Inequalities in enrollment of women and racial minorities in trials testing uric acid lowering drugs |
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| Institution: | 1. Hypertension and Cardiovascular Risk Factors Research Center, Medical and Surgical Sciences Department, Alma Mater Studiorum University of Bologna, Bologna, Italy;2. IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;1. Department of Clinical Laboratory, Zhenhai District Refining Hospital, Ningbo City, Zhejiang province, 315207, China;2. Departmeng of Internal Medicine,College of Clinical Medicine, QiLu Medical University, Zibocity, Shandong province, 255300, China;3. School of Medicine, Federal University of Uberlandia (UFU), Uberlandia, Minas Gerais, Brazil;4. Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania;5. Department of Hematology, Center of Hematology and Bone Marrow Transplantation, Fundeni Clinical Institute, Bucharest, Romania;6. Medical Surgical Nursing Department, Manipal College of Nursing, Manipal, Manipal Academy of Higher Education, Karnataka, India;7. Department of Endocrinology, Ankang Hospital of Traditional Chinese Medicine, Ankang City, Shaanxi Province, 725000, China;1. Department of Cardiovascular Medicine, The University of Tokyo, Tokyo, Japan;2. Department of Clinical Laboratory, The University of Tokyo, Tokyo, Japan;3. Department of Medicine, Columbia University, New York, NY, USA;1. Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA;2. Department of Cardiology, Medical University of Graz, Graz, Austria;3. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;4. MIND Center, University of Mississippi Medical Center, Jackson, MS, USA;5. Division of Cardiovascular Medicine, Brigham and Women''s Hospital, Boston, MA, USA;1. Instituto de Investigaciones en Ciencias de la Salud (INICSA), CONICET, Universidad Nacional de Córdoba, Córdoba, Argentina;2. Escuela de Nutrición, Facultad de Ciencias Médicas, Universidad Nacional de Córdoba, Córdoba, Argentina;3. Southern Cone American Center of Excellence for Cardiovascular Health, Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina;4. Lown Scholars Program, Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA;5. Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, USA;6. Universidad de La Frontera, CIGES, Temuco, Chile;7. Municipalidad de Marcos Paz, Buenos Aires, Argentina;8. Escuela de Medicina, Universidad de la República, Montevideo, Uruguay;9. Centro de Investigaciones en Epidemiología y Salud Pública (CIESP-CONICET), Buenos Aires, Argentina;1. Department of Earth, Environment and Life Sciences (DISTAV), University of Genova, Corso Europa 26, 16132, Italy;2. Nanoscopy and NIC@IIT, Istituto Italiano di Tecnologia, Genoa, Italy;3. Clinica Medica “A. Murri”, Dept. of Biomedical Sciences and Human Oncology, Medical School, University of Bari “Aldo Moro”, Italy;1. Faculty of Health, Department of Nutrition and Dietetics, University of Canberra, Australia;2. University of Canberra, Canberra, Australia;3. Department of Nutrition and Dietetics, School of Health Science and Education, Harokopio University, Athens, Greece;4. School of Public Health, College of Health Sciences, Addis Ababa University, Ethiopia;5. University of Navarra, Spain |
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| Abstract: | AimsWe investigated sex and racial inequalities in clinical trials testing serum uric acid (SUA) lowering drugs and analyzed the temporal trends of participation among the pre-specified demographic groups.Data were collected from publications of clinical trials testing SUA-lowering drugs. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled in clinical studies.Data synthesisThe mean percentage enrollment of women in clinical trials significantly decreased over the time (r = ?0.43, P-value = 0.02). Moreover, there was a statistically significant difference in mean percentage enrollment of women among trials testing different SUA-lowering drugs, with the highest representation in rasburicase (71.1%) and the lowest representation of women in dotinurad (0.8%). Over the time, also the mean percentage enrollment of racial minorities decreased, passing from 8.7% to 2.2% in a 10-year period.Women were proportionally underrepresented compared with their share of the population with asymptomatic hyperuricemia, overall (participation-to-prevalence ratio (PPR) = 0.34), in trials testing xanthine oxiase inhibitors (PPR = 0.38) and uricosurics (PPR = 0.29), and in trials with febuxostat, allopurinol, pegloticase, halofenate/arhalofenate, verinurad, lesinurad and dotinurad. Women were proportionally underreppresented also compared with their share of the population with gout, overall (PPR = 0.69) and in trials testing XOIs (PPR = 0.69), uricosurics (PPR = 0.68), and all SUA-lowering drugs excepted for rasburicase, pegloticase and topiroxostat.ConclusionsOur analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes. |
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| Keywords: | Uric acid lowering drugs Sex Minorities Clinical trials CI"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"confidence interval GBD"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"global burden of disease IQR"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"interquartile range PPR"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"participation-to-prevalence ratio SD"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"standard deviation SUA"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"serum uric acid XOIs"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"xanthine oxidase inhibitors |
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