News Article | May 15, 2017
CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Pharma, a world leader in innovative drug delivery systems, is pleased to announce the approval by the European Medicines Agency (EMA) of the first integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International AG. Aptar Pharma agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl®. The EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuardTM. This represents a major milestone for Aptar Pharma, with the e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a U.S. or European regulatory authority. Already available in unidose and multidose nasal spray versions, Takeda will launch Instanyl® DoseGuard in Europe in several multidose strengths, all using Aptar Pharma’s patented electronic lockout system, which marks another product innovation in the management of breakthrough pain. Instanyl® is a fast-acting nasal opioid approved for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite having taken one’s usual pain relieving medicines. Aptar Phama’s e-Lockout device uses advanced electronic technology to help patient compliance in the treatment of chronic disease. Aptar Pharma’s e-Lockout device is intended to ensure safe patient compliance by limiting the number of doses available during a 24 hour period. The system’s built-in lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations. The electronic display shows the number of priming strokes, the number of doses left in the device and whether the nasal spray is locked or ready for use. The e-Lockout also features a child-resistant cap. The multi-year supply agreement reinforces a long-standing partnership between Takeda and Aptar Pharma, who currently supplies Takeda with unidose and multidose nasal spray devices for Instanyl® in Europe. Committed to accompanying pharmaceutical companies throughout their product lifecycle management, Aptar Pharma continues to partner to provide customers with innovative and smart solutions to enable safe, convenient and compliant medication delivery. “This approval and subsequent product launch underscores Aptar Pharma’s ability to partner with the pharma industry to bring innovative, compliant and safer devices through the regulatory authorization process,” explained Salim Haffar, President, Aptar Pharma. “This is yet another example of Aptar Pharma’s expertise and technology at the heart of a new market launch. This is a significant step in strengthening Aptar Pharma’s credentials in the electronics and connected health markets. We are pleased to be building on our trusted, long-term partnership with Takeda,” he added. Aptar Pharma is part of AptarGroup, Inc. (NYSE: ATR), a leading global supplier of a broad range of innovative dispensing and sealing solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets. AptarGroup is headquartered in Crystal Lake, Illinois, with manufacturing facilities in North America, Europe, Asia and South America. For more information, visit aptar.com/pharma. This press release contains forward-looking statements. Words such as “expects,” “anticipates,” “believes,” “estimates,” “future” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment. Additionally, forward-looking statements include statements that do not relate solely to historical facts, such as statements which identify uncertainties or trends, discuss the possible future effects of current known trends or uncertainties or which indicate that the future effects of known trends or uncertainties cannot be predicted, guaranteed or assured. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Ks and Form 10-Qs. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
News Article | April 27, 2017
CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--AptarGroup, Inc. (NYSE:ATR) today announced increased revenue, net income and earnings per share for the first quarter of 2017. In addition, AptarGroup announced its continued investment in the field of connected electronic drug delivery devices. For the quarter ended March 31, 2017, reported sales increased 3% to $601 million from $582 million a year ago. Core sales, which exclude the negative impact from changes in currency exchange rates and the positive contribution from the Mega Airless acquisition, also increased by 3%. Commenting on the quarter, Stephan Tanda, President and CEO, said, “We are pleased to report core sales growth after a challenging second half of 2016. The diversity of our business continues to be a key strength. Our Pharma segment had an excellent quarter with growth across all three of its markets. The destocking effect that we saw at the end of 2016 appears to be over and we saw more normalized order levels in the prescription market and strong demand in the consumer health care market for decongestants and ophthalmics. We also achieved core sales growth in our Beauty + Home segment and were able to offset continuing challenges in the U.S. market with growth in the other regions. Our Beauty + Home and Food + Beverage segments were negatively affected by rising raw material costs, and our Food + Beverage segment was further impacted by lower sales volumes in the Chinese beverage market.” Aptar reported earnings per share of $0.81 compared to $0.67 per share a year ago. Comparable adjusted earnings per share for the first quarter of 2016 totaled $0.74 per share. In the quarter, Aptar received an order for the first integrated electronic nasal lockout device (Aptar’s eLockout) approved by the EMA following a multi-year development with Takeda Pharmaceuticals International AG. This represents a major milestone, with the eLockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a European regulatory authority. The Aptar eLockout device uses advanced electronic technology that facilitates safe patient compliance by limiting the number of doses available during a 24 hour period and features a child-resistant cap. In addition, Aptar signed an agreement to acquire a 20% minority ownership position in Kali Care, a Silicon Valley-based technology company, which provides digital-monitoring systems for ophthalmic medications. Kali Care’s sensing technology allows clinicians to collect real time compliance data. For example, the ability to see the medication-adherence score of patients with glaucoma is a powerful tool for ophthalmologists in managing the care of their patients. Aptar’s leading dispensing technologies combined with Kali Care’s smart sensors, data analytics and cloud services has the potential to become a valuable solution for clinicians. In 2016, we announced our partnership with Propeller Health, a leading digital platform for respiratory health management, to develop a fully-integrated connected metered dose inhaler (cMDI) that combines electronic sensing, dose counting and wireless communicating capabilities. Commenting on the strategy, Tanda explained, “This is an important step in our journey to leverage our leading drug delivery technologies to develop the next generation of connected electronic devices. These strategic collaborations underline Aptar’s commitment to breaking new ground with health care innovations.” Commenting on Aptar’s outlook, Tanda said, “Looking to the second quarter, we currently expect growth in our Pharma and Food + Beverage segments. Our Beauty + Home segment may be impacted by uncertainties, including the pace of economic growth in the U.S. and Brazil. I am optimistic that we will continue to grow each of our business segments over the long-term by executing on customer projects and developing new business. I am also excited to continue to meet with our customers and visit our facilities as we focus on key areas such as innovation, sales, marketing and business development and pursue further growth opportunities.” Aptar expects earnings per share for the second quarter to be in the range of $0.92 to $0.97 compared to $0.91 per share reported in the prior year. Our guidance range is based on an effective tax rate range of 26.5% to 27.5% which includes an estimate of a potential tax benefit from our adoption of the new accounting standard for share-based compensation. Adjusting for changes in foreign currency exchange rates, comparable adjusted earnings per share for the prior year were approximately $0.87. As previously reported, the Board of Directors declared a quarterly cash dividend of $0.32 per share. The payment date is May 24, 2017, to stockholders of record as of May 3, 2017. There will be a conference call on Friday, April 28, 2017 at 8:00 a.m. Central Time to discuss Aptar’s first quarter results for 2017. The call will last approximately one hour. Interested parties are invited to listen to a live webcast by visiting the Investor Relations page at www.aptar.com. Replay of the conference call can also be accessed for a limited time on the Investor Relations page of the website. Aptar is a leading global supplier of a broad range of innovative dispensing and sealing solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets. Aptar is headquartered in Crystal Lake, Illinois, with manufacturing facilities in North America, Europe, Asia and South America. For more information, visit www.aptar.com. This press release refers to certain non-GAAP financial measures, including prior year adjusted earnings per share and adjusted EBITDA, which exclude the impact of transaction costs and purchase accounting adjustments that affected inventory values related to the Mega Airless acquisition. Core sales and adjusted earnings per share also exclude the impact of foreign currency translation effects. Non-GAAP financial measures may not be comparable to similarly titled non-GAAP financial measures provided by other companies. Aptar’s management believes these non-GAAP financial measures provide useful information to our investors because they allow for a better period over period comparison of operating results by removing the impact of items that, in management’s view, do not reflect Aptar’s core operating performance. These non-GAAP financial measures also provide investors with certain information used by Aptar’s management when making financial and operational decisions. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial results, but should be read in conjunction with the unaudited condensed consolidated statements of income and other information presented herein. A reconciliation of non-GAAP financial measures to the most directly comparable GAAP measures is included in the accompanying tables. This press release contains forward-looking statements, including certain statements set forth under the “Outlook” section of this press release. Words such as “expects,” “anticipates,” “believes,” “estimates,” “future,” “potential” and other similar expressions or future or conditional verbs such as “will,” “should,” “would” and “could” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to, the possible impact and consequences of the fire at the Company’s facility in Annecy, France; economic conditions worldwide including potential deflationary conditions in regions we rely on for growth; political conditions worldwide; significant fluctuations in foreign currency exchange rates; changes in customer and/or consumer spending levels; financial conditions of customers and suppliers; consolidations within our customer or supplier bases; fluctuations in the cost of materials, components and other input costs; the availability of raw materials and components; our ability to successfully implement facility expansions and new facility projects; our ability to increase prices, contain costs and improve productivity; changes in capital availability or cost, including interest rate fluctuations; volatility of global credit markets; cybersecurity threats that could impact our networks and reporting systems; fiscal and monetary policies and other regulations, including changes in tax rates; direct or indirect consequences of acts of war or terrorism; work stoppages due to labor disputes; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Ks and Form 10-Qs. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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.
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.
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.