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Gary T. Ferguson - One of the best experts on this subject based on the ideXlab platform.
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effects of tiotropium olodaterol versus tiotropium or placebo by copd disease severity and previous Treatment History in the otemto studies
Respiratory Research, 2016Co-Authors: Dave Singh, L Gronke, Leif Bjermer, Mina Gaga, O. Schmidt, Gary T. FergusonAbstract:As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and Treatment History. Four subgroup analyses were performed: Global initiative for chronic Obstructive Lung Disease (GOLD) 2/3, GOLD A/B/C/D, Treatment naive/not Treatment naive and receiving inhaled corticosteroids (ICS) at baseline/not receiving ICS at baseline. Primary end points were change in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h response, change in trough FEV1 and St George’s Respiratory Questionnaire (SGRQ) total score. Transition Dyspnoea Index (TDI) focal score was a secondary end point, and SGRQ and TDI responder analyses were further end points; all were assessed at 12 weeks. In all subgroups, patients receiving tiotropium + olodaterol responded better overall than those receiving tiotropium monotherapy. Improvements with tiotropium + olodaterol over placebo or tiotropium monotherapy were noted across GOLD 2/3 and GOLD A/B/C/D; however, improvements in SGRQ total score were most evident in the GOLD B subgroup. Moreover, lung-function outcomes were generally greater in those patients who had been receiving previous long-acting bronchodilator and/or ICS maintenance Treatment. These data suggest that tiotropium + olodaterol should be considered as a Treatment option in patients with moderate COPD who are initiating maintenance therapy, as well as those with more severe disease. ClinicalTrials.gov: NCT01964352 and NCT02006732 .
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Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous Treatment History in the OTEMTO® studies
Respiratory Research, 2016Co-Authors: Dave Singh, L Gronke, Leif Bjermer, Florian Voß, Mina Gaga, O. Schmidt, Gary T. FergusonAbstract:As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and Treatment History. Four subgroup analyses were performed: Global initiative for chronic Obstructive Lung Disease (GOLD) 2/3, GOLD A/B/C/D, Treatment naive/not Treatment naive and receiving inhaled corticosteroids (ICS) at baseline/not receiving ICS at baseline. Primary end points were change in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h response, change in trough FEV1 and St George’s Respiratory Questionnaire (SGRQ) total score. Transition Dyspnoea Index (TDI) focal score was a secondary end point, and SGRQ and TDI responder analyses were further end points; all were assessed at 12 weeks. In all subgroups, patients receiving tiotropium + olodaterol responded better overall than those receiving tiotropium monotherapy. Improvements with tiotropium + olodaterol over placebo or tiotropium monotherapy were noted across GOLD 2/3 and GOLD A/B/C/D; however, improvements in SGRQ total score were most evident in the GOLD B subgroup. Moreover, lung-function outcomes were generally greater in those patients who had been receiving previous long-acting bronchodilator and/or ICS maintenance Treatment. These data suggest that tiotropium + olodaterol should be considered as a Treatment option in patients with moderate COPD who are initiating maintenance therapy, as well as those with more severe disease. ClinicalTrials.gov: NCT01964352 and NCT02006732 .
Jorge A. Marrero - One of the best experts on this subject based on the ideXlab platform.
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Second interim analysis of Global Investigation of Therapeutic Decisions in Unresectable HCC and of its Treatment with Sorafenib (GIDEON): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Alec Goldenberg, Robert C.g. Martin, Anthony B. El-khoueiry, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan Mcguire, Arun Sanyal, Jean-francois Geschwind, Jorge A. MarreroAbstract:e14581 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Using data from the second interim analysis, we compare safety and efficacy of sorafenib in US pts with the entire (global) study population. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: The safety population comprised 1571 pts. In the 313 US pts, hepatitis B was less common (18% vs 37% global), but hepatitis C was more frequent (53% vs 32% global) (Table). Rate of alcoholic liver disease was higher in US pts (41% vs 29% global). At start of SOR, fewer US pts had BCLC stage C-D disease (49% vs 60% global), but more US pts were Child-Pugh (CP) B or C status (38% vs 25% global) (Table). Rates of prior surgery and locoregional Treatment (LRT) were similar in US (11% and 49%, respectively) and global pts (19% and 55%, respectively). US pts received fewer TACE procedures (≥3 Treatments: 13.8% vs 38.9% global); most (59%) TACE-treated pts in the US received 1 Treatment. In US vs global pts, median time from prior surgery to start of SOR was 10 months (range 1-61) vs 14 months (range 1-181) and median time from last TACE to start of SOR was 3.2 months vs 3.1 months. Conclusions: Disease characteristics and Treatment patterns differ in the US and global GIDEON populations. Although its limitations as an observational study must be considered, GIDEON is a valuable repository of data reflecting real-world practices in a variety of regions and pt types. [Table: see text]
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Second interim analysis of GIDEON (Global Investigation of Therapeutic Decisions in Unresectable HCC and of Its Treatment with Sorafenib): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Robert C.g. Martin, Anthony B. El-khoueiry, Alec Goldenberg, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan M. Mcguire, Arun J. Sanyal, Jeff H. Geschwind, Jorge A. MarreroAbstract:278 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Detailed regional data were presented by Kudo et al (ILCA 2011, abstr 0-030). Data from the second US interim analysis are compared to global results. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: Global and US safety populations comprised 1571 and 313 pts, respectively. In the US, hepatitis B was less common (18% vs 37% global) whereas hepatitis C was more frequent (53% vs 32% global). Alcoholic liver disease etiology was higher in US pts (41% vs 29% global). US pts were diagnosed with later-stage disease, but fewer US pts had documented BCLC and Child-Pugh status. Fewer US pts had an ECOG PS 0 at start of SOR (28...
Dave Singh - One of the best experts on this subject based on the ideXlab platform.
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effects of tiotropium olodaterol versus tiotropium or placebo by copd disease severity and previous Treatment History in the otemto studies
Respiratory Research, 2016Co-Authors: Dave Singh, L Gronke, Leif Bjermer, Mina Gaga, O. Schmidt, Gary T. FergusonAbstract:As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and Treatment History. Four subgroup analyses were performed: Global initiative for chronic Obstructive Lung Disease (GOLD) 2/3, GOLD A/B/C/D, Treatment naive/not Treatment naive and receiving inhaled corticosteroids (ICS) at baseline/not receiving ICS at baseline. Primary end points were change in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h response, change in trough FEV1 and St George’s Respiratory Questionnaire (SGRQ) total score. Transition Dyspnoea Index (TDI) focal score was a secondary end point, and SGRQ and TDI responder analyses were further end points; all were assessed at 12 weeks. In all subgroups, patients receiving tiotropium + olodaterol responded better overall than those receiving tiotropium monotherapy. Improvements with tiotropium + olodaterol over placebo or tiotropium monotherapy were noted across GOLD 2/3 and GOLD A/B/C/D; however, improvements in SGRQ total score were most evident in the GOLD B subgroup. Moreover, lung-function outcomes were generally greater in those patients who had been receiving previous long-acting bronchodilator and/or ICS maintenance Treatment. These data suggest that tiotropium + olodaterol should be considered as a Treatment option in patients with moderate COPD who are initiating maintenance therapy, as well as those with more severe disease. ClinicalTrials.gov: NCT01964352 and NCT02006732 .
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Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous Treatment History in the OTEMTO® studies
Respiratory Research, 2016Co-Authors: Dave Singh, L Gronke, Leif Bjermer, Florian Voß, Mina Gaga, O. Schmidt, Gary T. FergusonAbstract:As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and Treatment History. Four subgroup analyses were performed: Global initiative for chronic Obstructive Lung Disease (GOLD) 2/3, GOLD A/B/C/D, Treatment naive/not Treatment naive and receiving inhaled corticosteroids (ICS) at baseline/not receiving ICS at baseline. Primary end points were change in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h response, change in trough FEV1 and St George’s Respiratory Questionnaire (SGRQ) total score. Transition Dyspnoea Index (TDI) focal score was a secondary end point, and SGRQ and TDI responder analyses were further end points; all were assessed at 12 weeks. In all subgroups, patients receiving tiotropium + olodaterol responded better overall than those receiving tiotropium monotherapy. Improvements with tiotropium + olodaterol over placebo or tiotropium monotherapy were noted across GOLD 2/3 and GOLD A/B/C/D; however, improvements in SGRQ total score were most evident in the GOLD B subgroup. Moreover, lung-function outcomes were generally greater in those patients who had been receiving previous long-acting bronchodilator and/or ICS maintenance Treatment. These data suggest that tiotropium + olodaterol should be considered as a Treatment option in patients with moderate COPD who are initiating maintenance therapy, as well as those with more severe disease. ClinicalTrials.gov: NCT01964352 and NCT02006732 .
Alec Goldenberg - One of the best experts on this subject based on the ideXlab platform.
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Second interim analysis of Global Investigation of Therapeutic Decisions in Unresectable HCC and of its Treatment with Sorafenib (GIDEON): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Alec Goldenberg, Robert C.g. Martin, Anthony B. El-khoueiry, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan Mcguire, Arun Sanyal, Jean-francois Geschwind, Jorge A. MarreroAbstract:e14581 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Using data from the second interim analysis, we compare safety and efficacy of sorafenib in US pts with the entire (global) study population. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: The safety population comprised 1571 pts. In the 313 US pts, hepatitis B was less common (18% vs 37% global), but hepatitis C was more frequent (53% vs 32% global) (Table). Rate of alcoholic liver disease was higher in US pts (41% vs 29% global). At start of SOR, fewer US pts had BCLC stage C-D disease (49% vs 60% global), but more US pts were Child-Pugh (CP) B or C status (38% vs 25% global) (Table). Rates of prior surgery and locoregional Treatment (LRT) were similar in US (11% and 49%, respectively) and global pts (19% and 55%, respectively). US pts received fewer TACE procedures (≥3 Treatments: 13.8% vs 38.9% global); most (59%) TACE-treated pts in the US received 1 Treatment. In US vs global pts, median time from prior surgery to start of SOR was 10 months (range 1-61) vs 14 months (range 1-181) and median time from last TACE to start of SOR was 3.2 months vs 3.1 months. Conclusions: Disease characteristics and Treatment patterns differ in the US and global GIDEON populations. Although its limitations as an observational study must be considered, GIDEON is a valuable repository of data reflecting real-world practices in a variety of regions and pt types. [Table: see text]
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Second interim analysis of GIDEON (Global Investigation of Therapeutic Decisions in Unresectable HCC and of Its Treatment with Sorafenib): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Robert C.g. Martin, Anthony B. El-khoueiry, Alec Goldenberg, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan M. Mcguire, Arun J. Sanyal, Jeff H. Geschwind, Jorge A. MarreroAbstract:278 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Detailed regional data were presented by Kudo et al (ILCA 2011, abstr 0-030). Data from the second US interim analysis are compared to global results. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: Global and US safety populations comprised 1571 and 313 pts, respectively. In the US, hepatitis B was less common (18% vs 37% global) whereas hepatitis C was more frequent (53% vs 32% global). Alcoholic liver disease etiology was higher in US pts (41% vs 29% global). US pts were diagnosed with later-stage disease, but fewer US pts had documented BCLC and Child-Pugh status. Fewer US pts had an ECOG PS 0 at start of SOR (28...
Robert C.g. Martin - One of the best experts on this subject based on the ideXlab platform.
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Second interim analysis of Global Investigation of Therapeutic Decisions in Unresectable HCC and of its Treatment with Sorafenib (GIDEON): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Alec Goldenberg, Robert C.g. Martin, Anthony B. El-khoueiry, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan Mcguire, Arun Sanyal, Jean-francois Geschwind, Jorge A. MarreroAbstract:e14581 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Using data from the second interim analysis, we compare safety and efficacy of sorafenib in US pts with the entire (global) study population. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: The safety population comprised 1571 pts. In the 313 US pts, hepatitis B was less common (18% vs 37% global), but hepatitis C was more frequent (53% vs 32% global) (Table). Rate of alcoholic liver disease was higher in US pts (41% vs 29% global). At start of SOR, fewer US pts had BCLC stage C-D disease (49% vs 60% global), but more US pts were Child-Pugh (CP) B or C status (38% vs 25% global) (Table). Rates of prior surgery and locoregional Treatment (LRT) were similar in US (11% and 49%, respectively) and global pts (19% and 55%, respectively). US pts received fewer TACE procedures (≥3 Treatments: 13.8% vs 38.9% global); most (59%) TACE-treated pts in the US received 1 Treatment. In US vs global pts, median time from prior surgery to start of SOR was 10 months (range 1-61) vs 14 months (range 1-181) and median time from last TACE to start of SOR was 3.2 months vs 3.1 months. Conclusions: Disease characteristics and Treatment patterns differ in the US and global GIDEON populations. Although its limitations as an observational study must be considered, GIDEON is a valuable repository of data reflecting real-world practices in a variety of regions and pt types. [Table: see text]
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Second interim analysis of GIDEON (Global Investigation of Therapeutic Decisions in Unresectable HCC and of Its Treatment with Sorafenib): U.S. versus global perspective on patient and disease characteristics, Treatment History, and sorafenib use.
Journal of Clinical Oncology, 2012Co-Authors: Robert C.g. Martin, Anthony B. El-khoueiry, Alec Goldenberg, Alan P. Venook, Parvez S. Mantry, Pierre M. Gholam, Brendan M. Mcguire, Arun J. Sanyal, Jeff H. Geschwind, Jorge A. MarreroAbstract:278 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Detailed regional data were presented by Kudo et al (ILCA 2011, abstr 0-030). Data from the second US interim analysis are compared to global results. Methods: Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, Treatment History, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. Results: Global and US safety populations comprised 1571 and 313 pts, respectively. In the US, hepatitis B was less common (18% vs 37% global) whereas hepatitis C was more frequent (53% vs 32% global). Alcoholic liver disease etiology was higher in US pts (41% vs 29% global). US pts were diagnosed with later-stage disease, but fewer US pts had documented BCLC and Child-Pugh status. Fewer US pts had an ECOG PS 0 at start of SOR (28...
