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Deerfield, IL, United States

Mody R.R.,Takeda Pharmaceuticals International Inc | Izat E.,Decision Sciences, Inc.
Digestive Diseases and Sciences

Background: Few studies have explored the satisfaction with proton pump inhibitors (PPIs) for gastroesophageal reflux disease (GERD). Aim: The aim of this study was to assess patient and physician satisfaction with currently prescribed PPIs for patients with GERD. Methods: Separate online surveys were completed by 1,002 physicians and 1,013 GERD patients. Physician surveys examined satisfaction, symptom relief, long-term therapy, side-effects, breakthrough symptoms, and use of supplemental medications with PPIs. Patient surveys evaluated PPI regimen, length of therapy, satisfaction with PPI, symptom relief, use of supplemental medications, and perceptions about long-term use and side-effects. Results: Most respondents were satisfied with PPI therapy, but 35.4% of GERD patients and 34.8% of physicians perceived patients as "somewhat satisfied" to "completely dissatisfied" with PPI therapy. Patients who were highly satisfied were more likely to indicate complete symptom relief (P < 0.001) relative to patients who were less satisfied. However, over 35% of patients on once-daily and 54% on twice-daily PPI indicated that therapy failed to completely relieve symptoms. Patients who were highly satisfied were more likely to recommend medication to patients with the same symptoms (P < 0.001) and less likely to report that the medication is too expensive (P < 0.001), worry about long-term use (P < 0.001), or add OTC medications for supplemental control (P < 0.004). Conclusions: Approximately one-third of GERD patients reported persistent symptoms and were dissatisfied with PPI therapy. © 2010 Springer Science+Business Media, LLC. Source

Erdmann E.,University of Cologne | Song E.,Takeda Global Research and Development Center Inc. | Spanheimer R.,Takeda Pharmaceuticals International Inc | van Troostenburg de Bruyn A.-R.,Takeda Global Research and Development Europe Ltd | Perez A.,Takeda Global Research and Development Center Inc.
Diabetes, Obesity and Metabolism

Aims: The PROactive study investigated pioglitazone for secondary prevention of macrovascular events in type 2 diabetes mellitus. Pioglitazone showed a 10% (non-significant) relative risk (RR) reduction for the primary composite endpoint and a significant 16% reduction for the main secondary endpoint (death, myocardial infarction, stroke) after a mean 34.5months. There was no difference in cumulative malignancy incidence, but an imbalance in bladder malignancies (pioglitazone 14, placebo 5). We present a pre-specified 6-year interim analysis of a 10-year observational follow-up. Methods: Any patient completing PROactive was eligible. No study treatments were provided. A Cox proportional hazard model compared non-adjudicated macrovascular events (same endpoints as PROactive excluding acute coronary syndrome) based on original randomization. Malignancies were compared using conventional RR ratios. Results: Of 5238 randomized patients, 3599 (74%) entered the follow-up. For the follow-up (mean 5.8years) or combined double-blind and follow-up periods (≤9.5years, mean 8.7), there were no statistically significant differences in primary or main secondary endpoints. For the combined period, a similar percentage of patients had any diagnosed malignancy (RR=1.05, 95% CI [0.89, 1.24]) or bladder malignancy (RR=1.06, 95% CI [0.59, 1.89]) in the pioglitazone and placebo groups. There were fewer cases of bladder malignancy with pioglitazone (15 [0.6%] vs. 19 [0.7%] for placebo) for the combined period when events diagnosed in the first 365days were excluded, and fewer cases for the follow-up period alone (10 [0.5%] vs. 17 [1.0%] for placebo). Further analyses of pioglitazone use (including use during follow-up) found no significant difference in bladder malignancies between any and no pioglitazone use for the combined period. Conclusions: These data suggest that improved macrovascular outcomes seen with pioglitazone subside without continued pioglitazone treatment. The double-blind period bladder cancer imbalance did not persist in follow-up. © 2013 John Wiley & Sons Ltd. Source

Wyant T.,Takeda Cambridge | Leach T.,Takeda Cambridge | Sankoh S.,Takeda Cambridge | Wang Y.,Takeda Cambridge | And 4 more authors.

Design: In this randomised, double-blind, placebo-controlled, phase I trial, healthy participants received a single intravenous dose of vedolizumab 750 mg (n=64) or placebo (n=63). After 4 days, participants began intramuscular hepatitis B vaccine (HBV; days 4, 32, 60) and oral cholera vaccine (OCV; days 4, 18) regimens. The study was designed to demonstrate a 15% non-inferiority margin for the between-group difference in the primary end point: percentage of participants with HBV seroconversion at day 74 (serum hepatitis B surface antigen (HBs) antibody titre ≥10 IU/L). OCV seroconversion at day 74 (>4-fold increase in serum cholera toxin (CT) antibodies) was a secondary end point.Objective: The α4β7 integrin monoclonal antibody vedolizumab is hypothesised to be gut selective. Effects of vedolizumab on immune responses to parenterally or enterally administered antigens were investigated.Conclusions: Vedolizumab did not alter the response to parenterally administered antigens but reduced the response to oral antigens, demonstrating its gut-selective mechanism of action.Results: A total of 56 (90.3%) placebo-treated and 54 (88.5%) vedolizumab-treated participants responded to HBV. Geometric mean anti-HBs titres were similar for placebo (114.4 IU/L) and vedolizumab (129.6 IU/L) at day 74. A total of 60 (96.8%) placebo-treated and 52 (82.5%) vedolizumab-treated participants responded to OCV at day 74. Geometric mean anti-CT IgG levels were higher for placebo than for vedolizumab at day 74 (9210.08 vs 3007.8 ELISA Units (EU)/mL) and day 32 (11629.3 vs 1575.4 EU/mL). Anti-CT IgA results were similar. Adverse events were consistent with previous experience. One serious adverse event (spontaneous abortion) was reported for placebo. Source

Zhu Y.,Boston University | Pandya B.J.,Takeda Pharmaceuticals International Inc | Choi H.K.,Boston University
American Journal of Medicine

PURPOSE: The objective of this study was to estimate the latest prevalence of major comorbidities associated with gout and hyperuricemia in the US based on a recent, nationally representative sample of US men and women. METHODS: Using data from 5707 participants aged 20 years and older in the National Health and Nutrition Examination Survey 2007-2008, we calculated the national prevalence and population estimates of major comorbidities according to gout status and various hyperuricemia levels, compared with those without these conditions. Case definitions of gout and comorbidities were based on an affirmative answer to a question that asked whether a physician or a health professional had diagnosed the corresponding condition. RESULTS: Among these individuals with gout, 74% (6.1 million) had hypertension, 71% (5.5 million) had chronic kidney disease stage ≥2, 53% (4.3 million) were obese, 26% (2.1 million) had diabetes, 24% (2.0 million) had nephrolithiasis, 14% (1.2 million) had myocardial infarction, 11% (0.9 million) had heart failure, and 10% (0.9 million) had suffered a stroke. These proportions were substantially higher than those among individuals without gout (all P-values <.67). With increasing levels of hyperuricemia, there were graded increases in the prevalences of these comorbidities. In the top category (serum urate ≥10 mg/dL), 86% of subjects had chronic kidney disease stage ≥2, 66% had hypertension, 65% were obese, 33% had heart failure, 33% had diabetes, 23% had myocardial infarction, and 12% had stroke. These prevalences were 3-33 times higher than those in the lowest serum urate category (<4 mg/dL). Sex-specific odds ratios tended to be larger among women than men, and the overall comorbidity prevalence was highest among individuals with both gout and hyperuricemia. CONCLUSIONS: These findings from the latest nationally representative data highlight remarkable prevalences and population estimates of comorbidities of gout and hyperuricemia in the US. Appropriate preventive and management measures of these comorbidities should be implemented in gout management, with a preference to strategies that can improve gout and comorbidities together. © 2012 Elsevier Inc. All rights reserved. Source

Rubin D.T.,University of Chicago | Mody R.,Takeda Pharmaceuticals International Inc | Davis K.L.,RTI Health Solutions | Wang C.-C.,RTI Health Solutions
Alimentary Pharmacology and Therapeutics

Background Treatments for Crohn's disease (CD) and ulcerative colitis (UC) are not uniformly effective, thus necessitating dose changes, switching, and augmentation and carry adverse event risk, often requiring discontinuation, which reduces treatment benefits. Aim To assess continuity of and changes to initial CD and UC treatments, as well as costs associated with specific parameters defining suboptimal therapy. Methods Commercial US insurance claims (2006-2010) were retrospectively analysed. CD and UC patients receiving monotherapy with 5-aminosalicylates (5-ASAs), corticosteroids (CS), immunomodulators (IM) or biologics were included. Continuity of and changes to initial (index) therapy and associated costs (2011 US) were assessed over 12 months following therapy initiation. Suboptimal therapy included discontinuation or switch (except for CS), dose escalation, augmentation, inadequate loading (biologics only), prolonged CS use (>3 months), surgery or hospitalisation. Results The study included 13 005 CD and 19 878 UC patients. Augmentation was a common index therapy change (~20% of 5-ASA initiators, ~40% of CS initiators, ≥40% of IM initiators and 26-55% of biologic initiators) in both CD and UC patients. Approximately 50% of CD and UC 5-ASA initiators discontinued/ interrupted treatment. Approximately 80% of CD and UC patients had ≥1 suboptimal therapy marker. Mean all-cause total costs per CD patient were significantly higher in those with vs. without suboptimal therapy (18 736 vs. 10 878; P < 0.001); in UC, the disparity was smaller (12 679 vs. 9653; P < 0.001). Conclusions Frequent dose and treatment changes were observed in all classes of initial UC and CD treatments. The economic impact of suboptimal therapy among UC and CD patients is substantial. © 2014 John Wiley & Sons Ltd. Source

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