One‐year trends from the LANDMARC trial: A 3‐year, pan‐India, prospective, longitudinal study on the management and real‐world outcomes of type 2 diabetes mellitus

Endocrinology, Diabetes & Metabolism

卷:5

Subhash K. Wangnoo¹  Sanjay Kalra²  Hemant Thacker³  Bipin Sethi⁴  Abdul H. Zargar⁵  Prasanna Kumar K. M.⁶  Ambika G. Unnikrishnan⁷  Nadeem Rais⁸  Deepa Chodankar⁹  Sukanya Krishnan⁹  Chirag Trivedi⁹  Vaibhav Salvi⁹  Saket Thaker⁹  Subhankar Chowdhury¹⁰  Shashank Joshi¹¹  Ambrish Mithal¹²  Senthilnathan Mohanasundaram¹³  Romik Ghosh¹³  Arjun Nair¹³  Shalini K. Menon¹³  Ashok K. Das¹⁴ 

[1] Apollo Hospital Education and Research Foundation New Delhi India;

[2] Bharti Hospital Karnal India;

[3] Bhatia Hospital Mumbai India;

[4] Care Hospital Hyderabad India;

[5] Center for Diabetes and Endocrine Care Srinagar India;

[6] Centre for Diabetes and Endocrine Care Bengaluru India;

[7] Chellaram Diabetes Institute Pune India;

[8] Chowpatti Medical Centre Mumbai India;

[9] Clinical Study Unit Sanofi Mumbai India;

[10] IPGME and R and SSKM Hospital Kolkata India;

[11] Lilavati Hospital Mumbai India;

[12] Medanta‐The Medicity Gurgaon India;

[13] Medical Affairs Sanofi Mumbai India;

[14] Pondicherry Institute of Medical Sciences Puducherry India;

关键词: diabetes mellitus;    glycaemic control;    India;    real‐world outcomes;   

DOI  :  10.1002/edm2.316

来源: DOAJ

【 摘 要 】

Abstract Introduction Longitudinal data on management and progression of type 2 diabetes mellitus (T2DM) in India are scarce. LANDMARC (CTRI/2017/05/008452), first‐of‐its‐kind, pan‐India, prospective, observational study aimed to evaluate real‐world patterns and management of T2DM over 3 years. Methods Adults (≥25 to ≤60 years old at T2DM diagnosis; diabetes duration ≥2 years at enrolment; controlled/uncontrolled on ≥2 anti‐diabetic agents) were enrolled. The first‐year trends for glycaemic control, therapy and diabetic complications, including those from metropolitan and non‐metropolitan cities are reported here. Results Of 6236 enrolled participants, 5654 completed 1 year in the study. Although the overall mean glycated haemoglobin (HbA1c) improved by 0.5% (baseline: 8.1%) at 1 year, only 20% of the participants achieved HbA1c <7%. Participants from metropolitan and non‐ metropolitan cities showed similar decrease in glycaemic levels (mean change in HbA1c: −0.5% vs. −0.5%; p = .8613). Among diabetic complications, neuropathy was the predominant complication (815/6236, 13.1% participants). Microvascular complications (neuropathy, nephropathy and retinopathy) were significantly (p < .0001) higher in non‐metropolitan than metropolitan cities. Hypertension (2623/6236, 78.2%) and dyslipidaemia (1696/6236, 50.6%) continued to be the most commonly reported cardiovascular risks at 1 year. After 1 year, majority of the participants were taking only oral anti‐diabetic drugs (OADs) (baseline: 4642/6236 [74.4%]; 1 year: 4045/6013 [67.3%]), while the proportion of those taking insulin along with OADs increased (baseline: 1498/6236 [24.0%] vs. 1 year: 1844/6013 [30.7%]). Biguanides and sulfonylureas were the most used OADs. The highest increase in use was seen for dipeptidyl peptidase‐IV inhibitors (baseline: 3047/6236 [48.9%]; 1 year: 3529/6013 [58.7%]). Improvement in all glycaemic parameters was significantly (p < .0001) higher in the insulin vs. the insulin‐naïve subgroups; in the insulin‐naïve subgroup, no statistical difference was noted in those who received >3 vs. ≤3 OADs. Conclusions First‐year trends of the LANDMARC study offer insights into real‐world disease progression, suggesting the need for controlling risk factors and timely treatment intensification in people with T2DM.

【 授权许可】

Unknown