[Characterization of the drug supply in Argentina]. / Caracterización de la oferta de medicamentos en la República Argentina.

INTRODUCTION: Knowing the characteristics of the pharmaceutical market allows obtaining sensitive information to understand the supply, demand and access of the population to medicines. In order to provide primary data regarding the marketing of drugs in Argentina, the following research was performed. METHOD: This is a cross-sectional quantitative-qualitative descriptive study of the Argentine pharmaceutical market, taking into account 30 years of official information provided by the National Regulatory Agency (ANMAT). RESULTS: Two hundred and sixteen laboratories (182 national) drug producers / importers, 53 distributors and 479 drugstores (wholesale drug distribution establishments) were identified. A high concentration of marketing was detected, grouping 90% in only 5 intermediaries. There are currently 6670 products/certificates in the country, an amount that fluctuated over the last 30 years. Six laboratories are owners of between 116 and 208 certificates; 84% of these products come from national laboratories, 5002 are mono-drugs, while 83% are marketed under a fancy name. The three main indications for which the registration of drugs in Argentina is intended are diseases of digestive system, nervous system and infectious diseases; 58% of the marketed products consist of oral formulations. DISCUSSION: Based on data provided by this study, it is possible to assert that the Argentinian pharmaceutical market has a majority share of national capital, with a great concentration in a few pharmaceutical companies and distributors. The products are mostly available as non-combined drugs, in their oral form, and available by their brand names.

Introducción: Conocer las características del mercado farmacéutico permite obtener información sensible para entender la oferta, la demanda y el acceso de la población a los medicamentos. Con el objetivo de aportar datos primarios respecto a la comercialización de fármacos en Argentina, se desarrolló la siguiente investigación. Métodos: Se trata de un estudio descriptivo cuantitativo-cualitativo transversal del mercado farmacéutico argentino, tomando en cuenta 30 años de información oficial aportada por la Agencia Reguladora Nacional (ANMAT). Resultados: Se identificaron 216 laboratorios (182 nacionales) productores/importadores de medicamentos, 53 distribuidores y 479 droguerías (establecimientos de distribución de medicamentos al por mayor). Se detectó una alta concentración de la comercialización, agrupándose el 90% de la misma, en solo 5 intermediarios. En el país existen actualmente 6670 productos/certificados, cantidad que fluctuó a lo largo de los últimos 30 años. Seis laboratorios son dueños de entre 116 y 208 certificados. El 84% de estos productos provienen de laboratorios nacionales, 5002 son monofármacos, mientras que el 83% se comercializa bajo un nombre de fantasía. Las tres principales indicaciones a las que se destina el registro de medicamentos en la Argentina son enfermedades del aparato digestivo, sistema nervioso, e infecciosas; el 58% es comercializado como formulaciones orales. Discusión: el presente trabajo muestra que el mercado farmacéutico argentino tiene una participación mayoritaria de capitales nacionales, existiendo gran concentración en pocas empresas productoras y distribuidoras. Los productos son mayormente monodrogas comercializadas en forma oral y ofrecidas por su nombre de fantasía.

Caracterización de la oferta de medicamentos en la República Argentina / Characterization of the drug supply in Argentina

Resumen Introducción : Conocer las características del mercado farmacéutico permite obtener información sensible para entender la oferta, la demanda y el acceso de la pobla ción a los medicamentos. Con el objetivo de aportar da tos primarios respecto a la comercialización de fármacos en Argentina, se desarrolló la siguiente investigación. Métodos : Se trata de un estudio descriptivo cuanti tativo-cualitativo transversal del mercado farmacéutico argentino, tomando en cuenta 30 años de información oficial aportada por la Agencia Reguladora Nacional (ANMAT). Resultados : Se identificaron 216 laboratorios (182 nacionales) productores/importadores de medicamentos, 53 distribuidores y 479 droguerías (establecimientos de distribución de medicamentos al por mayor). Se detectó una alta concentración de la comercialización, agrupán dose el 90% de la misma, en solo 5 intermediarios. En el país existen actualmente 6670 productos/certificados, cantidad que fluctuó a lo largo de los últimos 30 años. Seis laboratorios son dueños de entre 116 y 208 certifica dos. El 84% de estos productos provienen de laboratorios nacionales, 5002 son monofármacos, mientras que el 83% se comercializa bajo un nombre de fantasía. Las tres principales indicaciones a las que se destina el registro de medicamentos en la Argentina son enfermedades del aparato digestivo, sistema nervioso, e infecciosas; el 58% es comercializado como formulaciones orales. Discusión : el presente trabajo muestra que el mer cado farmacéutico argentino tiene una participación mayoritaria de capitales nacionales, existiendo gran concentración en pocas empresas productoras y distri buidoras. Los productos son mayormente monodrogas comercializadas en forma oral y ofrecidas por su nombre de fantasía.

Abstract Introduction : Knowing the characteristics of the phar maceutical market allows obtaining sensitive informa tion to understand the supply, demand and access of the population to medicines. In order to provide primary data regarding the marketing of drugs in Argentina, the following research was performed. Method : This is a cross-sectional quantitative-quali tative descriptive study of the Argentine pharmaceutical market, taking into account 30 years of official information provided by the National Regulatory Agency (ANMAT). Results : Two hundred and sixteen laboratories (182 national) drug producers/importers, 53 distributors and 479 drugstores (wholesale drug distribution establishments) were identified. A high concentration of market ing was detected, grouping 90% in only 5 intermediaries. There are currently 6670 products/certificates in the country, an amount that fluctuated over the last 30 years. Six laboratories are owners of between 116 and 208 certificates; 84% of these products come from na tional laboratories, 5002 are mono-drugs, while 83% are marketed under a fancy name. The three main indica tions for which the registration of drugs in Argentina is intended are diseases of digestive system, nervous system and infectious diseases; 58% of the marketed products consist of oral formulations. Discussion : Based on data provided by this study, it is possible to assert that the Argentinian pharmaceutical market has a majority share of national capital, with a great concentration in a few pharmaceutical companies and distributors. The products are mostly available as non-combined drugs, in their oral form, and available by their brand names.

Effectiveness of rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV vaccines for risk of infection with SARS-CoV-2 and death due to COVID-19 in people older than 60 years in Argentina: a test-negative, case-control, and retrospective longitudinal study.

BACKGROUND: In January, 2021, a vaccination campaign against COVID-19 was initiated with the rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV vaccines in Argentina. The objective of this study was to estimate vaccine effectiveness at reducing risk of SARS-CoV-2 infection and COVID-19 deaths in people older than 60 years. METHODS: In this test-negative, case-control, and retrospective longitudinal study done in Argentina, we evaluated the effectiveness of three vaccines (rAd26-rAd5, ChAdOx1 nCoV-19, and BBIBP-CorV) on SARS-CoV-2 infection and risk of death in people with RT-PCR confirmed COVID-19, using data from the National Surveillance System (SNVS 2.0). All individuals aged 60 years or older reported to SNVS 2.0 as being suspected to have COVID-19 who had disease status confirmed with RT-PCR were included in the study. Unvaccinated individuals could participate in any of the analyses. People with suspected COVID-19 who developed symptoms before the start of the implementation of the vaccination programme for their age group or district were excluded from the study. The odds ratio of SARS-CoV-2 infection was evaluated by logistic regression and the risk of death in individuals with RT-PCR confirmed COVID-19 was evaluated by proportional hazard regression models, adjusted for possible confounders: age at the time of the symptom onset date, sex, district of residence, epidemiological week corresponding to the symptom onset date, and history of COVID-19. The estimation of vaccine effectiveness to prevent death due to COVID-19 was done indirectly by combining infection and death estimates. In addition, we evaluated the effect of the first dose of viral vector vaccines across time. FINDINGS: From Jan 31, to Sept 14, 2021, 1 282 928 individuals were included, of whom 687 167 (53·6%) were in the rAd26-rAd5 analysis, 358 431 (27·6%) in the ChAdOx1 nCoV-19 analysis, and 237 330 (18·5%) in the BBIBP-CorV analysis. Vaccine effectiveness after two doses was high for all three vaccines, adjusted odds ratio 0·36 (95% CI 0·35-0·37) for rAd26-rAd5, 0·32 (0·31-0·33) for ChAdOx1 nCoV-19, and 0·56 (0·55-0·58) for BBIBP-CorV. After two doses, the effect on deaths was higher than that on risk of infection: adjusted hazard ratio 0·19 (95% CI 0·18-0·21) for rAd26-rAd5, 0·20 (0·18-0·22) for ChAdOx1 nCoV-19, and 0·27 (0·25-0·29) for BBIBP-CorV. The indirectly estimated effectiveness on deaths was 93·1% (95% CI 92·6-93·5) for rAd26-rAd5, 93·7% (93·2-94·3) for ChAdOx1 nCoV-19, and 85·0% (84·0-86·0) for BBIBP-CorV following two doses. First dose effect of viral vector vaccines remained stable over time. INTERPRETATION: The vaccines used in Argentina showed effectiveness in reducing infection and death by SARS-CoV-2 and COVID-19. FUNDING: None.

Seroepidemiologicalmonitoring of SARS-CoV-2 IgG in main railway stations in the city of Buenos Aires, Argentina / Monitoreo seroepidemiológico de igg contra el sars-cov-2 en estaciones ferroviarias cabeceras de la ciudad autónoma de buenos aires, argentina

RESUMEN INTRODUCCIÓN : Los estudios de seroprevalencia permiten monitorear la circulación del SARS-CoV-2 y dan información para evaluar medidas sanitarias. El objetivo fue conocer la proporción y evolución de la seropositividad en puntos de gran circulación de la Ciudad Autónoma de Buenos Aires (CABA) y las características clínico-epidemiológicas de los seropositivos, de abril a octubre de 2020. MÉTODOS : Se realizó un estudio descriptivo transversal de seis rondas de testeos rápidos serológicos y una encuesta de datos epidemiológicos. Se realizó un muestreo por conveniencia en tres estaciones ferroviarias cabeceras de CABA consideradas puntos de alto tránsito bidireccional del Área Metropolitana de Buenos Aires. RESULTADOS : Participaron 7339 personas. La proporción de seropositivos fue 0,6% (IC95%: 0,2-0,9) en la primera ronda y aumentó a 5,6% en la última (IC95%: 4,3-7). Al inicio aumentó la seropositividad en residentes de CABA y de la zona sur de la Región Metropolitana de Buenos Aires. El antecedente de haber presentado síntomas y el de contacto con personas con COVID-19 fueron las únicas variables relacionadas con el resultado de inmunoglobulina G positivo (p <0,05). El 56,1% (n = 97) de los seropositivos no tuvo síntomas. El 78,4% (n = 134) no fue diagnosticado en la etapa aguda. DISCUSIÓN : La seropositividad fue en ascenso en cada ronda, en coincidencia con la situación epidemiológica de la zona de residencia. Las características epidemiológicas como la proporción de seropositivos sin antecedentes de síntomas, reafirman la importancia de las medidas sanitarias poblacionales.

ABSTRACT INTRODUCTION : Seroprevalence studies allow monitoring the circulation of SARS-CoV-2, providing information to evalúate public health measures. The aim of this study was to determine the proportion and evolution of seropositivity in high circulation points in the Ciudad Autónoma de Buenos Aires (CABA) and clinical and epidemiological characteristics of seropositive individuals from April to October 2020. METHODS : A descriptive cross-sectional study was conducted during six rounds, using rapid serological testing together with an epidemiological data survey. A convenience sample was selected in three CABA railway stations considered as high bi-directional traffic points in the Buenos Aires Metropolitan Area (AMBA). RESULTS : 7,339 people participated. The seropositive proportion was 0.6% (95%CI: 0.2-0.9) in the first round, and rose to 5.6% in the last one (95%CI: 4.3-7). Initially, seropositivity increased in CABA residents and those living in the southern part of the Buenos Aires Metropolitan Region. Having presented symptoms and history of contact with COVID-19 cases were the only variables found to be related to positive IgG results (p<0.05). Among seropositive participantes, 56.1% (n=97) had no symptoms and 78.4% (n=134) didn't receive a COVID-19 diagnosis in the acute stage. DISCUSSION : Seropositivity increased between rounds, according to the epidemiological situation in the area of residence. Epidemiological characteristics, such as the proportion of seropositive individuals with no history of symptoms, reaffirm the importance of public health and social measures.

Monitoreo seroepidemiológico de IGG contra el SARS-COV-2 en estaciones ferroviarias cabeceras de la Ciudad Autónoma de Buenos Aires / Seroepidemiological monitoring of SARS-CoV-2 IgG in main railway stations in the city of Buenos Aires, Argentina

INTRODUCCIÓN: Los estudios de seroprevalencia permiten monitorear la circulación del SARS-CoV-2 y dan información para evaluar medidas sanitarias. El objetivo fue conocer la proporción y evolución de la seropositividad en puntos de gran circulación de la Ciudad Autónoma de Buenos Aires (CABA) y las características clínico-epidemiológicas de los seropositivos, de abril a octubre de 2020. MÉTODOS: Se realizó un estudio descriptivo transversal de seis rondas de testeos rápidos serológicos y una encuesta de datos epidemiológicos. Se realizó un muestreo por conveniencia en tres estaciones ferroviarias cabeceras de CABA consideradas puntos de alto tránsito bidireccional del Área Metropolitana de Buenos Aires. RESULTADOS: Participaron 7339 personas. La proporción de seropositivos fue 0,6% (IC95%: 0,2-0,9) en la primera ronda y aumentó a 5,6% en la última (IC95%: 4,3-7). Al inicio aumentó la seropositividad en residentes de CABA y de la zona sur de la Región Metropolitana de Buenos Aires. El antecedente de haber presentado síntomas y el de contacto con personas con COVID-19 fueron las únicas variables relacionadas con el resultado de inmunoglobulina G positivo (p <0,05). El 56,1% (n = 97) de los seropositivos no tuvo síntomas. El 78,4% (n = 134) no fue diagnosticado en la etapa aguda. DISCUSIÓN: La seropositividad fue en ascenso en cada ronda, en coincidencia con la situación epidemiológica de la zona de residencia. Las características epidemiológicas como la proporción de seropositivos sin antecedentes de síntomas, reafirman la importancia de las medidas sanitarias poblacionales.

Safe and unsafe abortions: Total monetary costs and health care system costs in Argentina in 2018. / Abortos seguros e inseguros: Costos monetarios totales y costos para el sistema de salud de la Argentina en 2018.

During the first semester of 2018, a profound debate on the legalization of the practice of abortion was initiated in Argentina, which exposed the lack of scientific studies addressing the economic dimension of abortion in this country. This work seeks to move forward in the quantification of the costs of abortion under two scenarios: the current context of illegality and the potential costs if the recommended international protocols were applied in a context of legalization of the practice. The results of the comparison between, on the one hand, the total monetary costs in 2018 (private or out-of-pocket expenditure and costs for the health care system) of the current scenario of illegality and unsafe practice of abortion and, on the other hand, potential scenarios of safe practices, shows that a large amount of resources could be saved if the recommended protocols were implemented. These results proved to be robust after carrying out a series of sensitivity exercises on the main assumptions included in the comparisons.

Durante el primer semestre de 2018, en Argentina se inició un profundo debate sobre la legalización de la práctica del aborto, que puso en evidencia la falta de estudios científicos que aborden la dimensión económica del tema en la Argentina. Este trabajo busca avanzar en la cuantificación de los costos del aborto bajo dos escenarios: el del actual contexto de ilegalidad y los costos potenciales si se aplicaran los protocolos internacionales recomendados, en un contexto de legalización de la práctica. Los resultados de la comparación de los costos monetarios totales en 2018 (privados o de bolsillo y para el sistema de salud) del escenario actual de ilegalidad y práctica insegura del aborto, frente a escenarios potenciales de prácticas seguras, muestran que se podría ahorrar una gran cantidad de recursos si se implementaran los protocolos recomendados. Dichos resultandos, además, se muestran robustos al realizar una serie de ejercicios de sensibilidad sobre los principales supuestos incluidos en las comparaciones.

Abortos seguros e inseguros: Costos monetarios totales y costos para el sistema de salud de la Argentina en 2018 / Safe and unsafe abortions: Total monetary costs and health care system costs in Argentina in 2018

RESUMEN Durante el primer semestre de 2018, en Argentina se inició un profundo debate sobre la legalización de la práctica del aborto, que puso en evidencia la falta de estudios científicos que aborden la dimensión económica del tema en la Argentina. Este trabajo busca avanzar en la cuantificación de los costos del aborto bajo dos escenarios: el del actual contexto de ilegalidad y los costos potenciales si se aplicaran los protocolos internacionales recomendados, en un contexto de legalización de la práctica. Los resultados de la comparación de los costos monetarios totales en 2018 (privados o de bolsillo y para el sistema de salud) del escenario actual de ilegalidad y práctica insegura del aborto, frente a escenarios potenciales de prácticas seguras, muestran que se podría ahorrar una gran cantidad de recursos si se implementaran los protocolos recomendados. Dichos resultandos, además, se muestran robustos al realizar una serie de ejercicios de sensibilidad sobre los principales supuestos incluidos en las comparaciones.

ABSTRACT During the first semester of 2018, a profound debate on the legalization of the practice of abortion was initiated in Argentina, which exposed the lack of scientific studies addressing the economic dimension of abortion in this country. This work seeks to move forward in the quantification of the costs of abortion under two scenarios: the current context of illegality and the potential costs if the recommended international protocols were applied in a context of legalization of the practice. The results of the comparison between, on the one hand, the total monetary costs in 2018 (private or out-of-pocket expenditure and costs for the health care system) of the current scenario of illegality and unsafe practice of abortion and, on the other hand, potential scenarios of safe practices, shows that a large amount of resources could be saved if the recommended protocols were implemented. These results proved to be robust after carrying out a series of sensitivity exercises on the main assumptions included in the comparisons.

Comparison of cost-effectiveness of oral rapamycin plus bare-metal stents versus first generation of drug-eluting stents (from the Randomized Oral Rapamycin in Argentina [ORAR] 3 trial).

The aim of this study was to compare 5-year cost-effectiveness and clinical outcomes of patients with oral rapamycin (OR) plus bare-metal stent versus the drug-eluting stent (DES) strategy. During 2006 to 2007, a total of 200 patients were randomized to OR (n = 100) and DES (n = 100). Primary end point was to compare costs of initial procedure and cost-effectiveness of both revascularization strategies. Safety was evaluated by the composite of death, myocardial infarction, and cerebrovascular accident. Efficacy was assessed by target vessel and target lesion revascularizations. The 2 groups had similar baseline demographic, clinical, and angiographic characteristics. In the DES group, paclitaxel-, zotarolimus-, and sirolimus-eluting stents were used. Five-year clinical follow-up was accomplished in 99% patients. The DES group had significantly higher procedural (p <0.001), discharge to first-year (p = 0.02), and 1- to 5-year costs (p <0.001) compared with the OR group. At 5 years, the composite end point of death, myocardial infarction, and cerebrovascular accident (12% in the OR group vs 25% in the DES group, p = 0.01) was significantly less in the OR group. Target vessel revascularization (14.5% in the OR group vs 21% in the DES group, p = 0.16) and target lesion revascularization (10% in the OR group vs 17.6% in the DES group, p = 0.05) were not significantly different. In conclusion, a strategy of OR plus bare-metal stent was cost saving than a first-generation DES.

Diseño y preparación de formas farmacéuticas sólidas de Benznidazol para el tratamiento de la Enfermedad de Chagas / Design and Preparation fo Pharmaceutical Solid Dosage Forms of Benznidazole for the Treatment of Chagas Disease

INTRODUCCIÓN: En Argentina se emplea el benznidazolcomo terapéutica de primera línea para el tratamiento etiológico del Chagas. Desde su lanzamiento (hace más de 40 años), sólo se dispone de comprimidos convencionales de 100 mg; no se han desarrollado nuevas formas farmacéuticas que aumenten la eficacia y seguridad, ni alternativas con dosis pediátricas. OBJETIVOS: Desarrollar formas farmacéuticas de benznidazol que ofrezcan ventajas farmacoterapéuticas. MÉTODOS: Preformulación y diseño de nuevas formulaciones de benznidazol, con caracterización físico-química y selección de las formulaciones más favorables. Frente a la discontinuidad de producción del ingrediente activo benznidazol, se desarrolló una metodología de extracción a partir de 8520/8520/nica alternativa comercial disponible. RESULTADOS: Se obtuvieron nuevas formulaciones de comprimidos de 50 y 100 mg debenznidazol, con una rápida disolución del producto de referencia. Además, se obtuvieron formulaciones masticables de 50 mg bajo la forma de hidrogeles azucarados, con un efectivo enmascaramiento del mal sabor. Todas las formulaciones cumplieron los ensayos de evaluación de las propiedades farmacotécnicas y biofarmacéuticas, superando los perfiles de referencia. CONCLUSIONES: Se desarrollaron nuevas alternativas farmacéuticas de benznidazol de rápida disolución, que podrían mejorar el tratamiento etiológico de la enfermedad(especialmente en pediatría) y convertirse en herramientas aptas para su explotación comercial

INTRODUCTION: In Argentina, benznidazole is the drug of choice for the etiological treatment of Chagas disease. Since it was launched (more than 40 years ago), there are only 100 mg tablets available; the development included neither new pharmaceutical forms improving efficacy and safety, nor a pediatric dosage option. OBJECTIVES: To develop pharmaceutical form sof benznidazole with pharmacotherapeutic advantages. METHODS: Preformulation and design of new formulation sof benznidazole, with physicochemical characterization and selection of the most favorable formulations. Due to the discontinuity in the production of the active ingredient benznidazole, a specific methodology was developed in order to obtain it from the only commercially available alternative. RESULTS: New benznidazole tablet formulations were obtained (50 and 100 mg), with a rapid dissolution of the reference product, as well as chewable formulation sof 50 mg as sugar hydrogels featuring an effective taste masking. All formulations passed the evaluation tests for pharmacotechnical and biopharmaceutical properties, out performing the reference profiles. CONCLUSIONS:New fast-dissolving pharmaceutical dosage forms of benznidazole were developed, which could improve the etiological treatment of the disease (especially in the pediatric field) and become a proper tool for its commercial exploitation

Dengue en la Argentina: un análisis económico del impacto de la epidemia de 2009 / Dengue in Argentina: an economic analysis of the impact of the 2009 epidemic

El presente estudio estima la carga económica de los casos notificados de dengue durante la epidemia argentina de 2009. Entre los costos considerados, se encuentran los costos médicos para el tratamiento de las personas afectadas y los costos de oportunidad de aquellas personas que dejaron de trabajar o estudiar a causa de la enfermedad. Para la determinación de los costos, a fines de 2009 se llevó a cabo una encuesta ad hoc a 201 hogares en los que habitaban personas que habían padecido la enfermedad durante la epidemia. Los resultados obtenidos permiten estimar entre los 26 y los 40 millones de pesos (entre 6 y 9 millones de dólares) el costo total de los casos notificados. Las regiones del norte argentino son las que habrían soportado la mayor carga económica (más del 90% de la carga total). Para todas las regiones, el costo social de un caso de dengue representaría más del 40% de la remuneración neta mensual promedio de los individuos.

The present study estimates the economic burden associated with the cases of dengue recorded during the 2009 Argentine epidemic. Among the costs considered are the medical costs necessary for the treatment of those affected and the opportunity costs for those who stopped working or studying because of the disease. In order to assess the costs of the disease, at the end of 2009 an ad-hoc survey was carried out in 201 households where people that had contracted dengue during the 2009 epidemic lived. The results allow us to estimate between 26 to 40 million Argentine pesos (6 to 9 million US dollars) as the total cost of the recorded cases. The regions in the north of Argentina bore the highest economic burden of the disease (more than 90% of the total burden). For all regions, the social cost of one dengue case accounts for more than 40% of the average monthly net individual income.

[Dengue in Argentina: an economic analysis of the impact of the 2009 epidemic]. / Dengue en la Argentina: un análisis económico del impacto de la epidemia de 2009.

The present study estimates the economic burden associated with the cases of dengue recorded during the 2009 Argentine epidemic. Among the costs considered are the medical costs necessary for the treatment of those affected and the opportunity costs for those who stopped working or studying because of the disease. In order to assess the costs of the disease, at the end of 2009 an ad-hoc survey was carried out in 201 households where people that had contracted dengue during the 2009 epidemic lived. The results allow us to estimate between 26 to 40 million Argentine pesos (6 to 9 million US dollars) as the total cost of the recorded cases. The regions in the north of Argentina bore the highest economic burden of the disease (more than 90% of the total burden). For all regions, the social cost of one dengue case accounts for more than 40% of the average monthly net individual income.

Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study.

AIMS: Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. METHODS AND RESULTS: Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. CONCLUSIONS: A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.