Ospedaletto, Italy
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Chmielewska-Wilkon D.,Gabinet Endoskopii Przewodu Pokarmowego | Reggiardo G.,World Trade Center | Egan C.G.,Primula Multimedia SRL
World Journal of Gastroenterology | Year: 2014

AIM: To examine the efficacy and safety of otilonium bromide (OB) in treatment-sensitive functional irritable bowel syndrome (IBS) clinical parameters. METHODS: Ninety-three patients (44.8 ± 12.6 years, 69% female) with IBS symptoms complying with Rome II criteria participated in this double-blind, placebo-controlled, randomised, dose-ranging phase I/II study. Patients were administered OB 20 mg (n = 24), 40mg (n = 23) and 80 mg (n = 23) tid or placebo (n = 23) in 4 parallel groups for 4 wk. Primary efficacy variables included abdominal discomfort, intestinal habits, number of daily evacuations and stool consistency. Secondary efficacy measures included return to regular intestinal habits and global discomfort. Safety was also assessed. RESULTS: Baseline clinical characteristics were similar among the 4 groups. Although individual parameters such as intensity and frequency of abdominal discomfort, bloating or pain were reduced by OB over the 4 wk, no significant differences were observed between groups. Similarly, no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation. However, evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo (-8.36% for placebo vs -41.9% for 80 mg OB, p < 0.01). While 21.7% of patients in the placebo group experienced regular intestinal habits after 4 wk, this improvement was greater for patients treated with 40 mg OB (p < 0.01 vs placebo). Furthermore, a dose-dependent reduction in frequency of diarrhoea (χ2-test for trend = 11.5, p < 0.001) and an increase in normal stool frequency was observed. Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses, favouring 40 mg (p = 0.013) and 80mg OB (p = 0.001) over placebo. No difference was observed between frequency of adverse events for placebo vs OB. CONCLUSION: This dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period. © 2014 Baishideng Publishing Group Inc. All rights reserved.

Costanzo A.M.,S Giovanni Evangelista Hospital | Gorini A.,Abbott Laboratories | Egan C.G.,Primula Multimedia S.r.l. | di Luzio Paparatti U.,Abbott Laboratories
Journal of Nephrology | Year: 2012

Background: Chronic kidney disease (CKD) is a major worldwide problem. A lack of CKD awareness and knowledge of associated risk factors may delay diagnosis and treatment. The purpose of this epidemiolog-ical study was to assess the presence and awareness of CKD, in addition to evaluating associated clinical characteristics. Methods: This cross-sectional observational study included 573 healthy volunteers (aged 21-62 years) based in central Italy. All participants underwent a nephrological visit, providing data on medical history, anamnesis and CKD awareness. Blood and urine samples were also collected. Results: Estimated glomerular filtration rate (eGFR) calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) study formula revealed that 55% of participants had an eGFR of <90 ml/min per 1.73 m 2 compared with 24.6% by the Cockcroft-Gault formula (C-G; p<0.0001). Approximately 45% of participants showed an awareness of CKD, these subjects also having a significantly lower Framingham score (p<0.046). Approximately half of participants (51%) had insufficient levels (<30 ng/mL) of serum 25-hydroxyvi-tamin D (25(OH)D), with a higher proportion observed in female (58.3%) than male participants (45.6%, p=0.0016). Levels of 25(OH)D were negatively correlated with eGFR, measured by either MDRD or C-G (r=-0.12, p=0.0039 and r=-0.09, p=0.029 respectively). Logistic regression analysis revealed that male sex and increased serum creatinine levels were predictors associated with study outcomes (clinical risk factors). Conclusions: This study suggests that screening for CKD in the general population by eGFR calculations (MDRD or C-G) is unreliable; therefore, the monitoring of serum creatinine and other risk factors may be more appropriate. The presence of vitamin D insufficiency in apparently healthy individuals warrants further investigation. © 2011 Società Italiana di Nefrologia.

Balsamo R.,Dompe SPA | Lanata L.,Dompe SPA | Egan C.G.,Primula Multimedia SRL
European Respiratory Review | Year: 2010

Mucus hypersecretion is a clinical feature of severe respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. Airway mucosal infection and/or inflammation associated with these diseases often gives rise to inflammatory products, including neutrophil-derived DNA and filamentous actin, in addition to bacteria, apoptotic cells and cellular debris, that may collectively increase mucus production and viscosity. Mucoactive agents have been the medication of choice for the treatment of respiratory diseases in which mucus hypersecretion is a clinical complication. The main purpose of mucoactive drugs is to increase the ability to expectorate sputum and/or decrease mucus hypersecretion. Many mucoactive drugs are currently available and can be classified according to their putative mechanism of action. Mucoactive medications include expectorants, mucoregulators, mucolytics and mucokinetics. By developing our understanding of the specific effects of mucoactive agents, we may result in improved therapeutic use of these drugs. The present review provides a summary of the most clinically relevant mucoactive drugs in addition to their potential mechanism of action. © ERS 2010.

Leonetti G.,Instituto Auxologico Italiano | Egan C.G.,Primula Multimedia SRL
Vascular Health and Risk Management | Year: 2012

β-blockers are effective antihypertensive agents and, together with diuretics, have been the cornerstone of pioneering studies showing their benefits on cardiovascular morbidity and mortality as a consequence of blood pressure reduction in patients with hypertension. However, evidence from recent meta-analyses have demonstrated no benefit afforded by atenolol compared with placebo in risk of mortality, myocardial infarction, or stroke, and a higher risk of mortality and stroke with atenolol/propranolol compared with other antihypertensive drug classes. Thus, the effect of these agents on cardiovascular morbidity and mortality in hypertensive patients, especially their use in uncomplicated hypertension, has remained largely controversial. However, it is recognized that the clinical studies used in these meta-analyses were mainly based on the older second-generation β-blockers, such as atenolol and metoprolol. Actually, considerable heterogeneity in, eg, pharmacokinetic, pharmacological, and physicochemical properties exists across the different classes of β-blockers, particularly between the second-generation and newer third-generation agents. Carvedilol is a vasodilating noncardioselective third-generation β-blocker, without the negative hemodynamic and metabolic effects of traditional β-blockers, which can be used as a cardioprotective agent. Compared with conventional β-blockers, carvedilol maintains cardiac output, has a reduced prolonged effect on heart rate, and reduces blood pressure by decreasing vascular resistance. Studies have also shown that carvedilol exhibits favorable effects on metabolic parameters, eg, glycemic control, insulin sensitivity, and lipid metabolism, suggesting that it could be considered in the treatment of patients with metabolic syndrome or diabetes. The present report provides an overview of the main clinical studies concerning carvedilol administered as either monotherapy or in combination with another antihypertensive or more frequently a diuretic agent, with particular focus on the additional benefits beyond blood pressure reduction. © 2012 Leonetti and Egan, publisher and licensee Dove Medical Press Ltd.

Savi L.,University of Turin | Mogavero S.,Primula Multimedia SRL | Egan C.G.,Primula Multimedia SRL
Drug Design, Development and Therapy | Year: 2014

Background: Migraine is a painful neurological disorder that affects over 10% of the general population. Frovatriptan and rizatriptan are antimigraine agents belonging to the triptan class. Although previous studies have independently compared the efficacy of these agents, contemporaneous data examining both pharmacokinetic (PK) properties and efficacy in parallel have not previously been available. Materials and methods: In this single-center double-blind study, 18 subjects (ten female) were treated for a single migraine attack with frovatriptan 2.5 mg or rizatriptan 10 mg. Plasma concentrations were measured predose and at 2, 4, 6, 12, 24, 48, and 72 hours after drug administration. The primary end point of this study was to evaluate the association between PK parameters and efficacy measures and recurrence rate. Secondary end points were pain-free and pain-relief episodes at 2 and 4 hours, recurrent episodes within 48 hours, and cumulative hazard of recurrence within 72 hours. Results: At baseline, approximately 17% of patients had mild migraine, while 83% had moderate-severe migraine. Although the time to maximum concentration was similar for both drugs (2.7 versus 2.3 hours), the terminal half-life for frovatriptan was longer than rizatriptan (29.3 versus 3.2 hours, P<0.0001). The proportion of patients who were pain-free at 4 hours without rescue medication was higher in the frovatriptan-treated group, (38.9 versus 5.6%, P=0.045). The cumulative hazard of recurrence over 72 h was reduced by frovatriptan compared to rizatriptan-treated patients (log-rank test, P=0.04). Pain-free and pain-relief episodes for the study period were positively correlated with the concentration:maximum concentration (Cmax) ratio for frovatriptan (r=0.52, P=0.028), but not rizatriptan. Recurrence rate was negatively correlated with the concentration:Cmax ratio for both frovatriptan (r=-0.96, P=0.0024) and rizatriptan (r=-0.98, P=0.0004). Fewer adverse events were observed for frovatriptan compared to rizatriptan (one versus eight, P=0.021). Conclusion: This pilot study indicates that a similar extent of initial pain relief is afforded by both triptans in migraine treatment. The longer duration of action of frovatriptan parallels and correlates with its PK profile. © 2014 Savi et al.

Egan C.G.,Primula Multimedia S.R.L. | Pontremoli R.,University of Genoa
Journal of Nephrology | Year: 2011

Even with the availability of novel and efficacious antihypertensive agents, an insufficient number of hypertensive patients achieve their desired blood pressure (BP) target. This failure is partly due to the fact that many patients do not strictly adhere to their drug therapy and/or they report the presence of adverse effects. Traditionally, monotherapy is used as first-line treatment to achieve BP targets; however, when this fails, combination therapy is then required. In light of the need to attain BP goals, combination therapy (especially fixed-dose) is currently recommended. The main advantages of combination therapy over monotherapy are not only that of reduced dose, improved efficacy and reduced adverse effects, but also of target protection and reduced cardiovascular (CV) risk. Therefore, the development of single-administration drug combinations should also improve patient adherence to therapy and therefore help in achieving BP control. Among the various combinations available, calcium channel blockers (CCBs) and angiotensinconverting enzyme (ACE) inhibitors have been proven to be extremely effective, while also displaying good tolerability. Individually, both the third-generation CCB lercanidipine and the ACE inhibitor enalapril are effective antihypertensive agents. In addition, both of these agents also show other beneficial effects when administered as monotherapy. Of particular importance is the fact that when lercanidipine plus enalapril are administered in combination, they show synergism, thus providing added efficacy with reduced side effects. The present report provides an overview of the main clinical studies examining lercanidipine and enalapril administered as monotherapy, with particular focus on the potential renoprotective effects afforded by the fixed-dose combination lercanidipine-enalapril. © 2011 Società Italiana di Nefrologia.

Galli L.,University of Pisa | Ricci C.,Primula Multimedia SRL | Egan C.G.,Primula Multimedia SRL
OncoTargets and Therapy | Year: 2015

Epoetin beta belongs to the class of erythropoiesis-stimulating agents (ESAs) that are currently available to treat anemic patients receiving chemotherapy. Chemotherapy-induced anemia affects a high percentage of cancer patients and, due to its negative effects on disease outcome and the patient’s quality of life, should be treated when first diagnosed. Initial trials with ESAs have shown efficacy in improving quality of life and reducing the need for blood transfusions in patients with chemotherapy-induced anemia. However, recent meta-analyses have provided conflicting data on the impact of ESAs on survival and tumor progression. Here we provide an overview of these recent data and review the role of epoetin beta in the treatment of chemotherapy-induced anemia over the past 20 years. © 2015 Galli et al.

Giorgino F.L.,University of Padua | Egan C.G.,Primula Multimedia S.R.L.
Arzneimittel-Forschung/Drug Research | Year: 2010

The aim of this systematic review was to evaluate the efficacy of isoxsuprine (1-(4-hydroxyphenyl)-2-(1-methyl-2-phenoxyethylamino)-1-propanol, CAS 395-28-8), a tocolytic agent used in both preterm labour and risk of abortion. Two analyses were conducted on data reporting the use of isoxsuprine in the prevention of preterm delivery. The first analysis examined two double-blind studies to determine the effect of isoxsuprine compared to placebo. The second analysis reviewed data from 25 publications containing individual and general patient data. Main outcome measures included delay of pregnancy and patient outcome. Analysis of double-blind studies demonstrated a positive outcome with isoxsuprine in 92% of cases compared to placebo control (44.4%, p < 0.001). This beneficial effect was maintained when either risk of abortion (92.5% in isoxsuprine treated compared to 46.4% in placebo, p < 0.001) or risk of premature delivery (89.5% in isoxsuprine treated compared to 29.4% in placebo, p < 0.001) was examined. Secondary analysis of individual patient data also revealed a beneficial effect of isoxsuprine in prolonging pregnancy in 54.5% of women at risk of abortion and in 82.3% of women at risk of premature delivery. Combination of individual and general data revealed a beneficial effect of isoxsuprine in 77.3% of cases at risk of abortion and 89% for risk of premature delivery. These findings provide preliminary evidence in favour of the effectiveness of isoxsuprine in prolonging pregnancy in women at risk of abortion or premature delivery. © ECV • Editio Cantor Verlag.

Mesenchymal stem cells (MSCs) are recognized for their potential in regenerative medicine. Due to long-term negative effects associated with insulin administration and difficulty with pancreas transplantation, patients with type-1 diabetes could significantly benefit from organ-targeted cell-based therapy. Although several pharmacological agents increase the homing capacity of MSCs, the mechanisms regulating this process are still poorly understood. In this issue, Najafi et al. have demonstrated that pre-treatment of bone marrow-derived MSCs with the iron chelator and hypoxia mimetic, deferoxamine, can increase homing to the pancreas in a rat model of diabetes. This effect appears to be driven through specific chemokines in addition to hypoxia-inducing factor 1-alpha. Results from this study provide important clues in our endeavour to solve a complex process. Further studies will help determine whether these findings may offer potential therapeutic benefit to patients with diabetes. © Informa UK, Ltd.

PubMed | University of Catania and Primula Multimedia SRL
Type: Journal Article | Journal: Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) | Year: 2016

Effective non-invasive techniques to monitor plaque psoriasis progression and treatment are desirable. The aim of the study was to evaluate changes in vascular pattern using videodermatoscopy (VD) and in skin thickness by ultrasound (US), along with clinical observation, during treatment with biologicals.Forty-two patients with moderate-to-severe plaque psoriasis treated with adalimumab, etanercept, or ustekinumab were evaluated. Following the identification of a target plaque at baseline, lesion changes were monitored at 15, 30 and 60 days by clinical observation using a Target Lesion Score (TLS), and by VD and US.After 60 days, a significant improvement in all three parameters was observed. In adalimumab-treated patients mean values of TLS, VD, and US were reduced by 83.9%, 73.5%, and 90%, respectively; in etanercept-treated patients by 67.9%, 49.7%, and 79.3%; in ustekinumab-treated patients by 80.9%, 66.4%, and 80.1%. Skin thickness was the first parameter to improve. Vascular improvement was slower compared to clinical and US responses.VD and US may be useful to monitor psoriasis treatment. Further investigations are warranted to assess if the persistence of an altered vascular pattern despite clinical and US normalization, as observed in 22% of patients, may influence disease progression and/or correlate with rate and severity degree of relapse.

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