A multicentre, multinational, randomised, double-blind, pilot, ascending dose for non responder, parallel group study on the therapeutic efficacy and safety of o.d. Zofenopril 30 mg plus HCTZ 12.5 mg vs. Irbersartan 150 mg plus HCTZ 12.5 mg in elderly subjects (age > 65 years) affected by Isolated Systolic Hypertension never treated or non responder to previous antihypertensive therapy (monotherapy or association of maximum two treatments) - LUMI/10/ZOF- HYP/001

开始日期2010-09-27

申办/合作机构

Istituto Lusofarmaco D'Italia S.p.A.

EUCTR2009-011577-32-IT / Not yet recruitingN/A

Comparison between frovatriptan plus different treatment regimens of dexketoprofen (25 mg and 37.5 mg) and frovatriptan alone in the acute treatment of migraine without aura and migraine with aura attacks - ND

开始日期2009-05-29

申办/合作机构

Istituto Lusofarmaco D'Italia S.p.A.

EUCTR2008-007681-30-IT / Not yet recruitingN/A

EFFICACY AND SAFETY OF ZOFENOPRIL + HYDROCHLOROTHIAZIDE COMBINATION VS. IRBESARTAN + HYDROCHLOROTHIAZIDE COMBINATION IN ESSENTIAL HYPERTENSIVE PATIENTS NOT CONTROLLED BY PREVIOUS MONOTHERAPY - ZENITH

开始日期2009-02-06

申办/合作机构

Istituto Lusofarmaco D'Italia S.p.A.

100 项与 Istituto Lusofarmaco D'Italia S.p.A. 相关的临床结果

登录后查看更多信息

0 项与 Istituto Lusofarmaco D'Italia S.p.A. 相关的专利（医药）

登录后查看更多信息

项与 Istituto Lusofarmaco D'Italia S.p.A. 相关的文献（医药）

2013-11-26·Circulation

Abstract 9337: Zofenopril is Cost Effective for Treatment of Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: A Post- Hoc Analysis of the SMILE-4 Study

作者: Ambrosioni, Ettore ; Cicero, Arrigo F ; Reggiardo, Giorgio ; Zava, Dario ; Borghi, Claudio ; Ambrosio, Giuseppe ; Vinereanu, Dragos ; Degli Esposti, Daniela ; Novo, Salvatore ; Bacchelli, Stefano ; Omboni, Stefano

Background and objective: in the Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) zofenopril associated with ASA was superior to ramipril plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following acute myocardial infarction (AMI). The present post-hoc analysis was performed to evaluate cost-effectiveness of zofenopril compared to ramipril. Methods: a total of 771 patients with LVD and AMI were randomized double-blind to zofenopril 60 mg/day (n=389) or ramipril 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the National Health Service databases of the European countries participating into the study. The incremental cost-effectiveness ratio (ICER) was used to quantify the cost per event prevented with zofenopril vs. ramipril. Results: zofenopril significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with zofenopril was 13 less than with ramipril. The cost of drug therapies was higher with zofenopril (328.78 Euros per patient per year, n=365) than with ramipril (165.12 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 4983.64 Euros for zofenopril and 4850.01 Euros for ramipril. The ICER of zofenopril vs. ramipril was 2125.45 Euros per event prevented (worst- and best-case scenario in the sensitivity analysis: 3590.09 and 3243.96 Euros, respectively).Conclusions: zofenopril is a viable and cost-effective treatment for managing patients with LVD after AMI.

Arzneimittelforschung

Pharmacokinetics of Isoxsuprine Hydrochloride Administered Orally and Intramuscularly to Female Healthy Volunteers

Article

作者: Cantoni, Vittorio ; Ismaili, Shefqet ; Tavazzi, Simona ; Marzo, Antonio ; Coa, Katrin ; Zava, Dario ; Bo, Lorenzo

Isoxsuprine (1-(4-hydroxyphenyl)-2-(1-methyl-2-phenoxyethylamino)-1-propanol, CAS 395-28-8) is a peripheral vasodilator that also stimulates beta-adrenergic receptors. It causes a direct relaxation of vascular and uterine smooth muscles and produces positive inotropic and chronotropic effects. It is widely used to arrest premature labour and miscarriage. The aim of this trial was to investigate the pharmacokinetics of isoxsuprine hydrochloride administered orally to healthy young female volunteers as an extended-release formulation at the doses of 30, 60 and 90 mg compared to 10 mg by i.m. route. A randomised, crossover, four-period, multisequence, single-dose design was adopted. Plasma and urine concentrations of free and total isoxsuprine were evaluated by tandem mass spectrometry that reached a low quantification limit of 1 ng/ml. From plasma concentrations Cmax, tmax, AUC(0-t), AUC(0-infinity), t1/2 and Vd and from urine concentration CUE(0-24h) were evaluated by the non-compartmental model. The free drug was present only in plasma after i.m. route, whereas total isoxsuprine, namely the drug after an enzymatic hydrolysis of the conjugate form, was detected in all plasma and urine samples. The distribution volume of the free drug proved to be 2.5 times higher than that of total isoxsuprine, which indicates a good penetration of the free drug into tissue compartments. Oral absorption was evaluated from the p.o./i.m. percentualized ratio of AUC and CUE and proved to be on average around 51%, being linearly correlated with the three doses administered. The oral absorption proved to be sustained as expected from the zero-order kinetics of the drug release from the core of the extended-release formulation. This has justified different values of half-life that was on average 2.2 h after the i.m. route and around 10 h after the three oral doses. After isoxsuprine administration, both oral and i.m. routes, the heart rate increased from baseline during the 9 h monitoring period. This was an expected finding attributable to the stimulating activity of beta-adrenergic receptors. The tolerability of isoxsuprine proved to be very good with all the four administrations performed.

Arzneimittelforschung

Pharmacokinetics and pharmacodynamics of ritodrine hydrochloride administered orally and intramuscularly to female healthy volunteers

Article

作者: Zava, Dario ; Coa, Katrin ; Cantoni, Vittorio ; Marzo, Antonio ; Fontana, Elena ; Bertolini, Andrea ; Bo, Lorenzo ; Tavazzi, Simona ; Ismaili, Shefqet

Ritodrine hydrochloride ((R,S)-4-hydroxy-alpha-[1-[2-((4-hydroxyphenyl)ethyl]amino)ethyl]benzenemethanol, CAS 26652-09-5) is a direct-acting sympathomimetic agent with a predominant beta-adrenergic activity and a selective action on beta2-receptors. A clinical trial was carried out to investigate the pharmacokinetics, pharmacodynamics and safety of ritodrine hydrochloride administered at the doses of 10, 20 and 30 mg p.o. and 10 mg by i. m. route. A four-way randomised crossover design was adopted on 12 healthy female volunteers with a wash-out of at least 14 days. Concentrations of ritodrine and of the pool of ritodrine in plasma and concentrations of the pool of ritodrine in urine of volunteers were bioassayed with tandem mass spectrometry. The following pharmacokinetic parameters were calculated, using the non-compartmental model: Cmax, AUC0-t, AUC0-INF, t1/2, Vd/f, and Aet after each administration. The distribution volume of ritodrine proved to be about 3 times higher than that of the pool of ritodrine after i. m. injection, confirming the good permeability of ritodrine that massively enters tissue compartments. Statistical analyses of pharmacokinetic parameters ascertained that the p. o. absorption of ritodrine hydrochloride was linearly related with the doses administered in the 10-30 mg range. The pharmacodynamic parameters evaluated complied with the mechanism of action of this drug.

100 项与 Istituto Lusofarmaco D'Italia S.p.A. 相关的药物交易

登录后查看更多信息

100 项与 Istituto Lusofarmaco D'Italia S.p.A. 相关的转化医学

登录后查看更多信息