Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial.

BACKGROUND: Previous evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management. OBJECTIVES: The main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS. DESIGN: The SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization. SUMMARY: The SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.

Economic evaluation of the new oral anticoagulants for the prevention of thromboembolic events: a cost-minimization analysis.

CONTEXT AND OBJECTIVE: Randomized clinical trials have shown that the new oral anticoagulants have at least similar impact regarding reduction of thromboembolic events, compared with warfarin, with similar or improved safety profiles. There is little data on real costs within clinical practice. Our aim here was to perform economic analysis on these strategies from the perspective of Brazilian society and the public healthcare system. DESIGN AND SETTING: Cost-minimization analysis; anticoagulation clinic of Hospital Municipal Odilon Behrens, Belo Horizonte, MG, Brazil. METHODS: Patients at the anticoagulation clinic were recruited between August and October 2011, with minimum follow-up of four weeks. Operational and non-operational costs were calculated and corrected to 2015. RESULTS: This study included 633 patients (59% women) of median age 62 years (interquartile range -49-73). The mean length of follow-up was 64 ± 28 days. The average cost per patient per month was $ 54.26 (US dollars). Direct costs accounted for 32.5% of the total cost. Of these, 69.5% were related to healthcare professionals. With regards to indirect costs, 52.4% were related to absence from work and 47.6% to transportation. Apixaban, dabigatran and rivaroxaban were being sold to Brazilian public institutions, on average, for $ 49.87, $ 51.40 and $ 52.16 per patient per month, respectively, which was lower than the costs relating to warfarin treatment. CONCLUSION: In the Brazilian context, from the perspective of society and the public healthcare system, the cumulative costs per patient using warfarin with follow-up in anticoagulation clinics is currently higher than the strategy of prescribing the new oral anticoagulants.

Cost-Effectiveness of High, Moderate and Low-Dose Statins in the Prevention of Vascular Events in the Brazilian Public Health System / Efetividade de Estatinas em Dose Alta, Moderada e Baixa na Prevenção de Eventos Vasculares no SUS

Background: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. Objective: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. Methods: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40mg), intermediate dose; and above 40% (atorvastatin 20-80mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. Results: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. Conclusions: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil. .

Fundamento: Estatinas tem eficácia comprovada na redução de eventos cardiovasculares, mas o impacto financeiro de seu uso disseminado pode ser substancial. Objetivo: Conduzir análise de custo-efetividade de três esquemas de doses de estatinas na perspectiva do SUS. Métodos: Foi desenvolvido modelo de Markov para avaliar a razão de custo-efetividade incremental (RCEI) de regimes de dose baixa, intermediária e alta, em prevenção secundária e quatro cenários de prevenção primária (risco em 10 anos de 5%, 10%, 15% e 20%). Regimes com redução de LDL abaixo de 30% (ex: sinvastatina 10mg) foram considerados dose baixa; entre 30-40% (atorvastatina 10mg, sinvastatina 40mg), dose intermediária; e acima de 40% (atorvastatina 20-80 mg, rosuvastatina 20 mg), dose alta. Dados de efetividade foram obtidos de revisão sistemática com aproximadamente 136.000 pacientes. Dados nacionais foram usados para estimar utilidades e custos (expressos em dólares internacionais - Int$). Um limiar de disposição a pagar (LDP) igual ao produto interno bruto per capita nacional (aproximadamente Int$11.770) foi utilizado. Resultados: A dose baixa foi dominada por extensão nos cenários de prevenção primária. Nos cinco cenários, a RCEI da dose intermediária ficou abaixo de Int$10.000 por QALY. A RCEI de dose alta ficou acima de Int$27.000 por QALY em todos os cenários. Nas curvas de aceitabilidade de custo-efetividade, dose intermediária teve probabilidade de ser custo-efetiva acima de 50% com RCEIs entre Int$9.000-20.000 por QALY em todos os cenários. Conclusões: Considerando um LDP razoável, uso de estatinas em doses intermediárias é economicamente atrativo, e deveria ser intervenção prioritária na redução de eventos cardiovasculares no Brasil. .

Cost-effectiveness of high, moderate and low-dose statins in the prevention of vascular events in the Brazilian public health system.

BACKGROUND: Statins have proven efficacy in the reduction of cardiovascular events, but the financial impact of its widespread use can be substantial. OBJECTIVE: To conduct a cost-effectiveness analysis of three statin dosing schemes in the Brazilian Unified National Health System (SUS) perspective. METHODS: We developed a Markov model to evaluate the incremental cost-effectiveness ratios (ICERs) of low, intermediate and high intensity dose regimens in secondary and four primary scenarios (5%, 10%, 15% and 20% ten-year risk) of prevention of cardiovascular events. Regimens with expected low-density lipoprotein cholesterol reduction below 30% (e.g. simvastatin 10mg) were considered as low dose; between 30-40%, (atorvastatin 10mg, simvastatin 40 mg), intermediate dose; and above 40% (atorvastatin 20-80 mg, rosuvastatin 20mg), high-dose statins. Effectiveness data were obtained from a systematic review with 136,000 patients. National data were used to estimate utilities and costs (expressed as International Dollars - Int$). A willingness-to-pay (WTP) threshold equal to the Brazilian gross domestic product per capita (circa Int$11,770) was applied. RESULTS: Low dose was dominated by extension in the primary prevention scenarios. In the five scenarios, the ICER of intermediate dose was below Int$10,000 per QALY. The ICER of the high versus intermediate dose comparison was above Int$27,000 per QALY in all scenarios. In the cost-effectiveness acceptability curves, intermediate dose had a probability above 50% of being cost-effective with ICERs between Int$ 9,000-20,000 per QALY in all scenarios. CONCLUSIONS: Considering a reasonable WTP threshold, intermediate dose statin therapy is economically attractive, and should be a priority intervention in prevention of cardiovascular events in Brazil.

Suprimento de micronutrientes, adequação energética e progressão da dieta enteral em adultos hospitalizados / Adequacy of energy and micronutrient supply and progression of enteral diet in hospitalized adult patients

OBJETIVO: Avaliar a adequação da dieta enteral, em termos de micronutrientes e energia e identificar fatores interferentes na progressão da dieta enteral prescrita a adultos hospitalizados em um hospital geral de alta complexidade. MÉTODOS: Entre junho de 2004 e maio de 2005, adultos internados em um hospital de alta complexidade do sul do Brasil foram avaliados quanto às suas características clínicas e da prescrição da nutrição enteral. As características da nutrição enteral foram avaliadas e comparadas às recomendações diárias de ingestão, obtendo-se o percentual de adequação de nutrientes prescritos na dieta enteral em relação aos valores de recomendação para cada paciente. Os fatores associados à prescrição de energia foram identificados por meio de Regressão Linear Múltipla. RESULTADOS: Foram acompanhados 230 pacientes em uso de nutrição enteral. As recomendações diárias foram alcançadas satisfatoriamente para vitaminas hidrossolúveis (exceto ácido fólico), lipossolúveis (exceto vitamina D) e minerais (exceto cálcio). Em média, as prescrições iniciais de nutrição enteral ofereceram 24,0kcal/kg/dia (desvio-padrão=10,8, e valores mínimo e máximo de 4,3 a 69,2), e progrediram até 28,4kcal/kg/dia (desvio-padrão=11,8, valores mínimo e máximo de 1,4 a 69,2). A recomendação de 25 a 35kcal/kg/dia foi prescrita para 32,6% dos pacientes. Para 15,7% dos pacientes foram prescritas acima de 40kcal/kg/dia. Somente o índice de massa corporal e o número de dias de hospitalização, ajustados para a quantidade de energia já inicialmente prescrita, associaram-se de forma independente à prescrição energética final. CONCLUSÃO: Pequena proporção das prescrições esteve adequada em relação à quantidade de energia, e a progressão da dieta enteral ocorreu independentemente das características clínicas dos pacientes.

OBJECTIVE: To asses the adequacy of enteral diet, in terms of micronutrients and energy and to identify factors that interfere in the progression of enteral diets prescribed to adults hospitalized in a high complexity general hospital. METHODS: From June 2004 to May 2005, adult patients hospitalized in a high complexity hospital, in Southern Brazil, were assessed in terms of enteral diet prescription and clinical characteristics. The characteristics of the enteral nutrition were assessed and compared with the recommended daily intakes, obtaining percentages of nutrient adequacy of the enteral diet. Factors associated with energy prescription were identified by multiple linear regression. RESULTS: Two hundred and thirty tube-fed patients were followed. The dietary reference intakes were satisfatory met for water-soluble vitamins (except for folic acid), fat-soluble vitamins (except for vitamin D) and minerals (except for calcium). The mean initial energy prescription was 24.0 kcal/kg/day (standard deviation=10.8, minimum and maximum values ranging from 4.3 to 69.2kcal/kg/day) and progressed to 28.4kcal/kg/day (standard deviation=11.8, minimum and maximum values ranging from 1.4 to 9.2kcal/kg/day).The recommendation of 25 to 35kcal/kg/day was prescribed to 32.% of patients. Forty or more kcal/kg/day was presuibed to 15.7% of the patients. Only body mass index and the number of hospital stay days, adjusted to the energy prescribed at the beginning, were independently associated with the final energy prescription. CONCLUSION: A small proportion of the prescriptions were adequate in terms of Kcal/kg/day, and the progression of enteral diet occurs regardless of the clinical characteristics of the patients.