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- Burden of disease and cost of illness of atrial fibrillation in PortugalPublication . Gouveia, Miguel; Costa, João; Alarcão, Joana; Augusto, Margarida; Caldeira, Daniel; Pinheiro, Luís; Carneiro, António Vaz; Borges, MargaridaIntroduction and Objectives: Atrial fibrillation is the most prevalent sustained arrhythmia. This paper estimates the burden and cost of illness attributable to atrial fibrillation in Portugal based on demographic and health statistics. Methods: Mortality data by cause of death came from the European Detailed Mortality Database of the World Health Organization (WHO). Hospital data were taken from the Portuguese diagnosis-related groups database. The burden of disease was measured using DALYs (disability-adjusted life years), a metric adopted by the WHO. Costs studied included resource use and lost productivity. The burden and cost of illness are those attributable to atrial fibrillation and its main complication, ischemic stroke. Results: In Portugal, 4070 deaths were attributable to atrial fibrillation in 2010, corresponding to 3.8% of all deaths. In total, the burden of disease attributable to atrial fibrillation was estimated at 23 084 DALYs: 10 521 resulting from premature deaths (1.7% of the total DALYs due to death in 2010 in Portugal), and 12 563 resulting from disability. The total estimated direct costs attributable to atrial fibrillation at 2013 prices were 115 MD (million euros): 34 MD for inpatient care and 81 MD for outpatient care. Indirect costs resulting from lost production due to disability were estimated at 25 MD. Conclusions: Atrial fibrillation has an important social impact in Portugal due to its associated mortality and morbidity, and was responsible in 2013 for a total cost of 140 MD , about 0.08% of gross domestic product.
- Indicadores (outcomes) primários e secundários em ensaios clínicos oncológicos : definição e usosPublication . Carneiro, António Vaz; Luz, Ricardo; Borges, Margarida; Costa, JoãoIntroduction: The proof of efficacy from a therapeutic intervention in oncology must be defined through well conducted clinical trials. One of the most important methodological issue is the outcome selection needed to calculate measures of association allowing definition of clinical efficacy. Material and Methods: We designed a narrative revision based on some of the international regulatory instructions from drug agencies, as well as consensus papers from scientific oncology societies, listing and critically assessing each outcome used in oncology clinical trials. Results: We identified as being the most important outcomes in oncology trials the overall survival, the progression free survival/disease-free survival, the toxicity, the quality of life/patient-reported outcomes and the objective response rate. Discussion: The selection of the primary outcome must be based on therapeutic efficacy as well as toxicity, expected survival, alternative drug regimens and even disease prevalence. Conclusion: The selection of efficacy outcomes for clinical trials in oncology is very important and its selection must be well justified, and depends on the type of disease, the patients and the drug being studied.
- Carga da doença atribuível ao tabagismo em PortugalPublication . Borges, Margarida; Gouveia, Miguel; Costa, João; Pinheiro, Luís dos Santos; Paulo, Sérgio; Carneiro, António VazThe World Health Organization's (WHO) 2002 Annual Report estimated that about 14% of the burden of disease in wealthier countries is attributable to smoking. Smoking related diseases include cardiovascular diseases, cancer and respiratory diseases. This paper presents an estimate of the burden of disease attributable to smoking in Portugal. The estimates are based on the Portuguese demographic and health statistics available for 2005. The most important conclusion of the analysis is that 11.7% of deaths in Portugal are attributable to smoking. If we use disability adjusted life years (DALYs) to measure the burden of disease, we find that 11.2% of death DALYs in Portugal is attributable to smoking. The gender distribution of this amount is very unequal; 15.4% of the male burden of disease and 17.7% of all male deaths can be attributed to smoking, but only 4.9% of the female burden of disease and 5.2% of all female deaths. These estimates are higher than death estimates previously available (Peto et al. 2006); 14% in men and only 0.9% in women. This paper also presents estimates of the burden of reducible disease, that is, the reduction in mortality and DALYs that would occur if all current smokers quit and thus experienced the mean risk of ex-smokers, which is lower than for current smokers but typically not as low as for never-smokers. Our estimates are that the burden of disease would decrease by 5.8% (7.8% in men and 2.8% in women), and that deaths would decrease by 5.8% as well (with an 8.5% and 2.9% decrease in men and women, respectively). The paper also includes estimates of the burden of disease generated by smoking related disability. Smoking related illnesses generated 121,643 DALYs, 72,126 (59%) of which are attributable to smoking and 12,417 would be reducible if all smokers were to quit.
- Efficacy of lipid lowering drug treatment for diabetic and non-diabetic patients : meta-analysis of randomised controlled trialsPublication . Costa, João; Borges, Margarida; David, Cláudio; Carneiro, António VazObjective: To evaluate the clinical benefit of lipid lowering drug treatment in patients with and without diabetes mellitus, for primary and secondary prevention. Design: Systematic review and meta-analysis. Data sources: Cochrane, Medline, Embase, and reference lists up to April 2004. Study selection: Randomised, placebo controlled, double blind trials with a follow-up of at least three years that evaluated lipid lowering drug treatment in patients with and without diabetes mellitus. Data extraction: Two independent reviewers extracted data. The primary outcome was major coronary events defined as coronary heart disease death, non-fatal myocardial infarction, or myocardial revascularisation procedures. Results: Twelve studies were included. Lipid lowering drug treatment was found to be at least as effective in diabetic patients as in non-diabetic patients. In primary prevention, the risk reduction for major coronary events was 21% (95% confidence interval 11% to 30%; P < 0.0001) in diabetic patients and 23% (12% to 33%; P = 0.0003) in non-diabetic patients. In secondary prevention, the corresponding risk reductions were 21% (10% to 31%; P = 0.0005) and 23% (19% to 26%; P . 0.00001). However, the absolute risk difference was three times higher in secondary prevention. When results were adjusted for baseline risk, diabetic patients benefited more in both primary and secondary prevention. Blood lipids were reduced to a similar degree in both groups. Conclusions The evidence that lipid lowering drug treatment (especially statins) significantly reduce cardiovascular risk in diabetic and non-diabetic patients is strong and suggests that diabetic patients benefit more, in both primary and secondary prevention. Future research should define the threshold for treatment of these patients and the desired target lipid concentrations, especially for primary prevention.
- Cost and burden of non-small cell lung cancer's in PortugalPublication . Borges, Margarida; Gouveia, Miguel; Alarcão, Joana; Sousa, Rita; Teixeira, E.; Barata, F.; Laranjeira, E.; Lopes, F.; Parente, B.; Pinheiro, L.; Carneiro, António Vaz; Costa, JoãoObjectives: This study estimates the impact of Non-Small Cell Lung Cancer (NSCLC) on population health levels and its economic impact in Portugal in 2012.
- Custos da doença atribuíveis à hipercolesterolémia em PortugalPublication . Gouveia, Miguel; Borges, Margarida; Costa, João; Oliveira, Eduardo Infante de; David, Cláudio; Carneiro, António VazCardiovascular diseases are the main cause of death in Portugal, in developed countries and, indeed, worldwide. Hypercholesterolemia is a major risk factor for these diseases, including ischemic heart disease, cerebrovascular disease, and peripheral vascular disease. This paper reports the results of a study of the cost of illness associated with hypercholesterolemia and the costs directly attributable to hypercholesterolemia in Portugal, estimated from data for the year 2000. The results indicate that the cost of the health care provided to deal with illnesses associated with hypercholesterolemia was Euros 735.9 million (direct costs) and the costs of lost production due to disability of patients of working age was Euros 74.82 million (indirect costs). The costs attributable to hypercholesterolemia, those that would be avoided if hypercholesterolemia were completely eliminated, amount to Euros 358.84 million in direct costs and Euros 28.31 million in indirect costs. These results confirm that hypercholesterolemia is a source of major health costs. This means that hypercholesterolemia deserves special attention from those who formulate health policy and should be given priority in implementing such policies.
- Atrial fibrillation’s burden of disease in PortugalPublication . Gouveia, M.; Borges, Margarida; Alarcão, J.; Caldeira, Daniel; Pinheiro, L.; Sousa, R.; Ascenção, R.; Costa, João; Carneiro, António VazObjectives: To estimate the Disability Adjusted Life-Years (DALY) attributable to Atrial Fibrillation (AF) during 2010 in Portugal, including both AF and AF related stroke.
- 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.
- Costs and consequences of the Portuguese needle-exchange program in community pharmaciesPublication . Borges, Margarida; Gouveia, Miguel; Fiorentino, Francesca; Jesus, Gonçalo; Cary, Maria; Guerreiro, José Pedro; Costa, Suzete; Carneiro, António VazBackground: Needle-exchange programs (NEPs) reduce infections in people who inject drugs. This study assesses the impact community pharmacies have had in the Needle-Exchange Program in Portugal since 2015. Methods: Health gains were measured by the number of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections averted, which were estimated, in each scenario, based on a standard model in the literature, calibrated to national data. The costs per infection were taken from national literature; costs of manufacturing, logistics and incineration of injection materials were also considered. The results were presented as net costs (i.e., incremental costs of the program with community pharmacies less the costs of additional infections avoided). Results: Considering a 5-year horizon, the Needle Exchange Program with community pharmacies would account for a 6.8% (n = 25) and a 6.5% reduction (n = 22) of HCV and HIV infections, respectively. The present value of net savings generated by the participation of community pharmacies in the program was estimated at €2,073,347. The average discounted net benefit per syringe exchanged is €3.01, already taking into account a payment to community pharmacies per needle exchanged. Interpretation: We estimate that the participation of community pharmacies in the Needle Exchange Program will lead to a reduction of HIV and HCV infections and will generate over €2 million in savings for the health system. Conclusions: The intervention is estimated to generate better health outcomes at lower costs, contributing to improving the efficiency of the public health system in Portugal.
- Atherosclerosis in the primary health care setting: a real-word data studyPublication . Ascenção, Raquel; Alarcão, Joana; Araujo, Francisco; Costa, João; Fiorentino, Francesca; Gil, Victor; Gouveia, Miguel; Lourenço, Francisco; Mello e Silva, Alberto; Carneiro, António Vaz; Borges, MargaridaIntroduction and objectives: To characterize patients with atherosclerosis, a disease with a high socioeconomic impact, in the Lisbon and Tagus Valley Health Region. Methods: A cross-sectional observational study was carried out through the Lisbon and Tagus Valley Regional Health Administration primary health care database, extracting data on the clinical and demographic characteristics and resource use of adult primary health care users with atherosclerosis during 2016. Different criteria were used to define atherosclerosis (presence of clinical manifestations, atherothrombotic risk factors and/or consumption of drugs related to atherosclerosis). Comparisons between different subpopulations were performed using parametric tests. Results: A total of 318 692 users were identified, most of whom (n=224 845 users; 71%) had no recorded clinical manifestations. The subpopulation with clinical manifestations were older (72.0±11.5 vs. 71.3±11.0 years), with a higher proportion of men (58.0% vs. 45.9%), recorded hypertension (78.3% vs. 73.5%) and dyslipidemia (55.8% vs. 53.5%), and a lower proportion of recorded obesity (18.2% vs. 20.8%), compared to those without clinical manifestations (p<0.001). Mean blood pressure, LDL-C and glycated hemoglobin values were lower in the subpopulation with manifestations (142/74 vs. 146/76 mmHg, 101 vs. 108 mg/dl, and 6.80 vs. 6.84%, respectively; p<0.001). Each user with atherosclerosis attended 4.1±2.9 face-to-face medical consultations and underwent 8.6±10.0 laboratory test panels, with differences in subpopulations with and without clinical manifestations (4.4±3.2 vs. 4.0±2.8 and 8.3±10.3 vs. 8.7±9.8, respectively; p<0.001). Conclusions: About one in three adult primary health care users with atherosclerosis have clinical manifestations. The results suggest that control of cardiovascular risk factors is suboptimal in patients with atherosclerosis.