Carme Piñol

Acarbose in ambulatory treatment of non-insulin-dependent diabetes mellitus associated to imminent sulfonylurea failure: A randomised-multicentric trial in primary health-care

To assess the efficacy and safety of acarbose as an adjunct to high sulfonylurea (SU) doses in patients with imminent SU failure, a randomised, multicentric, 6 month double-blind, parallel and placebo-controlled trial was performed in primary healthcare. Entry criteria were: NIDDM patients in concomitant dietary follow-up, age > 40 year-old, more than 3 years of diagnosed diabetes, baseline HbAlc levels between 8-12% (N: 4-6%), stable body mass index < 35 kg m-2 and glibenclamide daily dose > 10 mg. After 1 month placebo run-in period all patients were randomly allocated into two groups of treatment (acarbose 100 mg t.i.d. vs placebo). HbAlc levels, the main efficacy variable, lipid profile, fasting and postprandial blood glucose levels were performed and adverse events were also recorded. A total number of 65 patients were randomised, 36 in acarbose and 29 in a placebo group. No statistical differences were found on age (60.2/61.7 year-old), BMI (28.7/27.4 kg m-2), glibenclamide dose (14.5/14.0 mg/day) and baseline HbAlc (9.0/8.8%). Acarbose-treated patients significantly reduced HbAlc levels (9.0/7.9 vs 8.8/8.5%; P < 0.01), based upon a marked decrease, but statistically not significant, in mean postprandial plasma glucose levels (11.9/9.6 vs 12.4/11.1 mmol l-1). No significant differences between fasting plasma glucose and lipid profile were detected. A total of 31 patients (47.7%) reported adverse events, 20 (55.5%) and 11 (37.9%) in acarbose and placebo treatment group respectively. Relationship with drug was estimated as possible or probable in 16 (44.4%) of acarbose-treated patients. None of them were excluded from study participation due to insulin requirement. Only seven patients (10.7%), six with acarbose (16.6%) and one with placebo (3.8%), withdrew the study because of the adverse events. Thus, acarbose seems to be a useful option in order to improve HbAlc levels in non-insulin-dependent diabetes mellitus with imminent sulfonylurea failure.

Evaluación económica del tratamiento con ácido acetilsalicílico en dosis bajas en la prevención primaria de enfermedades cardiovasculares

Introduccion y objetivos El acido acetilsalicilico (AAS) en dosis bajas es un tratamiento estandar en pacientes con antecedentes de enfermedades cardiovasculares (ECV); se discute su empleo en prevencion primaria. Recientes estudios apoyan su uso en personas de alto riesgo y sin antecedentes de ECV. Se evaluo la repercusion economica del uso de AAS en la prevencion primaria de ECV en Espana. Metodos Se desarrollo un modelo para estimar la relacion coste/efectividad del tratamiento con AAS a dosis bajas en la prevencion primaria de ECV a los 10 anos. Se estudiaron los costes directos desde la perspectiva del Sistema Nacional de Salud (SNS) espanol. Los resultados se expresaron como coste por anos de vida ganados y por anos de vida ajustados por calidad. Resultados La administracion de AAS en dosis bajas a personas con riesgo de enfermedad coronaria (EC) ≥ 15% a los 10 anos produce un ahorro neto medio de 797 euros (intervalo de confianza [IC] del 95%, 263-1.331 euros), que empieza el primer ano. A partir de un riesgo annual ≥ 0,24%, este tratamiento ahorra costes al SNS. El tratamiento con AAS a toda la poblacion espanola con riesgo produciria un ahorro de 26,5 millones de euros en servicios sanitarios desde el primer ano. Conclusiones El tratamiento con AAS en dosis bajas de individuos con riesgo de EC ≥ 15% a los 10 anos produciria un ahorro de costes significativo al SNS. Los analisis de sensibilidad prueban la robustez de los resultados.

Coste-efectividad de la adición de acarbosa al tratamiento de pacientes con diabetes tipo 2 en España

Objectives: To assess the cost-effectiveness of the addition of acarbose to existing treatment in patients with type 2 dia- betes mellitus (DM2) in Spain. Methods: The CORE Diabetes Model (a published and va- lidated computer simulation model) was used to project long- term clinical and cost outcomes in DM2. Transition probabili- ties and risk adjustments were derived from published sources. Treatment effects and baseline cohort characteris- tics were based on a meta-analysis. Direct costs were retrie- ved from published sources and projected over patient lifeti- mes from the perspective of the Spanish National Health Service. Costs and clinical benefits were discounted at 3% per year. Sensitivity analyses were performed. Results: Acarbose treatment was associated with improved life expectancy (0.23 years) and quality-adjusted life years (QALY) (0.21 years). Direct costs were on average A 468 per patient more expensive with acarbose than with placebo. The incremental cost-effectiveness ratios were A 2,002 per life year gained and A 2,199 per QALY gained. An acceptability curve showed that with a willingness to pay A 20,000, which is ge- nerally accepted to represent very good value for money, acar- bose treatment was associated with a 93.5% probability of being cost-effective. Conclusions: This long-term economic study showed that the addition of acarbose to existing therapy for DM2 was asso- ciated with improvements in life expectancy and QALYs in these patients.

Cost-effectiveness of the addition of acarbose to the treatment of patients with type-2 diabetes in Spain

OBJECTIVES To assess the cost-effectiveness of the addition of acarbose to existing treatment in patients with type 2 diabetes mellitus (DM2) in Spain. METHODS The CORE Diabetes Model (a published and validated computer simulation model) was used to project long-term clinical and cost outcomes in DM2. Transition probabilities and risk adjustments were derived from published sources. Treatment effects and baseline cohort characteristics were based on a meta-analysis. Direct costs were retrieved from published sources and projected over patient lifetimes from the perspective of the Spanish National Health Service. Costs and clinical benefits were discounted at 3% per year. Sensitivity analyses were performed. RESULTS Acarbose treatment was associated with improved life expectancy (0.23 years) and quality-adjusted life years (QALY) (0.21 years). Direct costs were on average euro 468 per patient more expensive with acarbose than with placebo. The incremental cost-effectiveness ratios were euro 2,002 per life year gained and euro 2,199 per QALY gained. An acceptability curve showed that with a willingness to pay euro 20,000, which is generally accepted to represent very good value for money, acarbose treatment was associated with a 93.5% probability of being cost-effective. CONCLUSIONS This long-term economic study showed that the addition of acarbose to existing therapy for DM2 was associated with improvements in life expectancy and QALYs in these patients.

[Health economic evaluation of low-dose acetylsalicylic acid in the primary prevention of cardiovascular disease].

INTRODUCTION AND OBJECTIVES Low-dose aspirin is standard treatment for patients with a history of cardiovascular disease. Its use in primary prevention is more controversial. However, recent studies also support the use of aspirin in high-risk individuals with no history of cardiovascular disease. This study investigated the health economic implications of using low-dose aspirin in the primary prevention of cardiovascular disease in Spain. METHODS A model was developed to predict the cost-effectiveness of low-dose aspirin in the primary prevention of cardiovascular disease over a period of 10 years. The direct costs used were those of the Spanish National Health Service (NHS). Results were expressed as cost per life-year gained and per quality-adjusted life-year gained. RESULTS Administering low-dose aspirin to an individual with a 10-year risk of coronary heart disease > or =15% resulted in an average net saving of e 797 (95% CI, e 263-1331) over the 10-year period, with savings starting in the first year. For an annual risk > or =0.24%, this form of treatment would reduce NHS costs. Treating all at-risk individuals in the Spanish population with aspirin would save e 26.5 million from the healthcare budget, starting in the first year. CONCLUSIONS Administering low-dose aspirin to individuals with a 10-year risk of coronary heart disease > or =15% would result in significant cost savings for the Spanish NHS. Sensitivity analysis confirmed the robustness of these findings.

Análisis de minimización de costes de fludarabina (Beneflur®) oral vs. vía intravenosa en España

Introduction: Various international studies have shown that fl udarabine is effective, safe, and effi cient for treating B-cell chronic lymphocytic leukemia (B-CLL). The purpose of the present study was to carry out a cost-minimization analysis for two alternative forms of fl udarabine (oral and intravenous) used to treat B-CLL in Spain. Methods: The presence of clinical evidence about the treatment equivalence of the two options being compared (oral fl udarabine vs. intravenous fl udarabine) led us to carry out a cost-minimization analysis. A pharmacoeconomic model was constructed to compile data from the literature and experts’ opinions in order to determine the use of health resources associated with the treatment; unit costs were obtained from Spanish databases. The analysis contemplated two perspectives: that of the national health service, which includes only direct health costs, and the social perspective, which also includes the indirect costs that result from loss of productivity. Results: Although fludarabine in its oral form has a higher purchase price than generic intravenous fl udarabine does, increased administration costs for the latter, which is used in hospitals, mean that oral fl udarabine use produces total savings of €1,908 and €1,292 for single-drug therapy and combined therapy with cyclophosphamide, respectively. Including indirect costs increased the savings associated with the oral form of the drug. Conclusions: In B-CLL patients, treatment with oral fl udarabine has a lower cost than treatment with intravenous fludarabine, in both single-drug therapy and combined therapy. Various sensitivity analyses confi rmed these results and showed that oral fl udarabine should be the treatment of choice for B-CLL in Spain, unless contraindicated.

Evaluación económica del tratamiento con ácido acetilsalicílico más esomeprazol comparado con clopidogrel en la prevención de la hemorragia gastrointestinal

Objetivo: Evaluar la eficiencia del acido acetilsalicilico (AAS) mas esomeprazol frente a clopidogrel en la prevencion de la hemorragia gastrointestinal. Metodos: Analisis coste-efectividad (arbol de decision de 2 ramas: AAS mas esomeprazol y clopidogrel) respecto a la evitacion de casos de hemorragia gastrointestinal en 2 anos, y analisis de sensibilidad. Resultados: El coste total del tratamiento con AAS mas esomeprazol (2.865 S por paciente libre de hemorragia) fue inferior al clopidogrel (2.965 S). El tratamiento con AAS resulto dominante. En todos los analisis de sensibilidad la combinacion siguio siendo dominante. Al sustituir esomeprazol 40 mg por omeprazol 40 mg, el coste del tratamiento combinado descendio hasta 1.934S/por episodio evitado. Conclusiones: La asociacion de esomeprazol y AAS es mas coste-efectiva que clopidogrel en la prevencion de la hemorragia gastrointestinal. La combinacion con omeprazol resulta aun mas coste-efectiva.

PCN16 COST-EFFECTIVENESS OF SORAFENIB VERSUS BEST SUPPORTIVE CARE IN ADVANCED RENAL CELL CARCINOMA IN SPAIN

PCN14 COST-EFFECTIVENESS STUDY OF AN ASPIRIN CHEMOPREVENTION ASSOCIATED OR NOT WITH A COLONOSCOPIC SURVEILLANCE IN THE COLORECTAL CANCER Francesconi C, Benamouzig R, Launois R REES, Paris, France, Hopital Avicenne, Bobigny, France OBJECTIVES: To compare the medical and economical impact of four strategies in the prevention of colorectal cancer (CRC) in France: (1) no treatment and no surveillance (reference strategy); (2) chemoprevention with 325 mg daily aspirin; (3) colonoscopic surveillance with a 3, 5 or 10-year periodicity; and (4) the combination of the two latter strategies. METHODS: A Markov decision model was built, following a fictive 50-year-old cohort during 30 years. Effectiveness was assessed by CRC incidence and life expectancy. Transition probabilities were defined after an extensive review of literature. Only direct costs were considered. The various strategies were compared calculating incremental cost-effectiveness ratios. Determinist and probabilistic sensitivity analyses were carried out. RESULTS: Given an effectiveness of chemoprevention of 25%, the most effective strategy was the association chemoprevention and colonoscopic surveillance. While 4248 CRC for 100,000 persons were expected in a population without treatment or surveillance, 3228 CRC could be avoided with this association, 2798 with a colonoscopic surveillance and 1339 with the chemoprevention only. The more effective the strategy was, the more expensive it was. Compared with the reference strategy, the incremental cost-effectiveness ratio of the chemoprevention was €3279 per life-year gained. Compared with chemoprevention, colonoscopic surveillance involved an incremental cost of €6611 per life-year gained. The addition of a chemoprevention by aspirin among a screened population would result in an incremental cost-effectiveness ratio of €22,000 per life-year saved. Moreover, in the 5000 Monte Carlo simulations, the combination strategy was dominated by colonoscopic surveillance in 16% of cases. CONCLUSIONS: The 3 strategies of prevention or screening has acceptable incremental cost-effectiveness ratios according to the international standards. Contrary to common opinion, primary prevention through colonoscopic surveillance is cost-effective. Moreover, chemoprevention by aspirin appears to be an efficient strategy when it is associated to a colonoscopic surveillance.

Análisis de coste-efectividad del ácido acetilsalicílico frente al clopidogrel en prevención secundaria tras infarto agudo de miocardio

ResumenObjetivo: Realizar una evaluación económica del tipo coste-efectividad, desde la perspectiva del Sistema Nacional de Salud (SNS) español, del uso de ácido acetil salicílico (AAS) a bajas dosis en comparación con clopidogrel en la prevención secundaria de nuevos eventos cardiovasculares en pacientes con un infarto agudo de miocardio (IAM) previo. Material y métodos: Con los datos de eficacia del estudio CAPRIE sobre la incidencia de nuevos eventos cardiovasculares en un grupo de pacientes con un IAM previo, se modelizan las consecuencias sanitarias y económicas del uso de dos tratamientos: AAS y clopidogrel, en esta indicación. El horizonte temporal fue de dos años. Los costes utilizados en este análisis se refieren al SNS español para el año 2004. Resultados: En el caso base, el coste total del tratamiento con AAS (1.515 €) resulta muy inferior al coste con clopidogrel (2.942 €). Los resultados de eficacia en el subgrupo con un IAM previo, son relativamente mejores para el AAS, aunque las diferencias no son estadísticamente significativas. Con los supuestos adoptados en el caso base, el tratamiento con el AAS resulta dominante (mayor o igual eficacia y menor coste) respecto al tratamiento con clopidogrel. Bajo ninguno de los supuestos estudiados en el análisis de sensibilidad el tratamiento con AAS dejó de ser dominante respecto al clopidogrel. Conclusiones: El AAS es un tratamiento efectivo, seguro y coste-efectivo en la prevención secundaria de eventos cardiovasculares en pacientes con un IAM previo, y continua siendo el antiagregante plaquetario de elección para esta indicación.SummaryObjective: To perform an economic evaluation of the use of low dose acetylsalicylic acid (ASA) in comparison with clopidogrel in the prevention of cardiovascular events in patients with a previous myocardial infarction (MI) using a cost-effectiveness analysis in the setting of the Spanish National Health Service. Material and methods: Using the efficacy data from the CAPRIE study on the incidence of new cardiovascular events in a group of patients with a previous MI, the sanitary and economic consequences of the use of the two treatments, ASA and clopidogrel, in this indication were modelled. The temporal horizon was two years. The costs used in this analysis refer to the year 2004 in the Spanish National Health Service setting. Results: In the base case, the total cost of the ASA treatment (1,515 €) was considerably inferior to that of clopidogrel (2,942 €). The efficacy results in the subgroup of patients with a previous MI, are comparatively better with ASA, however the difference is not statistically significant. With the assumptions adopted in the base case, treatment with ASA is superior (better or equal efficacy and less cost) when compared to treatment with clopidogrel. The treatment with ASA was found to be superior to that of clopidogrel in all of the scenarios studied in the analysis of sensitivity. Conclusions: The treatment with ASA is effective, safe and cost-effective in the secondary prevention of cardiovascular events in patients with a previous MI, and is still the first choice antiplatelet therapy for this indication.

PHC8 COST-EFFECTIVENESS OF RIVAROXABANVERSUS ENOXAPARIN FORTHROMBOPROPHYLAXIS AFTER TOTAL KNEE REPLACEMENT IN THE UK AND SPAIN

Objective Venous thromboembolism (VTE: the composite of deep vein thrombosis [DVT] and pulmonary embolism [PE]) is the outcome of a clot, which forms within a vein and then travels through the blood vessels to a different site Total knee replacement (TKR) surgery is an important risk factor for VTE1 With more than 66,000 TKRs being performed in the UK2 and almost 17,000 being performed in Spain annually, the potential impact is large3