129 research outputs found

    Pharmacovigilance in children in Camagüey Province, Cuba

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    Purpose: Our aim was to describe the adverse drug reactions (ADRs) detected following increased education about pharmacovigilance and drug toxicity in children in Camagüey Province, Cuba. Methods: Over a period of 24 months (January 2009 to December 2010), all reports of suspected ADRs in children to the Provincial Pharmacovigilance Centre in Camagüey Province were analysed. ADRs were classified in relation to causality and severity. Results: There were 533 reports involving suspected ADRs in children in the period. Almost one third of the reports received were classified as moderate (155, 29%) or severe (10, 2%). There was one fatality in association with the use of ceftriaxone. Vaccines and antibiotics were responsible for most of the ADR reports (392, 74%) and for all ten severe ADRs. After an intensive educational package, both within the community and the Children’s Hospital, the number of reports increased from 124 in 2008 to 161 in 2009 and 372 in 2010. This was equivalent to a reporting rate of 879 and 2,031 reports per million children per year for 2009 and 2010, respectively. Conclusions: The incidence of ADRs in children Camagüey Province, Cuba, is greater than previously reported. An educational intervention about pharmacovigilance and drug toxicity in children can improve the reporting of ADRs

    Estimates for vector valued Dirichlet polynomials

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    [EN] We estimate the -norm of finite Dirichlet polynomials with coefficients in a Banach space. Our estimates quantify several recent results on Bohr's strips of uniform but non absolute convergence of Dirichlet series in Banach spaces.A. Defant and P. Sevilla-Peris were supported by MICINN Project MTM2011-22417.Defant, A.; Schwarting, U.; Sevilla Peris, P. (2014). Estimates for vector valued Dirichlet polynomials. Monatshefte f�r Mathematik. 175(1):89-116. https://doi.org/10.1007/s00605-013-0600-4S891161751Balasubramanian, R., Calado, B., Queffélec, H.: The Bohr inequality for ordinary Dirichlet series. Studia Math. 175(3), 285–304 (2006)Bayart, F.: Hardy spaces of Dirichlet series and their composition operators. Monatsh. Math. 136(3), 203–236 (2002)Bennett, G.: Inclusion mappings between lpl^{p} l p spaces. J. Funct. Anal. 13, 20–27 (1973)Bohnenblust, H.F., Hille, E.: On the absolute convergence of Dirichlet series. Ann. Math. (2) 32(3), 600–622 (1931)Bohr, H.: Über die Bedeutung der Potenzreihen unendlich vieler Variablen in der Theorie der Dirichlet–schen Reihen anns\sum \frac{a_n}{n^s} ∑ a n n s . Nachr. Ges. Wiss. Göttingen Math. Phys. Kl., Heft 4, 441–488 (1913)Bohr, H.: Über die gleichmäßige Konvergenz Dirichletscher Reihen. J. Reine Angew. Math. 143, 203–211 (1913)Carl, B.: Absolut- (p,1)(p,\,1) ( p , 1 ) -summierende identische Operatoren von lul_{u} l u in lvl_{v} l v . Math. Nachr. 63, 353–360 (1974)Carlson, F.: Contributions à la théorie des séries de Dirichlet. Note i. Ark. fö”r Mat., Astron. och Fys. 16(18), 1–19 (1922)de la Bretèche, R.: Sur l’ordre de grandeur des polynômes de Dirichlet. Acta Arith. 134(2), 141–148 (2008)Defant, A., Frerick, L., Ortega-Cerdà, J., Ounaïes, M., Seip, K.: The Bohnenblust–Hille inequality for homogeneous polynomials is hypercontractive. Ann. Math. (2) 174(1), 485–497 (2011)Defant, A., García, D., Maestre, M., Pérez-García, D.: Bohr’s strip for vector valued Dirichlet series. Math. Ann. 342(3), 533–555 (2008)Defant, A., García, D., Maestre, M., Sevilla-Peris, P.: Bohr’s strips for Dirichlet series in Banach spaces. Funct. Approx. Comment. Math. 44(part 2), 165–189 (2011)Defant, A., Maestre, M., Schwarting, U.: Bohr radii of vector valued holomorphic functions. Adv. Math. 231(5), 2837–2857 (2012)Defant, A., Popa, D., Schwarting, U.: Coordinatewise multiple summing operators in Banach spaces. J. Funct. Anal. 259(1), 220–242 (2010)Defant, A., Sevilla-Peris, P.: Convergence of Dirichlet polynomials in Banach spaces. Trans. Am. Math. Soc. 363(2), 681–697 (2011)Diestel, J., Jarchow, H., Tonge, A.: Absolutely Summing Operators. Cambridge Studies in Advanced Mathematics, vol. 43. Cambridge University Press, Cambridge (1995)Harris, L.A.: Bounds on the derivatives of holomorphic functions of vectors. In: Analyse fonctionnelle et applications (Comptes Rendus Colloq. Analyse, Inst. Mat., Univ. Federal Rio de Janeiro, Rio de Janeiro, 1972), pp. 145–163. Actualités Aci. Indust., No. 1367. Hermann, Paris (1975)Hedenmalm, H., Lindqvist, P., Seip, K.: A Hilbert space of Dirichlet series and systems of dilated functions in L2(0,1)L^2(0,1) L 2 ( 0 , 1 ) . Duke Math. J. 86(1), 1–37 (1997)Kahane, J.-P.: Some Random Series of Functions. Cambridge Studies in Advanced Mathematics, vol. 5, 2nd edn. Cambridge University Press, Cambridge (1985)Konyagin, S.V., Queffélec, H.: The translation 12\frac{1}{2} 1 2 in the theory of Dirichlet series. Real Anal. Exch. 27(1):155–175 (2001/2002)Kwapień, S.: Some remarks on (p,q)(p,\, q) ( p , q ) -absolutely summing operators in lpl_{p} l p -spaces. Studia Math. 29, 327–337 (1968)Ledoux, M., Talagrand, M.: Probability in Banach Spaces: Isoperimetry and Processes, reprint of the 1991 edn. Classics in Mathematics. Springer, Berlin (2011)Lindenstrauss, J., Tzafriri, L.: Classical Banach Spaces. I. Sequence Spaces, Ergebnisse der Mathematik und ihrer Grenzgebiete, vol. 92. Springer, Berlin (1977)Lindenstrauss, J., Tzafriri, L.: Classical Banach Spaces. II, Function Spaces. Ergebnisse der Mathematik und ihrer Grenzgebiete [Results in Mathematics and Related Areas], vol. 97. Springer, Berlin (1979)Maurizi, B., Queffélec, H.: Some remarks on the algebra of bounded Dirichlet series. J. Fourier Anal. Appl. 16, 676–692 (2010)Prachar, K.: Primzahlverteilung. Springer, Berlin (1957)Queffélec, H.: H. Bohr’s vision of ordinary Dirichlet series; old and new results. J. Anal. 3, 43–60 (1995)Tomczak-Jaegermann, N.: Banach–Mazur Distances and Finite-Dimensional Operator Ideals. Pitman Monographs and Surveys in Pure and Applied Mathematics, vol. 38. Longman Scientific & Technical, Harlow (1989

    Impact of EU regulatory label changes for diclofenac in people with cardiovascular disease in four countries:interrupted time series regression analysis

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    Objective: Due to cardiovascular safety concerns, the European Medicines Agency (EMA) recommended new contraindications and changes to product information for diclofenac across Europe in 2013. This study aims to measure their impact among targeted populations. Method: Quarterly interrupted time series regression (ITS) analyses of diclofenac initiation among cohorts with contraindications (congestive cardiac failure [CHF], ischaemic heart disease [IHD], peripheral arterial disease [PAD], cerebrovascular disease [CVD]) and cautions (hypertension, hyperlipidaemia, diabetes) from Denmark, the Netherlands, England and Scotland. Results: The regulatory action was associated with significant immediate absolute reductions in diclofenac initiation in all countries for IHD (Denmark −0.08%, 95%CI −0.13, −0.03; England −0.09%, 95%CI −0.13 to −0.06%; the Netherlands −1.84%, 95%CI −2.51 to −1.17%; Scotland −0.34%, 95%CI −0.38 to −0.30%), PAD and hyperlipidaemia, the Netherlands, England and Scotland for hypertension and diabetes, and England and Scotland for CHF and CVD. Post-intervention there was a significant negative trend in diclofenac initiation in the Netherlands for IHD (−0.12%, 95%CI −0.19 to −0.04), PAD (−0.13%, 95%CI −0.22 to −0.05), hypertension, hyperlipidaemia and diabetes, and in Scotland for CHF (−0.01%, 95%CI −0.02 to −0.007%), IHD (−0.017, 95%CI −0.02, −0.01%), PAD and hypertension. In England, diclofenac initiation rates fell less steeply. In Denmark changes were more strongly associated with the earlier EMA 2012 regulatory action. Conclusion: Although significant reductions in diclofenac initiation occurred, patients with contraindications continued to be prescribed diclofenac, the extent of which varied by country and target condition. Understanding reasons for such variation may help to guide the design or dissemination of future safety warnings

    One-component plasma on a spherical annulus and a random matrix ensemble

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    The two-dimensional one-component plasma at the special coupling \beta = 2 is known to be exactly solvable, for its free energy and all of its correlations, on a variety of surfaces and with various boundary conditions. Here we study this system confined to a spherical annulus with soft wall boundary conditions, paying special attention to the resulting asymptotic forms from the viewpoint of expected general properties of the two-dimensional plasma. Our study is motivated by the realization of the Boltzmann factor for the plasma system with \beta = 2, after stereographic projection from the sphere to the complex plane, by a certain random matrix ensemble constructed out of complex Gaussian and Haar distributed unitary matrices.Comment: v2, typos and references corrected, 24 pages, 1 figur

    Comparison of the influence of cyclosporine and tacrolimus on the pharmacokinetics of prednisolone in adult male kidney transplant recipients

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    Cyclosporine has been observed to precipitate cushingoid features in kidney transplant recipients already on prednisolone. Some pharmacokinetic studies have demonstrated increased prednisolone exposure in patients on cyclosporine therapy compared with azathioprine, whereas other studies have found no difference. The objective of this study was to determine whether cyclosporine impacts on prednisolone exposure as compared with tacrolimus

    Systematic review of safety in paediatric drug trials published in 2007

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    Background: There is now greater involvement of children in drug trials to ensure that paediatric medicines are supported by sound scientific evidence. The safety of the participating children is of paramount importance. Previous research shows that these children can suffer moderate and severe adverse drug reactions (ADRs) in clinical trials, yet very few of the trials designated a data safety monitoring board (DSMB) to oversee the trial. Methods: Safety data from a systematic review of paediatric drug randomised controlled trials (RCTs) published in 2007 were analysed. All reported adverse events (AEs) were classified and assessed to determine whether an ADR had been experienced. ADRs were then categorised according to severity. Each trial report was examined as to whether an independent DSMB was in place. Results: Of the 582 paediatric drug RCTs analysed, 210 (36%) reported that a serious AE had occurred, and in 15% mortality was reported. ADRs were detected in more than half of the RCTs (305); 66 (11%) were severe, and 79 (14%) were moderate. Severe ADRs involved a wide range of organ systems and were frequently associated with cytotoxic drugs, antiparasitics, anticonvulsants and psychotropic drugs. Two RCTs reported significantly higher mortality rates in the treatment group. Only 69 (12%) of the RCTs stated there was a DSMB. DSMBs terminated five RCTs and changed the protocol in one. Conclusions: Children participating in drug RCTs experience a significant amount and a wide range of ADRs. DSMBs are needed to ensure the safety of paediatric participants in clinical drug trial
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