13 research outputs found

    Efficacy and Safety of Tadalafil Once Daily in the Treatment of Men With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Results of an International Randomized, Double-Blind, Placebo-Controlled Trial

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    Background: Tadalafil is being investigated for the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH-LUTS). Objective: To assess efficacy, including onset, and safety of tadalafil on BPH-LUTS and the subject's and clinician's perception of changes in urinary symptoms. Design, setting, and participants: This randomized, double-blind, placebo-controlled, 12-week trial enrolled men >= 45 yr of age with BPH-LUTS for >6 mo, International Prostate Symptom Score (IPSS) >= 13, and maximum urine flow rate (Q(max)) >= 4 to <= 15 ml/s. Intervention: Tadalafil 5 mg (n = 161) or placebo (n = 164), once daily. Measurements: Analysis of covariance (ANCOVA) modeling evaluated change from baseline in continuous efficacy variables. Categoric efficacy variables were analyzed with the Cochran-Mantel-Haenszel test, and between-group differences in treatment-emergent adverse events (TEAEs) were assessed using the Fisher exact test. Results and limitation: Tadalafil significantly improved IPSS results, from baseline to endpoint, compared to placebo (-5.6 vs -3.6; p = 0.004). Reduction in IPSS results was apparent after 1 wk and significant after 4 wk (tadalafil -5.3 vs placebo -3.5; p = 0.003). The BPH Impact Index (BII) was not assessed at week 1; however, BII improvement was apparent at 4 wk (tadalafil -1.8 vs placebo -1.2; p = 0.029) and continued at 12 wk (tadalafil -1.8 vs placebo -1.3; p = 0.057). Tadalafil significantly improved the International Index of Erectile Function-Erectile Function score in sexually active men with erectile dysfunction (ED; 6.7 vs 2.0; p < 0.001) at 12 wk (not assessed at week 1). Few subjects reported one TEAE or more (p = 0.44). For tadalafil, the most common TEAEs were headache (3.7%) and back pain (3.1%). Tadalafil did not significantly improve Q(max) or reduce postvoid residual volume. Conclusions: Tadalafil 5 mg once daily for 12 wk resulted in a clinically meaningful reduction in total IPSS results as early as 1 wk and achieved statistical significance at 4 wk in men with BPH-LUTS. The adverse event profile was consistent with that previously reported in men with ED. Trial registration: This clinical trial is registered on the clinicaltrials.gov website (http://www.clinicaltrials.gov). The registration number is NCT00827242. (C) 2011 Published by Elsevier B. V. on behalf of European Association of Urology

    Effects of Ramipril and Rosiglitazone on Cardiovascular and Renal Outcomes in People With Impaired Glucose Tolerance or Impaired Fasting Glucose : Results of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial

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    OBJECTIVE—Impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) are risk factors for diabetes, cardiovascular disease (CVD), and kidney disease. We determined the effects of ramipril and rosiglitazone on combined and individual CVD and renal outcomes in people with IGT and/or IFG in the Diabetes REduction Assessment With ramipril and rosiglitazone Medication (DREAM) trial. RESEARCH DESIGN AND METHODS—A total of 5,269 people aged ≥30 years, with IGT and/or IFG without known CVD or renal insufficiency, were randomized to 15 mg/day ramipril versus placebo and 8 mg/day rosiglitazone versus placebo. A composite cardiorenal outcome and its CVD and renal components were assessed during the 3-year follow-up. RESULTS—Compared with placebo, neither ramipril (15.7% [412 of 2,623] vs. 16.0% [424 of 2,646]; hazard ratio [HR] 0.98 [95% CI 0.84–1.13]; P = 0.75) nor rosiglitazone (15.0% [394 of 2,635] vs. 16.8% [442 of 2,634]; 0.87 [0.75–1.01]; P = 0.07) reduced the risk of the cardiorenal composite outcome. Ramipril had no impact on the CVD and renal components. Rosiglitazone increased heart failure (0.53 vs. 0.08%; HR 7.04 [95% CI 1.60–31.0]; P = 0.01) but reduced the risk of the renal component (0.80 [0.68–0.93]; P = 0.005); prevention of diabetes was independently associated with prevention of the renal component (P &amp;lt; 0.001). CONCLUSIONS—Ramipril did not alter the cardiorenal outcome or its components. Rosiglitazone, which reduced diabetes, also reduced the development of renal disease but not the cardiorenal outcome and increased the risk of heart failure.The DREAM Trial Investigator

    Cause of death and predictors of all-cause mortality in anticoagulated patients with nonvalvular atrial fibrillation: Data from ROCKET AF

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    Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intentionto- treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P&lt;0.0001) and age 6575 years (hazard ratio 1.69, 95% CI 1.51-1.90, P&lt;0.0001) were associated with higher all-cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C-index 0.677). Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, 487 in 10 deaths were cardiovascular, whereas &lt;1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival

    Infective Endocarditis in Patients on Chronic Hemodialysis

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    295sinoneBackground: Infective endocarditis (IE) is a common and serious complication in patients receiving chronic hemodialysis (HD). Objectives: This study sought to investigate whether there are significant differences in complications, cardiac surgery, relapses, and mortality between IE cases in HD and non-HD patients. Methods: Prospective cohort study (International Collaboration on Endocarditis databases, encompassing 7,715 IE episodes from 2000 to 2006 and from 2008 to 2012). Descriptive analysis of baseline characteristics, epidemiological and etiological features, complications and outcomes, and their comparison between HD and non-HD patients was performed. Risk factors for major embolic events, cardiac surgery, relapses, and in-hospital and 6-month mortality were investigated in HD-patients using multivariable logistic regression. Results: A total of 6,691 patients were included and 553 (8.3%) received HD. North America had a higher HD-IE proportion than the other regions. The predominant microorganism was Staphylococcus aureus (47.8%), followed by enterococci (15.4%). Both in-hospital and 6-month mortality were significantly higher in HD versus non–HD-IE patients (30.4% vs. 17% and 39.8% vs. 20.7%, respectively; p &lt; 0.001). Cardiac surgery was less frequently performed among HD patients (30.6% vs. 46.2%; p &lt; 0.001), whereas relapses were higher (9.4% vs. 2.7%; p &lt; 0.001). Risk factors for 6-month mortality included Charlson score (hazard ratio [HR]: 1.26; 95% confidence interval [CI]: 1.11 to 1.44; p = 0.001), CNS emboli and other emboli (HR: 3.11; 95% CI: 1.84 to 5.27; p &lt; 0.001; and HR: 1.73; 95% CI: 1.02 to 2.93; p = 0.04, respectively), persistent bacteremia (HR: 1.79; 95% CI: 1.11 to 2.88; p = 0.02), and acute onset heart failure (HR: 2.37; 95% CI: 1.49 to 3.78; p &lt; 0.001). Conclusions: HD-IE is a health care–associated infection chiefly caused by S. aureus, with increasing rates of enterococcal IE. Mortality and relapses are very high and significantly larger than in non–HD-IE patients, whereas cardiac surgery is less frequently performed.nonePericas J.M.; Llopis J.; Jimenez-Exposito M.J.; Kourany W.M.; Almirante B.; Carosi G.; Durante-Mangoni E.; Fortes C.Q.; Giannitsioti E.; Lerakis S.; Montagna-Mella R.; Ambrosioni J.; Tan R.-S.; Mestres C.A.; Wray D.; Pachirat O.; Moreno A.; Chu V.H.; de Lazzari E.; Fowler V.G.; Miro J.M.; Clara L.; Sanchez M.; Casabe J.; Cortes C.; Nacinovich F.; Oses P.F.; Ronderos R.; Sucari A.; Thierer J.; Altclas J.; Kogan S.; Spelman D.; Athan E.; Harris O.; Kennedy K.; Tan R.; Gordon D.; Papanicolas L.; Korman T.; Kotsanas D.; Dever R.; Jones P.; Konecny P.; Lawrence R.; Rees D.; Ryan S.; Feneley M.P.; Harkness J.; Post J.; Reinbott P.; Gattringer R.; Wiesbauer F.; Andrade A.R.; Passos de Brito A.C.; Guimaraes A.C.; Grinberg M.; Mansur A.J.; Siciliano R.F.; Varejao Strabelli T.M.; Campos Vieira M.L.; de Medeiros Tranchesi R.A.; Paiva M.G.; de Oliveira Ramos A.; Weksler C.; Ferraiuoli G.; Golebiovski W.; Lamas C.; Karlowsky J.A.; Keynan Y.; Morris A.M.; Rubinstein E.; Jones S.B.; Garcia P.; Cereceda M.; Fica A.; Mella R.M.; Fernandez R.; Franco L.; Gonzalez J.; Jaramillo A.N.; Barsic B.; Bukovski S.; Krajinovic V.; Pangercic A.; Rudez I.; Vincelj J.; Freiberger T.; Pol J.; Zaloudikova B.; Ashour Z.; El Kholy A.; Mishaal M.; Osama D.; Rizk H.; Aissa N.; Alauzet C.; Alla F.; Campagnac C.C.; Doco-Lecompte T.; Selton-Suty C.; Casalta J.-P.; Fournier P.-E.; Habib G.; Raoult D.; Thuny F.; Delahaye F.; Delahaye A.; Vandenesch F.; Donal E.; Donnio P.Y.; Flecher E.; Michelet C.; Revest M.; Tattevin P.; Chevalier F.; Jeu A.; Remadi J.P.; Rusinaru D.; Tribouilloy C.; Bernard Y.; Chirouze C.; Hoen B.; Leroy J.; Plesiat P.; Naber C.; Neuerburg C.; Mazaheri B.; Sophia Athanasia C.N.; Deliolanis I.; Giamarellou H.; Thomas T.; Mylona E.; Paniara O.; Papanicolaou K.; Pyros J.; Skoutelis A.; Papanikolaou K.; Sharma G.; Francis J.; Nair L.; Thomas V.; Venugopal K.; Hannan M.M.; Hurley J.P.; Wanounou M.; Gilon D.; Israel S.; Korem M.; Strahilevitz J.; Iossa D.; Orlando S.; Ursi M.P.; Pafundi P.C.; D'Amico F.; Bernardo M.; Cuccurullo S.; Dialetto G.; Covino F.E.; Manduca S.; Della Corte A.; De Feo M.; Tripodi M.F.; Cecchi E.; De Rosa F.; Forno D.; Imazio M.; Trinchero R.; Grossi P.; Lattanzio M.; Toniolo A.; Goglio A.; Raglio A.; Ravasio V.; Rizzi M.; Suter F.; Magri S.; Signorini L.; Kanafani Z.; Kanj S.S.; Sharif-Yakan A.; Abidin I.; Tamin S.S.; Martinez E.R.; Soto Nieto G.I.; van der Meer J.T.M.; Chambers S.; Holland D.; Morris A.; Raymond N.; Read K.; Murdoch D.R.; Dragulescu S.; Ionac A.; Mornos C.; Butkevich O.M.; Chipigina N.; Kirill O.; Vadim K.; Vinogradova T.; Edathodu J.; Halim M.; Liew Y.-Y.; Lejko-Zupanc T.; Logar M.; Mueller-Premru M.; Commerford P.; Commerford A.; Deetlefs E.; Hansa C.; Ntsekhe M.; Almela M.; Azqueta M.; Brunet M.; Castro P.; Falces C.; Fuster D.; Fita G.; Garcia- de- la- Maria C.; Garcia-Gonzalez J.; Gatell J.M.; Marco F.; Miro J.M.; Ortiz J.; Ninot S.; Pare J.C.; Pericas J.M.; Quintana E.; Ramirez J.; Rovira I.; Sandoval E.; Sitges M.; Tellez A.; Tolosana J.M.; Vidal B.; Vila J.; Anguera I.; Font B.; Guma J.R.; Bermejo J.; Bouza E.; Garcia Fernandez M.A.; Gonzalez-Ramallo V.; Marin M.; Munoz P.; Pedromingo M.; Roda J.; Rodriguez-Creixems M.; Solis J.; Fernandez-Hidalgo N.; Tornos P.; de Alarcon A.; Parra R.; Alestig E.; Johansson M.; Olaison L.; Snygg-Martin U.; Pachirat P.; Pussadhamma B.; Senthong V.; Casey A.; Elliott T.; Lambert P.; Watkin R.; Eyton C.; Klein J.L.; Bradley S.; Kauffman C.; Bedimo R.; Corey G.R.; Crowley A.L.; Douglas P.; Drew L.; Holland T.; Lalani T.; Mudrick D.; Samad Z.; Sexton D.; Stryjewski M.; Wang A.; Woods C.W.; Cantey R.; Steed L.; Dickerman S.A.; Bonilla H.; DiPersio J.; Salstrom S.-J.; Baddley J.; Patel M.; Peterson G.; Stancoven A.; Levine D.; Riddle J.; Rybak M.; Cabell C.H.Pericas, J. M.; Llopis, J.; Jimenez-Exposito, M. J.; Kourany, W. M.; Almirante, B.; Carosi, G.; Durante-Mangoni, E.; Fortes, C. Q.; Giannitsioti, E.; Lerakis, S.; Montagna-Mella, R.; Ambrosioni, J.; Tan, R. -S.; Mestres, C. A.; Wray, D.; Pachirat, O.; Moreno, A.; Chu, V. H.; de Lazzari, E.; Fowler, V. G.; Miro, J. M.; Clara, L.; Sanchez, M.; Casabe, J.; Cortes, C.; Nacinovich, F.; Oses, P. F.; Ronderos, R.; Sucari, A.; Thierer, J.; Altclas, J.; Kogan, S.; Spelman, D.; Athan, E.; Harris, O.; Kennedy, K.; Tan, R.; Gordon, D.; Papanicolas, L.; Korman, T.; Kotsanas, D.; Dever, R.; Jones, P.; Konecny, P.; Lawrence, R.; Rees, D.; Ryan, S.; Feneley, M. P.; Harkness, J.; Post, J.; Reinbott, P.; Gattringer, R.; Wiesbauer, F.; Andrade, A. R.; Passos de Brito, A. C.; Guimaraes, A. C.; Grinberg, M.; Mansur, A. J.; Siciliano, R. F.; Varejao Strabelli, T. M.; Campos Vieira, M. L.; de Medeiros Tranchesi, R. A.; Paiva, M. G.; de Oliveira Ramos, A.; Weksler, C.; Ferraiuoli, G.; Golebiovski, W.; Lamas, C.; Karlowsky, J. A.; Keynan, Y.; Morris, A. M.; Rubinstein, E.; Jones, S. B.; Garcia, P.; Cereceda, M.; Fica, A.; Mella, R. M.; Fernandez, R.; Franco, L.; Gonzalez, J.; Jaramillo, A. N.; Barsic, B.; Bukovski, S.; Krajinovic, V.; Pangercic, A.; Rudez, I.; Vincelj, J.; Freiberger, T.; Pol, J.; Zaloudikova, B.; Ashour, Z.; El Kholy, A.; Mishaal, M.; Osama, D.; Rizk, H.; Aissa, N.; Alauzet, C.; Alla, F.; Campagnac, C. C.; Doco-Lecompte, T.; Selton-Suty, C.; Casalta, J. -P.; Fournier, P. -E.; Habib, G.; Raoult, D.; Thuny, F.; Delahaye, F.; Delahaye, A.; Vandenesch, F.; Donal, E.; Donnio, P. Y.; Flecher, E.; Michelet, C.; Revest, M.; Tattevin, P.; Chevalier, F.; Jeu, A.; Remadi, J. P.; Rusinaru, D.; Tribouilloy, C.; Bernard, Y.; Chirouze, C.; Hoen, B.; Leroy, J.; Plesiat, P.; Naber, C.; Neuerburg, C.; Mazaheri, B.; Sophia Athanasia, C. N.; Deliolanis, I.; Giamarellou, H.; Thomas, T.; Mylona, E.; Paniara, O.; Papanicolaou, K.; Pyros, J.; Skoutelis, A.; Papanikolaou, K.; Sharma, G.; Francis, J.; Nair, L.; Thomas, V.; Venugopal, K.; Hannan, M. M.; Hurley, J. P.; Wanounou, M.; Gilon, D.; Israel, S.; Korem, M.; Strahilevitz, J.; Iossa, D.; Orlando, S.; Ursi, M. P.; Pafundi, P. C.; D'Amico, F.; Bernardo, M.; Cuccurullo, S.; Dialetto, G.; Covino, F. E.; Manduca, S.; Della Corte, A.; De Feo, M.; Tripodi, M. F.; Cecchi, E.; De Rosa, F.; Forno, D.; Imazio, M.; Trinchero, R.; Grossi, P.; Lattanzio, M.; Toniolo, A.; Goglio, A.; Raglio, A.; Ravasio, V.; Rizzi, M.; Suter, F.; Magri, S.; Signorini, L.; Kanafani, Z.; Kanj, S. S.; Sharif-Yakan, A.; Abidin, I.; Tamin, S. S.; Martinez, E. R.; Soto Nieto, G. I.; van der Meer, J. T. M.; Chambers, S.; Holland, D.; Morris, A.; Raymond, N.; Read, K.; Murdoch, D. R.; Dragulescu, S.; Ionac, A.; Mornos, C.; Butkevich, O. M.; Chipigina, N.; Kirill, O.; Vadim, K.; Vinogradova, T.; Edathodu, J.; Halim, M.; Liew, Y. -Y.; Lejko-Zupanc, T.; Logar, M.; Mueller-Premru, M.; Commerford, P.; Commerford, A.; Deetlefs, E.; Hansa, C.; Ntsekhe, M.; Almela, M.; Azqueta, M.; Brunet, M.; Castro, P.; Falces, C.; Fuster, D.; Fita, G.; Garcia- de- la- Maria, C.; Garcia-Gonzalez, J.; Gatell, J. M.; Marco, F.; Miro, J. M.; Ortiz, J.; Ninot, S.; Pare, J. C.; Pericas, J. M.; Quintana, E.; Ramirez, J.; Rovira, I.; Sandoval, E.; Sitges, M.; Tellez, A.; Tolosana, J. M.; Vidal, B.; Vila, J.; Anguera, I.; Font, B.; Guma, J. R.; Bermejo, J.; Bouza, E.; Garcia Fernandez, M. A.; Gonzalez-Ramallo, V.; Marin, M.; Munoz, P.; Pedromingo, M.; Roda, J.; Rodriguez-Creixems, M.; Solis, J.; Fernandez-Hidalgo, N.; Tornos, P.; de Alarcon, A.; Parra, R.; Alestig, E.; Johansson, M.; Olaison, L.; Snygg-Martin, U.; Pachirat, P.; Pussadhamma, B.; Senthong, V.; Casey, A.; Elliott, T.; Lambert, P.; Watkin, R.; Eyton, C.; Klein, J. L.; Bradley, S.; Kauffman, C.; Bedimo, R.; Corey, G. R.; Crowley, A. L.; Douglas, P.; Drew, L.; Holland, T.; Lalani, T.; Mudrick, D.; Samad, Z.; Sexton, D.; Stryjewski, M.; Wang, A.; Woods, C. W.; Cantey, R.; Steed, L.; Dickerman, S. A.; Bonilla, H.; Dipersio, J.; Salstrom, S. -J.; Baddley, J.; Patel, M.; Peterson, G.; Stancoven, A.; Levine, D.; Riddle, J.; Rybak, M.; Cabell, C. H

    Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial

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    Background Rosiglitazone is a thiazolidinedione that reduces insulin resistance and might preserve insulin secretion. The aim of this study was to assess prospectively the drugs ability to prevent type 2 diabetes in individuals at high risk of developing the condition

    Surgery and outcome of infective endocarditis in octogenarians: prospective data from the ESC EORP EURO-ENDO registry

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    Purpose: High mortality and a limited performance of valvular surgery are typical features of infective endocarditis (IE) in octogenarians, even though surgical treatment is a major determinant of a successful outcome in IE. Methods: Data from the prospective multicentre ESC EORP EURO-ENDO registry were used to assess the prognostic role of valvular surgery depending on age. Results: As compared to &lt; 80&nbsp;yo patients, ≥ 80&nbsp;yo had lower rates of theoretical indication for valvular surgery (49.1% vs. 60.3%, p &lt; 0.001), of surgery performed (37.0% vs. 75.5%, p &lt; 0.001), and a higher in-hospital (25.9% vs. 15.8%, p &lt; 0.001) and 1-year mortality (41.3% vs. 22.2%, p &lt; 0.001). By multivariable analysis, age per se was not predictive of 1-year mortality, but lack of surgical procedures when indicated was strongly predictive (HR 2.98 [2.43–3.66]). By propensity analysis, 304 ≥ 80&nbsp;yo were matched to 608 &lt; 80&nbsp;yo patients. Propensity analysis confirmed the lower rate of indication for valvular surgery (51.3% vs. 57.2%, p = 0.031) and of surgery performed (35.3% vs. 68.4%, p &lt; 0.0001) in ≥ 80&nbsp;yo. Overall mortality remained higher in ≥ 80&nbsp;yo (in-hospital: HR 1.50[1.06–2.13], p = 0.0210; 1-yr: HR 1.58[1.21–2.05], p = 0.0006), but was not different from that of &lt; 80&nbsp;yo among those who had surgery (in-hospital: 19.7% vs. 20.0%, p = 0.4236; 1-year: 27.3% vs. 25.5%, p = 0.7176). Conclusion: Although mortality rates are consistently higher in ≥ 80&nbsp;yo patients than in &lt; 80&nbsp;yo patients in the general population, mortality of surgery in ≥ 80&nbsp;yo is similar to &lt; 80&nbsp;yo after matching patients. These results confirm the importance of a better recognition of surgical indication and of an increased performance of surgery in ≥ 80&nbsp;yo patients
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