Evaluación de costo/efectividad de tres combinaciones fijas de acetaminofén y opiáceos para el manejo del dolor agudo en Colombia

ResumenObjetivoComparar diferencias en costo-efectividad de 3 formulaciones comercializadas en Colombia (acetaminofén 500mg + codeína 30mg [AC], acetaminofén 500mg + hidrocodona 5mg [AH] y acetaminofén 325mg + tramadol 37,5mg [AT]) indicadas para el tratamiento del dolor agudo moderado-severo.Materiales y métodosAnálisis de costo-efectividad, usando el NNT como medida de desenlace. Los costos fueron evaluados en 2 canales específicos: canal institucional (CI), representado por los costos relacionados con el medicamento consignados en SISMED 2011, y canal al por menor (CM), que representa los precios al consumidor tomados de IMS promedio anual 2011 más margen de farmacia (10%). Se calcularon las razones de costo-efectividad incremental (RCEI) para las 3 formulaciones en cada canal (CI y CM). Los valores de las intervenciones fueron expresados en pesos colombianos.ResultadosLos precios/NNT para cada formulación fueron $1.816 COP/2,2 para AC,$4.772 COP/2,3 para AH y $5.342/2,6 para AT. Con base en estos datos y tomando AC como el comparador, las RCEI para las otras formulaciones fueron: en el CM,$5.065COP para la formulación AT y $19.600COP para la formulación AH; en el CI,$8.790COP para la formulación AT y $29.460COP para la formulación AH. El análisis de sensibilidad probabilístico evidencia que las observaciones simuladas se ubican entre el primer y el cuarto cuadrante del plano de costo-efectividad, tomando como referente AC.ConclusiónEl análisis, desde la perspectiva del tercer pagador y el paciente, permite concluir que la formulación AC tiene un menor costo y mayor efectividad para reducir el dolor en las primeras 4-6h, comparada con AH y AT es sus indicadores específicos.AbstractObjectiveTo compare the cost–effectiveness of three different formulations indicated for moderate and severe acute pain, commercialized in Colombia [acetaminophen500 mg + codeine 30 mg (AC), acetaminophen 500 mg + hydrocodone 5 mg (AH) andacetaminophen 325 mg + tramadol 37.5 mg (AT)].Materials and methodsCost–effectiveness analysis using the NNT as the health outcome indicator. The costs were evaluated in two specific settings: Institutional Channel (IC), rep-resenting the cost for the Colombian Ministry of Health (SISMED 2011); Retail Channel (RC), representing consumer prices, obtained from the IMS annual average for 2011, plus an adjustment to include the average profit margin for pharmacies (10$1816 COP/2.2 for AC, $4772 COP/2.3 for AH and$5342/2.6 for AT. Using these data and taking AC as the comparator, the ICER for the other formulations shows the following results: in the RC, $5065 COP for AT and$19,600COP for AH; in the IC setting, $8790 COP for AT and$29,460 COP for AH. The probabilistic sensitivity analysis demonstrated that the majority of simulation results fell between the1st and 4th quadrants of the cost–effectiveness matrix, using AC as a reference.ConclusionThe analysis, from the payer and patient perspectives, demonstrates that the AC formulation has a lower cost and is more effective in reducing pain within the first 4–6 h after administration, compared with the AH and AT formulations in their specific indications

Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone

<p>Abstract</p> <p>Background</p> <p>Poor control of type 2 diabetes results in substantial long-term consequences. Studies of new diabetes treatments are rarely designed to assess mortality, complication rates and costs. We sought to estimate the long-term consequences of liraglutide and rosiglitazone both added to glimepiride.</p> <p>Methods</p> <p>To estimate long-term clinical and economic consequences, we used the CORE diabetes model, a validated cohort model that uses epidemiologic data from long-term clinical trials to simulate morbidity, mortality and costs of diabetes. Clinical data were extracted from the LEAD-1 trial evaluating two doses (1.2 mg and 1.8 mg) of a once daily GLP-1 analog liraglutide, or rosiglitazone 4 mg, on a background of glimepiride in type 2 diabetes. CORE was calibrated to the LEAD-1 baseline patient characteristics. Survival, cumulative incidence of cardiovascular, ocular and renal events and healthcare costs were estimated over three periods: 10, 20 and 30 years.</p> <p>Results</p> <p>In a hypothetical cohort of 5000 patients per treatment followed for 30 years, liraglutide 1.2 mg and 1.8 mg had higher survival rates compared to the group treated with rosiglitazone (15.0% and 16.0% vs. 12.6% after 30 years), and fewer cardiovascular, renal, and ocular events. Cardiovascular death rates after 30 years were 69.7%, 68.4% and 72.5%, for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively. First and recurrent amputations were lower in the rosiglitazone group, probably due to a 'survival paradox' in the liraglutide arms (number of events: 565, 529, and 507, respectively). Overall cumulative costs per patient, were lower in both liraglutide groups compared to rosiglitazone (US$38,963,$39,239, and $40,401 for liraglutide 1.2 mg, 1.8 mg, and rosiglitazone, respectively), mainly driven by the costs of cardiovascular events in all groups.</p> <p>Conclusion</p> <p>Using data from LEAD-1 and epidemiologic evidence from the CORE diabetes model, projected rates of mortality, diabetes complications and healthcare costs over the long term favor liraglutide plus glimepiride over rosiglitazone plus glimepiride.</p> <p>Trial registration</p> <p>LEAD-1 NCT00318422; LEAD-2 NCT00318461; LEAD-3 NCT 00294723; LEAD-4 NCT00333151; LEAD-5 NCT00331851; LEAD-6 NCT00518882.</p

Estudio IDEA (International Day for Evaluation of Abdominal Obesity) : prevalencia de obesidad abdominal y factores de riesgo asociados en atención primaria en Colombia

Introducción. La obesidad está asociada con factores de riesgo para enfermedades cardiovasculares y metabólicas. La obesidad central, marcador de adiposidad intraabdominal aumentada, es mejor factor de riesgo para aterosclerosis y diabetes que el índice de masa corporal (IMC), y buen predictor de riesgo de morbimortalidad cardiovascular, síndrome metabólico y diabetes. Objetivo. Estimar prevalencias de obesidad por IMC y de obesidad abdominal por circunferencia abdominal en pacientes de atención primaria en Colombia. Materiales y métodos. Como parte de un estudio internacional, 105 médicos de atención primaria elegidos al azar reclutaron consecutivamente a pacientes de 18 a 80 años, que consultaran por cualquier razón, en dos medios días especificados previamente. Se registraron edad, sexo, tabaquismo, antecedentes cardiovasculares, diabetes, altura, peso y circunferencia abdominal mediante métodos estandarizados. Se excluyeron mujeres embarazadas y quienes no quisieran participar. Resultados. Se evaluaron 3.795 pacientes, con edad promedio de 45 años (69 % mujeres). El 60,7% de los hombres y el 53,9 % de las mujeres tenían sobrepeso u obesidad según el IMC. El 24,6 % de los hombres y el 44,6 % de las mujeres tenían obesidad abdominal (según las guías del National Cholesterol Education Program), pero las cifras cambiaban a 62,5 % y 67,0 %, respectivamente, si se consideraban las guías de la International Diabetes Federation. La obesidad, determinada por el IMC o por la circunferencia abdominal, se asoció con mayor prevalencia de diabetes, hipertensión y dislipidemia. Conclusiones. El aumento de la circunferencia abdominal es un marcador práctico y útil para enfermedades cardiovasculares y metabólicas. La prevalencia de obesidad abdominal en pacientes de atención primaria en Colombia fue alta, y más frecuente en mujeres.Q3Artículo original610-616Introduction. Obesity is frequently associated with risk factors for cardiovascular and metabolic diseases. Central obesity is a marker of increased intra-abdominal adiposity and a known risk factor for atherosclerosis and diabetes; it is also a good predictor of risk for coronary events, cardiovascular mortality, diabetes and metabolic syndrome. A less predictive alternate measurement is known as the body mass index (BMI). Objective. Obesity prevalence was estimated first by BMI and then by abdominal obesity (measured by waist circumference, WC) in primary care patients. Materials and methods. As part of an international study, primary care physicians recruited consecutive patients aged 18 to 80 years who consulted for any reason on two pre-specified half-days. Age, gender, smoking status and history of cardiovascular disease or diabetes were recorded. Height, weight and WC were measured using standard methods. Pregnant women and subjects unwilling to participate were excluded. Results. A total of 3,795 patients from 105 primary care centers located throughout Colombia were evaluated. The mean age was 45 years (69% females). Of these, 60.7% of males and 53.9% of females were overweight or obese according to their BMI; 24.6% of males and 44.6% of females had abdominal obesity when National Cholesterol Education Program guidelines were used, but numbers changed to 62.5% and 67.0% when the International Diabetes Federation guidelines were used. Obesity, either determined by BMI or by WC, was associated with higher prevalence of diabetes, hypertension and dyslipidemia. Conclusions. Increased waist circumference is a practical and useful marker for cardiovascular and metabolic conditions. The prevalence of abdominal obesity in Colombian primary care patients is high and more frequent in females

Estudio IDEA (International Day for Evaluation of Abdominal Obesity): prevalencia de obesidad abdominal y factores de riesgo asociados en atención primaria en Colombia

Introduction. Obesity is frequently associated with risk factors for cardiovascular and metabolic diseases. Central obesity is a marker of increased intra-abdominal adiposity and a known risk factor for atherosclerosis and diabetes; it is also a good predictor of risk for coronary events, cardiovascular mortality, diabetes and metabolic syndrome. A less predictive alternate measurement is known as the body mass index (BMI).Objective. Obesity prevalence was estimated first by BMI and then by abdominal obesity (measuredby waist circumference, WC) in primary care patients.Materials and methods. As part of an international study, primary care physicians recruited consecutive patients aged 18 to 80 years who consulted for any reason on two pre-specified half-days. Age, gender, smoking status and history of cardiovascular disease or diabetes were recorded. Height, weight and WC were measured using standard methods. Pregnant women and subjects unwilling to participate were excluded.Results. A total of 3,795 patients from 105 primary care centers located throughout Colombia were evaluated. The mean age was 45 years (69% females). Of these, 60.7% of males and 53.9% of females were overweight or obese according to their BMI; 24.6% of males and 44.6% of females had abdominal obesity when National Cholesterol Education Program guidelines were used, but numbers changed to62.5% and 67.0% when the International Diabetes Federation guidelines were used. Obesity, either determined by BMI or by WC, was associated with higher prevalence of diabetes, hypertension and dyslipidemia.Conclusions. Increased waist circumference is a practical and useful marker for cardiovascular and metabolic conditions. The prevalence of abdominal obesity in Colombian primary care patients is highand more frequent in females. doi: http://dx.doi.org/10.7705/biomedica.v32i4.799Introducción. La obesidad está asociada con factores de riesgo para enfermedades cardiovasculares y metabólicas. La obesidad central, marcador de adiposidad intraabdominal aumentada, es mejor factor de riesgo para aterosclerosis y diabetes que el índice de masa corporal (IMC), y buen predictor de riesgo de morbimortalidad cardiovascular, síndrome metabólico y diabetes.Objetivo. Estimar prevalencias de obesidad por IMC y de obesidad abdominal por circunferencia abdominal en pacientes de atención primaria en Colombia.Materiales y métodos. Como parte de un estudio internacional, 105 médicos de atención primaria elegidos al azar reclutaron consecutivamente a pacientes de 18 a 80 años, que consultaran por cualquier razón, en dos medios días especificados previamente. Se registraron edad, sexo, tabaquismo, antecedentes cardiovasculares, diabetes, altura, peso y circunferencia abdominal mediante métodos estandarizados. Se excluyeron mujeres embarazadas y quienes no quisieran participar.Resultados. Se evaluaron 3.795 pacientes, con edad promedio de 45 años (69 % mujeres). El 60,7% de los hombres y el 53,9 % de las mujeres tenían sobrepeso u obesidad según el IMC. El 24,6 % de los hombres y el 44,6 % de las mujeres tenían obesidad abdominal (según las guías del National Cholesterol Education Program), pero las cifras cambiaban a 62,5 % y 67,0 %, respectivamente, si se consideraban las guías de la International Diabetes Federation. La obesidad, determinada por el IMC o por la circunferencia abdominal, se asoció con mayor prevalencia de diabetes, hipertensión y dislipidemia.Conclusiones. El aumento de la circunferencia abdominal es un marcador práctico y útil para enfermedades cardiovasculares y metabólicas. La prevalencia de obesidad abdominal en pacientes de atención primaria en Colombia fue alta, y más frecuente en mujeres. doi: http://dx.doi.org/10.7705/biomedica.v32i4.799

Effect of inhaled corticosteroid particle size on asthma efficacy and safety outcomes: a systematic literature review and meta-analysis

BACKGROUND: Inhaled corticosteroids (ICS) are the primary treatment for persistent asthma. Currently available ICS have differing particle size due to both formulation and propellant, and it has been postulated that this may impact patient outcomes. This structured literature review and meta-analysis compared the effect of small and standard particle size ICS on lung function, symptoms, rescue use (when available) and safety in patients with asthma as assessed in head-to-head randomized controlled trials (RCTs). METHODS: A systematic literature search of MEDLINE was performed to identify RCTs (1998-2014) evaluating standard size (fluticasone propionate-containing medications) versus small particle size ICS medication in adults and children with asthma. Efficacy outcomes included forced expiratory volume in 1 s (FEV1), morning peak expiratory flow (PEF), symptom scores, % predicted forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%), and rescue medication use. Safety outcomes were also evaluated when available. RESULTS: Twenty-three independent trials that met the eligibility criteria were identified. Benefit-risk plots did not demonstrate any clinically meaningful differences across the five efficacy endpoints considered and no appreciable differences were noted for most safety endpoints. Meta-analysis results, using a random-effects model, demonstrated no significant difference between standard and small size particle ICS medications in terms of effects on mean change from baseline FEV1 (L) (-0.011, 95% confidence interval [CI]: -0.037, 0.014 [N = 3524]), morning PEF (L/min) (medium/low doses: -3.874, 95% CI: -10.915, 3.166 [N = 1911]; high/high-medium doses: 5.551, 95% CI: -1.948, 13.049 [N = 749]) and FEF25-75% predicted (-2.418, 95% CI: -6.400; 1.564 [N = 115]). CONCLUSIONS: Based on the available literature, no clinically significant differences in efficacy or safety were observed comparing small and standard particle size ICS medications for the treatment of asthma. TRIAL REGISTRATION: GSK Clinical Study Register No: 202012

Examining the BMI-mortality relationship using fractional polynomials

<p>Abstract</p> <p>Background</p> <p>Many previous studies estimating the relationship between body mass index (BMI) and mortality impose assumptions regarding the functional form for BMI and result in conflicting findings. This study investigated a flexible data driven modelling approach to determine the nonlinear and asymmetric functional form for BMI used to examine the relationship between mortality and obesity. This approach was then compared against other commonly used regression models.</p> <p>Methods</p> <p>This study used data from the National Health Interview Survey, between 1997 and 2000. Respondents were linked to the National Death Index with mortality follow-up through 2005. We estimated 5-year all-cause mortality for adults over age 18 using the logistic regression model adjusting for BMI, age and smoking status. All analyses were stratified by sex. The multivariable fractional polynomials (MFP) procedure was employed to determine the best fitting functional form for BMI and evaluated against the model that includes linear and quadratic terms for BMI and the model that groups BMI into standard weight status categories using a deviance difference test. Estimated BMI-mortality curves across models were then compared graphically.</p> <p>Results</p> <p>The best fitting adjustment model contained the powers -1 and -2 for BMI. The relationship between 5-year mortality and BMI when estimated using the MFP approach exhibited a J-shaped pattern for women and a U-shaped pattern for men. A deviance difference test showed a statistically significant improvement in model fit compared to other BMI functions. We found important differences between the MFP model and other commonly used models with regard to the shape and nadir of the BMI-mortality curve and mortality estimates.</p> <p>Conclusions</p> <p>The MFP approach provides a robust alternative to categorization or conventional linear-quadratic models for BMI, which limit the number of curve shapes. The approach is potentially useful in estimating the relationship between the full spectrum of BMI values and other health outcomes, or costs.</p

Global, regional, and national levels and causes of maternal mortality during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

The fifth Millennium Development Goal (MDG 5) established the goal of a 75% reduction in the maternal mortality ratio (MMR; number of maternal deaths per 100 000 livebirths) between 1990 and 2015. We aimed to measure levels and track trends in maternal mortality, the key causes contributing to maternal death, and timing of maternal death with respect to delivery

Global, regional, and national incidence and mortality for HIV, tuberculosis, and malaria during 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

BACKGROUND: The Millennium Declaration in 2000 brought special global attention to HIV, tuberculosis, and malaria through the formulation of Millennium Development Goal (MDG) 6. The Global Burden of Disease 2013 study provides a consistent and comprehensive approach to disease estimation for between 1990 and 2013, and an opportunity to assess whether accelerated progress has occured since the Millennium Declaration. METHODS: To estimate incidence and mortality for HIV, we used the UNAIDS Spectrum model appropriately modified based on a systematic review of available studies of mortality with and without antiretroviral therapy (ART). For concentrated epidemics, we calibrated Spectrum models to fit vital registration data corrected for misclassification of HIV deaths. In generalised epidemics, we minimised a loss function to select epidemic curves most consistent with prevalence data and demographic data for all-cause mortality. We analysed counterfactual scenarios for HIV to assess years of life saved through prevention of mother-to-child transmission (PMTCT) and ART. For tuberculosis, we analysed vital registration and verbal autopsy data to estimate mortality using cause of death ensemble modelling. We analysed data for corrected case-notifications, expert opinions on the case-detection rate, prevalence surveys, and estimated cause-specific mortality using Bayesian meta-regression to generate consistent trends in all parameters. We analysed malaria mortality and incidence using an updated cause of death database, a systematic analysis of verbal autopsy validation studies for malaria, and recent studies (2010-13) of incidence, drug resistance, and coverage of insecticide-treated bednets. FINDINGS: Globally in 2013, there were 1·8 million new HIV infections (95% uncertainty interval 1·7 million to 2·1 million), 29·2 million prevalent HIV cases (28·1 to 31·7), and 1·3 million HIV deaths (1·3 to 1·5). At the peak of the epidemic in 2005, HIV caused 1·7 million deaths (1·6 million to 1·9 million). Concentrated epidemics in Latin America and eastern Europe are substantially smaller than previously estimated. Through interventions including PMTCT and ART, 19·1 million life-years (16·6 million to 21·5 million) have been saved, 70·3% (65·4 to 76·1) in developing countries. From 2000 to 2011, the ratio of development assistance for health for HIV to years of life saved through intervention was US$4498 in developing countries. Including in HIV-positive individuals, all-form tuberculosis incidence was 7·5 million (7·4 million to 7·7 million), prevalence was 11·9 million (11·6 million to 12·2 million), and number of deaths was 1·4 million (1·3 million to 1·5 million) in 2013. In the same year and in only individuals who were HIV-negative, all-form tuberculosis incidence was 7·1 million (6·9 million to 7·3 million), prevalence was 11·2 million (10·8 million to 11·6 million), and number of deaths was 1·3 million (1·2 million to 1·4 million). Annualised rates of change (ARC) for incidence, prevalence, and death became negative after 2000. Tuberculosis in HIV-negative individuals disproportionately occurs in men and boys (versus women and girls); 64·0% of cases (63·6 to 64·3) and 64·7% of deaths (60·8 to 70·3). Globally, malaria cases and deaths grew rapidly from 1990 reaching a peak of 232 million cases (143 million to 387 million) in 2003 and 1·2 million deaths (1·1 million to 1·4 million) in 2004. Since 2004, child deaths from malaria in sub-Saharan Africa have decreased by 31·5% (15·7 to 44·1). Outside of Africa, malaria mortality has been steadily decreasing since 1990. INTERPRETATION: Our estimates of the number of people living with HIV are 18·7% smaller than UNAIDS's estimates in 2012. The number of people living with malaria is larger than estimated by WHO. The number of people living with HIV, tuberculosis, or malaria have all decreased since 2000. At the global level, upward trends for malaria and HIV deaths have been reversed and declines in tuberculosis deaths have accelerated. 101 countries (74 of which are developing) still have increasing HIV incidence. Substantial progress since the Millennium Declaration is an encouraging sign of the effect of global action. FUNDING: Bill & Melinda Gates Foundation