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1. Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases

Author

Claudia A. Salinas, Anthony Louder, Jennifer Polinski, Tancy C. Zhang, Hannah Bower, Syd Phillips, Yufei Song, Emaan Rashidi, Rafia Bosan, Hsiu-Ching Chang, Nicole Foster, Bernice Gershenson, Hisashi Yamanaka, Mitsumasa Kishimoto, Yoshiya Tanaka, Peter Fischer, Baojin Zhu, Douglas Faries, Xiaodan Mai, Brett T. Doherty, Angela Grelaud, Nicolas H. Thurin, Johan Askling, Walter Deberdt, and the B023 Study Consortium

Subjects
Baricitinib, Rheumatoid arthritis, Venous thromboembolism, Major adverse cardiovascular event, Serious infection, JAK inhibitors, Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Introduction The aim of this work is to evaluate baricitinib safety with respect to venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infection relative to tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA). Methods Patients with RA from 14 real-world data sources (three disease registries, eight commercial and three government health insurance claims databases) in the United States (n = 9), Europe (n = 3), and Japan (n = 2) were analyzed using a new user active comparator design. Propensity score matching (1:1) controlled for potential confounding. Meta-analysis of incidence rate ratios (IRR) and incidence rate differences (IRD) for each outcome, from each data source was executed using modified Poisson regression and Cochran–Mantel–Haenszel analysis. Results Of 9013 eligible baricitinib-treated patients, 7606 were propensity score-matched with TNFi-treated patients, contributing 5879 and 6512 person-years of baricitinib and TNFi exposure, respectively. Across data sources, 97 patients (56 baricitinib) experienced VTE during follow-up, 93 experienced MACE (54 baricitinib), and 321 experienced serious infection (176 baricitinib). Overall IRRs comparing baricitinib with TNFi treatment were 1.51 (95% CI 1.10, 2.08) for VTE, 1.54 (95% CI 0.93, 2.54) for MACE, and 1.36 (95% CI 0.86, 2.13) for serious infection. IRDs for VTE, MACE, and serious infection, respectively, were 0.26 (95% CI −0.04, 0.57), 0.22 (95% CI −0.07, 0.52), and 0.57 (95% CI −0.07, 1.21) per 100 person-years greater for baricitinib than TNFi. Conclusions Overall results suggest increased risk of VTE with baricitinib versus TNFi, with consistent point estimates from the two largest data sources. A numerically greater risk was observed for MACE and serious infection when comparing baricitinib versus TNFi, with different point estimates from the two largest data sources. Findings from this study and their impact on clinical practice should be considered in context of limitations and other evidence regarding the safety and efficacy of baricitinib and other Janus kinase inhibitors. Trial registration: EU PAS Register ( http://encepp.eu ), identifier #32271.

Published
2022
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2. Decline in hospitalization risk and health care cost after initiation of depot antipsychotics in the treatment of schizophrenia

Author

Xiaomei Peng, Haya Ascher-Svanum, and Douglas Faries et al

Subjects
Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950
Abstract

Xiaomei Peng, Haya Ascher-Svanum, Douglas Faries, Robert R Conley, Kory J SchuhEli Lilly and Company, Indianapolis, IN, USAPurpose: To assess change in hospitalization and cost of care from 6 months pre- to 6 months post-initiation on any depot antipsychotic among schizophrenia patients.Patients and methods: Using a large United States commercial claims and encounters database, patients younger than 65 years diagnosed with schizophrenia were identified. Patients initiated on a depot antipsychotic were studied in a mirror-image design to assess change in hospitalization rates, mean duration hospitalized, and hospitalization cost. McNemar’s test and paired t-tests compared the proportions of patients hospitalized and the mean duration. Paired t-test and bootstrapping methods compared costs.Results: In these patients (n = 147), psychiatric hospitalizations declined from 49.7% pre-initiation to 22.4% post-initiation (P < 0.001), and the mean hospitalized duration for psychiatric purposes numerically declined from 7.3 to 4.7 days (P = 0.05). Total health care costs declined from $11,111 to $7884 (P < 0.05) driven by reduction in costs for psychiatric hospitalizations from $5384 to $2538 (P < 0.05).Conclusion: Initiation of depot antipsychotic therapy appeared to be associated with a decline in hospitalization rates and costs. Current findings suggest that treatment with depot antipsychotics may be a cost-effective option for a subgroup of patients with schizophrenia who are at high risk of nonadherence with their oral antipsychotic medication regimen.Keywords: mirror-image, claims database, treatment outcomes, depot antipsychotics

Published
2011

6. Comparative Effectiveness of Dexamethasone in Hospitalized COVID-19 Patients in the United States

Author

Casey Kar-Chan Choong, Mark Belger, Alisa E. Koch, Kristin J. Meyers, Vincent C. Marconi, Hamed Abedtash, Douglas Faries, and Venkatesh Krishnan

Subjects
Adult, Oxygen, Inpatients, SARS-CoV-2, Humans, Pharmacology (medical), General Medicine, Hospital Mortality, Dexamethasone, United States, COVID-19 Drug Treatment
Abstract

To compare the mortality of hospitalized patients with COVID-19 between those that required supplemental oxygen and received dexamethasone with a comparable set of patients who did not receive dexamethasone.We utilized the Premier Health Database to identify hospitalized adult patients with COVID-19 from July 1, 2020-January 31, 2021. Index date was when patients first initiated oxygen therapy. The primary endpoint was in-hospital mortality for patients receiving dexamethasone versus those not receiving dexamethasone 1-day pre- to 1-day post-index period. Secondary endpoints included 28-day mortality, time to in-hospital mortality, progression to invasive mechanical ventilation or death, time to discharge, and proportion discharged alive by day 28. Twenty-three models using weighting, matching, stratification, and regression were deployed through the concept of frequentist model average (FMA) to estimate the effect of dexamethasone on all-cause mortality up to the 28-day hospitalization period.A total of 1,208,881 patients with COVID-19 were screened; as an inpatient 255,216 used oxygen, and 251,536 were included in the analysis. In the dexamethasone group, odds of in-hospital mortality were higher than those of the comparator (FMA: odds ratio [OR] 1.15, 95% CI 1.08, 1.22). Using a best fit model, OR for in-hospital mortality was non-significant for the dexamethasone group compared with the comparator (OR 1.02, 95% CI 0.92, 1.14). Dexamethasone treatment was associated with poorer outcomes versus the comparator group across the majority of secondary endpoints, except for number of days in hospital, which was lower in the dexamethasone group versus the comparator group (mean difference - 2.14, 95% CI - 2.43, - 1.47).Hospitalized adult patients with COVID-19 who required supplemental oxygen and received dexamethasone did not have a survival benefit versus similar patients not receiving dexamethasone. The dexamethasone group was not associated with favorable responses for outcomes such as progression to death or mechanical ventilation and time to in-hospital death.

Published
2022

7. Real World Health Care Data Analysis : Causal Methods and Implementation Using SAS

Author

Douglas Faries, Xiang Zhang, Zbigniew Kadziola, Uwe Siebert, Felicitas Kuehne, Robert L Obenchain, Josep Maria Haro, Douglas Faries, Xiang Zhang, Zbigniew Kadziola, Uwe Siebert, Felicitas Kuehne, Robert L Obenchain, and Josep Maria Haro

Subjects
Medical records--Management--Data processing
Abstract

Discover best practices for real world data research with SAS code and examples Real world health care data is common and growing in use with sources such as observational studies, patient registries, electronic medical record databases, insurance healthcare claims databases, as well as data from pragmatic trials. This data serves as the basis for the growing use of real world evidence in medical decision-making. However, the data itself is not evidence. Analytical methods must be used to turn real world data into valid and meaningful evidence. Real World Health Care Data Analysis: Causal Methods and Implementation Using SAS brings together best practices for causal comparative effectiveness analyses based on real world data in a single location and provides SAS code and examples to make the analyses relatively easy and efficient. The book focuses on analytic methods adjusted for time-independent confounding, which are useful when comparing the effect of different potential interventions on some outcome of interest when there is no randomization. These methods include: propensity score matching, stratification methods, weighting methods, regression methods, and approaches that combine and average across these methods methods for comparing two interventions as well as comparisons between three or more interventions algorithms for personalized medicine sensitivity analyses for unmeasured confounding

Published
2020

8. Adaptive truncated weighting for improving marginal structural model estimation of treatment effects informally censored by subsequent therapy

Author

Xiaofei, Bai, Jingyi, Liu, Li, Li, and Douglas, Faries

Subjects
Lung Neoplasms, Models, Statistical, Time Factors, Bias, Clinical Trials, Phase III as Topic, Carcinoma, Non-Small-Cell Lung, Humans, Confounding Factors, Epidemiologic, Proportional Hazards Models, Randomized Controlled Trials as Topic
Abstract

Randomized clinical trials are designed to estimate the direct effect of a treatment by randomly assigning patients to receive either treatment or control. However, in some trials, patients who discontinued their initial randomized treatment are allowed to switch to another treatment. Therefore, the direct treatment effect of interest may be confounded by subsequent treatment. Moreover, the decision on whether to initiate a second-line treatment is typically made based on time-dependent factors that may be affected by prior treatment history. Due to these time-dependent confounders, traditional time-dependent Cox models may produce biased estimators of the direct treatment effect. Marginal structural models (MSMs) have been applied to estimate causal treatment effects even in the presence of time-dependent confounders. However, the occurrence of extremely large weights can inflate the variance of the MSM estimators. In this article, we proposed a new method for estimating weights in MSMs by adaptively truncating the longitudinal inverse probabilities. This method provides balance in the bias variance trade-off when large weights are inevitable, without the ad hoc removal of selected observations. We conducted simulation studies to explore the performance of different methods by comparing bias, standard deviation, confidence interval coverage rates, and mean square error under various scenarios. We also applied these methods to a randomized, open-label, phase III study of patients with nonsquamous non-small cell lung cancer.

Published
2014

9. A new sequential approximation method

Author

Douglas Faries and Barry Kurt Moser

Subjects
Statistics and Probability, Sequential estimation, Applied Mathematics, Logit, Estimator, Expected value, Normal distribution, Sample size determination, Parametric model, Statistics, Applied mathematics, Statistics, Probability and Uncertainty, Random variable, Mathematics
Abstract

A sequential method for estimating the expected value of a random variable is proposed. Using a parametric model, the updating formula is based on the maximum likelihood estimators of the roots of the expected value function. Under certain conditions, it is demonstrated that the estimators of the roots are consistent, when a two-parameter logit model version of the procedure is used for binary data. In addition, the estimators of the logit parameters have an asymptotic normal distribution. A simulation study is performed to evaluate the effectiveness of the new method for small to medium sample sizes. Compared to other sequential approximation methods, the proposed method performed well, especially when estimating several roots simultaneously.

Published
1996
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11. Abstract 63: Hospital Length of Stay after Percutaneous Coronary Intervention among Acute Coronary Syndrome Patients Treated with Clopidogrel or Prasugrel in a United States Hospital Database

Author

Jay Bae, Frank Ernst, Craig Lipkin, Douglas Faries, Zhenxiang Zhao, and Chad Moretz

Subjects
Cardiology and Cardiovascular Medicine
Abstract

Background: Research on the use of newer antiplatelet agents and their outcomes from a real-world setting is scarce. Hospital length of stay (LOS) has been used as a measure for resource use and as a proxy for patient outcomes. We analyzed a large geographically diverse database from the US and compared LOS between patients on clopidogrel or prasugrel. Patients were hospitalized for acute coronary syndrome (ACS) and had undergone percutaneous coronary intervention (PCI). Methods: Using a large database maintained by PREMIER, Inc., we analyzed patient characteristics and LOS during the index (first) hospitalization among ACS-PCI patients treated with clopidogrel or prasugrel between July 2009 and June 2011. Observed LOS was analyzed with t-tests. A multivariate regression model with a negative binomial distribution was used to evaluate differences in LOS, adjusting for the following covariates: age, ACS type (non-ST-elevation myocardial infarction [NSTEMI], STEMI, Unstable Angina [UA]), gender, race, renal insufficiency, diabetes, anemia, heart failure, number of vessels, bleeding events, and comorbidities based on the Charlson-Deyo weighting of disease states. Results: Data were available for 75,315 patients who received clopidogrel and 9,483 patients with prasugrel. For clopidogrel and prasugrel, respectively, the observed mean LOS (SD) was 3.5 (4.4) days and 2.9 (2.4) days (P Conclusion: In this study, prasugrel- treated patients had a shorter average LOS compared to clopidogrel-treated patients. After adjusting for patient demographics and clinical characteristics, the results still held. The unobserved confounder bias, however, may exist in this real-world observational database research.

Published
2012
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12. Abstract 211: A Comparison of Bleeding in Patients Treated with Clopidogrel or Prasugrel in a US Hospital Database

Author

Frank Ernst, Jay Bae, Craig Lipkin, Douglas Faries, Zhenxiang Zhao, and Chad Moretz

Subjects
cardiovascular diseases, Cardiology and Cardiovascular Medicine
Abstract

Background: Newer, more potent antiplatelet therapy is commonly perceived as being associated with a higher incidence of bleeding complications. There are limited real-world data on bleeding among patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) with new antiplatelet therapy. The objective of this study was to compare “real-world” incidence of bleeding among patients on clopidogrel vs. prasugrel therapy in a large database from diverse US hospitals. Methods: We analyzed patient characteristics and the incidence of bleeding complications during the index (first) hospitalization among ACS-PCI patients treated with clopidogrel or prasugrel between July 2009 and June 2011. Bleeding was defined as the presence of bleeding ICD-9 codes and transfusion. Cohort differences in outcomes were assessed with unadjusted chi-square tests and adjusted for demographics and baseline clinical differences using logistic regression. Results: 105,490 patients received clopidogrel and 10,544 received prasugrel. Among clopidogrel and prasugrel patients, respectively, 66% and 75% were men, 37% and 46% presented with STEMI, with median age of 64 and 57. During the index hospitalization, the unadjusted incidence of bleeding events was 7% in clopidogrel-treated patients and 4% in prasugrel-treated patients (P Conclusion: It appears that observed bleeding complications among patients treated with prasugrel is not higher than those treated with clopidogrel, even after multivariate adjustments. However, the potential for unobserved confounders remains a limitation for such observational research. It is conceivable that appropriate patient selection helps to control bleeding complications, as shown here in this large, “real-world” database.

Published
2012
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13. Symposia

Author

Christoph Correll, Stanley P. Kutcher, John McClellan, Jan Buitelaar, Elizabeth Pappadopulos, Aribert Rothenberger, Fritz Mattejat, Stephen Scott, John Weisz, Eberhard Schulz, Wilhelm Felder, Christian Fleischhaker, R. Böhme, B. Sixt, Rutger Jan van der Gaag, Laurence Y. Katz, Brian J. Cox, Shiny Gunasekara, Alec L. Miller, Nathaniel Laor, Peter Riedesser, Ernesto Caffo, James Leckman, Massimo Ammaniti, Giampaolo Nicolais, Mario Speranza, Hans Steiner, Laura Delizonna, Astrid Schallauer, Margo Thienemann, Alexander C. McFarlane, Miranda van Hooff, Michael Sawyer, Carlo Cianchetti, Naoufel Gaddour, Mokni Sana, Mechri Anouar, Letaief Mondher, Gaha Lotfi, Fabian Härtling, Robert Bittner, Corinna Haenschel, Marcus Cap, Tanja Goncharova, David E. J. Linden, Ralf Dittmann, Anneliese Maestele, Claudia Mehler, Eberhard Meyer, Jack A. Jenner, Leonie Boeing, Val Murray, Anthony Pelosi, Robert McCabe, Douglas Blackwood, Robert Wrate, S. Pellerano, M. Pintor, G. L. Mellis, T. Piroddi, Alan Flisher, Monique Nesa, Rosanna Rooney, Clare Roberts, Robert Kane, Sven Silburn, Lisbeth Pike, Helge Staby Deaton, Stuart Lustig, Michelle Funk, Anne Rickards, Dinah Reddihough, Roslyn Wright-Rossi, Jacqui Simpson, Dieter David Seuthe, H. Vielhaber, Kinderklinik Dritter Orden, H. Backmund, M. Gerlinghoff, Mary Schwab-Stone, Ine Jespers, Robert Vermeiren, Vladislav Ruchkin, Marek Blatny, Michal Hrdlicka, Tomas Urbanek, Martin Jelinek, Veronika Balastikova, Philippe Jeammet, Alain Frottin, Andjelka Filipovic, Eric Albert, Dora Musetti Schelotto, Mladen Knezevic, Milivoj Jovancevic, Jonathan Hill, Maria Lawlor, Christian Kienbacher, Carolin Prause, Margit Stöckl, Gertrude Bogyi, Max H. Friedrich, Michael Klein, Katrin Kürschner, Lynne Murray, Victoria Leidecker, Helen Sharp, Ilona Luoma, Pälvi Kaukonen, Tuula Tamminen, Barry Nurcombe, Graham Martin, Brett McDermott, Franz Resch, Benno Graf Schimmelman, Jane Edwards, Patrick D. McGorry, Martin Lambert, Philippe Conus, Ulrich Preuss, Dieter Bürgin, Monika Strauss, Peter Parzer, Georg Spiel, C. von Korff, H.-A. Ballin, R. Gößler, M. Günter, G. Sange, Heiner Meng, Eginhard Koch, Klaus Minde, Mary True, L. Pisani, F. Oumar, J. Padilla, Jean-François Bouville, Wendy Vogel, Klaus Schmeck, Kirstin Goth, Diane Purper-Ouakil, Véronique Dessons, Catherine Doyen, Fernando Perez-Diaz, Marie-Christine Mouren-Simeoni, Andreas Karwautz, Gudrun Wagner, Klaus Schwienbacher, Maria Haidvogl, Gerald Nobis, Janet Linda Treasure, David Andrew Collier, Romuald Brunner, A. Hueg, Johann Haffner, Marc Schmid, Lutz Goldbeck, Jakob Nützel, Volkmar Höfling, Karin Schermelleh-Engel, Helfried Moosbrugger, Josep Tomàs, Josep Cornellà, Alex Llusent, Anna Bielsa, Myron Belfer, Brian Robertson, Custodia Mandlhate, Birama Seck, Barbara Zwirs, Huib Burger, Tom Schulpen, A. Karem Salman Al-Obedy, Oleh Romanchuk, Irena Namyslowska, Björn S. Reigstad, Kirsti Margrethe Jorgensen, Walter Matthys, John Lochman, Marjo Zonnevylle-Bender, Nicolle van de Wiel, Angela Wagner, Christine Jennen-Steinmetz, Christopher Goepel, Irene van Bokhoven, Stephanie van Goozen, L. Patt Franciosi, Leode Graaf Acquoy, Anne Tischlinger, B. Pharm, Knut Halyard Bronder, Kari Schleimer, Joachim Walter, Boia Ephraime, Tatjana Dmitrieva, Alvaro Seligman Silva, Katja Becker, Hans-Christoph Steinhausen, C. Winkler Metzke, Erikson F. Furtado, Manfred Laucht, Oliver Bilke, Petra Zimmermann, Hans-Ulrich Wittchen, Roselind Lieb, Helga Hannesdottir, Thorarinn Tyrfingsson, Manfred Döpfner, Kurt Hahlweg, Annett Kuschel, Heike Bertram, Nina Heinrichs, Inez Freund-Braier, Gabriele Brix, Christopher Hautmann, Julia Pluck, Alfons Crijnen, Pol van Lier, Patricia Vuijk, Reiner Frank, Inger Helene Vandvik, Rainer Schäfert, Jeanne van Weel, Jan Schieveld, Jörg M. Fegert, William Friedrich, Smadar Celestin-Westreich, Leon Patrice Celestin, Ingrid Ponjaert-Kristoffersen, Keizo Nagao, M. Kisida, E. Shindo, Helmer Baying Larsen, Karin Helweg-Larsen, Ramón Lindauer, Jan Booij, Miranda Olff, Gerard den Heeten, Berthold Gersons, Frits Boer, Eric Schoentjes, Sarah Bal, Michael Schulte-Markwort, Tytti Solantaus, Sini Toikka, Maarit Alasuutari, Barbara Steck, Andrea Grether, M. Ehrensperger, Felix Amsler, L. Kappos, Rina Saha, Bela Paschen, Christiane Baldus, Miriam Haagen, Martina Pott, Georg Romer, Yoshiro Ono, H. Homma, Y. Ishida, H. Ide, M. Okamoto, S. Kameoka, Hiroshi Nakayama, A. Yamamoto, Nahit Motavalli Mukaddes, Sam Tyano, Tamar Mozes, R. Caplan, Savita Malhotra, Maria Giuseppina Ledda, Al Fratta, S. Mannino, Simona Corona, A. Zuddas, Macarena Marin Olalla, Ruth Garcia, Bernardo Perez Ramirez, Ross Campion, Peter Hindley, Nitin Gupta, Anish Bhattacharaya, Mehak Kapoor, G. van de Willge, Silke Klemm, S. Smesny, M. Stockebrand, S. Grunwald, Femmie Juffer, Marinus H. van Ijzendoorn, Marian J. Bakermans-Kranenburg, Ute Ziegenhain, B. Derksen, R. Dreisörner, Daniel Gutschner, Martin Maldonado-Duran, Manuel Ferndndez-Criado, Felicia Heidenreich, Marie Rose Moro, Charles Millhuff, Kirby Pope, Frank Theisen, Hubertus Himmerich, T. Kraus, A. Schuld, T. Pollmächter, Alan Apter, D. Gothelf, A. Brand-Gothelf, Gidi Ratzoni, L. Kikinzon, A. Weizman, Yuval Bloch, Michael Haberhausen, Daniel Müller, John Fayyad, Altino Bessa Marques Filho, Adolfo Bezerra de Menezes, John Campo, Sheree Shafer, Jennifer Strohm, Amanda Lucas, David Shaeffer, Harold Altman, Christine Gelachek, Naoyasu Motomura, Yozo Takino, Masahiro Iwakiri, Patrick Pössel, Simone Seemann, Martin Hautzinger, Theodore Mutale, Christian Haase, Majid Ali Abidi, Shehla Raheem, Leyla Faw, Aaron Hogue, Howard Liddle, Kirsten Catthoor, Joost Hutsebaut, Donald Jasinski, Douglas Faries, Rodney Moore, Annette Streeck-Fischer, Renate Sannwald, Gottfried Maria Barth, Christoph Schwarz, Monika Staigle, Manh-Hiep Pham, Dario Balanzin, Joelle Materi, Pia Eresund, Alexander Mokhovikov, Sandra Stankovic, Kerim Munir, Nese Erol, Füsun Çuhadarodlu Çetin, Angela Hassiotis, Martine Flament, Michael Scholz, Maud Rix, Franziska Nestler, Annegret Selisko, Nathalie Godart, Fabienne Perdereau, Zoé Rein, Florence Curt, Jane Akister, Pei-Chin Peggy Lee, Sho-Man Susan Tsai, Lai-Shiun Ho, Su-Chun Wu, Jacques Miermont, Joel Swenson, Mardjane Teherani, Bruno Falissard, Jean Cottraux, Julia Plück, Robert Oades, Mirjam Simons-Sprong, P. F. Schothorst, J. T. Swaab-Barneveld, Stephanie Juran, Matthias Weisbrod, Eric Chen, Bernd Röpcke, Smiljka Popovic-Deusic, Luise Poustka, Nele Wild-Wall, Mechthilde Papousek, Mirelle Keren, Ruth Feldman, S. Maestro, A. Chilosi, C. Pecini, L. Pfanner, Laurence Greenhill, K. Jahnsen, L. T. W. Jong-van den Berg, J. M. Zito, Kelly Posner, Anne Skrobala, Pablo Goldberg, Lisa Kotler, Robert Findling, Regina Bussing, Kapil Sayal, Geoffrey Mitchell, Michael Huss, Barbara Högl, Renate Grimmlinger, Karl Christoph Käppler, Maycoln M. L. Teodoro, Sylvia Hiromi Oswald, Janine M. Dagnoni, M. I. Pinheiro, C. T. Heleno, R. Rothe-Neves, V. G. Haase, A. Del Prette, Marimilia Rodrigues Lambertucci, J. L. Rodrigues, P. M. Freitas, C. A. P. Lourenco, H. C. W. Carvalho, J. Baumeister, M. Weisenhorn, S. Stadelmann, S. H. Oswald, H. Ruder, Ciro Ruggerini, Stefania Vicini, Enrico Pupulin, Antonio Guidi, Kaija Puura, Mirjami Mäntymaa, Kai von Klitzing, Orna Rosvald, Hans-Ludwig Kröber, A. Stöver, R. Proske, Rainer Semmelbeck, Marc Walther, Matthias Schmelzle, Monika Egli-Alge, Richard Beckett, Constanze Gerhold, Lieselotte Turkmen-Barta, Colette Chiland, Heino Meyer-Bahlburg, Domenico Di Ceglie, Ulrike Lehmkuhl, Orlando Uccellini, Mario Bertolini, Francesca Neri, Delia Albanese, Raffaella Bertola, Maartje Snoek, Martien Kas, Ulrike Margarete Elisabeth Schulze, Silke Calame, Ferdinand Keller, Stephanie Santel, Kerstin Krauel, Michael Rotte, Thomas F. Münte, Annemarie van Elburg, Fritz Poustka, Sven Bölte, Sabine Feineis-Matthews, Sven Boite, D. Hubl, D. Prvulovic, T. Dierks, Sabine Klauck, Irma Moilanen, M. Mattila, J. Laurila, K. Jussila, A. Pyper, S. L. Linna, Hanna Ebeling, D. Pauls, Pirjo Korpilahti, Soile Loukusa, Eira Jansson-Verkasalo, Johannes Hebebrand, Beate Herpertz-Dahlmann, Anke Hinney, Anne-Kathrin Wermter, Susann Friedel, Frank Geller, Helmut Schafer, Fernando Fernandez-Aranda, Joanna Holliday, Kristian Holtkamp, C. Mika, M. Heer, Rudolf Uher, Nicole Barbarich, Shannan E. Henry, Ursula Bailer, Guido Frank, Walter H. Kaye, Elisabet Wentz, J. Hubert Lacey, Glenn Waller, Maria Rastam, Jeremy Turk, Christopher Gillberg, Frank C. Verhulst, Marieke Zwaanswijk, Peter Verhaak, Jozien Bensing, Jan van der Ende, Frank Verhulst, Andre Sourander, Paivi Santalahti, Tamsin Ford, Robert Goodman, Howard Meltzer, Inge Seiffge-Krenke, Richard Fritsch, Marika Cutler, E. James Anthony, Per-Anders Rydelius, Rolf Castell, Milica Pejovic-Milovancevic, Miroslav Pavlovic, Noa Kalman, Muli Linder, Ido Luria, Yechiel Levkovitz, Kosuke Yamazaki, Pedro Caldeira da Silva, Grata Santos, Filipa Martins, Yen-Nan Chiu, Wen-Jer Tsai, Shur-Fen Gau, Chang-Chang Tseng, Shu-Chen Su, Jan Croonenberghs, Lucas Brouw, Annick Wauters, Nicole Bruning, Zina Manjaly, Gereon Fink, Olivera Aleksic, Nenad Rudic, Lucres Jansen, Christine C. Gispen-De Wied, Bertine Lahuis, Hanna Swaab, Jolijn Pietersen, Carolien Gevers, Inge Kamp-Becker, Isabell Germerott, Patricia Howlin, null Gaudière, Barbara Forresi, G. Lepri, Soumaila Laval, Andreas Wiefel, Z. Biringen, Karl Titze, K. Lenz, C. Seither, B. Witte, Marguerite Dunitz-Scheer, Markus Wilken, Alexandra Krasnovsky, Peter Scheer, Maria Cordeiro, Filippo Muratori, B. Felloni, A. Cesari, Linda Helmig, Peter Fonagy, Chris Moody, Jim Fultz, René Glanzmann, Nathalie Lutz-Latil, Agnes van Wyl, Dainius Puras, Amaia Hervds, John Tsiantis, T. Dragonas, H. Davis, V. Ispanovic, A. Paradisiotou, Mimoza Shanini, Lynne Jones, A. Uka, A. Rrustemi, Anne-Liis von Knorring, Dirk Deboutte, Souraya Dorhmi, Mohamed Agoub, Driss Moussaoui, Omar Battas, Inger Halvorsen, Anne Andersen, Sonja Heyerdahl, Denise Baillot, Michele La Roche, Claudia Furino, Annick Buchholtz, Gary Goldfield, Katherine Henderson, Ulrich Hagenah, Varinja Blume, Marlene Flacke-Redanz, Beate Herpertz Dahlmann, Angelique A. Sallas, Hubertus Adam, null Mozambique, Aferdita Goci-Uka, Susanne Schlüter-Müller, Umesh Bawa, Fakhri Khalik, Nima Forouher, Miyuki Sadamatsu, null Nanba, Nobumasa Kato, Kiyoto Kasai, Eiji Nanba, Martin H. Schmidt, Günter Esser, Herman van Engeland, Sophie Willemsen-Swinkels, Claudine Dietz, Anne Claire Beernink, Oliver Vidojevic, Ivona Milacic, Rael Strous, Roni Hegesh, Simion Kertzman, Z. Ben-Nahum, Moshe Kotler, Emma van Daalen, Mijke Zeegers, Hilleke Hulshoff Pol, Charles Williams, Jessica Sank, Martha Paulk, George Schwarz, Paul Wharton, Marija Raleva, Kamka Paketchieva, Angelina Filipovska, Carole Müller Nix, Margarita Forcada Guex, Abdel-Mohsen Daigham, Marit S. Indredavik, Torstein Vik, Siri Kulseng, Ann-Mari Brubakk, Marion Cuddy, Katharine Riley, Brigitte Vollmer, John Wyatt, Robin Murray, Mika Soininen, E. Juulia Paavonen, Mika Fjällberg, Juha Salmi, Almgvist Fredrik, Eeva T. Aronen, Olaf Reis, Stephanie P. Bohne, Susanne Kraenz, Dong-Hyun Ahn, Tae-Ho Kim, Jun-Ho Choi, Yun-Young Kim, Ivan Begovac, Milena Skocic, Vlasta Rudan, Oleg Filipovic, Tomasz Wolanczyk, Anita Brynska, Stanislaw Wojtowicz, Salvador Celia, Cisca Aerts, Elisabeth Cleve, Hellmut Hartmann, Hans-Jürgen Kühle, Fridjof Heidorn, Solveigh Zeyer, Joaquin Fuentes, Andrés Martin, Denis G. Sukhodolsky, Riittakerttu Kaltiala-Heino, Matti Rimpelä, Henrik Andershed, Deborah O’Donnell, Michelle Pearce, Dieter Burgin, Andreas Becker, Nicola Hagenberg, Matthias Berking, Veit Roessner, Ketil Hanssen-Bauer, Odd Aalen, Jürgen Junglas, Yoon-Seok Huh, Yun Young Kim, Kyung-Ja Oh, Kai Wang, Michael Tarren-Sweeney, D. M. Leiblum, Renate Kühl, Cornelia Nötzel, Ernst Pfeiffer, Klaus Lenz, Agneta Rosling, Marianne Poller, Donna Cross, Simone Klabin, Diana Kaplan, Lars Mickel, Gerd Lehmkuhl, Regina Möckel, Shani Leor, Leor Frisch, Amos Frisch, Abraham Weizman, Andrey Zanozin, Sylvie Jamart, Jean-Yves Hayez, Agnes Leor, Maria Elisabeth Ahle, Galit Ben Amitay, Irene Kosov, Ahuva Reiss, Moses Tamar, Hans Smedje, Hiie Allik, Jean Steyaert, Dries Castermans, John Creemers, Koenraad Devriendt Marta Kaczynska-Haladyj, Maria Claustre Jané Ballabriga, Joaquima Judez, Empar Pelaez, Pilar Sole, Lidia Rodriguez, Saskia Palmen, Chantal Kemner, Hugo Schnack, Rene Kahn, Anna Fabrizi, Levi Gabriel, Marcos Mercadante, Sergiode Paula Ramos, Maria Concecao Rosario-Campos, Michael Rutter, Stephan Collishaw, Barbara Maughan, Andrew Pickles, Julie Messer, Avshalom Caspi, Terrie Moffitt, Jana Kreppner, Anne Inger H. Borge, Suniya Luthar, Stephanie Hamarman, C. Ulger, J. Fossella, M. Brimacombe, J. Dermody, Mark Stein, L. D. Waldman, C. Sarampote, A. Robb, E. H. Cook, Aiveen Kirley, N. Lowe, Z. Hawi, C. Mullins, G. Daly, I. Waldman, M. McCarro, null O’Donell, Emma van der Meulen, S. C. Bakker, D. L. Pauls, R. J. Sinke, Guilherme Polanczyk, C. Zeni, J. P. Genro, Tatiana Roman, Mara Hutz, Christa Schaff, Patrick Haemmerle, Harald Sontag, Agnes Vetro, Julia Gadoros, Gotthard Roosen-Runge, Jocelyn Hattab, Peter Hummel, Orna Braun-Lewensohn, Daniel Schechter, Charles Zeanah, Michael Myers, Michael Liebowitz, Mark Davies, Wei-Tsuen Soong, Deborah James, Nick Sofroniou, Marine Gegelashvili, Umesh Parikh, John M. Kane, Anil K. Malhotra, Manoj Shah, Richard R. Pleak, Ronen Hizami, David Michelson, Marina Danckaerts, Alessandro Zuddas, Shuyu Zhang, Philip Hazell, P. Zeiner, M. Johnson, Frank Häßler, Prasad Suyash, Edmund Sonuga-Barke, Lynne Poole, Sarah Mares, Jon Jureidini, Zachary Steel, Louise Newman, Torsten Lucas, Stephanie Paulus, Martin Aßhauer, Birgit Miller, Gunilla Jarkman Björn, Christina Bodén, Per Gustafsson, Viola Povse Ivkic, Lazar Tenjovic, Radosavljev Jelena, Smiljka Popovic Deusic, Philip Graham, Henrikje Klasen, Jacinta Tan, Tony Hope, Anne Stewart, Raymond Fitzpatrick, Michael Kölch, Angeles Diaz-Caneja, Sonia Johnson, Ines Dippold, Katja Wiethoffi Ferdinand Keller, Sue Bailey, Nathan Whittle, Klaus Hennighausen, Gregor Kohls, Verena Maas, Tanja Rinker, Swantje Zachau, Gabriele Christmann, Anna Jaremkiewicz, Michael Schecker, Waldemar von Suchodoletz, Ruth Uwer, Ronald Albrecht, Lisa Glass, Valéria Csépe, Ferenc Honbology, Anett Rago, Eva Mészdros, Richard G. Schwartz, Valerie L. Shafer, Jonathan Green, C. Jacobs, L. Kroll, J. Briskman, G. Dunn, J. Beecham, B. Tobias, L. Baird, Terje Ogden, Michael Fitzgerald, Mark Bellgrove, Michael Gill, Ian H. Robertson, Paul McArdle, Amanda Burke, K. Michael Hong, Christina Hoven, Danuta Wasserman, Katharina Braun, Jórg Bock, Carina Helmecke, Michael Gruß, Gerd Poeggel, Charles Marsden, S. Muchimapura, M.-C. Pardon, M. Bianchi, Joram Feldon, Daniela Rüedi-Bettschen, Andrea C. Dettling, Christopher R. Pryce, Hans-Willi Clement, O. Sommer, A. Pschibul, C. Rombach, M. Gerlach, Claudia Mehler-Wex, S. Zeiske, E. Grünblatt, G. Gille, D. Rausch, Manfred Gerlach, Amira Seif El-Din, Nadia Kadri, Houda Hjiej Andaloussi, Khadija Chihabeddine, Mohammed Almaqrami, Alexander von Gontard, M. Okuno, Kurt Quaschner, Niels Bilenberg, Carsten Obel, Tine Brink Henriksen, Morten Hedegaard, Niels Jurgen Secher, Jorn Olsen, Antonio Fonseca, Isabelle Nathalie Koch, Ieva Bite, Phyllis Cohen, Katrin Russell, Nichaela Broyden, Gillian Lancaster, Christina Eichhorn, Karola Tiedtke, Ronald Feldman, Andreas Warnke, Peter Scheuerpflug, V. Vetter, Jürgen Bartling, Kerstin Konrad, Susanne Neufang, Charlotte Hanisch, Gereon R. Fink, Sarah Durston, Matthew C. Davidson, Nim Tottenham, Julie Spicer, Adriana Galvan, John Horvitz, John A. Fossella, Richard Watts, B. J. Casey, Daniel Brandeis, Andreas J. Fallgatter, Ann-Christine Ehlis, Jürgen Seifert, W. K. Strik, K. E. Zillessen, Martin J. Herrmann, Gerd Schulte-Körne, Heikki Lyytinen, Tomi Guttorm, Anna-Maija Poikkeus, Kenneth M. Eklund, Paula Lyytinen, Minna Torppa, M.-L. Laakso, E. Leskinen, A. Tolvanen, Silvia Paracchini, J. Schumacher, I. R. König, Claudia Libertus, Heide Griesemann, A. Kleensang, A. Ziegler, P. Propping, M. 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Karvonen, Jouko Miettunen, Edelmira Domenech Llaberia, Teresa Corbella Domenech, Maria Claustre Jane Ballabriga, Josepa Canals Sanz, Griselda Esparo, Sergi Ballespi Sola, Xuejun Liu, Yukiko Kano, Masataka Ohta, Yoko Nagai, Takashi Arai, Su Linyan, Jeff Bridge, Boris Birmaher, Carlo Di Lorenzo, Satish Iyengar, David Brent, Bernhard Blanz, Laura Weninger, Gerhard Libal, Anna Skrabal, Michael Bowden, Howard Cooper, Inger Simonsen, Carl Bechstrom, Mette Medby, Ritva Erkolahti, Gunther Klosinski, Mihoko Oba, Satomi Murase, Takashi Murakami, Jiro Takai, Hitoshi Kaneko, Shuji Honjo, Katrina Rickards, Annhild Weber, Michael Karle, Alain Lazartigues, Pascale Planche, Eric Lemonnier, Mani Pavuluri, Lindsay Schenkel, Ryan Shaw, John Sweeny, Giancarlo Rigon, Stefano Costa, Alessandra Mancaruso, Roberta Mansi, Daniele Giovanni Poggioli, Simona Chiodo, Maja Radobuljac, Urban Groleger, Nada Ovsenik, Martina Tomori, Barbara Haas, Susanne Denoix, Franz Kimmig, Marc Weinhardt, Günter Schmitz, Berit Filschke, Conny Fliegauf, Ji-Hae Kim, Maya Krischer, Michael H. Stone, Kathrin Sevecke, Manfred Doepfner, Cornelia König, Dörte Grasmann, Michael Schlander, Stephen Ralston, R. Rodrigues Pereira, W. Brussel, L. Vlasveld, H. G. Tuynman-Qua, M. J. Lorenzo, R. Tauscher-Wisniewski, Stefano Palazzi, Ettore Guaia, Artur Kolakowski, Agnieszka Pisula, Timothy Wilens, Tobias Banaschewski, Henrik Uebel, Björn Albrecht, Monika Robatzek, Kristen Migliaccio-Walle, Jaime Caro, Albert J. Allen, R. Bart Sangal, Judith Owens, Douglas Kelsey, Virginia Sutton, Kory Schuh, Aliye Tugba Bahadir, Zeynep Yaman, Ayse Rodopman Arman, Kemal Kuscu, Yanki Yazgan, Meral Berkem, Peter Feldman, Milton Denai, Alexander Simpson, Christopher Kratochvil, Jeffrey Newcorn, Joseph Biederman, Douglas Gelowitz, Christine Thomason, Haitao Gao, Patricia Bijttebier, Steff Decoene, Pia Niklaus, Nils Duits, Ulrich Auer, Kathleen Schnoor, Detlef Schläfke, Füsun Çuhadaroälu Çetin, Gordon Harper, Sami Hamdan, Muhammed El-Haib, Saynur Canat, Olivier Halfon, Monique Bolognini, B. Plancherel, Olivier Phan, Maurice Corcos, Jean-René Cardinaux, Pierre J. Magistretti, Blaise Pierrehumbert, Minna Koskinen, Ulf Engqvist, Matthew Allin, Larry Rifkin, Sandra Lancaster, Ayala Borghini, Laure Jaugey, Margarita Forcada-Guex, Lyne Jaunin, Carole Müller-Nix, François Ansermet, Mariada Conceicao Taborda Simoes, Luiza Nobre Lima, Mariada Luz Vale Dias, Rainer Georg Siefen, Ariel Como, Valbona Alikaj, Sonila Tomori, Flavia Capozzi, Angela Romano, Mara Roello, Francesca Piperno, Mali A. Mann, Dieter Stösser, Gottfried Barth, Alina Pimenov, Jenny Schwab, Hülya Bingöl, Rémy Barbe, Heba Elkshishy, Ana Jovanovic, Aneta Lakic, Vesna Milovanovic, Milorad Vukasinovic, Jeffrey Bridge, David Kolko, David A. Brent, Kathryn Gilson, Roslyn Montague, Ian Shochet, Cristina Maria Ribeiro Marques, Teresa Cepeda, Carolin Ligges, Marc Ligges, Ralph Huonker, Paavo Leppänen, Torni K. Guttorm, Jarmo Hämäläinen, Anne Puolakanaho, Ellen Plume, Inke R. König, Wolfgang Deimel, Markus M. Nöthen, Peter Propping, André Kleensang, Bertram Müller-Myhsok, Andreas Ziegler, Sung-Do David Hong, Xueping Gao, Xuerong Li, Soyoung Irene Lee, Eui-Jung Kim, In-Hee Cho, Ji-Hoon Kim, Se-Hyun Park, J-Wook Choi, Steffen Heger, Andreas Schreiner, Klaus Rettig, Rossella Medori, Peik Gustafsson, Kjell Hansson, Lena Eidevall, Gunilla Thernlund, Philip Heiser, A. Dempfle, Judith Smidt, Justyna Grabarkiewicz, Hans Kiefl, U. Hemminger, K. Saar, James Swanson, Nora D. Volkov, S. Gupta, L. Williams, D. Agler, M. Wasdell, S. Wigal, Silvia Martins, Silza Tramontina, Mariana Eizirik, Benedetto Vitiello, Walter Clevenger, Stephen Faraone, James McGough, James McCracken, Luis Augusto Rohde, Larry Greenhill, Michael Leary, Bo Larsson, W. Boudewijn Gunning, Jean-Marie Villat, Redmond O’Connell, Mark A. Bellgrove, Paul Dockree, Raymond Traube, Mary Braunschweig, Jacques Chabanier, Germana De Leo, Margerita Ibanez, Olivette Mikolajaks, Ida Ropstad, J. Gerald Young, Rachele Aiello, Viviana Porcari, Maria Patrizia Salatiello, Anna Lo Bue, Valentina Dell’Oglio, Rosaria Cardella, Sabrina Chifari, Anne Mari Undheim, Linyan Su, Xuerong Luo, Joanne Barton, Lioba Baying, Thomas Rellum, Emrah Duezel, Hermann Hinrichs, Christoph Bartel, Iris Linde, E. Friederichs, Mark Bangs, Helmut Remschmidt, Theodore Doreleijers, Elisabeth Rebernig, Giovanni Battista Camerini, Soraya Otero, Ana Rivas, Guadalupe Pombo, Maruke Yeghiyan, Gasparyan Kachatur, Arman Danileyan, Tord Ivarsson, Robert Valderhaug, Susanne Walitza, Christoph Wewetzer, Nikolaus Barth, F. Hahn, Fernando Asbahr, Ana Regina Castillo, Ligia Ito, Mariado Rosario Latorre, Michelle Moreira, Francisco Lotufo-Neto, Sophie Symann, Dominique Charlier, Belinda Plattner, Astrid Elisabeth Schallauer, Beat Mohler, P. Staub, Carsten Müller, Rieke Oelkers-Ax, Jochen Fischer, Uta Hermanns, Anne Nickel, Hans Volker Bolay, Miguel Cherro-Aguerre, Merete Juul Sorensen, Judith Becker Nissen, Ole Mors, Per Hove Thomsen, Anne Mari Sund, May Britt Drugli, Lars Wichstrom, Matthias Schwannauer, Emily Taylor, Rob Wrate, Matthias Martin, Jan-Olov Larsson, Henrik Larsson, Paul Lichtenstein, Andrea G. Ludolph, Felix Mottaghy, Susanne Kraemer, Dieter Claus, Bernhard Krause, Jbrg M. Fegert, Tuula Hurtig, Anna Malakhova, Katerina Maniadaki, Efthymios Kakouros, Peter Jensen, Joe Albert Garcia, Sherry Glied, Maura Crowe, E. Michael Foster, Bernard Golse, Jenny Junghanß, Aino-Maija Salin, Päivi Rytölä, and Pauliina Hiltunen

Published
2004
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14. Randomised, double-blind, placebo-controlled trial of pindolol in combination with fluoxetine antidepressant treatment

Author

Francesc Artigas, Víctor Pérez, Enric Álvarez, Douglas Faries, and Inmaculada Gilaberte

Subjects
Adult, Male, Time Factors, Population, Placebo-controlled study, Placebo, Double-Blind Method, Fluoxetine, medicine, Humans, education, Pindolol, Psychiatric Status Rating Scales, education.field_of_study, business.industry, Depression, General Medicine, Middle Aged, Treatment Outcome, Anesthesia, Antidepressant, Antidepressive Agents, Second-Generation, Drug Therapy, Combination, Female, Onset of action, Reuptake inhibitor, business, Selective Serotonin Reuptake Inhibitors, medicine.drug
Abstract

[Background] Major depression affects more than 5% of the population and is a serious health and economic problem. Antidepressants have a slow onset of action and are effective in less than two-thirds of patients. The biochemical effects of selective serotonin reuptake inhibitors may be limited by the negative feedback from serotonin autoreceptors. Pindolol is an antagonist of both serotonin autoreceptors and β-adrenoceptors. We studied the effect of the addition of pindolol to fluoxetine antidepressant treatment., [Methods] Of 132 eligible patients with major depression, 111 were randomly assigned to treatment with fluoxetine (20 mg daily) and either placebo or pindolol (7·5 mg daily). Patients were assessed twice a week for the first 3 weeks of active treatment and then once a week until the end of the study (42 days). Hamilton and Montgomery-Asberg depressionrating scales were used to assess depression severity., [Finding] The proportion of patients who responded to treatment with fluoxetine and pindolol was greater than that with fluoxetine and placebo (41/55 [75%] vs 33/56 [59%], [90% CI 1·1—30·1], p=0·04). The proportion of patients who achieved a sustained response was also greater in the fluoxetine and pindolol group than in the fluoxetine and placebo group (38/55 [69%] vs 27/56 [48%] [5·9—35·9], p=0·03). The number of days to reach a sustained response was lower in the fluoxetine and pindolol group than in the fluoxetine and placebo group (median 19 vs 29 days, p=0·01), however, there was no difference in the time-toonset of clinical improvement when stringent conditions were used (15 vs 18 days, p=0·20)., [Interpretation] The addition of pindolol to fluoxetine antidepressant treatment increases the effectiveness of fluoxetine therapy. Further work is needed to resolve whether the time to clinical improvement benefits from this combination and whether the increase in efficacy occurs with other antidepressants.

Published
1997

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