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Mody R.R.,Takeda Pharmaceuticals International Inc. | Izat E.,Decision Sciences, Inc.
Digestive Diseases and Sciences | Year: 2010

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.


Sands B.E.,Mount Sinai School of Medicine | Feagan B.G.,University of Western Ontario | Rutgeerts P.,University Hospital Gasthuisberg and Katholieke University | Colombel J.-F.,Mount Sinai School of Medicine | And 11 more authors.
Gastroenterology | Year: 2014

Background & Aims There is an increasing need for new treatments for patients with Crohn's disease (CD) in whom previous therapy with tumor necrosis factor (TNF) antagonists has failed. We performed a placebo-controlled, phase 3, double-blind trial to evaluate the efficacy and safety of vedolizumab, an antibody against the integrin α4β7, as induction therapy. Methods Patients with moderately to severely active CD (CD activity index [CDAI] score, 220-400 points) were assigned randomly to groups given vedolizumab (300 mg) or placebo intravenously at weeks 0, 2, and 6. The primary analysis involved 315 patients with previous TNF antagonist failure (ie, an inadequate response to, loss of response to, or intolerance of ≥1 TNF antagonists); we determined the proportion of patients in clinical remission (CDAI, ≤150 points) at week 6. Secondary analyses evaluated outcomes at weeks 6 and 10 in this population and in the overall population (N = 416), which included patients naive to TNF antagonist therapy (n = 101). Results Among patients who had experienced previous TNF antagonist failure, 15.2% of those given vedolizumab and 12.1% of those given placebo were in remission at week 6 (P =.433). At week 10, a higher proportion of this population given vedolizumab was in remission (26.6%) than those given placebo (12.1%) (nominal P =.001; relative risk, 2.2; 95% confidence interval, 1.3-3.6). A higher proportion of patients with previous TNF antagonist failure given vedolizumab also had a CDAI-100 response (≥100-point decrease in CDAI score from baseline) at week 6 than those given placebo (39.2% vs 22.3%; nominal P =.001; relative risk, 1.8; 95% confidence interval, 1.2-2.5). Adverse event results were similar among all groups. Conclusions Vedolizumab was not more effective than placebo in inducing clinical remission at week 6 among patients with CD in whom previous treatment with TNF antagonists had failed. The therapeutic benefits of vedolizumab in these patients were detectable at week 10. ClinicalTrials.gov number: NCT01224171. © 2014 by the AGA Institute.


Singh J.A.,University of Alabama at Birmingham | Akhras K.S.,Takeda Pharmaceuticals International Inc. | Shiozawa A.,Takeda Pharmaceuticals International Inc.
Arthritis Research and Therapy | Year: 2015

Introduction: To assess the comparative effectiveness of febuxostat and allopurinol in reducing serum urate (sUA) levels in a real-world U.S. managed care setting. Methods: This retrospective study utilized 2009 to 2012 medical and pharmacy claims and laboratory data from a large U.S. commercial and Medicare Advantage health plan. Study patients had at least one medical claim with a diagnosis of gout, at least one filled prescription for febuxostat or allopurinol and at least one sUA measurement post-index prescription. Reduction in sUA was examined using propensity score-matched cohorts, matched on patient demographics (gender, age), baseline sUA, comorbidities, geographic region and insurance type. Results: The study sample included 2,015 patients taking febuxostat and 14,025 taking allopurinol. At baseline, febuxostat users had a higher Quan-Charlson comorbidity score (0.78 vs. 0.53; P <0.001), but similar age and gender distribution. Mean (standard deviation (SD)) sUA level following propensity score matching among treatment-naïve febuxostat vs. allopurinol users (n = 873 each) were: pre-index sUA, 8.86 (SD, 1.79) vs. 8.72 (SD, 1.63; P = 0.20); and post-index sUA, 6.53 (SD, 2.01) vs. 6.71 (SD, 1.70; P = 0.04), respectively. A higher proportion of febuxostat users attained sUA goals of <6.0 mg/dl (56.9% vs. 44.8%; P <0.001) and <5.0 mg/dl (35.5% vs. 19.2%; P <0.001), respectively. Time to achieve sUA goals of <6.0 mg/dl (346 vs. 397 days; P <0.001) and <5.0 mg/dl was shorter in febuxostat vs. allopurinol users (431 vs. 478 days; P <0.001), respectively. Similar observations were made for overall propensity score-matched cohorts that included both treatment-naïve and current users (n = 1,932 each). Conclusions: Febuxostat was more effective than allopurinol at the currently used doses (40 mg/day for febuxostat in 83% users and 300 mg/day or lower for allopurinol in 97% users) in lowering sUA in gout patients as demonstrated by post-index mean sUA level, the likelihood of and the time to achieving sUA goals. © 2015 Singh et al.; licensee BioMed Central.


Krishnan E.,Stanford University | Pandya B.J.,Takeda Pharmaceuticals International Inc. | Chung L.,Stanford University | Dabbous O.,Takeda Pharmaceuticals International Inc.
Arthritis Research and Therapy | Year: 2010

Introduction: Our purpose was to test the hypothesis that hyperuricemia is associated with coronary artery calcification (CAC) among a relatively healthy population, and that the extent of calcification is directly proportional to the serum uric acid (sUA) concentration.Methods: Data from 2,498 participants in the Coronary Artery Risk Development in Young Adults (CARDIA) study were analyzed using logistic regression models. Subjects were free of clinical heart disease, diabetes, and renal impairment. The main measure was the presence of any CAC by computerized tomography (Agatston score >0).Results: Forty-eight percent of the study participants were male and 45% were African-American. Mean (± SD) age was 40 ± 4 years, body mass index 28 ± 6 kg/m2, Framingham risk score -0.7 ± 5%, blood pressure 113 ± 14/75 ± 11 mmHg, alcohol consumption 12 ± 27 ml/day, and sUA 297 ± 89 μmol/L (5.0 ± 1.5 mg/dL). Prevalence of CAC increased with sUA concentration among both men and women. Adjusted for age, gender, race, lipoproteins, triglycerides, smoking, blood pressure, presence of metabolic syndrome, C-reactive protein, waist circumference, alcohol use, creatinine, and serum albumin, the highest quartile of sUA (>393 μmol/L [6.6 mg/dL] for men and >274 μmol/L [4.6 mg/dL] for women) was associated with an odds ratio of 1.87 (1.19-2.93) compared to the lowest quartile (<291 μmol/L [4.9 mg/dL] for men and <196 μmol/L [3.3 mg/dL] for women). Among those with any CAC, each unit increase in sUA was associated with a 22% increase in Agatston score (P = 0.008) after adjusting for the above covariates.Conclusions: Hyperuricemia is an independent risk factor for subclinical atherosclerosis in young adults. © 2011 Krishnan et al.; licensee BioMed Central Ltd.


Krishnan E.,Stanford University | Pandya B.J.,Takeda Pharmaceuticals International Inc. | Lingala B.,Stanford University | Hariri A.,Takeda Pharmaceuticals North America Inc. | Dabbous O.,Takeda Pharmaceuticals International Inc.
Arthritis Research and Therapy | Year: 2012

Introduction: Patients with a history of myocardial infarction (MI) are often at risk for complications, including subsequent MI and death. Use of prognostic markers may aid in preventing these poor outcomes. Hyperuricemia is associated with increased risk for coronary heart disease (CHD) and/or mortality; however, it is unknown if serum urate (sUA) levels predict outcomes in patients with previous MI. The purpose of this study was to assess hyperuricemia as a biomarker of CHD outcomes in such patients.Methods: These were post hoc analyses of datasets from the Aspirin Myocardial Infarction Study, a 1:1 randomized, double-blind clinical trial, conducted from 1975 to 1979, that examined mortality rates following daily aspirin administration over three years in individuals with documented MI. The primary outcome measures were all-cause death, CHD mortality, coronary incidence, and stroke by quartile of baseline sUA. A sub-analysis of all outcome measures in the presence or absence of gouty arthritis was also performed.Results: Of 4,524 enrolled participants, data on 4,352 were analyzed here. All outcomes were greatest for patients in the fourth sUA quartile. In multivariate regression models, the hazard ratios (HR) for patients in the highest quartile were 1.88 for all-cause mortality (95% confidence interval (CI), 1.45 to 2.46), 1.99 for CHD mortality (95% CI, 1.49 to 2.66), and 1.36 for coronary incidence (95% CI, 1.08 to 1.70). Participants with untreated gout had an adjusted hazard ratio ranging from 1.5 to 2.0 (all P < 0.01) for these outcomes. Participants with gout who were receiving treatment did not exhibit this additional risk.Conclusions: sUA and untreated gout may be independent prognostic markers for poor all-cause and CHD mortality in patients with recent acute MI. © 2012 Krishnan et al.; licensee BioMed Central Ltd.


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 | Year: 2014

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.


Wyant T.,Takeda Cambridge | Leach T.,Takeda Cambridge | Sankoh S.,Takeda Cambridge | Wang Y.,Takeda Cambridge | And 4 more authors.
Gut | Year: 2015

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.


Zhu Y.,Boston University | Pandya B.J.,Takeda Pharmaceuticals International Inc. | Choi H.K.,Boston University
American Journal of Medicine | Year: 2012

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.


Krishnan E.,Stanford University | Hariri A.,Takeda Pharmaceuticals International Inc. | Dabbous O.,Takeda Pharmaceuticals International Inc. | Pandya B.J.,Takeda Pharmaceuticals International Inc.
Congestive Heart Failure | Year: 2012

Few studies have investigated the association between hyperuricemia and subclinical myocardial dysfunction. The authors analyzed the relationship between serum uric acid and subclinical markers of heart failure in participants in the Framingham Offspring Cohort (N=2169, mean age 57.3years, 55.4% women). Cardiac dysfunction was assessed through echocardiographic measurements of left ventricular (LV) mass and thickness, end-diastolic LV thickness, and LV fractional shortening at the sixth visit, approximately 24years after study onset. Participants in the highest serum uric acid quartile (≥6.2mg/dL serum uric acid) had a significantly greater frequency of echocardiographic abnormalities compared with those in the lowest quartile (<4.3mg/dL). Those in the highest quartile had multivariable-adjusted odds ratios of 9.013 (95% confidence interval, 2.051-39.604) for abnormal LV ejection fraction and 4.584 (95% confidence interval, 1.951-10.768) for LV systolic dysfunction compared with those in the lowest quartile. Hyperuricemia in young adults can be a marker for subsequent heart failure. ©2011 Wiley Periodicals, Inc. © 2011 Wiley Periodicals, Inc.


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 | Year: 2014

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.

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