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2. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease

Author

Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, Bergna, M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi HJ, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, L, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, Ss, Cheah, C, Kan, S, Raja Mohamed RB, Selman, M, de Vries-Bouwstra JK, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena MC, Román Ivorra JA, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., Distler, O, Highland, Kb, Gahlemann, M, Azuma, A, Fischer, A, Mayes, Md, Raghu, G, Sauter, W, Girard, M, Alves, M, Clerisme-Beaty, E, Stowasser, S, Tetzlaff, K, Kuwana, M, Maher, Tm, SENSCIS Trial Investigators., Bergna M, Casado, G, Mannucci Walter, P, Proudman, S, Stevens, W, Thakkar, V, Troy, L, Loeffler-Ragg, J, Olschewski, H, Bondue, B, Houssiau, F, Smith, V, Wuyts, W, Johnson, S, Keystone, E, Khalidi, N, Levesque, M, Maturana Rozas, R, Silva Orellana, A, Huang, C, Li, J, Jiang, Z, Liu, Y, Xiao, W, Xu, J, Zeng, X, Zheng, Y, Zou, H, Becvar, R, Madsen, H, Søndergaard, K, Kilpeläinen, M, Myllärniemi, M, Agard, C, Allanore, Y, Bourdin, A, Cottin, V, Crestani, B, Diot, E, Dominique, S, Hachulla, E, Jouneau, S, Leroy, S, Nunes, H, Prevot, G, Wallaert, B, Wemeau, L, Aringer, M, Bewig, B, Blaas, S, Distler, J, Ehrchen, J, Ewert, R, Gläser, S, Henes, J, Hunzelmann, N, König, R, Kötter, I, Kreuter, M, Prasse, A, Schulze-Koops, H, Sfikakis, P, Vlachoyiannopoulos, P, Losonczy, G, Behera, D, Gayathri Devi, Hj, Kadel, J, Kawedia, M, Kumar, D, Kumar, U, Lokhande, R, Malpani, A, Mohan, M, Nalawade, A, Parakh, U, Swarnakar, R, Shobha, V, Thangakunam, B, Udwadia, Z, Henry, M, O'Reilly, K, Balbir-Gurman, A, Kramer, M, Litinsky, I, Rosner, I, Cutolo, M, Gabrielli, A, Iaccarino, Laura, Pesci, A, Riccieri, V, Vettori, S, Funakubo, Y, Inoue, Y, Kawakami, A, Kawaguchi, Y, Kawamura, T, Kondoh, Y, Nanki, T, Nishioka, Y, Nozawa, K, Oguragawa, T, Okamoto, M, Sano, H, Sasai, R, Sasaki, N, Suda, T, Takahashi, H, Takeuchi, T, Tanaka, S, Yamasaki, Y, Ch'Ng, S, Cheah, C, Kan, S, Raja Mohamed, Rb, Selman, M, de Vries-Bouwstra, Jk, van den Toorn, L, Vonken, M, Voskuyl, Ae, Hoffmann-Vold, Am, Seip, M, Dankiewicz-Fares, I, Olesiejuk, R, Pulka, G, Szepietowski, J, Alves, J, Bernardes, M, Cordeiro, A, Costa, J, Neves, S, Salvador, Mj, Alegre Sancho, J, Carreira Delgado, P, Castellví Barranco, I, Cifrián Martínez, J, Guillén Del Castillo, A, Ovalles, Jg, López-Longo, Fj, Rivera Gallego, A, Freire Dapena, Mc, Román Ivorra, Ja, Ekwall, Ah, Maurer, B, Mihai, Cm, Müller, R, Mahakkanukrauh, A, Nantiruj, K, Siripaitoon, B, Denton, Cp, Herrick, A, Madhok, R, West, A, Bascom, R, Criner, G, Csuka, Me, Dematte D'Amico, J, Ettinger, N, Gerbino, A, Gerke, A, Glassberg, M, Glazer, C, Golden, J, Gripaldo, R, Gupta, N, Hamblin, M, Highland, K, Ho, L, Huggins, Jt, Hummers, L, Jones, L, Kahaleh, M, Khanna, D, Kim, H, Lancaster, Lh, Luckhardt, T, Mayes, M, Mendoza Ballesteros, F, Mooney, J, Mohabir, P, Morrissey, B, Moua, T, Padilla, M, Patel, N, Perez, R, Roman, J, Rossman, M, Russell, T, Saketkoo, L, Shah, A, Shlobin, O, Scholand, Mb, Simmssetts, R, Spiera, R, Steen, V, Veeraraghavan, S, Weigt, S., National Institute for Health Research, British Lung Foundation, University of Zurich, and Distler, Oliver

Subjects
Male, Vital capacity, Indoles, Vital Capacity, Administration, Oral, 2700 General Medicine, 030204 cardiovascular system & hematology, Pulmonary function testing, law.invention, oral, Idiopathic pulmonary fibrosis, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, SENSCIS Trial Investigators, CYCLOPHOSPHAMIDE, Clinical endpoint, scleroderma, 030212 general & internal medicine, Enzyme Inhibitors, 11 Medical and Health Sciences, lung diseases, Lung Diseases, Interstitial -- drug therapy -- etiology -- physiopathology, 10051 Rheumatology Clinic and Institute of Physical Medicine, General Medicine, respiratory system, Sciences bio-médicales et agricoles, Middle Aged, Protein-Tyrosine Kinases, MANIFESTATIONS, Disease Progression, Nintedanib, Female, TYROSINE KINASE INHIBITOR, Life Sciences & Biomedicine, CLINICAL-TRIALS, Adult, Diarrhea, medicine.medical_specialty, FIBROBLASTS, 610 Medicine & health, Placebo, administration, behavioral disciplines and activities, 03 medical and health sciences, FEV1/FVC ratio, Medicine, General & Internal, Double-Blind Method, Internal medicine, General & Internal Medicine, Enzyme Inhibitors -- adverse effects -- therapeutic use, SCORE, medicine, Humans, Indoles -- adverse effects -- therapeutic use, Scleroderma, Systemic -- complications -- drug therapy, Science & Technology, Scleroderma, Systemic, Protein-Tyrosine Kinases -- antagonists & inhibitors, business.industry, MORTALITY, interstitial, PULMONARY-FUNCTION, systemic, STANDARDIZATION, medicine.disease, EFFICACY, respiratory tract diseases, body regions, chemistry, adult, diarrhea, disease progression, double-blind method, enzyme inhibitors, female, humans, indoles, lung diseases, interstitial, male, middle aged, protein-tyrosine kinases, scleroderma, systemic, vital capacity, business, Lung Diseases, Interstitial, Diarrhea -- chemically induced
Abstract

Interstitial lung disease (ILD) is a common manifestation of systemic sclerosis and a leading cause of systemic sclerosis-related death. Nintedanib, a tyrosine kinase inhibitor, has been shown to have antifibrotic and antiinflammatory effects in preclinical models of systemic sclerosis and ILD., info:eu-repo/semantics/published

Published
2019

3. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials

Author

Lancaster, L., Albera, C., Bradford, W. Z., Costabel, U, Du Bois, R. M., Fagan, E. A., Fishman, R. S., Glaspole, I, Glassberg, M. K, King, T. E., J, R., Lederer, D. J., Lin, Z., Nathan, S. D., Pereira, C. A., Swigris, J. J., Valeyre, D., and Noble, P. W.

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Nausea, Medizin, Interstitial Lung Disease, 03 medical and health sciences, Idiopathic pulmonary fibrosis, 0302 clinical medicine, Internal medicine, medicine, 030212 general & internal medicine, Adverse effect, business.industry, Interstitial lung disease, Pirfenidone, medicine.disease, Rash, Surgery, Discontinuation, Interstitial Fibrosis, Clinical trial, 030228 respiratory system, medicine.symptom, business, medicine.drug
Abstract

Background Pirfenidone is an oral antifibrotic agent that has been shown to reduce the decline in lung function in patients with idiopathic pulmonary fibrosis (IPF). We performed an integrated analysis of safety data from five clinical trials evaluating pirfenidone in patients with IPF. Methods All patients treated with pirfenidone in the three multinational Phase 3 studies (CAPACITY (studies 004 and 006), ASCEND (study 016)) and two ongoing open-label studies (study 002 and study 012 (RECAP)) were included in the analysis. Safety outcomes were assessed during the period from the first dose until 28 days after the last dose of study drug. Results A total of 1299 patients were included in the analysis. The cumulative total exposure to pirfenidone was 3160 person exposure years (PEY). The median duration of exposure was 1.7 years (range 1 week to 9.9 years), and the mean (±SD) daily dose was 2053.8 (±484.9) mg. Gastrointestinal events (nausea (37.6%), diarrhoea (28.1%), dyspepsia (18.4%), vomiting (15.9%)) and rash (25.0%) were the most common adverse events; these were generally mild to moderate in severity and without significant clinical consequence. Elevations in alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal occurred in 40/1299 (3.1%) patients (adjusted incidence, 2.3 per 100 PEY). Elevations were generally transient and reversible with dose modification or discontinuation. Conclusions A comprehensive analysis of safety outcomes in a large and well-defined cohort of 1299 patients with IPF who were followed prospectively for up to 9.9 years demonstrated that long-term treatment with pirfenidone is safe and generally well tolerated. Trial registration numbers NCT00287716, NCT00287729, NCT00662038, NCT01366209.

Published
2016

4. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial

Author

Raghu, G, Behr, J, Brown, K, Egan, J, Kawut, S, Flaherty, K, Martinez, F, Nathan, S, Wells, A, Collard, H, Costabel, U, Richeldi, L, de Andrade, J, Khalil, N, Morrison, L, Lederer, D, Shao, L, Li, X, Pedersen, P, Montgomery, A, Chien, J, O'Riordan, T, Amin, D, Baker, A, Baratz, D, Baughman, R, Cagino, A, Chan, A, Chapman, J, Cordova, F, Edelman, J, Enelow, R, Ettinger, N, Glassberg, M, Golden, J, Ilowite, J, Kreider, M, Kureishy, S, Lancaster, L, Limper, A, Strek, M, Padilla, M, Fisher, M, Riley, D, Mohabir, P, Safdar, Z, Sahn, S, Schaumberg, T, Scholand, M, Smith, C, Sussman, R, Yung, G, Saggar, R, Geffen, D, Zibrak, J, Alvarez, J, Chan, K, Ruzi, J, Mcconnell, J, Mehta, J, Verghese, G, Talwar, A, Haddad, T, Sood, N, Goldberg, H, Sundar, K, Ziedalski, T, Gibson, K, Chan, C, Lien, D, Fell, C, Fox, G, Poirier, C, Provencher, S, Wilcox, P, Vilayi Weiler, Z, Kramer, M, Yigla, M, Baloira, A, Parakova, Z, Kra, H, Schwarz, Y, Martinez, C, Ben Dov, I, Kahler, C, Xaubet, A, Skrickova, J, Kolek, V, Parfrey, H, Echave Sustaeta, J, Wuyts, W, Geiser, T, Muller Quernheim, J, Whyte, M, Pfeifer, M, Grohe, C, Bourdin, A, Olschewski, H, Sibille, Y, Snizek, T, Vytiska, J, Pesek, M, Crestani, B, Wallaert, B, Chanez, P, Biet, D, Pompidou, G, Dromer, C, Gläser, S, Wagner, U, Witt, C, Herth, F, Hoeffken, G, Coswig, F, Breuer, R, Kerem, E, Adir, Y, Agostini, C, Cremona, G, Vitulo, P, Poletti, V, Rottoli, P, Rybacki, C, Piotrowski, W, Morera, J, Hattotuwa, K, Warburton, C, Corris, P, Leonard, C, Booth, H, Britton, M, Marchand Adam, S, Marquette, C, Tamm, M, Lazor, R, Chalmers, G, Hirani, N, De Vuyst, P, Saltini, C, Harari, S, Maher, T, Campos, F, Ramirez, A, Wehbe, L, Altieri, H, Fuchigami, A, Salinas, C, Mattos, W, Posadas, R, Fiss, E, Diaz Castanon, J, Munoz, S, Ramirez, L, Chercoff, J, Fritscher, C, Cardoso, A, Moreira, M, Steidle, L, Arakaki, J, Florenzano, M, Leon, L, Bernardini, S, Gilberto, A, Duque, C, Awad, C, Severiche, D, Lucro, D, Grimaldos, F, Rubin, A, Barrera, C, Ore, D, Heredia, C, Mazzei, J, Matiz, C, Glanville, A, Hopkins, P, Smallwood, D, Veitch, E, Musk, M, Glaspole, I, Wood Baker, R, Veale, A, and Costabel, Ulrich (Beitragende*r)

Subjects
Adult, Male, medicine.medical_specialty, Ambrisentan, Endothelin A Receptor Antagonists, Settore MED/10 - Malattie dell'Apparato Respiratorio, Medizin, Placebo, Idiopathic pulmonary fibrosis, Aged, Aged, 80 and over, Disease Progression, Double-Blind Method, Female, Humans, Idiopathic Pulmonary Fibrosis, Lung, Middle Aged, Phenylpropionates, Prospective Studies, Pyridazines, Treatment Outcome, Internal medicine, 80 and over, Internal Medicine, medicine, Clinical endpoint, Prospective cohort study, business.industry, Hazard ratio, General Medicine, medicine.disease, Interim analysis, Pulmonary hypertension, Surgery, business, medicine.drug
Abstract

BACKGROUND Idiopathic pulmonary fibrosis (IPF) is characterized by formation and proliferation of fibroblast foci. Endothelin-1 induces lung fibroblast proliferation and contractile activity via the endothelin A (ETA) receptor. OBJECTIVE To determine whether ambrisentan, an ETA receptor-selective antagonist, reduces the rate of IPF progression. DESIGN Randomized, double-blind, placebo-controlled, event-driven trial. (ClinicalTrials.gov: NCT00768300). SETTING Academic and private hospitals. PARTICIPANTS Patients with IPF aged 40 to 80 years with minimal or no honeycombing on high-resolution computed tomography scans. INTERVENTION Ambrisentan, 10 mg/d, or placebo. MEASUREMENTS Time to disease progression, defined as death, respiratory hospitalization, or a categorical decrease in lung function. RESULTS The study was terminated after enrollment of 492 patients (75% of intended enrollment; mean duration of exposure to study medication, 34.7 weeks) because an interim analysis indicated a low likelihood of showing efficacy for the end point by the scheduled end of the study. Ambrisentan-treated patients were more likely to meet the prespecified criteria for disease progression (90 [27.4%] vs. 28 [17.2%] patients; P = 0.010; hazard ratio, 1.74 [95% CI, 1.14 to 2.66]). Lung function decline was seen in 55 (16.7%) ambrisentan-treated patients and 19 (11.7%) placebo-treated patients (P = 0.109). Respiratory hospitalizations were seen in 44 (13.4%) and 9 (5.5%) patients in the ambrisentan and placebo groups, respectively (P = 0.007). Twenty-six (7.9%) patients who received ambrisentan and 6 (3.7%) who received placebo died (P = 0.100). Thirty-two (10%) ambrisentan-treated patients and 16 (10%) placebo-treated patients had pulmonary hypertension at baseline, and analysis stratified by the presence of pulmonary hypertension revealed similar results for the primary end point. LIMITATION The study was terminated early. CONCLUSION Ambrisentan was not effective in treating IPF and may be associated with an increased risk for disease progression and respiratory hospitalizations. PRIMARY FUNDING SOURCE Gilead Sciences.

Published
2013

5. Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial

Author

King TE Jr, Albera, C, Bradford, Wz, Costabel, U, Hormel, P, Lancaster, L, Noble, Pw, Sahn, Sa, Szwarcberg, J, Thomeer, M, Valeyre, D, du Bois RM, INSPIRE Study Group, Agostini, Carlo, Allen, J, Anzueto, A, Behr, J, Bonnet, R, Buhl, R, Burge, S, Chan, A, Chan, C, Chanez, P, Chapman, J, Cordier, J, Covelli, H, Crimi, N, de Andrade, J, Delaval, P, Dromer, C, Egan, J, Enelow, R, Ettinger, N, Flaherty, K, Floreani, A, Frankel, S, Frost, A, Gibson, K, Glassberg, M, Gottfried, M, Harari, S, Helmersen, D, Hollingsworth, H, Horton, M, Jennings, J, Kallay, M, Lasky, J, Lee, A, Leonard, C, Lorch, D, Lynch, J, Mageto, Y, Mette, S, Millar, A, Morell Brotad, F, Müller Quernheim, J, Nathan, S, Noth, I, Padilla, M, Poletti, V, Raghu, G, Richeldi, L, Robbins, M, Rolf, J, Roman, J, Rosen, G, Rottoli, P, Saltini, C, Schaberg, T, Schaumberg, T, Scholand, M, Schönfeld, N, Sharma, S, Simonelli, P, Steele, M, Sussman, R, Tino, G, Vogelmeier, C, Wallaert, B, Wells, A, Wencel, M, Wesselius, L, Whelan, T, Wilcox, P, Wolters, P, Xaubet, A, and Zisman, D.

Subjects
Male, medicine.medical_specialty, Settore MED/10 - Malattie dell'Apparato Respiratorio, Injections, Subcutaneous, Vital Capacity, Placebo-controlled study, Kaplan-Meier Estimate, Placebo, Severity of Illness Index, Drug Administration Schedule, Pulmonary function testing, Injections, Idiopathic pulmonary fibrosis, Interferon-gamma, Double-Blind Method, Internal medicine, Pulmonary fibrosis, medicine, Humans, Aged, Analysis of Variance, Disease Progression, Europe, Exercise Test, Female, Idiopathic Pulmonary Fibrosis, North America, Proportional Hazards Models, Pulmonary Diffusing Capacity, Recombinant Proteins, Survival Rate, Treatment Failure, Medicine (all), Survival rate, business.industry, Subcutaneous, Hazard ratio, General Medicine, Interim analysis, medicine.disease, Surgery, business
Abstract

Summary Background Idiopathic pulmonary fibrosis is a fatal disease for which no effective treatment exists. We assessed whether treatment with interferon gamma-1b improved survival compared with placebo in patients with idiopathic pulmonary fibrosis and mild-to-moderate impairment of pulmonary function. Methods 826 patients with idiopathic pulmonary fibrosis were enrolled from 81 centres in seven European countries, the USA, and Canada. Patients were randomly assigned (double-blind) in a 2:1 ratio to receive 200 μg interferon gamma-1b (n=551) or equivalent placebo (n=275) subcutaneously, three times per week. Eligible patients were aged 40–79 years, had been diagnosed in the past 48 months, had a forced vital capacity of 55–90% of the predicted value, and a haemoglobin-corrected carbon monoxide diffusing capacity of 35–90% of the predicted value. The primary endpoint was overall survival time from randomisation measured at the second interim analysis, when the proportion of deaths had reached 75% of those expected by the study conclusion. This study is registered with ClinicalTrials.gov, number NCT00075998. Findings At the second interim analysis, the hazard ratio for mortality in patients on interferon gamma-1b showed absence of minimum benefit compared with placebo (1·15, 95% CI 0·77–1·71, p=0·497), and indicated that the study should be stopped. After a median duration of 64 weeks (IQR 41–84) on treatment, 80 (15%) patients on interferon gamma-1b and 35 (13%) on placebo had died. Almost all patients reported at least one adverse event, and more patients on interferon gamma-1b group had constitutional signs and symptoms (influenza-like illness, fatigue, fever, and chills) than did those on placebo. Occurrence of serious adverse events (eg, pneumonia, respiratory failure) was similar for both treatment groups. Treatment adherence was good and few patients discontinued treatment prematurely in either group. Interpretation We cannot recommend treatment with interferon gamma-1b since the drug did not improve survival for patients with idiopathic pulmonary fibrosis, which refutes previous findings from subgroup analyses of survival in studies of patients with mild-to-moderate physiological impairment of pulmonary function. Funding InterMune.

Published
2009

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