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- The current and future burden of heart failure in PortugalPublication . Gouveia, Miguel; Ascenção, Raquel; Fiorentino, Francesca; Costa, João; Caldeira, Daniel; Broeiro-Gonçalves, Paula; Fonseca, Candida; Borges, MargaridaAIMS: Heart failure (HF) is a clinical syndrome with significant social and economic burden. We aimed to estimate the burden of HF in mainland Portugal over a 22-year time horizon, between 2014 and 2036. METHODS AND RESULTS: Heart failure burden was measured in disability-adjusted life years (DALYs), resulting from the sum of years of life lost (YLL) due to premature death and years lost due to disability (YLD). YLL were estimated based on the Portuguese mortality rates reported by the European Detailed Mortality Database. For YLD, disease duration and the overall incidence were estimated using an epidemiological model developed by the World Health Organization (DISMOD II). Disability weights were retrieved from published literature. The impact of ageing was estimated with a shift-share analysis using official demographic projections. In 2014, 4688 deaths were attributed to HF, corresponding to 4.7% of the total deaths in mainland Portugal. DALYs totalled 21 162, 53.9% due to premature death (YLL: 11 398) and 46.1% due to disability (YLD: 9765). Considering only population ageing over a 22-year horizon, the deaths and burden of HF are expected to increase by 73.0% and 27.9%, respectively, reaching 8112 deaths and 27 059 DALYs lost due to HF in 2036. DALY's growth is mainly driven by the increase of YLL, whose contribution to overall burden will increase to 62.0%. CONCLUSIONS: Heart failure is an emerging and growing health problem where significant health gains may be obtained. The projected significant increase of HF burden highlights the need to set HF as a priority for healthcare system.
- O custo e a carga da esquizofrenia em Portugal em 2015Publication . Gouveia, Miguel; Ascenção, Raquel; Fiorentino, Francesca; Pascoal, João; Costa, João; Borges, MargaridaIntrodução: A esquizofrenia é uma importante causa de incapacidade e consumo de recursos económicos. Neste estudo pretendemos estimar os custos e a carga da esquizofrenia para 2015 em Portugal Continental. Métodos: A carga da doença foi medida pelos anos de vida ajustados pela incapacidade (DALY- Disability-adjusted life years), uma métrica adotada pela Organização Mundial de Saúde. O custo da doença foi estimado com base na prevalência adotando a perspetiva global da sociedade. Os custos incluíram os consumos de recursos e os custos indiretos dos doentes e cuidadores (perdas de produtividade). As principais fontes de informação de custos foram: a base de dados GDH; os contratos programa; dados de consumo de medicamentos e opinião de peritos. Resultados: A prevalência da esquizofrenia será cerca de 48 mil doentes, sendo que o número de doentes seguidos pelo sistema de saúde (público e privado) deverá estar na ordem dos 41 mil doentes. Em 2015, estima-se que se tenham perdido 28.588 DALY (84% por incapacidade; 16% por mortalidade prematura). A preços de 2015, o total estimado de custos diretos e indiretos da esquizofrenia foi respetivamente de € 96,1 e € 340,3 milhões (97% gerados pelos doentes). Conclusão: A esquizofrenia tem um importante impacto social em Portugal devido essencialmente à morbilidade gerada, podendo-se-lhe atribuir em 2015 um custo total de € 436,3 milhões, cerca de 0,24% do produto interno bruto. Os custos diretos representam 0,6 % de todas as despesas de saúde em 2015, enquanto a totalidade dos custos (diretos e indiretos) representam 2,7% da despesa em saúde.
- Clinical comparability of the new antiepileptic drugs in refractory partial epilepsy : a systematic review and meta-analysisPublication . Costa, João; Fareleira, Filipa; Ascenção, Raquel; Borges, Margarida; Sampaio, Cristina; Carneiro, António VazPurpose: Evaluate the clinical comparability of new antiepileptic drugs (AEDs) in partial refractory epilepsy. Methods: Systematic review of randomized trials (RCTs) comparing a new AED (add-on treatment) with placebo or another AED. Primary outcomes: responder (≥50% seizure reduction) and withdrawal (tolerability) rates. Pooled estimates of odds ratios (ORs) and number needed treat/harm (NNT/NNH) taking into account baseline risk were derived by random-effects meta-analysis. Adjusted frequentist indirect comparisons between AEDs were estimated. Key Findings: Sixty-two placebo-controlled (12,902 patients) and eight head-to-head RCTs (1,370 patients) were included. Pooled ORs for responder and withdrawal rates (vs. placebo) were 3.00 [95% confidence interval (CI) 2.63–3.41] and 1.48 (1.30–1.68), respectively. Indirect comparisons of responder rate based on relative measurements of treatment effect (ORs) favored topiramate (1.52; 1.06–2.20) in comparison to all other AEDs, whereas gabapentin (0.67; 0.46–0.97) and lacosamide (0.66; 0.48–0.92) were less efficacious, without significant heterogeneity. When analyses were based on absolute estimates (NNTs), topiramate and levetiracetam were more efficacious, whereas gabapentin and tiagabine were less efficacious. Withdrawal rate was higher with oxcarbazepine (OR 1.60; 1.12–2.29) and topiramate (OR 1.68; 1.07–2.63), and lower with gabapentin (OR 0.65; 0.42–1.00) and levetiracetam (OR 0.62; 0.43–0.89). Significance: The differences found are of relatively small magnitude to allow a definitive conclusion about which new AED(s) has superior effectiveness. This uncertainty probably reflects the limitations of conclusions based on indirect evidence. The process of pharmacologic clinical decision making in partial refractory epilepsy probably depends more on other aspects, such as individual patient characteristics and pharmacoeconomics, than on available controlled randomized evidence.
- Cost-effectiveness of sacubitril/valsartan for the treatment of patients with heart failure with reduced ejection fraction in PortugalPublication . Borges, Margarida; Afonso Silva, Marta; Laires, Pedro A.; Gouveia, Miguel; Alarcão, Joana; Ascenção, Raquel; Costa, JoãoObjectives: This study assesses the cost-effectiveness of sacubitril/valsartan versus enalapril in patients with symptomatic heart failure with reduced ejection fraction (HFrEF). Methods: We used a previously developed Markov model calibrated with patient-level data from the PARADIGM-HF trial, adapted to the Portuguese setting. The model considers two health states (alive or dead) and uses regression analyzes to estimate hospitalizations and deaths over time. A panel of experts estimated resource consumption in the outpatient setting. To estimate resource consumption with hospitalizations, the National Health Service Diagnosis Related Groups database was used. Unit costs were based on national legislation, and on the Infomed database. The model considers a societal perspective, a time horizon of 30-years, and a 5% annual discount rate. Sensitivity analyses assessed the robustness of results. Results: Sacubitril/valsartan increases life expectancy by 0.5 life-years, corresponding to 0.4 incremental quality adjusted life-years (QALY) versus enalapril. The estimated incremental cost-effectiveness ratio (ICER) is 22,702€/QALY. Sensitivity analysis shows that results are robust, but sensitive to the parameter estimates of the cardiovascular survival curve. Conclusion: Sacubitril/valsartan is a cost-effective therapeutic option in the treatment of Portuguese patients with HFrEF and translate into significant health gains and increased life expectancy versus the current standard of care.
- A generalização dos resultados de estudos clínicos através da análise de subgruposPublication . Costa, João; Fareleira, Filipa; Ascenção, Raquel; Carneiro, António VazSubgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.
- Cost and burden of hypercholesterolemia In PortugalPublication . Gouveia, M.; Borges, Margarida; Augusto, M.; Caldeira, Daniel; Alarcão, Joana; Pinheiro, L.; Sousa, R.; Fareleira, F.; Ascenção, Raquel; Costa, João; Laires, P.; Fiuza, Manuela; Cortez-Dias, Nuno; Martins, S.; Belo, A.; Carneiro, António VazHypercholesterolemia is a risk factor for ciculatory diseases. This study estimates the impact of hypercholesterolemia on populations’ health levels and its economic impact in Portugal.
- Atherosclerosis : real-world insights from a Portuguese primary care databasePublication . Ascenção, Raquel; Alarcão, Joana; Fiorentino, Francesca; Gouveia, Miguel; Costa, João; Araújo, F.; Mello e Silva, A.; Borges, MargaridaObjectives: Cardiovascular disease remains the leading cause of death in Portugal and across the world. Atherosclerosis is the most common pathophysiologic process underlying CVD. Its clinical manifestations include coronary artery disease (CAD), cerebrovascular disease (CVD) and peripheral artery disease (PAD). This study aims to determine the clinical and demographic characteristics of adult patients with atherosclerosis in a Portuguese primary care comprehensive administrative database.