102,471 research outputs found

    Analisi dei consumi di due classi di medicinali biotecnologici (ESA e G-CSF) in cinque Paesi europei.

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    The expected benefits of biosimilar drugs (a lower price and a competition effect on originators' price) offer an opportunity to contain the rising trend of the hospital pharmaceutical expenditure. This paper reviews the characteristics of biotechnological products and their regulatory features with the aim to evaluate if and how biosimilars are substituting the originators in the respective markets. Specifically, the study is focused on the two biologics markets ESA and G-CSF, because of their utilization and growth rate. The observation area includes five European countries (France, Germany, Italy, Spain, and UK) and the observation period encompasses the early years of the ESA/G-CSF biosimilars marketing in such area (2008-2011). Analytical sales data at package level were collected and converted to IU (ESA) or mcg (G-CSF). While the ESA total market (originators + biosimilars) did decline during the period and in the whole area under investigation (173 billion IUs in 2008 vs 158.1 billion in 2011), the biosimilars market alone soared (from 3.1 billion IUs in 2008 to 14.7 billion in 2011). So, a substitution effect did effectively occur, even if modest in relative terms (the biosimilars share of the total ESA market was only 8.5% in 2011). With reference to ESA biosimilars, the highest growth rate was in Italy and the largest market was in Germany. The overall G-CSF market grew from 2.7 million mcgs in 2008 to 3.4 million in 2011. However, biosimilars alone grew at a much higher speed (from 2.5 thousand mcgs to 432.3 thousand), implying a substitution effect similar to ESA's. G-CSF biosimilars market share in Italy ranked second in the five countries area. The substitution process of originators by biosimilars (at least in the markets, period and area observed in this study) appears relatively slow, mainly because of clinical reasons (only similarity, not therapeutic equivalence with originators, is acknowledged to biosimilars). However, the favorable impact of biosimilars on prices of, and expenditure for, biologic drugs cannot be denied. © 2013 Springer International Publishing Switzerland

    Total intravenous anaesthesia with “ketofol” (ketamine/propofol combination) in cats undergoing ovariectomy: intra and post-operative evaluation

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    Total intravenous anaesthesia with “ketofol” in cats undergoing ovariectomy: intra and post-operative evaluation G. Ravasio, D. Fonda, G. De Carli, Beccaglia M., L. Borghi, A.M. Carotenuto, M. Gallo, A. Zonca Università degli Studi di Milano, Facoltà di Medicina Veterinaria di Milano, via Celoria 10, 20133 (MI) Italy Ketamine (K) and propofol (P) combination CRI is intravenous (IV) association used in humans and veterinary medicine (Arora 2008, Ilkiw & Pascoe 2003). Intraoperative anaesthetic variables and postoperative analgesic and sedative effects were evaluated. Fifteen female cats undergoing ovariectomy received IV loading dose of K plus P (2 mg kg-1 each) (n=8) mixed in the same syringe (ketofol) or ketofol added of dexmedetomidine (0.003 mg kg-1 IV) (n=7), followed by IV infusion of the ketofol mixture (10 mg kg-1 h-1 each). Physiological parameters and venous emogasanalysis were monitored during surgery and the count in the Heinz bodies formation was investigated. Blood concentrations of ketamine, norketamine and propofol were quantified by HPLC analysis. Sedation degree, the quality of recovery and pain assessment were also evaluated in the postoperative period. The intraoperative HR was significantly higher and the time of extubation was significantly shorter in the group receiving ketofol without dexmedetomidine. Blood emogasanalyses were not substantial different among groups and the infusion of propofol did not significantly increase oxidative damage to the red blood cells. The pharmacokinetic profile was similar for propofol and ketamine. During recovery the animals in both groups appeared restful, without pain. The total intravenous anaesthesia (TIVA) with ketofol appeared to be safe in cats, with fast and smooth recovery and adequate analgesia during postoperative period. Decrease HR in dexmedetomidine group resulted in a more stable haemodynamic state, but prolonged recovery time. The infusion of ketofol could represent a useful protocol for TIVA in cats undergoing moderately painful surgery. References: Arora S (2008) Combining ketamine and propofol (“Ketofol”) for emergency department procedural sedation and analgesia: a review. WestJEM 9, 20-23. Ilkiw JE, Pascoe PJ (2003) Cardiovascular effects of propofol alone and in combination with ketamine for total intravenous anesthesia in cat. AJVR 64, 913-91

    Induction of general anaesthesia by rapid injection of propofol and dexmedetomidine or propofol and buthorphanol: cardiopulmonary and echocardiographic parameters in unpremedicated dogs

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    2011 The Authors. Veterinary Anaesthesia and Analgesia 20 2011 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesiologists, 38, 1–35 Induction of general anaesthesia by rapid injection of propofol and dexmedetomidine or propofol and butorphanol: cardiopulmonary and echocardiographic parameters in unpremedicated dogs G Ravasio, L Borghi, D Fonda, P Brambilla, V Bronzo, J Cincotti & C Locatelli Universita` degli Studi di Milano, Facolta` di Medicina Veterinaria di Milano, via Celoria 10, 20133 (MI) Italy The aim was to compare quality of induction, echocardiographic and cardiopulmonary effects of two different general anaesthesia induction protocols. Twelve dogs (ASA I-II) were assigned randomly into two groups. Both groups received a rapid bolus of propofol (2.2 mg kg)1 IV) immediately followed by a rapid bolus of dexmedetomidine 3 lg kg)1 IV (group A) or butorphanol 0MAP, SAP (NIBP) were recorded and 2, 5, 10, 15, 20 minutes after drug administration. Induction quality, intubation time, additional propofol dose to achieve intubation, sedation score (Fernandez et al. 2005) and adverse effects were recorded. Echocardiogram was performed at baseline and immediately after tracheal intubation. Data were analyzed using repeated measures ANOVA and Wilcoxon test (p < 0.05). Induction quality, intubation time (A: 75 ± 25, B: 145 ± 66.8 seconds) were statistically different between groups, HR was statistically lower in group A compared to baseline (62 ± 23; 101 ± 23), fR was not statistically different between groups but lower than baseline in group A, NIBP was statistically higher in group A and lower in group B compared to baseline. Body temperature, SpO2, PE¢CO2 were not statistically different. No apnoea (>30 seconds) or emesis were recorded. Five group B dogs required additional propofol (1.1 ± 0.7 mg kg)1 IV) to achieve tracheal intubation. Left ventricular end-diastolic diameter was statistically lower in group B and statistically higher in group A compared to baseline. Cardiac output decrease was 18.5% in group A and 24.4% in group B. Quality of induction was better in group A. Echocardiographic parameters varied compared to baseline in both groups but remained within normal ranges for adult dogs (Cornell et al. 2004). References: Fernandez JG, Parodi E, Garcia P et al. (2005) Clinical action of subarachnoid sevoflurane in vivo: a study in dogs. Brit J Anaesth 95(4), 530– 534. Cornell CC, Kittleson MD, Della Torre P et al. (2004) Allometric scaling of M-Mode cardiac measurements in normal adult dogs. J Vet Intern med 18(3), 311–321..4 mg kg)1 IV (group B) administered by a blinded operator. Baseline HR

    Random parallel algorithms for finding exact branchings, perfect matchings, and cycles

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    In this paper we devise randomized parallel algorithms which given a unary weighted (di)graph G=(V, E)construct in time O(log2| V|) branchings, perfect matchings, and disjoint cycles of weight exactly k belonging to G. These problems have been studied by Papadimitriou and Yannakakis [PY1], by Barahona and Pulleyblank [BP], by Camerini et al [CGM], and by Mulmuley et al. [MVV]. Our algorithms improve previous solutions. Moreover, we give an NC2 algorithm for computing the absolute value of the pfaffian of a skew-symmetric matrix

    Three dexmedetomidine constant rate infusion (CRI) in feline ovariectomized patients: sedative and analgesic effects

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    Three dexmedetomidine constant rate infusion (CRI) regimens in feline ovariectomized patients: sedative and analgesic effects. A.M. Carotenuto, G. Ravasio, L. Borghi, S Boveri, M. Beccaglia, D. Fonda Università degli Studi di Milano, Facoltà di Medicina Veterinaria di Milano, via Celoria 10, 20133 (MI) Italy In cats, few studies have investigated the clinical effect of dexmedetomidine (DMED) CRI during perioperative period. Our aim was to evaluate the analgesic and sedative effects of three rates of DMED CRI in feline patients undergoing ovariectomy, postoperatively monitored for 24 hours. Eighteen female cats were enrolled. After premedication (5 μg kg-1 DMED IM; 0.2 mg kg-1 meloxicam SC), patients were induced with propofol and randomly allocated into three groups (D1-D2-D3) to receive 0.5 (n=6), 1.5 (n=6) and 2.5 (n=6) μg kg-1 h-1 DMED CRI respectively. Anaesthesia was maintained with isoflurane in oxygen and respiration was mechanically controlled using intermittent positive pressure ventilation to maintain normocapnia. Intraoperative hemodynamic parameters and end tidal isoflurane concentration were recorded every 5 minutes. Rescue anaesthesia was provided by means of 0.5 mg kg-1 of propofol in response to acute increases in HR or MAP (20% or more). Postoperatively, sedation, analgesia, muscular relaxation and quality of recovery were evaluated using three postoperative scales (Ansah et al. 2002; Shaffran et al. 2008; Belda et al. 2008). Buprenorphine (10 μg kg-1) was provided as rescue postoperative analgesic drug. Data were analyzed by ANOVA and Kruskal-Wallis test (P<0.05). Intraoperatively, significant differences among groups were not found and any cat did not required rescue propofol, showing stable hemodynamic state. Isoflurane sparing effect of 40% was obtained in D1 and around 48% in D2 and D3. Postoperative analgesia and muscular relaxation showed to be significantly increased in D3 patients than in D1 and D2, while sedative effects resulted to be decreased. Although none patient in three groups required rescue analgesia, D3 showed the most favourable results. DMED infusion, used as part of a balanced anaesthesia, seemed to be safe, useful and effective to obtain adequate intra and postoperative analgesia in feline patients undergoing ovariectomy. References: Arora S (2008) Combining ketamine and propofol (“Ketofol”) for emergency department procedural sedation and analgesia: a review. WestJEM 9, 20-23. Ilkiw JE, Pascoe PJ (2003) Cardiovascular effects of propofol alone and in combination with ketamine for total intravenous anesthesia in cat. AJVR 64, 913-91

    Sexual and Reproductive Health in Women with Pulmonary Hypertension: A Qualitative Study

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    Pulmonary arterial hypertension (PAH) is a devastating disease characterized by elevation in pulmonary artery pressure causing progressive symptoms: shortness of breath, fatigue, and a decline in functional ability. Research on the impact of PAH on sexual and reproductive health was sparse. The aim of this study is to explore sexual and reproductive health of women with PAH in relation to their illness experience. Twenty-five women with PAH participated in semistructured interviews. A thematic analysis was conducted on the transcripts using the ATLAS.ti software. Four main themes were identified: illness experience, intimate relationship, sexuality, and attitudes toward pregnancy. Results showed that illness changed women’s self-perception, couples’ relationship, sexuality, and the idea of an eventual pregnancy. The relationship with the partner was usually indicated as an important resource, whereas communication with health care professionals was a critical but also potential key resource for the future. Results point to the need for intervention strategies to support women with PAH and help them make aware choices. Moreover, intervention strategies may inform health care interventions and policies for tackling the challenges posed by this illness

    Persistence, switch rates, drug consumption and costs of biological treatment of rheumatoid arthritis: an observational study in Italy

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    Luca Degli Esposti,1 Ennio Giulio Favalli,2 Diego Sangiorgi,1 Roberta Di Turi,3 Giuseppina Farina,4 Marco Gambera,5 Roberto Ravasio,6 1CliCon S.r.l. &ndash; Health, Economics&nbsp;&amp; Outcomes Research, Ravenna, 2Department of Rheumatology, Istituto Ortopedico Gaetano Pini, Milan, 3Local Pharmaceutical and Supplementary Assistance Unit, Roma Local Health Authority D, Rome, 4Internal Management Control Unit &ndash; Pharmaceutical Spending Control Sector, Caserta Local Health Authority, Caserta, 5Local Pharmaceutical Service, Bergamo Local Health Authority, Bergamo, 6Health Publishing &amp; Services Srl, Milan, Italy Objectives: The aim of this analysis was to provide an estimate of drug utilization indicators (persistence, switch rate and drug consumption) on biologics and the corresponding costs (drugs, admissions and specialist care) incurred by the Italian National Health Service in the management of adult patients with rheumatoid arthritis (RA).Methods: We conducted an observational retrospective cohort analysis using the administrative databases of three local health units. We considered all patients aged &ge;18&nbsp;years with a diagnosis of RA and at least one biologic drug prescription between January 2010 and December 2012 (recruitment period). Persistence was defined as maintenance over the last 3&nbsp;months of the follow-up period of the same biological therapy administered at the index date. A switch was defined as the presence of a biological therapy other than that administered at the index date during the last 3&nbsp;months of the follow-up period. Hospital admissions (with a diagnosis of RA or other RA-related diagnoses), specialist outpatient services, instrumental diagnostics and pharmaceutical consumption were assessed.Results: The drug utilization analysis took into account only biologics with at least 90 patients on treatment at baseline (adalimumab n=144, etanercept n=236 and infliximab n=94). In each year, etanercept showed better persistence with initial treatment than adalimumab or infliximab. Etanercept was characterized by the lowest number of patients increasing the initial drug consumption (2.6%) and by the highest number of patients reducing the initial drug consumption (10.5%). The mean cost of treatment for a patient persisting with the initial treatment was &euro;12,388 (&euro;14,182 for adalimumab, &euro;12,103 for etanercept and &euro;11,002 for infliximab). The treatment costs for patients switching from initial treatment during the first year of follow-up were higher than for patients who did not switch (&euro;12,710 vs. &euro;11,332).Conclusion: Persistence, switch rate and drug consumption seem to directly influence treatment costs. In subjects not persisting with initial treatment, other health care costs were approximately three times higher than for persistent patients. This difference could suggest a positive effect on the quality of life for persistent patients. Etanercept showed the highest persistence with treatment. Keywords: rheumatoid arthritis, biologic drugs, real-life clinical condition
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