Dataset Information

Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme.

ABSTRACT:

Objectives

To evaluate the extent to which patients with type 2 diabetes discontinue metformin therapy when initiating second-line treatment and factors associated with metformin discontinuation, using baseline data from the DISCOVER study programme.

Design

DISCOVER is a 3-year, prospective, observational study programme including data from 38 countries across 6 continents from 2014 to 2019.

Setting

Primary and secondary healthcare centres, hospitals and specialist diabetes centres in both urban and rural locations.

Participants

A total of 15 992 patients with type 2 diabetes initiating second-line glucose-lowering therapy.

Primary and secondary outcome measures

The proportion of patients who discontinued metformin as a second-line therapy and the factors associated with this treatment change.

Results

Of the 14 668 patients (from 37 countries) with valid treatment data, 11 837 (80.7%) received metformin as first-line glucose-lowering therapy; 8488 (71.7%) received metformin monotherapy and 3349 (28.3%) received metformin as part of a combination therapy. Overall, treatment with metformin was discontinued in 15.1% (1782) of patients who received first-line metformin (14.1% (1194) and 17.6% (588) in those who received metformin as monotherapy and as part of a combination, respectively); this proportion varied across regions from 6.9% (54) in Africa to 20.6% (628) in South-East Asia. On metformin discontinuation, 73.6% (1311) of patients received a non-insulin monotherapy at second line. Factors associated with an increased odds of metformin discontinuation were older age (≥75 years) and having a history of chronic kidney disease. The probability of metformin monotherapy discontinuation was lower in patients from Africa than in those from Europe.

Conclusions

A substantial number of patients discontinued taking metformin when beginning second-line therapy. Most of these patients subsequently received a non-insulin monotherapy at second line, in contradiction to international guidelines and potentially leaving them at an increased risk of hyperglycaemia and associated adverse outcomes.

Trial registration numbers

NCT02322762 and NCT02226822.

SUBMITTER: Khunti K

PROVIDER: S-EPMC7462233 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme.

Khunti Kamlesh K Gomes Marilia B MB Kosiborod Mikhail M Nicolucci Antonio A Pocock Stuart S Rathmann Wolfgang W Shestakova Marina V MV Shimomura Iichiro I Watada Hirotaka H Chen Hungta H Cid-Ruzafa Javier J Fenici Peter P Hammar Niklas N Tang Fengming F Ji Linong L

BMJ open 20200830 8

<h4>Objectives</h4>To evaluate the extent to which patients with type 2 diabetes discontinue metformin therapy when initiating second-line treatment and factors associated with metformin discontinuation, using baseline data from the DISCOVER study programme.<h4>Design</h4>DISCOVER is a 3-year, prospective, observational study programme including data from 38 countries across 6 continents from 2014 to 2019.<h4>Setting</h4>Primary and secondary healthcare centres, hospitals and specialist diabetes ...[more]

PMID: 32868349

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Project description:BackgroundMultiple glucose-lowering drugs are available as add-ons to metformin for a second-line treatment for type 2 diabetes. However, no systematic and comparative data are available for them in China. We aimed to compare the effects of glucose-lowering drugs added to metformin in China.MethodsPubMed, Embase, Web of Science, CNKI, WanFang Data, and Chongqing VIP from 1 January 2000 until 31 December 2020 were systematically searched for randomized controlled trials comparing a glucose-lowering drug added to metformin with metformin in Chinese type 2 diabetes patients. Drug classes included sulfonylureas (SUs), glinides (NIDEs), thiazolidinediones (TZDs), α-glucosidase inhibitors (AGIs), dipeptidyl peptidase-4 inhibitors (DPP-4is), sodium-glucose cotransporter-2 inhibitors (SGLT2is), glucagon-like peptide-1 receptor agonists (GLP-1RAs), and insulins (INSs). Two reviewers independently screened studies, extracted data, and appraised the risk of bias.Results315 trials were included. In patients receiving metformin alone, the addition of NIDEs produced the greatest additional HbA1c reductions (1.29%; 95% CI 0.97, 1.60); while INSs yielded both the largest additional FPG reductions (1.58 mmol/L; 95% CI 1.22, 1.94) and 2 hPG reductions (2.52 mmol/L; 95% CI 1.83, 3.20). INS add-ons also conferred the largest additional HDL-C increases (0.40 mmol/L; 95% CI 0.16, 0.64), whereas AGI add-ons generated the greatest TC reductions (1.08 mmol/L; 95% CI 0.78, 1.37). The greatest incremental SBP reductions (6.65 mmHg; 95% CI 4.13, 9.18) were evident with SGLT2i add-ons. GLP-1RA add-ons had the greatest BMI reductions (1.96 kg/m2, 95% CI 1.57, 2.36), meanwhile with the lowest (0.54 time) hypoglycemia risk. Overall, only the GLP-1RA add-ons demonstrated a comprehensive beneficial effect on all outcomes. Furthermore, our results corroborated intraclass differences among therapies. Given the limited evidence, we could not reach a conclusion about the optimal therapies regarding mortality and vascular outcomes.ConclusionThe results suggested a potential treatment hierarchy for clinicians and patients, with the GLP-1RA add-ons being most preferred based on their favorable efficacy and safety profiles; and provided a unified hierarchy of evidence for conducting country-specific cost-effectiveness analyses.

Project description:ObjectivesThe aim of the global DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings (DISCOVER) Study was to provide a comprehensive real world assessment of the treatment pattern changes for patients with type 2 diabetes. The aim of this analysis was to assess the metabolic control and the annual incidence of hypoglycaemia, hospitalisation and complications among Saudi patients with type 2 diabetes initiating second-line therapy.DesignThis study is part of the observational, longitudinal, prospective multinational DISCOVER Study.SettingGovernmental and private health sectors from different regions within Saudi Arabia.ParticipantsThe study recruited 519 patients with type 2 diabetes aged ≥18 years who were switching to second-line therapy. Patients who were already using insulin/injectable agents, patients with type 1 diabetes, pregnant women, and patients undergoing dialysis or with a history of renal transplantation were excluded.Primary and secondary outcome measuresMetabolic control among patients with type 2 diabetes mellitus; fear of hypoglycaemia; quality of life; and the incidence of complications, hypoglycaemic events and/or hospitalisations. Data were analysed using descriptive statistics.ResultsA total of 519 patients were recruited with a mean age of 52.4±11 years. Of these participants, 54.7% were male and 45.3% were female. The incidence of hypoglycaemia was 56.72/1000 patient-years. The Hypoglycemia Fear Survey II showed a significant increase in patient worry related to hypoglycaemia from 6.4±11.9 at baseline to (p=0.0446) at the 36-month follow-up. The incidence of hospitalisation was 30.81/1000 patient-years. There was a moderate improvement in glycaemic control, represented as an HbA1c reduction from 8.8% at baseline to 8.2% at the 36-month follow-up. The incidence of macroangiopathy was 24.51/1000 patient-years and the incidence of microvascular complications such as retinopathy and albuminuria was 47.00/1000 patient-years and 221.71/1000 patient-years, respectively. The mean score of fear of hypoglycaemia showed an increase with 13.0±21.5 at baseline to 16.1±22.2 at the 36-month follow-up. When assessing the patients' quality of life, there was an improvement in the mental component score from 47.4±9.1 at baseline to 53.0±6.7 at the 36-month follow-up.ConclusionsTreatment intensification decisions should be made individually, weighing the benefit of good glycaemic control against the risk of hypoglycaemia.Trial registration numberNCT02322762 and NCT02226822.

Project description:IntroductionJ-DISCOVER is a prospective, observational cohort study that aimed to understand characteristics, glycaemic control, comorbidities and real-world management of patients with early-stage type 2 diabetes mellitus (T2DM) in Japan, by enrolling patients initiating second-line treatment from both diabetes specialist and non-specialist care settings.MethodsAs part of the global DISCOVER programme, J-DISCOVER enrolled 1798 patients with T2DM aged at least 20 years old from 142 sites across Japan, from September 2014 to December 2015, and followed these patients for 3 years. Glycaemic control, body mass index (BMI), blood pressure, lipid profiles, treatment patterns, and prevalence of CKD and retinopathy were examined from baseline to 6, 12, 24 and 36 months, stratified by class of second-line treatment.ResultsAt baseline, the median time after T2DM diagnosis was 3.1 years and mean glycated haemoglobin (HbA1c) was 7.7%. The mean individualized HbA1c target was 6.7 ± 0.5%, and 55.3% of patients were set the target of < 7.0%. HbA1c reductions were noted from 6 months and mean HbA1c was 7.1% at 36 months. The proportion of patients with HbA1c < 7.0% increased from 28.8% at baseline to 53.3% at 36 months, and the achievement rate of individualized HbA1c targets increased from 6.1% to 30.3%. Only two cases of severe hypoglycaemia occurred during the study. No major changes in BMI, blood pressure, lipid profile or prescription of antihypertensive or dyslipidaemia medications were observed. The frequencies of screening to detect retinopathy and chronic kidney disease (CKD) were 17.0-21.0% and 14.5-16.0%, respectively, during the follow-up period. The prevalence of CKD, but not retinopathy, increased over the follow-up period.ConclusionsThis study provided an overview of the 3-year management of early-stage T2DM in patients initiating second-line treatment. Contemporary management improved glycaemic control with an acceptable risk-benefit balance, although hurdles remain to sufficient implementation of guideline-recommended treatments in current clinical practice.Trial registrationClinicalTrials.gov identifier, NCT02226822.

Dataset Information

Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme.

Objectives

Design

Setting

Participants

Primary and secondary outcome measures

Results

Conclusions

Trial registration numbers

Publications

Metformin discontinuation in patients beginning second-line glucose-lowering therapy: results from the global observational DISCOVER study programme.

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