Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial.

INTRODUCTION: To assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. METHODS: This was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated. RESULTS: Of the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION: Adalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.

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

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.

Cardiovascular risk factors and metabolic syndrome in a population of young students from the National University of Colombia / Fatores de risco cardiovascular e síndrome metabólica em uma população de estudantes jovens da Universidade Nacional de Colômbia

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 percent), arterial prehypertension (14.1 percent) and overweight (11.2 percent), 9.2 percent of study participants had prediabetes, and the most frequent dyslipidemia was low HDL cholesterol (13.3 percent). Alcoholic beverage consumption was declared by 60.6 percent 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 percent using REGODCI (Research Group on Diabetes and Chronic Illnesses) criteria, 2 percent using IDF (International Diabetes Federation) criteria, and 2.4 percent 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 por cento), pré-hipertensão arterial (14,1 por cento) e sobrepeso (11,2 por cento); 9,2 por cento dos participantes tinham pré-diabetes, e a mais frequente dislipidemia foi baixo HDL-colesterol (13,3 por cento). Um total de 66,6 por cento 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 por cento segundo REGODCI (Grupo de Pesquisa em Diabetes e Doenças Crônicas), 2 por cento segundo IDF (International Diabetes Federation), e 2,4 por cento 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.

Reduction of global cardiovascular risk with nutritional versus nutritional plus physical activity intervention in Colombian adults.

BACKGROUND: Cardiovascular disease is a major cause of morbidity/mortality in non-developed countries. Reports of the effects of non-pharmacological interventions on global cardiovascular risk in Latin American adults, however, are scarce. OBJECTIVE: To compare the change in global cardiovascular risk induced by a tailored, Adult Treatment Panel-III compliant nutrition program versus the same program with addition of supervised, regular physical activity in Colombian adults. DESIGN: The study was a randomized, controlled trial. METHODS: Seventy-five Colombian patients aged 40-70 years and with Framingham-estimated global cardiovascular risk of 1% or higher were randomly assigned to a nutritional intervention program or a combined nutritional intervention-physical exercise program for 16 weeks. Patients underwent medical and anthropometric evaluation, bioelectrical impedance, lipid profile and Framingham global cardiovascular risk determination at baseline and at the end of follow-up. RESULTS: The groups were comparable at baseline; 21 persons in the nutritional intervention program group and 27 in the nutritional intervention-physical exercise program group completed the follow-up. Global cardiovascular risk modification (mean+/-SE) was -2.04+/-1.1 absolute percentage points (relative reduction 19.6%) in the nutritional intervention-physical exercise program group, compared with 0.23+/-0.9 (relative increase 2.8%) in the nutritional intervention program group. Mean difference in global cardiovascular risk modification between groups reached borderline statistical significance in ANCOVA (P=0.054). Reductions in systolic and diastolic blood pressure, waist circumference and low-density lipoprotein cholesterol were similar, but the nutritional intervention-physical exercise program group achieved significantly greater improvements in body weight, body mass index, percentage body fat and high-density lipoprotein cholesterol. CONCLUSIONS: Our data suggest that a structured nutritional intervention-physical exercise program is more efficacious than a nutritional intervention program in the reduction of global cardiovascular risk and cardiovascular risk factors, in only 16 weeks.