Veronica Sciannameo1, Paola Berchialla2, Emanuela Orsi3, Olga Lamacchia4, Susanna Morano5, Fabrizio Querci6, Agostino Consoli7, Angelo Avogaro8, Gian Paolo Fadini. 1. Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy. 2. Department of Clinical and Biological Sciences, University of Turin, Turin, Italy. 3. Unit of Endocrinology and Metabolic Diseases, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico di Milano, Milan, Italy. 4. Unit of Endocrinology, Department of Medical and Surgical Sciences, University Hospital of Foggia, Foggia, Italy. 5. Unit of Diabetes Complications, V Clinica Medica, Department of Experimental Medicine, University of Rome "La Sapienza", Rome, Italy. 6. Unit of Diabetology, ASST Bergamo Est, Alzano Lombardo, Italy. 7. Department of Medicine and Aging Science, "G. D'Annunzio" University of Chieti, Chieti, Italy. 8. Department of Medicine, University of Padova, Padova, Italy.
Abstract
AIM: To evaluate the generalizability of cardiovascular outcome trials (CVOTs) on glucagon-like peptide-1 receptor agonists (GLP-1RAs), we assessed what proportion of real-world patients with type 2 diabetes (T2D) constitute true CVOT-like populations. MATERIALS AND METHODS: We applied inclusion/exclusion (I/E) criteria of each GLP-1RA CVOT to a cross-sectional database of 281 380 T2D patients from Italian diabetes outpatient clinics. We calculated the proportion of patients eligible for each CVOT and compared their clinical characteristics with those of trial patients. In addition, we used a Bayesian network-based method to sample the greatest subsets of real-world patients yielding true CVOT-like populations. RESULTS: Between 98 725 and 124 164 T2D patients could be evaluated for CVOT eligibility. After excluding patients who were already on GLP-1RAs and applying I/E criteria, 35.8% of patients would be eligible for REWIND, 34.1% for PIONEER-6, 13.4% for EXSCEL, 10.1% for SUSTAIN-6, 9.5% for HARMONY and 9.4% for LEADER. Overall, 45.4% of patients could be eligible for at least one of the CVOTs. These patients, however, were extremely different to trial patients in most of the clinical characteristics, including demographics, concomitant medications and complications. The greatest CVOT-like subsets of real-world patients were 0.5% for SUSTAIN-6, 1.0% for EXSCEL, 1.2% for LEADER, 1.8% for PIONEER-6 and 7.9% for REWIND. CONCLUSIONS: A very small proportion of real-world patients constitute true CVOT-like populations. These findings question whether any meaningful information can be drawn from applying trial enrolment criteria to real-world T2D patients.
AIM: To evaluate the generalizability of cardiovascular outcome trials (CVOTs) on glucagon-like peptide-1 receptor agonists (GLP-1RAs), we assessed what proportion of real-world patients with type 2 diabetes (T2D) constitute true CVOT-like populations. MATERIALS AND METHODS: We applied inclusion/exclusion (I/E) criteria of each GLP-1RA CVOT to a cross-sectional database of 281 380 T2Dpatients from Italian diabetesoutpatient clinics. We calculated the proportion of patients eligible for each CVOT and compared their clinical characteristics with those of trial patients. In addition, we used a Bayesian network-based method to sample the greatest subsets of real-world patients yielding true CVOT-like populations. RESULTS: Between 98 725 and 124 164 T2Dpatients could be evaluated for CVOT eligibility. After excluding patients who were already on GLP-1RAs and applying I/E criteria, 35.8% of patients would be eligible for REWIND, 34.1% for PIONEER-6, 13.4% for EXSCEL, 10.1% for SUSTAIN-6, 9.5% for HARMONY and 9.4% for LEADER. Overall, 45.4% of patients could be eligible for at least one of the CVOTs. These patients, however, were extremely different to trial patients in most of the clinical characteristics, including demographics, concomitant medications and complications. The greatest CVOT-like subsets of real-world patients were 0.5% for SUSTAIN-6, 1.0% for EXSCEL, 1.2% for LEADER, 1.8% for PIONEER-6 and 7.9% for REWIND. CONCLUSIONS: A very small proportion of real-world patients constitute true CVOT-like populations. These findings question whether any meaningful information can be drawn from applying trial enrolment criteria to real-world T2Dpatients.
Authors: Enrico Longato; Barbara Di Camillo; Giovanni Sparacino; Lorenzo Gubian; Angelo Avogaro; Gian Paolo Fadini Journal: BMJ Open Diabetes Res Care Date: 2020-06
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