Boehringer Ingelheim (Italy)

Low levels of physical activity (PA) lead to a worsening of physical condition and contributes to multimorbidity in Chronic Obstructive Respiratory Disease (COPD). Unsupervised PA related to dog ownership may contribute to reducing sedentary behavior. We aimed to investigate the relationship between dog walking, patient-reported outcomes (PROs) and exacerbations in COPD. A pre-defined sample of 200 COPD patients (dog owners and non-dog owners) with symptomatic COPD was sourced from a database representative of the Italian population. A computer-assisted personal interview was used to assess health status impairment (CAT), fatigue (FACIT), health-related quality of life (HRQoL) (EQ-5D), and PA frequency. In the whole sample, PA was associated with better CAT, EQ-5D, VAS, FACIT scores and reduced number of exacerbation (p < 0.001). Under the same CAT scores, dog-walking duration was associated with a better HRQoL (EQ5D, p = 0.015) and less fatigue (FACIT, p = 0.017). In an adjusted regression model, walking dogs >30 min was associated with lower fatigue (FACIT) than having no dogs and walking dogs <15 min (p = 0.026 and p = 0.009, respectively). Motivation related to dog walking could modify patients’ tendency to focus on symptoms during PA and, therefore, to perceive the fatigue. Dog walking may be effective for increasing and maintaining regular PA, reducing the subjective impact of COPD.

IntroductionClinical studies have shown significant improvements in exercise capacity in patients with chronic obstructive pulmonary disease (COPD) who are treated with a tiotropium/olodaterol fixed-dose combination (FDC). However, the effects of this treatment, which is administered in a single device, on physical functioning in a real-life setting of patients with COPD had not been fully determined.MethodsAn open-label, observational study was conducted in 309 patients with COPD from 29 sites across Italy who received tiotropium/olodaterol FDC for 6 weeks. Physical functioning was evaluated using the Physical Functioning Questionnaire (PF-10). The primary endpoint was the proportion of patients with therapeutic success, defined as a ten-point increase in the PF-10 score from the baseline visit. Secondary endpoints were absolute changes in PF-10 score from baseline visit, the patient’s general condition assessed by the Physician’s Global Evaluation (PGE) score, and patient satisfaction with treatment, inhaling and handling of the device.ResultsAccording to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) multimodality assessment, most patients were allocated to groups B (44.4%) and D (24.5%). Comorbidities were present in 73.9% of the patients. The primary endpoint was reached in more than half of the patients (52.5%), especially in groups B and D of GOLD. Patients’ satisfaction with treatment, inhaling and handling of device was high, with a range of more than 86% to more than 89%, and very high in both groups B and D. The rates of drug-related adverse events were very low.ConclusionsThis real-life study showed that the tiotropium/olodaterol FDC treatment delivered via the Respimat device improves physical functioning and general patients’ condition and is associated with a high degree of satisfaction and very low rates of drug-related adverse events, regardless of the group they belong to and their comorbidities.Clinical Trial IDNCT03003494.Electronic supplementary materialThe online version of this article (10.1007/s41030-020-00122-9) contains supplementary material, which is available to authorized users.

To assess over a period of 9 months in a sample of Italian Parkinson's disease (PD) patients reasons leading the neurologist to modify dopaminergic treatment and patients' causes of dissatisfaction with ongoing therapy. To evaluate the influence of disease severity on therapy persistence. A disease severity balanced sample of PD patients with stable anti-parkinsonian drugs (APD) treatment was enrolled and evaluated every 3 months. Patients requiring APD treatment modifications were discontinued from the study. The probability to modify APD treatment is greater for higher motor (UPDRS scores) and non-motor symptoms (NMSS score) severity. Both from neurologist's and patient's perspective, motor symptoms were the main determinants underlying APD treatment modifications. Non-motor symptoms were cause of dissatisfaction with ongoing APD treatment for 52 % of the patients, while only 36 % of the neurologists considered these as valid reasons for therapy change. REASON is the first study in PD patients that prospectively examined reasons driving APD treatment changes. Results show that the disease severity significantly increases the probability of APD treatment change. Patients attribute greater relevance than neurologists to non-motor symptoms as reason requiring treatment changes. This confirms that patient and neurologist perceptions only partially overlap.

The study evaluates to what extent symptoms of chronic venous insufficiency (CVI) and functional venous incompetence as investigated using color-coded duplex ultrasonography may interfere with activities of daily living (ADLs). This study comprises a cross-sectional survey conducted in urban areas surrounding 24 Italian cities. A spontaneous sample of 5,187 subjects (4,457 women [mean age, 54 years] and 730 men [mean age, 61 years]), selected by advertising on television and in newspapers, underwent a clinical examination that included duplex ultrasonography in 3 vein segments in both legs to determine the presence and severity of venous reflux. Subjective perception of lower limb symptoms of CVI and the effect of leg problems on the ability to perform normal ADLs are assessed by means of a self-administered questionnaire. Most of the respondents have some CVI symptoms, with women being 1.5 to 3 times as likely as men to report leg symptoms. The risk of developing the most frequent subjective symptoms such as heaviness and tiredness in the legs is not statistically significantly different for younger subjects compared with older subjects. Advanced age is considered to be a relevant risk factor only for heat sensation and swollen legs. Persons living in southern Italy are at higher risk of almost all lower limb symptoms. Results of duplex ultrasonography performed on 3875 subjects show that fewer than 1 in 5 young persons, regardless of sex, manifest some degree of venous reflux (primarily mild symptoms). The risk of developing venous incompetence increases rapidly with age until it triples among subjects 50 years and older. Adjusting for all other factors, men are on average 1.5 times as likely as childless women to have venous reflux, and the risk increases in the case of family history of CVI or (among women) in the case of past pregnancies. More women than men report that their leg problems affect their ADLs. Pregnancy and living in the south contribute to a reduction in the ability to perform most heavy housework. Although milder lower limb symptoms such as evening heaviness and tiredness in the legs may begin early in life, venous reflux and related symptoms of heat sensation and swollen legs become more pronounced with age, and their severity can be disabling for those afflicted.

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