Boehringer Ingelheim (Portugal)

Purpose:The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018 recommendations support maintenance treatment with long-acting bronchodilators in most symptomatic patients with chronic obstructive pulmonary disease (COPD). While restricting the overuse of inhaled corticosteroids (ICS) may influence healthcare utilization required to treat inadvertent respiratory (exacerbations and pneumonia) and diabetes-related events, it may also change the total medication cost. This analysis was performed to estimate the 5-year budget impact of switching from ICS-containing treatment combinations to dual bronchodilation, in line with the recommendations.Methods:The model quantified the budget impact of treatment and healthcare resource utilization when COPD patients were anticipated to switch from ICS-containing treatments to dual bronchodilation. Three switch scenarios were calculated with increasing proportions of patients on dual long-acting bronchodilators, to the detriment of ICS-containing double and triple combinations. Clinical and cost input data were based on results from clinical trials and Greek and Portuguese healthcare cost databases.Results:Healthcare resource use to manage exacerbations, pneumonia and diabetes-related events were projected to increase between 2019 and 2023 in parallel with the growing COPD patient population and associated costs were estimated at 52–57% of the total disease cost in the Greek and Portuguese base case scenarios. Total cost savings between 21 and 112 million EUR were projected when the proportion of patients on double and triple ICS-containing treatments was gradually reduced to 50% in scenario A, 20% in scenario B and 7% in scenario C. Sensitivity analyses showed that none of the model assumptions had a major impact on the projected savings.Conclusion:The alignment of COPD treatment with current recommendations may bring clinical benefits to patients, without substantial cost increases and even cost savings for payers.The reviews of this paper are available via the supplemental material section.

O estudo de Shen et al1 publicado recentemente no Journal of Clinical Oncology, juntamente com o acompanhamento editorial de Haymart,2 descreveu os resultados de uma grande série de pacientes com carcinoma papilífero de tireoide (CPT). shen et al testaram se a idade ao diagnóstico, um preditor bem reconhecido de desfecho ruim, especialmente a mortalidade específica da doença, mantém sua valor preditivo após o controle para a genética mais frequente alteração no PTC, a mutação BRAF V600E. Eles descobriram que o risco de mortalidade associado à idade estava presente apenas em pacientes com tumores portadores da mutação BRAF, e eles alegaram que esses Os resultados terão um grande impacto no manejo clínico de pacientes com CPT. Considerando que a frequência geral deste mutação é de 45% e a mortalidade específica da doença é bastante baixa no grupo de pacientes com BRAF tipo selvagem, pacientes mais velhos com tipo selvagem Os tumores BRAF podem ser poupados de procedimentos de tratamento agressivos.

Background: The TIOtropium Safety and Performance In Respimat ® (TIOSPIR™) trial showed that tiotropium delivered with the Respimat Soft Mist™ Inhaler (SMI) 5µg is as safe as delivered with the HandiHaler ® device 18µg in a wide range of patients including those with concomitant cardiac disease. However, patients with several recent severe cardiac diseases (myocardial infarction [MI], heart failure, or arrhythmia) were excluded from the trial. Aims: To evaluate the safety of tiotropium Respimatafter a cardiac event. Methods: All-cause mortality, major adverse cardiovascular events (MACE) including deaths due to MACE, were analyzed post hoc in patients who remained on blinded treatment following an initial cardiac event (MI, heart failure or arrhythmia) during TIOSPIR. Results: The same number of patients experienced a cardiac event during the examined trial period (randomization to end of treatment +30 days) in the Respimat (n/N=221/5705) and HandiHaler groups (n/N=221/5687). Of those, 174 patients on Respimat remained on blinded treatment and 178 on HandiHaler. The risk of death and MACE including deaths due to MACE was similar between groups after an on treatment cardiac event (Table). Conclusions: Safety profiles of tiotropium Respimat 5µg and HandiHaler 18µg were similar in patients with chronic obstructive pulmonary disease who had an initial cardiac event during the trial; however the number of patients with events was low.

Heart valve prostheses carry a risk for thrombosis and require an antithrombotic strategy to prevent stroke, systemic embolism, and prosthetic valve thrombosis. Contemporary randomized trials to guide the clinician on the optimal anticoagulant treatment are scarce, and the validity of the historical data for current recommendations can be questioned in view of the changes in valve prostheses, the patient population, and antithrombotic therapies. This limited evidence from clinical trials translates into divergent recommendations from the different scientific societies on the optimal intensity of oral anticoagulation and on the indication for antiplatelet therapy. The availability of new antithrombotic agents and the unclear thrombotic risk of the currently used prostheses underscore the need to redefine antithrombotic treatment in patients with heart valve prostheses.

The presence of atrial fibrillation (AF) increases the risk of stroke fivefold, but the risk is dependent upon the presence of stroke risk factors. The challenge is defining patients who would best benefit from thromboprophylaxis, and how to deliver it in the most effective and safe way. The objective of this brief overview is to address this question. Previously, attention has been directed towards identifying high-risk patients who could be subjected to an inconvenient (and potentially dangerous) drug, warfarin. Aspirin has been increasingly recognised as an inferior choice for stroke prevention, and may not be any safer than warfarin in terms of major bleeding, especially in the elderly. Thus, the focus more recently has been directed towards identifying truly low-risk patients who do not need any antithrombotic therapy, and all others with ≥ 1 stroke risk factors should be considered for oral anticoagulation therapy (whether as well-controlled warfarin or one of the new oral anticoagulant drugs), as the most effective means of reducing the risk of stroke and thromboembolism in AF.

Duloxetine, a serotonin/norepinephrine reuptake inhibitor, has been effective in the treatment of mild and moderate stress urinary incontinence. The aim of this trial was to assess its efficacy for women with severe stress urinary incontinence. One hundred nine women, aged 33-75 years, enrolled into this double-blind, randomized, placebo-controlled study. Subjects had to have a predominant symptom of stress urinary incontinence with an incontinence episode frequency 14 per week or more, pure urodynamic stress urinary incontinence, and continence surgery already scheduled. Women were randomized to placebo (n = 54) or duloxetine 80 mg/d (n = 55) for 4 weeks, escalated to 120 mg/d for 4 weeks. Assessment variables included incontinence episode frequency, continence pad use, the Incontinence Quality of Life (I-QOL) questionnaire, and the Willingness to Consider Surgery rating. A responder was defined as a subject with an incontinence episode frequency reduction of 50% or more. There were significant improvements with duloxetine compared with placebo in incontinence episode frequency (-60% versus -27%, P <.001), I-QOL score (+10.6 versus +2.4, P =.003), and pad use (-34.5% versus -4.8%, P =.008). At the conclusion of the 8-week study, 10/49 (20%) duloxetine-treated women were no longer interested in surgery, compared with 0/45 placebo-treated women (P =.001). Duloxetine-treated subjects were significantly more likely to be classified as responders (relative risk 4.68, 95% confidence interval 2.27-9.66). The number of subjects-needed-to-treat to gain an additional incontinence episode frequency responder with duloxetine was 2.02. All duloxetine responses were observed within 2 weeks. Side effects and discontinuations because of side effects were significantly more common with duloxetine. The data support duloxetine's efficacy in women with severe stress urinary incontinence and suggest that some women responding to duloxetine may reconsider their willingness to undergo surgery.