 8.7-9.7%), ranging from 4.1% in South-East Asia to 18.8% in Europe. Factors positively associated with vascular complications included age (per 10-year increment), male sex, diabetes duration (per 1-year increment), and history of hypoglycemia, with rate ratios (95% CIs) for microvascular complications of 1.14 (1.09-1.19), 1.30 (1.20-1.42), 1.03 (1.02-1.04) and 1.45 (1.25-1.69), respectively, and for macrovascular complications of 1.41 (1.34-1.48), 1.29 (1.16-1.45), 1.02 (1.01-1.02) and 1.24 (1.04-1.48), respectively. HbA1c levels (per 1.0% increment) were positively associated with microvascular (1.05 [1.02-1.08]) but not macrovascular (1.00 [0.97-1.04]) complications. CONCLUSIONS: The global burden of microvascular and macrovascular complications is substantial in these patients with type 2 diabetes who are relatively early in the disease process. These findings highlight an opportunity for aggressive early risk factor modification, particularly in regions with a high prevalence of complications. Trial registration ClinicalTrials.gov; NCT02322762. Registered 23 December 2014. https://clinicaltrials.gov/ct2/show/NCT02322762 . ClinicalTrials.gov; NCT02226822. Registered 27 August 2014. https://clinicaltrials.gov/ct2/show/NCT02226822.

Funding

The DISCOVER study program is funded by AstraZeneca. DISCOVER is a noninterventional study, and no drugs are supplied or funded.

History

Citation

Cardiovascular Diabetology, 2018, volume 17, Article number: 150

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Diabetes Research Centre

Version

  • VoR (Version of Record)

Published in

Cardiovascular Diabetology

Publisher

BMC (part of Springer Nature)

eissn

1475-2840

Acceptance date

2018-11-06

Copyright date

2018

Available date

2019-09-09

Publisher version

https://cardiab.biomedcentral.com/articles/10.1186/s12933-018-0787-8

Notes

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Additional fle 1: Table S1. Inclusion and exclusion criteria. DDP-4 dipeptidyl peptidase-4. a ≥20 years in Japan. b In Japan, only patients using an oral monotherapy as frst-line treatment were included. Table S2. Comparisons between patients for whom either HbA1c or total cholesterol data are unreported, and those with complete HbA1c and total cholesterol data. ACEi angiotensin-converting-enzyme inhibitor, ARB angiotensin receptor blocker, ASA acetylsalicylic acid, BMI body mass index, HbA1c glycated hemoglobin, SBP systolic blood pressure, SD standard deviation, TC total cholesterol. a Patients with reported data for all variables included in the hierarchical logistic model. b P values calculated for continuous variables using Student’s t-test, and for categorical variables using the χ2 or Fisher’s exact test, as appropriate. c Minor hypoglycemic event in the previous month or major hypoglycemic event in the previous year. Table S3. Number and proportion of patients with microvascular and macrovascular complications according to country (unadjusted). Percent‑ ages were calculated for all patients with data available; unreported data were excluded. UAE United Arab Emirates. Figure S1. Sensitivity analysis including only patients with complete data to assess factors associated with (A) microvascular and (B) macrovascular complications. a RRs adjusted for all variables in the fgure with the addition of SBP, total, cholesterol levels and comedication use, using a modifed Poisson model with clusterbased sandwich variance estimator as described in “Methods”. RRs for the associations between complication prevalence and SBP, total cholesterol levels, and comedication use are not reported due to reverse-causality. b Minor hypoglycemic event in the previous month or major hypogly‑ cemic event in the previous year. BMI body mass index, CI confdence interval, HbA1c glycated hemoglobin, RR rate ratio. Figure S2. Sensitivity analysis with additional variables for site specialty and patient-reported ethnicity to assess factors associated with (A) microvascular and (B) mac‑ rovascular complications. a RRs adjusted for all variables in the fgure with the addition of SBP, total, cholesterol levels and comedication use, using a modifed Poisson model with cluster-based sandwich variance estimator as described in “Methods”. RRs for the associations between complication prevalence and SBP, total cholesterol levels, and comedication use are not reported due to reverse-causality. b Minor hypoglycemic event in the previous month or major hypoglycemic event in the previous year. BMI body mass index, CI confdence interval, HbA1c glycated hemoglobin, RR rate ratio.

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