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How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area.

ABSTRACT: Objective:Regulatory agencies require the assessment of cardiovascular (CV) safety for new type 2 diabetes (T2D) therapies through CV outcome trials (CVOTs). However, patients included in CVOTs assessing sodium-glucose cotransporter-2 inhibitors (SGLT2i) might not be representative of those seen in clinical practice. This study examined the proportion of patients that would have been enrolled into three main SGLT2i CVOTs to determine whether these trials' eligibility criteria can be applied to a real-world Mediterranean T2D population. Methods:Cross-sectional, retrospective, cohort study of T2D patients registered in primary care centres of the Catalan Institute of Health using medical records from a population database (SIDIAP) that includes approximately 74% of the population in Catalonia (Spain). Eligibility criteria were according to those of three SGLT2i CVOTs: EMPA-REG OUTCOME (empagliflozin), CANVAS (canagliflozin), and DECLARE-TIMI 58 (dapagliflozin). Results:By the end of 2016, the database included 373,185 patients with T2D with a mean age of 70 ± 12 years, 54.9% male, with a mean duration of T2D of 9 ± 6 years, and a mean glycated haemoglobin (HbA1c) of 7.12% ± 1.32 (59% with HbA1c < 7%). Of these, 86,534 (23%) had established CV disease and 28% chronic renal failure (estimated glomerular filtration < 60 ml/min/1.73m2). Among all included patients, only 8.2% would have qualified for enrolment into the EMPA-REG OUTCOME trial, 29.6% into the CANVAS program, and 38% into the DECLARE-TIMI 58 trial. The main limiting factors for inclusion would have been a previous history of CV disease and the baseline HbA1c value. Conclusion:The external validity of the analysed CVOTs is clearly limited when applying the same eligibility criteria to a T2D Mediterranean population.

SUBMITTER: Canivell S

PROVIDER: S-EPMC6877986 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposeTo develop a statistical approach that compares patient selection strategies across clinical trials and apply this approach to acute ischemic stroke clinical trials to identify the optimal inclusion criteria.MethodsWe developed a statistical approach that compares the number needed to treat to achieve one success (NNT) along with the number needed to screen to achieve one success (NNS) and assesses if there are significant differences in inclusion criteria, treatment course, and clinical outcome among patients that may have been included/excluded in the trials. We applied this approach to the study population from four recent positive acute stroke clinical trials: MR CLEAN, EXTEND-IA, ESCAPE, and SWIFT PRIME, applying published trial criteria to an independent registry of 612 acute stroke patients, since we did not have access to the complete trial data.ResultsAlthough reported NNT were similar for EXTEND-IA, SWIFT PRIME and ESCAPE, and somewhat higher for MR CLEAN, NNS varied across the trials from 21 for EXTEND-IA, 27 for MR CLEAN, to 46 for ESCAPE and 64 for SWIFT PRIME, reflecting less and more stringent inclusion criteria, respectively. Although there were significant differences in imaging biomarkers and other clinical characteristics among patients that may have been included/excluded in the trials, these differences did not translate to significant differences in treatment course or clinical outcomes.ConclusionsOur study proposes a robust statistical approach that can be applied to a larger pooled trial dataset, if made available, to objectively compare across clinical trials and inform inclusion criteria of future trials. Pooled analysis of the acute stroke trial data is needed to determine which imaging biomarker inclusion criteria are critical and which may be relaxed. If this procedure were applied across the pooled trial data, it could decrease costs and refine the design of future trials to be the most efficacious for the greatest number of patients.

Project description:BACKGROUND:Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of treatments for nsLBP. METHODS:A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, using a mixed-methods approach to analysis. Study inclusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category. RESULTS:We included 168 studies. Two inclusion themes (anatomical area, and symptoms and signs) were identified. Anatomical area was most reported as between costal margins and gluteal folds (n =?8, 5%), while low back pain (n =?150, 89%) with or without referred leg pain (n =?27, 16%) was the most reported symptom. Exclusion criteria comprised 21 themes. Previous or scheduled surgery (n =?84, 50%), pregnancy (n =?81, 48%), malignancy (n =?78, 46%), trauma (n =?63, 37%) and psychological conditions (n =?58, 34%) were the most common. Sub-themes of exclusion criteria mostly related to neurological signs and symptoms: nerve root compromise (n =?44, 26%), neurological signs (n =?34, 20%) or disc herniation (n =?30, 18%). Specific conditions that were most often exclusion criteria were spondylolisthesis (n =?35, 21%), spinal stenosis (n =?31, 18%) or osteoporosis (n =?27, 16%). CONCLUSION:RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria. Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses. We propose a template for reporting inclusion and exclusion criteria.

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How Many Patients with Type 2 Diabetes Meet the Inclusion Criteria of the Cardiovascular Outcome Trials with SGLT2 Inhibitors? Estimations from a Population Database in a Mediterranean Area.

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