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6. Making Sense of Composite Endpoints in Clinical Research.

Author

Baracaldo-Santamaría, Daniela, Feliciano-Alfonso, John Edwin, Ramirez-Grueso, Raul, Rojas-Rodríguez, Luis Carlos, Dominguez-Dominguez, Camilo Alberto, and Calderon-Ospina, Carlos Alberto

Subjects
*MEDICAL research, *GOVERNMENT agencies, *DRUG approval
Abstract

Multiple drugs currently used in clinical practice have been approved by regulatory agencies based on studies that utilize composite endpoints. Composite endpoints are appealing because they reduce sample size requirements, follow-up periods, and costs. However, interpreting composite endpoints can be challenging, and their misuse is not uncommon. Incorrect interpretation of composite outcomes can lead to misleading conclusions that impact patient care. To correctly interpret composite outcomes, several important questions should be considered. Are the individual components of the composite outcome equally important to patients? Did the more and less important endpoints occur with similar frequency? Do the component endpoints exhibit similar relative risk reductions? If these questions receive affirmative answers, the use and interpretation of the composite endpoint would be appropriate. However, if any component of the composite endpoint fails to satisfy the aforementioned criteria, interpretation can become difficult, necessitating additional steps. Regulatory agencies acknowledge these challenges and have specific considerations when approving drugs based on studies employing composite endpoints. In conclusion, composite endpoints are valuable tools for evaluating the efficacy and net clinical benefit of interventions; however, cautious interpretation is advised. [ABSTRACT FROM AUTHOR]

Published
2023
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8. Cost-utility of azithromycin in patients with severe asthma.

Author

Buendía, Jefferson Antonio, Patiño, Diana Guerrero, and Feliciano-Alfonso, John Edwin

Subjects
AZITHROMYCIN, ASTHMATICS, MARKOV processes, COST estimates, SENSITIVITY analysis, COUGH
Abstract

An important proportion of asthma patients remain uncontrolled despite the use of inhaled corticosteroids and long-acting beta-agonists. Some add-on therapies, like azithromycin, have been recommended for this subgroup of patients. The purpose of this study was to assess the cost-effectiveness of azithromycin as an add-on therapy to ICS + LABA for patients with severe asthma. A probabilistic Markov model was created to estimate the cost and quality-adjusted life-years (QALYs) of patients with severe asthma in Colombia. The total costs and QALYS of two interventions, including standard therapy (ICS + LABA), and add-on therapy with azithromycin, were calculated over a lifetime horizon. Multiple sensitivity analyses were conducted. Cost-effectiveness was evaluated at a willingness-to-pay value of $19,000. The model suggests a potential gain of 0.037 QALYs per patient per year on azithromycin, with a difference of US $718 in favor of azithromycin, showing dominance with respect to SOC. A position of dominance negates the need to calculate an incremental cost-effectiveness ratio. In the deterministic sensitivity analyses, our base‐case results were robust to variations in all assumptions and parameters. Add-on therapy with azithromycin was found to be cost-effective when added to usual care in patients who remain uncontrolled despite treatment with medium or high-dose ICS/LABA. [ABSTRACT FROM AUTHOR]

Published
2022
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12. Papel de la Rosuvastatina en el paciente con alto riesgo cardiovascular

Author

Feliciano-Alfonso, John E

Subjects
Inhibidores de Hidroximetilglutaril-CoA Reductasas, enfermedades ardiovasculares, dislipidemias, nutritional and metabolic diseases, Cost-Effectiveness Evaluation, Hydroxymethylglutaryl-CoA Reductase Inhibitors, dyslipidemias, evaluación de Costo-Efectividad, cardiovascular diseases
Abstract

Statins are the lipid-lowering drug family of first choice in situations of hypercholesterolemia or mixed dyslipidemia with predominant increase in cholesterol. The evidence shows conclusively that each one of the commercially available statins have proven benefits on outcomes of cardiovascular morbidity and mortality. However, rosuvastatin has certain pharmacokinetic efficacy and cost-effectiveness characteristics that make it an attractive molecule to be the statin of choice in patients at high cardiovascular risk. Las estatinas son la familia farmacológica hipolipemiante de primera opción en situaciones de hipercolesterolemia o dislipiemia mixta con predominio de aumento en el colesterol. La evidencia demuestra contundentemente que cada una de las estatinas disponibles en el mercado ha mostrado beneficios en desenlaces de morbi-mortalidad cardiovascular. Sin embargo, la rosuvastatina presenta ciertas características farmacocinéticas de eficacia y de costo-efectividad que la hacen una molécula atractiva para ser la estatina de elección en pacientes de alto riesgo cardiovascular.

Published
2013

13. Cardiovascular risk factors and metabolic syndrome in a population of young students from the National University of Colombia

Author

Feliciano-Alfonso, John Edwin, Mendivil, Carlos Olimpo, Ariza, Iván Darío Sierra, and Pérez, Clara Eugenia

Subjects
Risk factors, Adolescent, Metabolic syndrome X obesity, Fatores de risco, Obesidade, Síndrome X metabólica, Alcohol consumption, Consumo de bebidas alcoólicas, Adolescente
Abstract

OBJECTIVE: To estimate prevalence and distribution of cardiovascular risk factors and Metabolic Syndrome (MS) in young individuals admitted to the National University of Colombia in Bogotá. METHODS: An analytic cross-sectional study was conducted in a sample of 249 individuals of both genders aged 15 to 20 years. A questionnaire was personally administered to collect demographic, socioeconomic, smoking, perinatal, and women's health data. Anthropometric measurements, blood pressure, and a fasting blood sample were taken. Prevalence of MS was determined and compared using criteria from several qualified institutions. RESULTS: We found a high prevalence of smoking (18.9%), arterial prehypertension (14.1%) and overweight (11.2%), 9.2% of study participants had prediabetes, and the most frequent dyslipidemia was low HDL cholesterol (13.3%). Alcoholic beverage consumption was declared by 60.6% of study terol and plasma triglyceride levels. Gestational age at birth was inversely associated with presence of low HDL cholesterol levels and high blood pressure. Prevalence of the MS varied markedly according to the definition employed: 9.2% using REGODCI (Research Group on Diabetes and Chronic Illnesses) criteria, 2% using IDF (International Diabetes Federation) criteria, and 2.4% using AHA (American Heart Association) criteria. CONCLUSION: The encountered prevalence of modifiable cardiovascular risk factors justifies promotion of therapeutic lifestyle changes among this age group in Colombia. Further harmonization of MS criteria in young individuals is needed. OBJETIVO: Estimar a prevalência e distribuição de fatores de risco cardiovasculares e da síndrome X metabólica (SM) em indivíduos jovens admitidos na Universidade Nacional da Colômbia, em Bogotá. MÉTODOS: Foi realizado um estudo analítico transversal em uma amostra de 249 indivíduos de ambos os sexos, com idades entre 15 e 20 anos. Um questionário foi administrado pessoalmente para recolher dados demográficos e socioeconômicos, presença ou ausência de tabagismo, características perinatais e sobre saúde da mulher. Medidas antropométricas e de pressão arterial foram realizadas, e uma amostra de sangue em jejum foi coletada. A prevalência da SM foi determinada e comparada utilizando-se os critérios de diferentes instituções especializadas. RESULTADOS: Encontramos uma alta prevalência de tabagismo (18,9%), pré-hipertensão arterial (14,1%) e sobrepeso (11,2%); 9,2% dos participantes tinham pré-diabetes, e a mais frequente dislipidemia foi baixo HDL-colesterol (13,3%). Um total de 66,6% dos participantes declarou consumir bebidas alcoólicas. O índice de massa corporal foi positivamente associado a aumento na pressão arterial, colesterol LDL e triglicérides plasmáticos. A idade gestacional ao nascimento foi inversamente associada a baixo HDL colesterol e à pressão arterial elevada. A prevalência de SM variou acentuadamente, de acordo com a definição empregada: 9,2% segundo REGODCI (Grupo de Pesquisa em Diabetes e Doenças Crônicas), 2% segundo IDF (International Diabetes Federation), e 2,4% segundo AHA (American Heart Association). CONClUSÃO: A prevalência encontrada de fatores de risco cardiovasculares justifica o incentivo a mudanças de estilo de vida neste grupo etário na Colômbia. Uma maior padronização dos critérios definidores de SM em indivíduos jovens é necessária.

Published
2010

14. Contributors

Author

Able, Antoinne C., Sosa, Sol M. Abreu, Adib, Farshad, Agarwal, Meena, Aghalar, Maryam R., Akuthota, Venu, Alfonso, John D., Alleva, Joseph T., Altschuler, Eric L., Amadera, Joao E.D., Amy, Eduardo, Babushkina, Anna, Bach, John R., Bailey, Allison, Bang, Moon Suk, Bavishi, Alpeshkumar, Beckworth, William J., Bengtson, Keith A., Berman, Andrew R., Bhatti, Omar M., Bienkowski, Peter, Bockenek, William L., Bogie, Kath, Borg, Kristian, Borg-Stein, Joanne, Bosques, Glendaliz, Bowen, Jay E., Brault, Jeffrey S., Braverman, Colonel Steven E., Braza, Diane W., Burke, David T., Caban, Mabel, Cabrera, Alison L., Cabrera, Juan A., Campbell, Mark, Carter, Gregory T., Cassidy, Charles, Cassius, David A., Cheville, Andrea, Chew, Kelvin, Childers, Martin K., Chinratanalab, Sallaya, Chow, Chien, Chung, Victor, Clinchot, Daniel M., Colberg, Ricardo, Colbert, Melissa, Craig, Earl J., Cui, Di, Curtis, Christine, Custodio, Christian M., Davis, Alan M., Deimel, George W., IV, Del Toro, David R., Diesselhorst, Matthew M., Dillingham, Timothy R., Dreyer, Susan J., Dudek, Nancy, Dudkiewicz, Israel, Dugan, Sheila, Eapen, Blessen C., Earle, Jennifer L., Ebenbichler, Gerold R., Egyhazi, Rachel, El Abd, Omar, Eliason, Jeffrey B., Ellenberg, Maury, Ellenberg, Michael J., Ennis, Jesse D., Ensrud, Erik, M. Esser, Stephan, Fast, Avital, Feeney, Richard, Feldman, Jeffery B., Finnoff, Jonathan T., Foster, Leslie S., Foye, Patrick M., Fredericson, Michael, Frontera, Joel E., Frontera, Walter R., Gittler, Michelle, Glenn, Mel B., Gonzalez, Peter, González-Fernández, Marlís, Groomes, Thomas E., Grosser, Dawn M., Guo, H. Michael, Gupta, Navneet, Hacker, Hope S., Hall, Lori, Hanada, Ed, Hanson, Toni J., Harrington, Amanda L., Hartigan, David E., Herman, Seth D., Herrera, Joseph E., Ho, Chester H., Hoch, Anne Z., Holm, Jason, Hon, Alice J., Hudgins, Thomas H., Ibanez, Katarzyna, Ibrahim, Mahmud M., Imamura, Marta, Imamura, Satiko T., Isaac, Zacharia, Joseph, Rathi L., Joshi, Shivang, Joyce, Nanette C., Jung, Se Hee, Kay, Jonathan, Kaynan, Ayal M., Keel, John C., Kent, Robert, Keplinger, Florian S., Kigner, Stuart, Kile, Todd A., King, John C., Kirschbaum, Neil, Klausmeyer, Melissa A., Kortte, Jason H., Krabak, Brian J., Latlief, Gail, Lee, Sammy M., Lee, Shi-Uk, Lennard, Ted A., Lento, Paul, Lexell, Jan, Lim, Peter A.C., Lin, Cindy, Lindgren, Karl-August, Lirofonis, Vasilios A., Loder, Elizabeth, Lopez, Edrick, Malanga, Gerard A., Martin, Julie, Mascarinas, Rafael, Massengale, Jill, Matsuo, Koichiro, McCarthy, Marissa, McInnis, Kelly C., McIntosh, Peter M., Meleger, Alec L., Merritt, Bryan, Micheli, Lyle J., Micheo, William, Miller, Matthew E., Miranda, Gerardo, Mohr, Nathan, Montero, Daniel P., Mookerjee, S. Jit, Mostoufi, Ali, Mudgal, Chaitanya S., Najera, Larry V., III, Nesathurai, Shanker, Nordin, Jess, O’Neill, Carina J., Origenes, Andrea K., Ortiguera, Cedric J., Osborne, Michael D., Palmer, Jeffrey B., Pasquina, Paul F., Patel, Atul T., Paterno, Josemaria, Perkash, Inder, Phillips, Edward M., Pimentel, Daniel C., Pobre, Thomas E., Posthuma, Rebecca, Putnam, Alison R., Rainville, James, Ramachandran, V.S., Ring, David, Riutta, Justin, Rivera-Vega, Alexandra, Rizzo, Thomas D., JR., Rosenberg, Darren, Rutkove, Seward B., Sabharwal, Sunil, Santiago, Francisco H., Scardina, Robert J., Schaufele, Michael K., Schneider, Jeffrey C., Scott, Steven, Sein, Michael, Sepúlveda, Fernando, Sergent, John, Shah, Vivek M., Sharma, Nutan, Sheikh, Huma, Shubert, Sarah, Siddiqui, Imran J., Silver, Julie K., Silver, Kenneth H., Singla, Aneesh, Slesinski, Michael, Slovik, David M., Spindler, Kurt, Standley, Do, Joseph, Stein, Joel, Stilp, Sonja K., Stitik, Todd P., Stretanski, Michael F., Stubblefield, Michael D., Tate, Jordan L., Therattil, Maya, Thomas, Ann-Marie, Thomas, Mark A., Tran, Jiaxin, Trudel, Guy, Urbisci, Tony, Vadivelu, Sathya, Vallarino, Ramon, JR., Verduzco-Gutierrez, Monica, Vora, Ariana, Wallace, Adam, Weinman, Beth M., Weiss, Jay M., Weiss, Lyn D., Wexler, David, Wierbicky, Jane, Wieting, J. Michael, Wilkins, Allen N., Williams, Faren H., Yin, Amy X., Young, Mark, and Zhao, Meijuan

Published
2015
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15. Cardiovascular risk factors and metabolic syndrome in a population of young students from the National University of Colombia.

Author

Feliciano-Alfonso JE, Mendivil CO, Ariza ID, and Pérez CE

Subjects
Adolescent, Birth Weight, Cardiovascular Diseases diagnosis, Colombia epidemiology, Epidemiologic Methods, Female, Gestational Age, Humans, Male, Metabolic Syndrome diagnosis, Metabolic Syndrome etiology, Reference Values, Risk Factors, Students statistics & numerical data, Universities, Young Adult, Cardiovascular Diseases etiology, Metabolic Syndrome epidemiology
Abstract

Objective: To estimate prevalence and distribution of cardiovascular risk factors and Metabolic Syndrome (MS) in young individuals admitted to the National University of Colombia in Bogotá., Methods: An analytic cross-sectional study was conducted in a sample of 249 individuals of both genders aged 15 to 20 years. A questionnaire was personally administered to collect demographic, socioeconomic, smoking, perinatal, and women's health data. Anthropometric measurements, blood pressure, and a fasting blood sample were taken. Prevalence of MS was determined and compared using criteria from several qualified institutions., Results: We found a high prevalence of smoking (18.9%), arterial prehypertension (14.1%) and overweight (11.2%), 9.2% of study participants had prediabetes, and the most frequent dyslipidemia was low HDL cholesterol (13.3%). Alcoholic beverage consumption was declared by 60.6% of study terol and plasma triglyceride levels. Gestational age at birth was inversely associated with presence of low HDL cholesterol levels and high blood pressure. Prevalence of the MS varied markedly according to the definition employed: 9.2% using REGODCI (Research Group on Diabetes and Chronic Illnesses) criteria, 2% using IDF (International Diabetes Federation) criteria, and 2.4% using AHA (American Heart Association) criteria., Conclusion: The encountered prevalence of modifiable cardiovascular risk factors justifies promotion of therapeutic lifestyle changes among this age group in Colombia. Further harmonization of MS criteria in young individuals is needed.

Published
2010
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