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Moncada I.,Hospital la Zarzuela | de Bethencourt F.R.,Hospital Universitario La Paz | Lledo-Garcia E.,Hospital General Universitario Gregorio Maranon | Romero-Otero J.,Hospital Universitario 12 Octubre | And 4 more authors.
World Journal of Urology | Year: 2014

Purpose We report time to erectile function (EF)-recovery data from a multicenter, randomized, double-blind, double-dummy, placebo-controlled trial evaluating tadalafil started after bilateral nerve-sparing radical prostatectomy (nsRP). Methods Patients ≤68 years were randomized post-nsRP 1:1:1 to 9-month double-blind treatment (DBT) with tadalafil 5 mg once daily (OaD), 20 mg tadalafil on demand ("pro-re-nata"; PRN), or placebo, followed by 6-week drug-free washout (DFW) and 3-month open-label OaD treatment. Secondary outcome measures included Kaplan-Meier estimates of time to EF-recovery (IIEF-EF ≥ 22) during DBT (Cox proportional hazard model adjusting for treatment, age, and country). Results A total of 423 patients were randomized to tadalafil OaD (N = 139), PRN (N = 143), and placebo (N = 141); 114/122/155 completed DBT. The proportion of patients achieving IIEF-EF ≥22 at some point during DBT with OaD, PRN, and placebo was 29.5, 23.9, and 18.4 %, respectively. DBT was too short to achieve EF-recovery (IIEF-EF ≥ 22) in >50 % of patients; median time to EF-recovery was non-estimable. Time for 25 % of patients to achieve EF-recovery (95 % CI) was 5.8 (4.9, 9.2) months for OaD versus 9.0 (5.5, 9.2) and 9.3 (9.0, 9.9) months for PRN and placebo, respectively. Showing a significant overall treatment effect (p = 0.038), the probability for EF-recovery was significantly higher for OaD versus placebo [hazard ratio (HR); 95 % CI 1.9; 1.2, 3.1; p = 0.011], but not for PRN versus placebo (p = 0.140). Of 57 OaD patients (41.0 %) with ED improved (by ≥1 IIEF-EF severity grade) at the end of DBT, 16 (28.1 % of 57) maintained this improvement through DFW and 27 (47.4 %) declined but maintained improvement from baseline after DFW. Conclusions Data suggest that the use of tadalafil OaD can significantly shorten the time to EF-recovery post-nsRP compared with placebo. © 2014 The Author(s).


Le Tourneau C.,Beaujon University Hospital | Faivre S.,Beaujon University Hospital | Ciruelos E.,Hospital Universitario 12 Octubre | Dominguez M.J.,Institute Catala dOncologia | And 4 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials | Year: 2010

Objectives: To assess clinical benefit of plitidepsin (Aplidine) in patients with advanced medullary thyroid carcinoma (MTC). Materials and Methods: We retrospectively reported the outcome of 10 patients with advanced MTC among 215 patients who have entered the phase I program with plitidepsin. Results: Median number of cycles was 5. Using World Health Organization criteria, 1 among 5 patients with measurable disease displayed a confirmed partial response, whereas 8 patients experienced a stable disease, and 1 patient had a progressive disease, corresponding to a disease control rate of 90%. Two patients treated at the maximum tolerated dose experienced muscular dose-limiting toxicity possibly related to palmitoyl transferase inhibition. One of these 2 patients was able to continue therapy with no dose reduction with the prophylactic addition of l-carnitine, which is used in the treatment of the carnitine palmitoyl transferase deficiency type 2. Discussion: Plitidepsin seems to be able to induce clinical benefit in patients with pretreated MTC, and its toxicity has been manageable at the recommended dose. Copyright © 2010 by Lippincott Williams & Wilkins.


Garcia-Romero A.,IE University | Estrada-Lorenzo J.M.,Hospital Universitario 12 Octubre
Scientometrics | Year: 2014

Plagiarism is one of the most important current debates among scientific stakeholders. A separate but related issue is the use of authors’ own ideas in different papers (i.e., self-plagiarism). Opinions on this issue are mixed, and there is a lack of consensus. Our goal was to gain deeper insight into plagiarism and self-plagiarism through a citation analysis of documents involved in these situations. The Déjà vu database, which comprises around 80,000 duplicate records, was used to select 247 pairs of documents that had been examined by curators on a full text basis following a stringent protocol. We then used the Scopus database to perform a citation analysis of the selected documents. For each document pair, we used specific bibliometric indicators, such as the number of authors, full text similarity, journal impact factor, the Eigenfactor, and article influence. Our results confirm that cases of plagiarism are published in journals with lower visibility and thus tend to receive fewer citations. Moreover, full text similarity was significantly higher in cases of plagiarism than in cases of self-plagiarism. Among pairs of documents with shared authors, duplicates not citing the original document showed higher full text similarity than those citing the original document, and also showed greater overlap in the references cited in the two documents. © 2014, Akadémiai Kiadó, Budapest, Hungary.


Lopez E.,Hospital Universitario 12 Of Octubre | Wesselink J.-J.,Biomol Informatics SL | Lopez I.,Servicio de Hematologia Hospital QUIRON | Mendieta J.,Biomol Informatics SL | Munoz S.R.,Hospital Universitario 12 Octubre
Journal of Clinical Bioinformatics | Year: 2011

Reversible protein phosphorylation is one of the most important forms of cellular regulation. Thus, phosphoproteomic analysis of protein phosphorylation in cells is a powerful tool to evaluate cell functional status. The importance of protein kinase-regulated signal transduction pathways in human cancer has led to the development of drugs that inhibit protein kinases at the apex or intermediary levels of these pathways. Phosphoproteomic analysis of these signalling pathways will provide important insights for operation and connectivity of these pathways to facilitate identification of the best targets for cancer therapies. Enrichment of phosphorylated proteins or peptides from tissue or bodily fluid samples is required. The application of technologies such as phosphoenrichments, mass spectrometry (MS) coupled to bioinformatics tools is crucial for the identification and quantification of protein phosphorylation sites for advancing in such relevant clinical research. A combination of different phosphopeptide enrichments, quantitative techniques and bioinformatic tools is necessary to achieve good phospho-regulation data and good structural analysis of protein studies. The current and most useful proteomics and bioinformatics techniques will be explained with research examples. Our aim in this article is to be helpful for cancer research via detailing proteomics and bioinformatic tools. © 2011 López et al; licensee BioMed Central Ltd.


Sanchez-Fructuoso A.,Hospital Clinico San Carlos | Guirado L.,Fundacion Puigvert | Ruiz J.C.,Hospital Universitario Marques Of Valdecilla | Torregrosa V.,Hospital Clinic i Provincial | And 3 more authors.
Transplantation Proceedings | Year: 2010

Background Kidney transplant, the gold standard treatment for chronic kidney disease (CKD), is increasingly complicated by anemia. Once-monthly dosing of methoxy polyethylene glycol-epoetin beta provides stable, sustained hemoglobin levels in CKD patients. The present study evaluated anemia control in recipients treated with methoxy polyethylene glycol-epoetin beta to correct or as conversion treatment from other erythropoiesis-stimulating agents (ESAs). Patients and Methods This observational, retrospective study included kidney transplant patients treated with methoxy polyethylene glycol-epoetin beta according to investigators' clinical practice. Information about demographics, CKD, anemia, blood analyses, treatment, and adverse events were collected from patients' medical charts at baseline as well as months 1, 3, and 6. Results From October 2009 to March 2010, the 285 patients in the study included: an overall mean age of 52.8 ± 13.9 years with 146 females (51.2%) and 152 patients (55.1%) in stage 3 CKD. Forty-five patients (15.8%) were in the immediate posttransplant period; 51, nave- treatment (17.9%) and 189, converted subjects (66.3%). Eighty-two of the converted patients (48.0%) had previously received darbepoietin; 81 (47.4%), epoetin beta; and 8 (4.7%), epoetin alfa. The mean doses of methoxy polyethylene glycol-epoetin beta at baseline were 75.0 ± 22.4 μg per month, 95.8 ± 45.5 μg per month, and 118.9 ± 58.9 μg per month among nave, converted, and immediate posttransplant patients, respectively. Mean hemoglobin content varied from baseline to month 6, namely 10.2 ± 0.7 versus 11.8 ± 0.9 g/dL in nave (P < .001) and 11.4 ± 1.3 versus 12.0 ± 1.2 g/dL in converted patients (P = .001). Patients in the immediate posttransplant period showed mean hemoglobin values maintained between 10.4 ± 1.7 g/dL at baseline and 11.5 ± 1.2 g/dL at month 3. The only study-drugrelated adverse event was hypertension. No patient died during the study. Conclusion These preliminary results suggested that hemoglobin stability can be achieved and maintained after correction or conversion to once-monthly methoxy polyethylene glycol-epoetin beta in kidney recipients. It was well tolerated; the safety profile was that expected and comparable with shorter acting ESAs. © 2010 Elsevier Inc.

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