Fixed Versus Free Combinations of Antihypertensive Drugs: Analyses Of Real-World Data Of Persistence With Therapy In Italy

Purpose: To analyse the pattern of use and cost of antihypertensive drugs in new users in an Italian population, and explore the patient/treatment factors associated with the risk of therapy discontinuation. Patients and methods: In this retrospective study, information was collected from a population-based electronic primary-care database. Persistence with medication use 1 year from therapy initiation was evaluated for each user using the gap method. Each new user was classified according to his/her pattern of use as: \u201ccontinuer\u201d, \u201cdiscontinuer\u201d \u201cswitching\u201d or \u201cadd-on\u201d. A Cox regression model was used to analyse the factors influencing therapy discontinuation. Primary-care costs comprised specialists\u2019 visits, diagnostic procedures and pharmacologic therapies. Results: Among 14,999 subjects included in persistence analyses, 55.1% of cases initially started on monotherapy were classified as discontinuers vs 36.5% of cases taking combination therapy (42.3% vs 32.7%, respectively, for free and fixed combinations, P < 0.01). Old age, high cardiovascular risk and being in receipt of fixed-combination therapy were associated with greater persistence. Overall, the primary-care cost/person/year of hypertension management was 3c\u20ac95.3 (IQR, 144.9). The monotherapy cost was \u20ac88 per patient (IQR, 132.9), and that for combination therapy was \u20ac151\ub1148.3. The median cost/patient with a fixed combination was lower than that for a free combination (\u20ac98.4 (IQR, 155.3) and \u20ac154.9 (IQR, 182.6), respectively). Conclusion: The initial type of therapy prescribed influences persistence. Prescribing fixed combinations might be a good choice as initial therapy

How to assess appearance distress and motivation in plastic surgery candidates: Italian validation of Derriford Appearance Scale 59 (DAS 59)

The Derriford Appearance Scale (DAS) 59 was specifically designed to measure psychosocial adjustment in patients with appearance problems. Previous studies using the DAS59 have proven it to be a reliable method of assessing the appearance-related quality of life after plastic surgery procedures. The aim of this study was to develop a valid and reliable Italian version of the DAS59

Cardiovascular comorbidities and pharmacological treatments of covid-19 patients not requiring hospitalization

Introduction: The Coronavirus disease 2019 (COVID-19) outbreak is a whole Earth health emergency related to a highly pathogenic human coronavirus responsible for severe acute respiratory syndrome (SARS-CoV-2). Despite the fact that the majority of infected patients were managed in outpatient settings, little is known about the clinical characteristics of COVID-19 patients not requiring hospitalization. The aim of our study was to describe the clinical comorbidity and the pharmacological therapies of COVID-19 patients managed in outpatient settings. Materials and Methods: We performed an observational, retrospective analysis of laboratory-confirmed COVID-19 patients managed in outpatient settings in Naples, Italy between March 9 and May 1, 2020. Data were sourced from the prospectively maintained Health Search (HS)/Thales database, shared by 128 primary care physicians (PCPs) in Naples, Italy. The clinical features and pharmacological therapies of COVID-19 patients not requiring hospitalization and managed in outpatient settings have been described. Results: A total of 351 laboratory-confirmed COVID-19 patients (mean age 54 ± 17 years; 193 males) with outpatient management were evaluated. Hypertension was the most prevalent comorbidity (35%). The distribution of cardiovascular comorbidities showed no gender-related differences. A total of 201 patients (57.3%) were treated with at least one experimental drug for COVID-19. Azithromycin, alone (42.78%) or in combination (27.44%), was the most widely used experimental anti-COVID drug in outpatient settings. Low Molecular Weight Heparin and Cortisone were prescribed in 24.87% and 19.4% of the study population, respectively. At multivariate regression model, diabetes (risk ratio (RR): 3.74; 95% CI 1.05 to 13.34; p = 0.04) and hypertension (RR: 1.69; 95% CI 1.05 to 2.7; p = 0.03) were significantly associated with the experimental anti-COVID drug administration. Moreover, only diabetes (RR: 2.43; 95% CI 1.01 to 5.8; p = 0.03) was significantly associated with heparin administration. Conclusions: Our data show a high prevalence of hypertension, more likely treated with renin– angiotensin–aldosterone system (RASS) inhibitors, among COVID-19 patients not requiring hospitalization. Experimental COVID-19 therapies have been prescribed to COVID-19 patients considered at risk for increased venous thromboembolism based on concomitant comorbidities, in particular diabetes and hypertension

Demographic and comorbidity profile of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a real-life clinical setting: Are 5-alpha-reductase inhibitor consumers different?

Purpose: We aimed to describe, in a daily clinical practice setting, the demographic and comorbidity profile of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH-LUTS), to compare the characteristics of patients receiving 5-alpha-reductase inhibitors (5-ARIs) with those not receiving them and to investigate predictors of 5-ARI prescription. Methods: We performed a retrospective observational study using data retrieved from a general practitioners database. Male patients with diagnosis of BPH-LUTS were included. The following demographic and clinical data were available and extracted: age, comorbidities, BPH-LUTS medical therapy, drugs for comorbidities. A subgroup analysis was performed according to the use of 5-ARIs. Factors associated with 5-ARI prescription were assessed with uni- and multivariate analyses. Results: A total of 7,103 patients were identified. Most patients (71.7 %) were aged ≥65 years. Hypertension was present in 64.9 % of patients; it was the most prevalent comorbidity followed by diabetes mellitus, hypercholesterolemia, coronary artery disease and other dyslipidemias. Overall, 38.22 % of patients were treated with 5-ARIs. Mean age of patients taking 5-ARIs was significantly higher. The prevalence of hypertension and the use of antihypertensive drugs were significantly higher among patients receiving 5-ARIs. Older age was an independent predictor of 5-ARI prescription. Conclusions: In a daily clinical practice setting, patients with BPH-LUTS receiving 5-ARIs are significantly older and have significantly higher prevalence of hypertension if compared with patients with BPH-LUTS not receiving 5-ARIs. Older age is an independent predictor of 5-ARI prescription

Role of a novel nutraceutical composition for irritable bowel syndrome management: symptoms relief and unexpected triglycerides-lowering effect

Background: Irritable bowel syndrome (IBS) is a functional bowel disorder characterized by abdominal pain or discomfort and an irregular bowel habit. The prevalence is up to 20% in Western adults, which makes IBS the most common diagnosis in gastroenterology. Despite extensive interest and investigation, IBS's precise aetiology and pathophysiology are poorly understood. Current knowledge suggests that an altered gut microbiota, altered motility, visceral hyperalgesia, and dysregulation of the brain-gut axis are central to IBS. This is also significantly related to a higher prevalence of metabolic syndrome and elevated triglycerides among the adult population. This retrospective study examines the effect of a novel nutraceutical compound, Triobiotix, on gastrointestinal symptoms in IBS patients. Effects on lipid profiles have also been recorded. Objectives: The focus of this study is to evaluate the effectiveness of Triobiotix, a nutraceutical compound composed of prebiotics and probiotics.Methods: Triobiotix is a nutraceutical consisting of Maltodextrin; mineralized extract of Lithothamnion (Lithothamnion calcareum (Pallas) Areschoug, thallus dry extract); Bioecolians (R) gluco-oligosaccharides; Ferment mix (corn starch, Bifidobacterium animalis ssp. Lactis BLC1 (DSM 17741), Lactobacillus acidophilus LA3 (DSM 17742), Lactobacillus rhamnosus IMC 501 (DSM 16104), Lactobacillus paracasei Streptococcus 501 IMC102 SP4 (DSM 19385); short-chain fructo-oligosaccharides powder. The database of 40 Italian General Practitioners (GPs) was analyzed. A total of 587 patients with IBS treated with Triobiotix were identified. Among them, 535/587 (91.1%) completed the first (T0) and second (T1) visits and their data were available. The primary endpoint of this analysis was to assess if Triobiotix, at a dosage of 1 sachet per day for 30 days, could reduce abdominal pain and bloating, thus resulting in a lower intensity of the main gastrointestinal symptoms. Secondary endpoints were to evaluate presence of any significant changes in triglycerides blood levels and glycaemia.Results: Treatment with this nutraceutical for one month resulted in a reduction in the frequency and intensity of bloating, abdominal pain, flatulence, and tenesmus. In the 85 patients who reported evacuative urgency, the frequency of the episodes didn't significantly change while their intensity was statistically reduced. Unexpectedly, triglyceride levels also significantly decreased.Conclusions: Our analysis demonstrates this formulation is effective in the relief of the main symptoms associated with IBS. Moreover, an unexpected effect of this combination of micronutrients on tryglicerides, beyond IBS symptoms, was also found. However, further studies are needed to confirm this evidence and to evaluate the particular compound responsible of this effect

Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial

Introduction: Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and efficacy in the reduction of different forms of idiopathic pain. Methods: Two-hundred and ten normoglycemic adults suffering from idiopathic pain (i.e. 57 subjects with primitive neuropathic pain, 141 subjects with arthralgia with unknown etiology, and 12 subjects with idiopathic myalgia) were randomized to receive placebo, 400 mg/day, or 800 mg/day of ALA. Participants underwent two visits (at baseline = t0, and after 2 months = t1) in which two validated questionaries for pain (numerical rating scale [NRS] and visual analogue scale [VAS]) were collected; fasting blood glucose assessment, adverse effects, and renal and hepatic toxicity were also monitored. Results: At t1, none of subjects treated with ALA reported a decreased glycemia or adverse effects. The treated subjects showed a significant reduction in NRS (p < 0.001) while the placebo group did not show any NRS reduction (p = 0.86). Similar results were also obtained for VAS. Statistical analysis aimed at detecting possible differences in NRS and VAS scores among treatment groups based on the source of pain did not reveal any significant effect. Conclusions: Since the management of idiopathic pain is challenging for physicians, the use of ALA food supplements could be a feasible option, based on its safety and efficacy compared to commonly-used analgesic drugs

Development of statistical methods to highlight differences between endurance limit of re-rolled steel sheets in an assumed homogeneous population

In this paper, we present the results of the activities carried out to estimate the axial fatigue strength of ASTM E566 Gr. 70 sheet metal. We describe the experimental setup, followed by the collected data. To highlight a possible inhomogeneity in some of the material properties, we estimate the endurance limit for the investigated material using various statistical approaches on the set of test articles. The data analysis was carried out both by considering as a whole the set of test articles and by dividing the set into two groups. As a new analysis technique, we propose a method introducing a bimodal distribution (Gaussian mixture