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PDM-ProValue meets cardiovascular outcome trials in diabetes.

ABSTRACT: Novel studies have increased our knowledge regarding optimal treatment options in diabetes. Key studies that have broadened our knowledge about optimal treatment options in diabetes in recent years are cardiovascular outcome trials (CVOTs) and studies investigating aspects of digitalisation and monitoring of glucose (e.g. PDM-ProValue). We aimed at highlighting similarities between the two important pillars for a successful diabetes management. We emphasise the need for a consideration of both approaches in future clinical trial designs and protocols.

SUBMITTER: Fritzen K

PROVIDER: S-EPMC6348620 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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PDM-ProValue meets cardiovascular outcome trials in diabetes.

Fritzen Katharina K Schnell Oliver O

Cardiovascular diabetology 20190128 1

Novel studies have increased our knowledge regarding optimal treatment options in diabetes. Key studies that have broadened our knowledge about optimal treatment options in diabetes in recent years are cardiovascular outcome trials (CVOTs) and studies investigating aspects of digitalisation and monitoring of glucose (e.g. PDM-ProValue). We aimed at highlighting similarities between the two important pillars for a successful diabetes management. We emphasise the need for a consideration of both a ...[more]

PMID: 30691463

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Project description:BackgroundRecent cardiovascular outcome trials (CVOTs) changed the therapeutic strategy of guidelines for type 2 diabetes. We compared the characteristics of patients from real-world hospital settings with those of participants in recent pragmatic randomized trials.MethodsThis electronic medical record (EMR)-based retrospective observational study investigated the data of patients with diabetes from inpatient and outpatient settings in West China Hospital of Sichuan University from January 1, 2011, to June 30, 2019. We identified patients meeting the inclusion criteria of a pragmatic randomized trial (EMPA-REG OUTCOME) based on EMRs and compared their baseline characteristics with those of the trial participants. The cutoff for the clinical significance of each characteristic was set as its minimal clinically important difference based on expert consultation.ResultsWe included 48,257 inpatients and 36,857 outpatients with diabetes and found that 8389 (17.4%) inpatients and 2646 (7.2%) outpatients met the inclusion criteria for the EMPA-REG OUTCOME trial. Compared with the trial population, the real-world inpatients meeting the eligibility criteria of the EMPA-REG OUTCOME had similar age, blood pressure, and lipid profiles but comprised of fewer males, metformin users, anti-hypertensive drug users, and aspirin users, and had a lower body mass index. The group of outpatients meeting the eligibility criteria had fewer males, similar age, fewer metformin users, fewer insulin users, fewer anti-hypertensive drug users, and fewer aspirin users compared with the trial population.ConclusionsThe trial population in EMPA-REG OUTCOME represents only a small portion of patients with diabetes from the inpatient and outpatient departments of a Chinese tertiary medical center. Evidence localization in different clinical settings and validation are essential to enabling extrapolation of the results from CVOTs in patients with diabetes to Chinese clinical practice.

Project description:Background The value of glycemic control and preexisting cardiovascular disease in determining the risk of major cardiovascular events (MACE) in type 2 diabetes mellitus is uncertain. Intensive glucose control trials suggest that the 9% lower risk of MACE associated with intensive glycemic control, as compared with conventional glycemic control, is only driven by patients with type 2 diabetes mellitus without cardiovascular disease at baseline. Methods and Results We did a meta-analysis of cardiovascular outcome trials dividing patients with or without preexisting cardiovascular disease; we found that the lower risk of MACE is confined to patients with cardiovascular disease at baseline. Compared with placebo, the use of both glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors was associated with a significant 14% lower MACE risk in patients with preexisting cardiovascular disease and with a nonsignificant 2% higher MACE risk in those without preexisting cardiovascular disease ( P for interaction=0.021). The meta-regression analysis of all 12 trials demonstrated a significant ( P=0.002) association between reductions of glycated hemoglobin in glycated hemoglobin A1C. Accordingly, the reduction of MACE expected if all cardiovascular outcome trials had achieved a 0.9% glycated hemoglobin reduction would have been 33%. Routine clinical care data complement the results of cardiovascular outcome trials but with some differences: the lower risk of MACE with sodium-glucose cotransporter-2 inhibitor use is evident in patients with type 2 diabetes mellitus with or without preexisting cardiovascular disease. Conclusions Sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists should be included in the therapeutic plan of patients with type 2 diabetes mellitus and overt cardiovascular disease, with due attention paid to improvement of glycemic control, which may amplify their benefit on MACE.

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PDM-ProValue meets cardiovascular outcome trials in diabetes.

Publications

PDM-ProValue meets cardiovascular outcome trials in diabetes.

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