Two-Year Safety and Efficacy Experience in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis Treated with Etanercept and Conventional Disease-Modifying Anti-rheumatic Drugs in the Latin American Region.

BACKGROUND: Although long-term data are available from biologic studies in North American/European populations with rheumatoid arthritis (RA), long-term findings in Latin American RA populations are limited. OBJECTIVE: To examine long-term safety/efficacy of etanercept, methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARDs) in Latin American patients with moderate-to-severe active RA. METHODS: In the first phase of this open-label study, patients were randomized to etanercept 50 mg weekly plus methotrexate or conventional DMARD (hydroxychloroquine or sulfasalazine) plus methotrexate for 24 weeks. At the start of the second phase (week 24), investigators selected a treatment regimen that included any combination/dosage of etanercept, methotrexate, hydroxychloroquine, or sulfasalazine based on previous treatment response, preference, and local product labeling, and was continued for the 104-week extension. RESULTS: In the extension, in the group previously randomized to etanercept-plus-methotrexate therapy, etanercept was continued in 259/260 patients; methotrexate continued in 260/260; and hydroxychloroquine and sulfasalazine added in 8/260 and 3/260, respectively. In the group previously randomized to conventional DMARD-plus-methotrexate therapy, conventional DMARD was discontinued in 86/126 and etanercept added in 105/126. Among etanercept-exposed patients (total exposure, 798.1 patient-year [PY]), rates of adverse events, serious adverse events, and serious infections per PY were 1.7, 0.07, and 0.02 events per PY. In both groups, after treatment modification was permitted, clinical response rates and improvements in clinical/patient-reported outcomes from baseline were sustained to week 128. CONCLUSION: After investigators were permitted to modify treatment, etanercept was part of the treatment regimen in 95% of patients. Continuation or addition of etanercept in the 2-year extension resulted in a consistently good risk:benefit profile. TRIAL REGISTRATION: Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy; ClinicalTrials.gov, number NCT00848354; https://clinicaltrials.gov/ct2/show/NCT00848354.

Vitamin D deficiency among medical residents and its relationship with metabolic indices.

OBJECTIVE: To evaluate different elements of the calciotropic system in a group of house staff physicians, comparing them with age, gender, and body mass index (BMI) matched controls. METHODS: We measured vitamin D, calcium, phosphorus, parathyroid hormone (PTH), glucose, insulin (estimating the insulin resistance index by the homeostatic model [HOMA]), and lipid levels in 20 medical residents and 20 age-, gender-, and BMI-matched controls. We looked for correlations between elements of the calciotropic system and metabolic indices. RESULTS: Medical residents and controls were similar in regard to gender distribution, weight, height, BMI, abdominal circumference, as well as systolic and diastolic blood pressure. No differences were found between the two groups in regard to low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, plasma insulin levels, and HOMA-IR. Vitamin D and calcium levels were significantly lower among the medical residents (P = .001 and P = .003, respectively), whereas PTH concentrations tended to be higher. We found an inverse correlation between triglyceride concentrations and vitamin D (r = -0.31, P = .04). CONCLUSION: Vitamin D deficiency among resident physicians is frequent and could have metabolic effects. Our findings highlight the consequences of the lack of sun exposure due to occupational reasons. We recommend a higher intake of vitamin D during this period.

Applicability of Framingham risk equations for studying a low-income Mexican population.

OBJECTIVE: To compare the predicted risk of coronary heart disease (CHD) and incident myocardial infarction (MI) using Framingham score equations with the observed rate of MI in Mexican subjects. MATERIAL AND METHODS: Longitudinal study that included 1 667 men and women aged 35 to 64 years without MI at baseline. Incident MI was defined by electrocardiogram or death certificate. The predicted risk of fatal MI, non-fatal MI, and both was calculated using Framingham score equations. Predicted to observed risk ratio of MI was estimated. RESULTS: There were 34 incident MI cases and 24 MI deaths (median follow-up 6.2 years). The score equations overestimated the prediction of incident MI and CHD death (ratio 2.27, 95% CI, 1.19-3.34) and incident MI (ratio 2.36, 95% CI, 1.07-3.65) in men. CONCLUSIONS: The Framingham score overestimated incident MI and CHD death risk in men; however, other studies are needed to confirm our results for recalibrating the score for Mexican subjects.

Applicability of Framingham risk equations for studying a low-income mexican population / Aplicabilidad del puntaje de Framingham en población mexicana de nivel socioeconómico bajo

Objective. To compare the predicted risk of coronary heart disease (CHD) and incident myocardial infarction (MI) using Framingham score equations with the observed rate of MI in Mexican subjects. Material and Methods. Longitudinal study that included 1 667 men and women aged 35 to 64 years without MI at baseline. Incident MI was defined by electrocardiogram or death certificate. The predicted risk of fatal MI, non-fatal MI, and both was calculated using Framingham score equations. Predicted to observed risk ratio of MI was estimated. Results. There were 34 incident MI cases and 24 MI deaths (median follow-up 6.2 years). The score equations overestimated the prediction of incident MI and CHD death (ratio 2.27, 95% CI, 1.19-3.34) and incident MI (ratio 2.36, 95% CI, 1.07-3.65) in men. Conclusions. The Framingham score overestimated incident MI and CHD death risk in men; however, other studies are needed to confirm our results for recalibrating the score for Mexican subjects.

Objetivo. Comparar el riesgo predicho y observado de enfermedad coronaria (EC) e infarto al miocardio (IM) usando ecuaciones del puntaje de Framingham en individuos mexicanos. Material y métodos. Estudio longitudinal de 1 667 hombres y mujeres de entre 35 a 64 años de edad y sin IM en la medición basal. IM se definió por electrocardiograma o certificado de defunción. Se estimó el riesgo predicho y la razón del riesgo predicho y observado de IM. Resultados. Durante el seguimiento (mediana de 6.2 años) hubo 34 casos y 24 defunciones por IM. El puntaje sobreestimó la predicciónde IM y muerte por EC (razón 2.27, IC 95% 1.19-3.34) e IM incidente (razón 2.36, IC 95% 1.07-3.65) en hombres. Conclusiones. En este estudio, el puntaje de Framingham sobreestimó el riesgo de IM y muerte por IM en hombres; sin embargo, estos resultados necesitan ser confirmados por otros estudios, para la posterior recalibración del puntaje en población mexicana.

[HIV in Mexican blood donors and estimated transfusional risk]. / VIH en donadores mexicanos de sangre y el riesgo calculado de la transfusión.

OBJECTIVE: To determine the HIV seroprevalence in Mexican blood donors and the residual risk of transfusion. MATERIAL AND METHODS: The seroprevalence was determined in a sample of first-time blood donors at one hospital center in Mexico City, from 2003 to 2007. To estimate the seroprevalence reported in Mexican blood donors, we reviewed recent papers. To determine the positive likelihood ratio (LR+) of the EIA test the specificity was calculated against the western-blot result. To infer the residual risk, the incident infections were assumed to be 1.8 times more frequent for first-time donors. RESULTS: We analyzed 29,318 donors; 66 were reactive to HIV by EIA (225/100,000; 95% Confidence Interval: 171 to 279/100,000), but western-blot confirmed only 5 (prevalence = 17/100,000 donors; 95% CI: 2 to 32/100,000). The maximal residual risk was inferred to be 6.2 per million, or about 6.8 per year. The LR+ of the EIA test was calculated to be 476. The Bayesian analysis estimated that the disease is present in only 7.5% donors with a reactive EIA. Published reports in medical literature do not inform confirmatory tests for Mexican donors. DISCUSSION: The residual risk for HIV had been calculated to be about 100 per million of blood donors. Although we inferred that the risk had been overestimated by not performing confirmatory tests, the results are a call for action as the risk is still several times higher than the one reported in industrialized countries.

[Microbiology of urinary tract infections in ambulatory patients. Therapeutic options in times of high antibiotic resistance]. / Microbiología de las infecciones urinarias en pacientes ambulatorios. Opciones terapéuticas en tiempos de alta resistencia a los antibióticos.

OBJECTIVE: To determine the antibiotic resistance of urinary pathogens in ambulatory patients from Mexico City, in order to infer therapeutic options in environments of high resistance. METHODS: Cross sectional survey performed between July 2006, and January 2007, in patients > or =3 year-old from a private institution. Cultured organisms were identified with a commercial biochemical system. For common antibiotics, susceptibility was performed by broth microdilution with a commercial system; for fosfomycin tromethamine, the disk diffusion test was performed. RESULTS: From 1685 urine specimens, 257 (15.3%) yielded a positive culture; 215 (83.7%) from women and 42 (16.3%) from men. Global resistance was the following: ampicillin, 68.4%; co-amoxiclav, 19.5%; ciprofloxacin, 36.3%; cephalothin, 64.7%; ceftriaxone, 12.2%; cefuroxime, 18.7%; nitrofurantoin, 19%; trimethoprim-sulphamethoxazol, 53.4%; gentamicin, 18.9%; and fosfomycin tromethamine, 0.8%. Escherichia coli was the main pathogen, with 203 (79%) isolations; its specific resistance was similar to the global one, and its production of extended-spectrum beta-lactamases (ESBLs) was 9.4%. CONCLUSIONS: The high resistance rate found is alarming; we have few options for the initial treatment of urinary tract infections in ambulatory patients. To control the problem, health authorities must regulate the indiscriminate use of antibiotics.

Microalbuminuria as a predictor of myocardial infarction in a Mexican population: the Mexico City Diabetes Study.

OBJECTIVE: Our objective was to evaluate whether microalbuminuria predicts myocardial infarction (MI) in a Mexican population. METHODS: The study was a prospective, population-based cohort. Baseline examination was carried out in 1989; the first follow-up in 1993 and the second in 1997. All men and non-pregnant women between 35 and 64 years of age at the start of the study were considered eligible. Clinical, anthropometric, and laboratory characteristics were evaluated. All patients with macroalbuminuria at baseline were excluded from the present analyses, as were all prevalent cases with MI. Remaining patients were classified as with or without microalbuminuria. Incident cases of MI were identified during follow-up phases using an electrocardiogram (according to the Minnesota Code) or the death certificate (in which underlying cause of death was listed as MI, Causes of Death codes 410.0-410.9). Results. From 2196 individuals, 1586 satisfied the inclusion criteria. Two hundred fifteen (13.6%) had microalbuminuria, and 1371 (86.4%) did not. During follow-up, 10 patients with microalbuminuria and 31 patients without microalbuminuria developed an MI. Using robust logistic regression, the probability of developing MI, adjusting by Framingham score, was estimated to be 1.90 (95% CI,.97-3.72) times higher in patients with microalbuminuria as compared with patients without microalbuminuria. CONCLUSION: We found that in a Mexican population the relationship between microalbuminuria and incidence of MI was borderline statistically significant after adjusting for other cardiovascular risk factors.

Seven-year incidence and progression of obesity. Characterization of body fat pattern evolution in low-income Mexico City urban population.

BACKGROUND: There are no prospective data regarding the natural history of obesity in Mexico. The objective of this research was to investigate the incidence and progression of obesity in a low-income sector of Mexico City and to characterize evolution of body fat pattern distribution. METHODS: We carried out a population-based, prospective survey. Total on-site population was 15,532 persons; we determined as eligible all 35 to 64-year-old men and nonpregnant women for a total of 3,505. We interviewed at baseline 3,319 (94.7%) individuals and examined 2,282 (65.1%). At follow-up approximately 7 years later, we interviewed 1,764 (77.3%) subjects and examined 1,594 (69.9%). Measurements for all participants included height, weight, body mass index (BMI), waist-hip circumference, and subscapular and triceps skinfold thickness. Overweight was defined as BMI > or = 25 and < or = 29.9 kg/m2, while grade 1 obesity was BMI >or = 30 and < or = 34.9 kg/m2, grade 2 was > or = 35 and < or = 39.9, and grade 3, > or = 40 kg/m2. RESULTS: At baseline, prevalence of overweight was 48.6%, and grade 1 obesity, 22.7%, grade 2, 5.1%, and grade 3 obesity was 1.4%; at follow-up, these were 45.2, 25.8, 6.6, and 2.3%, respectively. At baseline, mean BMI in women was 29.1 +/- 0.16 kg/m2 and in men, 27.3 +/- 0.15 kg/m2; at follow-up, it reached 29.4 +/- 0.17 kg/m2 in women and 27.4 +/- 0.16 kg/m2 in men. Waist circumference increased from mean of 99.7 +/- 0.44 cm in women to 101.2 +/- 0.42 cm; in men, mean waist circumference rose from 95.2 +/- 0.38 to 96.7 +/- 0.39 cm. CONCLUSIONS: The obesity epidemic in this population possesses serious proportions that increase risk for severe metabolic consequences. There is a need for intervention.

[Survival, clinical and laboratory characteristics of de novo and secondary megakaryoblastic leukemia]. / Supervivencia, características clínicas y de laboratorio en leucemias megacarioblásticas de novo y secundaria.

OBJECTIVE: To describe the frequency and compare the clinical characteristics, treatment response, survival and hematologic, immunophenotypic, cytogenetic, and histologic findings in adult patients with acute megakaryoblastic leukemia (AMegL) and megakaryocytic blast crisis of chronic myeloid leukemia (MegBC-CML). MATERIAL AND METHODS: The records of patients with AMegL and MegBC-CML attended in our institution between July 1993 and December 2000 were revised. Megakaryocytic lineage was established by the presence of one or more megakaryocyte/platelet associated antigens (CD41, CD42b, and CD61) in > 20% blast cells. RESULTS: In 90 months, 277 patients with acute leukemia were admitted and 25 with chronic myeloid leukemia (CML) in blast crisis (BC) were identified. Twelve of 125 patients (9.6%) with acute myeloid leukemia were AMegL and 32% of cases with CML-BC were MegBC-CML. Leukemic cells of patients with AMegL expressed more frequently CD15 antigen than blast cells of those with MegBC-CML (83% and 37.5%; p < 0.05). In contrast, blast cells expressing myeloperoxidase were present in 50% and 10% of cases with MegBC-CML and AMegL, respectively (p < 0.05). Only one patient in each group obtained remission. Although median survival in patients with AMegL was lower (70 days) than in those with MegBC-CML (175 days) the difference did not reach statistical significance. CONCLUSION: AMegL and MegBC-CML differ in some clinical and laboratory characteristics and are diseases with poor treatment response and short survival.