Publications by authors named "Eduardo Urdaneta"

11 Publications

  • Page 1 of 1

Comparative effectiveness of budesonide inhalation suspension and montelukast in children with mild asthma in Korea.

J Asthma 2020 Dec 6;57(12):1354-1364. Epub 2019 Aug 6.

College of Pharmacy, Seoul National University, Seoul, Republic of Korea.

The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea. Claims from Korea's national health insurance database for children (2-17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses. The number of children identified was 26,052 for unmatched ( = 1,221 BIS;  = 24,831 MON) and 2,290 for matched populations ( = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%;  < .001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively;  < .001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON ( < .001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%;  < .001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively;  < .001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225;  < .001). Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients.
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December 2020

Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis.

Allergy Asthma Proc 2019 05;40(3):173-179

Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, New Jersey.

Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1-15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.
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May 2019

Cross-sectional study on Asthma Insights and Management in the Gulf and Russia.

Allergy Asthma Proc 2018 Nov 16;39(6):430-436. Epub 2018 Oct 16.

Real-World & Analytics Solutions, IQVIA, Dubai, United Arab Emirates.

Asthma is a chronic and complex lung disease that is not completely understood. It involves airway inflammation, reversible airflow obstruction, and bronchial hyperresponsiveness. The most common symptoms are recurrent wheezing, chest tightness, shortness of breath, and coughing. The Asthma Insights and Management study gathered information on the burden of asthma in the Gulf region (United Arab Emirates, Kuwait, Saudi Arabia) and Russia. This was a cross-sectional, multinational, noninterventional, two-phase study that collected data from patients ages ≥ 12 years, through interviews and a survey questionnaire. Phase 1 consisted of survey questions focused on estimating the asthma prevalence in the community. Phase 2 was designed to assess the level of asthma control, asthma-related perceptions and behaviors, and presentation patterns. Data were summarized by using descriptive analyses. Analysis of data of 711 patients revealed that the prevalence of asthma among patients who lived in the community was 7.9% and that 66% subjectively perceived their asthma as being controlled. However, 97% of the patients' asthma were partially controlled or uncontrolled based on the Global initiative for Asthma control classification. Troubling symptoms were daytime coughing (33.3%) and shortness of breath (20.3%). With respect to medications for asthma, 76.2% of the patients reported the use of quick relief medication and 80.8% of maintenance medication during the past 4 weeks. Asthma exacerbation in the past year was reported by 40% of adults and adolescents in the study. The results showed that a significant proportion of the patients experienced bothersome symptoms and that many had a lack of knowledge about asthma control and treatment recommendations, which indicated that there is a need for improvements in patient education and asthma care in the Gulf and Russia regions.
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November 2018

Assessment of Different Cetirizine Dosing Strategies on Seasonal Allergic Rhinitis Symptoms: Findings of Two Randomized Trials.

Allergy Rhinol (Providence) 2018 Jan-Dec;9:2152656718783630. Epub 2018 Jul 13.

Johnson & Johnson Consumer Inc., Skillman, New Jersey.

Background: Cetirizine has been shown to be effective for relief of seasonal allergic rhinitis (SAR) symptoms. Allergic rhinitis symptoms have been reported to have circadian variations, with symptoms tending to be most bothersome overnight and in the morning.

Objective: To evaluate the effects of different cetirizine dosing schedules in comparison to twice daily (BID) chlorpheniramine and placebo on SAR symptoms at 12 and 24 hours postdose.

Methods: Study 1 subjects received cetirizine 10-mg once daily in the morning (QAM), cetirizine 10-mg once daily at bedtime (QHS), cetirizine 5-mg twice daily, or placebo. Study 2 subjects received cetirizine 5-mg QAM, cetirizine 10-mg QHS, chlorpheniramine 8-mg BID, or placebo. The primary end point was total symptom severity complex (TSSC); TSSC was the sum of symptom severity ratings averaged over the 2-week study period. Post hoc analyses of reflective symptom severity assessed in the morning (TSSC) and in the evening (TSSC) were conducted to evaluate cetirizine's effects at 12 and 24 hours postdose.

Results: In study 1, subject- and investigator-assessed TSSC was significantly lower in all cetirizine groups versus placebo ( ≤ .003). In study 2, subject-assessed TSSC was significantly lower in all cetirizine groups versus placebo ( ≤ .04) and was numerically lower for investigator-assessed TSSC. Post hoc analyses demonstrated that cetirizine significantly improved TSSC at 12 and 24 hours postdose versus placebo in both studies regardless of dosing schedule. TSSC significantly improved at 12 and 24 hours postdose in all study 1 cetirizine groups versus placebo. In study 2, versus placebo, TSSC significantly improved at 12 hours postdose in cetirizine 5-mg QAM group and numerically improved at 24 hours postdose in cetirizine 10-mg QHS group.

Conclusion: Regardless of dosing regimen, cetirizine demonstrates effective 24-hour relief of SAR symptoms, particularly on TSSC, which assesses overnight and early morning symptom control.
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July 2018

Practice Patterns for Chronic Respiratory Diseases in the Asia-Pacific Region: A Cross-Sectional Observational Study.

Int Arch Allergy Immunol 2018 6;177(1):69-79. Epub 2018 Jun 6.

Medical Affairs Asia-Pacific Region, Merck & Co., Inc., Kenliworth, New Jersey, USA.

Background: Allergic rhinitis (AR), asthma, chronic obstructive pulmonary disease (COPD), and rhinosinusitis are common and little studied in the Asia-Pacific region.

Objectives: We sought to investigate real-world practice patterns for these respiratory diseases in India, Korea, Malaysia, Singapore, Taiwan, and Thailand.

Methods: This cross-sectional observational study enrolled adults (age ≥18 years) presenting to general practitioners (GP) or specialists for physician-diagnosed AR, asthma, COPD, or rhinosinusitis. Physicians and patients completed study-specific surveys at one visit, recording patient characteristics, health-related quality of life (QoL), work impairment, and healthcare resource use. Findings by country and physician category (GP or specialist) were summarized.

Results: Of the 13,902 patients screened, 7,243 (52%) presented with AR (18%), asthma (18%), COPD (7%), or rhinosinusitis (9%); 5,250 of the 7,243 (72%) patients were eligible for this study. Most eligible patients (70-100%) in India, Korea, Malaysia, and Singapore attended GP, while most (83-85%) in Taiwan and Thailand attended specialists. From 42% (rhinosinusitis) to 67% (AR) of new diagnoses were made by GP. On average, patients with COPD reported the worst health-related QoL, particularly to GP. Median losses of work productivity for each condition and activity impairment, except for asthma, were numerically greater for patients presenting to GP vs. specialists. GP prescribed more antibiotics for AR and asthma, and fewer intranasal corticosteroids for AR, than specialists (p < 0.001 for all comparisons).

Conclusions: Our findings, albeit mostly descriptive and influenced by between-country differences, suggest that practice patterns differ between physician types, and the disease burden may be substantial for patients presenting in general practice.
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September 2018

Neuropsychiatric adverse drug reactions in children initiated on montelukast in real-life practice.

Eduardo Urdaneta

Eur Respir J 2017 11 22;50(5). Epub 2017 Nov 22.

Global Medical Affairs, Merck & Co., Inc., Kenilworth, NJ, USA

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November 2017

Randomized, placebo-controlled study of cetirizine and loratadine in children with seasonal allergic rhinitis.

Allergy Asthma Proc 2017 May;38(3):222-230

Background: Pharmacologic treatment is a mainstay of allergy therapy and many caregivers use over-the-counter antihistamines for the treatment of seasonal allergic rhinitis (SAR) symptoms in children.

Objective: To assess the efficacy and safety of cetirizine 10 mg syrup versus loratadine 10 mg syrup versus placebo syrup in a randomized double-blind study of children, ages 6-11 years, with SAR.

Methods: This randomized, double-blind, parallel-group, placebo-controlled study was conducted at 71 U.S. centers during the spring tree and grass pollen season. After a 1-week placebo run-in period, qualified subjects were randomized to once-daily cetirizine 10 mg (n = 231), loratadine 10 mg (n = 221), and placebo (n = 231) for 2 weeks. The primary efficacy end point was change from baseline in the subject's mean reflective total symptom severity complex (TSSC) score over 14 days.

Results: Children treated with cetirizine experienced significantly greater TSSC score reductions versus children treated with placebo over 14 days (least square mean change, -2.1 versus -1.6; p = 0.006). The differences in TSSC score improvement over 14 days between the cetirizine versus loratadine groups (-2.1 versus -1.8; p = 0.124) and between the loratadine versus placebo groups (-1.8 versus -1.6; p = 0.230) were not statistically significant. Predominant adverse events in the cetirizine, loratadine, and placebo groups were headache (3.5, 3.6, and 3.1%, respectively) and pharyngitis (3.5, 2.7, and 3.5%, respectively). Somnolence was reported in three subjects (1.3%) treated with cetirizine and in none of the other subjects.

Conclusion: Cetirizine 10 mg was statistically significantly more efficacious than placebo in the treatment of SAR symptoms in children ages 6-11 years. Symptom improvement was not significantly different between the loratadine 10 mg and placebo groups.
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May 2017

Effect of cetirizine on symptom severity and quality of life in perennial allergic rhinitis.

Allergy Asthma Proc 2014 Jul-Aug;35(4):338-45

Division of Allergy, Asthma, and Immunology, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA.

The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that particular condition. This study evaluated the effect of cetirizine on symptom severity and health-related QOL, using a disease-specific instrument, in adults with PAR. This randomized, double-blind, placebo-controlled study was conducted at 15 U.S. centers outside the pollen allergy season. After a 1-week placebo run-in period, qualified subjects aged 18-65 years with PAR were randomized to once-daily cetirizine 10 mg (n = 158) or placebo (n = 163) for 4 weeks. Change from baseline in total symptom severity complex (TSSC) and overall Rhinitis Quality of Life Questionnaire (RQLQ) scores were primary efficacy end points. Cetirizine produced significantly greater improvements in mean TSSC for each treatment week (p < 0.05) and for the entire 4-week treatment period (p = 0.005) compared with placebo. After 4 weeks, cetirizine-treated subjects reported significantly greater overall improvement in RQLQ scores compared with placebo-treated subjects (p = 0.004). After 1 week, cetirizine produced significant improvements in the nasal symptoms, practical problems, and activities RQLQ domain scores compared with placebo (p < 0.05). After 4 weeks, cetirizine-treated subjects reported significant reductions in these RQLQ domain scores and in emotion domain scores compared with placebo-treated subjects (p < 0.05). Cetirizine 10 mg daily produced significant improvements in symptom severity and allergic rhinitis-related QOL compared with placebo in adults with PAR.
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March 2015

Treatment with inhaled mometasone furoate reduces short-acting β(2) agonist claims and increases adherence compared to fluticasone propionate in asthma patients.

Value Health 2011 Mar-Apr;14(2):339-46

Eympres Research, LLC, Hilliard, OH 43026, USA.

Objectives: Differences between mometasone furoate (MF), administered once daily, and fluticasone propionate (FP), administered twice daily, dosing regimens may affect adherence and short-acting β(2) agonist (SABA) use. The objective of this analysis was to compare asthma control outcomes in matched cohorts of MF- and FP-treated asthma patients stratified by SABA claims.

Methods: A retrospective pharmacy claims database analysis identified matched cohorts of asthma patients (aged 12-65 years) who initiated treatment with MF or FP. Patients with none, one to four, five to eight, or more than eight SABA preindex claims were stratified to categories A, B, C, and D, respectively. Bivariate analyses compared postindex SABA canister claims, adherence, and exacerbations; multivariate analyses compared postindex SABA canister claims.

Results: Matched patients in categories A (n = 2517 per cohort) and B (n = 2329 per cohort) were analyzed; insufficient sample sizes were identified for categories C and D. Postindex bivariate analyses indicated that MF cohorts had fewer SABA claims compared to FP cohorts (category A, 0.80 vs. 1.17 [P < 0.0001]; category B, 1.39 vs. 1.58 [P < 0.0001]), better adherence to the index drug (category A, 24% vs. 15% [P < 0.0001]; category B, 27% vs. 15% [P < 0.0001]), and fewer exacerbations (category A, 0.17 vs. 0.19 [P = 0.011]; category B, 0.17 vs. 0.21 [P = 0.008]). Multivariate analyses indicated that MF cohorts had fewer postindex SABA claims compared to FP cohorts in categories A and B (P < 0.0001).

Conclusions: Data for SABA claims, treatment adherence, and exacerbations suggest that, compared to twice-daily FP, once-daily MF may provide better asthma control.
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June 2011

Mometasone furoate versus beclomethasone dipropionate: effectiveness in patients with mild asthma.

Am J Manag Care 2010 Jul 1;16(7):e151-6. Epub 2010 Jul 1.

Analytic Solutions, LLC, New York, NY, USA.

Objectives: To evaluate adherence to therapy and markers of asthma control among patients with mild asthma prescribed mometasone furoate dry powder inhaler or beclomethasone dipropionate hydrofluoroalkane aerosol inhaler.

Study Design: Retrospective healthcare claims database analysis (2005-2008).

Methods: Included were patients with mild asthma aged 12 to 65 years (1273 matched patients in each treatment cohort) who resided in the United States and were enrolled in their health plan for at least 1 year before (ie, preindex period) and after (ie, postindex period) they initiated treatment with mometasone furoate or beclomethasone dipropionate. Patients were propensity score matched based on demographic data and preindex variables. Claims were analyzed during the postindex period for adherence to mometasone furoate or beclomethasone dipropionate, measured as the percentage of days covered and the numbers of exacerbations and short-acting beta2-agonist (SABA) claims.

Results: Multivariate analyses indicated that the cohort receiving mometasone furoate had better outcomes than the cohort receiving beclomethansone dipropionate, including greater adherence (29.5% vs 20.2%, respectively, P <.001), fewer exacerbations (mean, 0.12 vs 0.19, P = .002), and decreased SABA canister claims (mean, 0.9 vs 1.1, respectively, P <.001).

Conclusions: Adherence to prescribed therapy among patients with mild asthma may be better with mometasone furoate versus beclomethasone dipropionate, as reflected in fewer exacerbations and more limited use of SABA rescue medications. Improved adherence to mometasone furoate versus beclomethasone dipropionate may be related to a simpler dosing regimen (ie, once daily vs twice daily).
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July 2010

Mometasone furoate vs fluticasone propionate with salmeterol: multivariate analysis of resource use and asthma-related charges.

Curr Med Res Opin 2009 Dec;25(12):2895-901

Eympres Research, LLC, Hilliard, OH, USA.

Objective: Although current National Asthma Education and Prevention Program (NAEPP) guidelines indicate low-dose inhaled corticosteroid (ICS) monotherapy as the preferred treatment for patients with mild persistent asthma, many patients receive ICS and long-acting beta(2)-agonist (LABA) combinations. The objective of the current study was to evaluate asthma-related charges in patients with mild asthma who began treatment with mometasone furoate (MF) versus those who began treatment with a fluticasone propionate/salmeterol (FPS) combination.

Research Design And Methods: This retrospective administrative claims database analysis collected data from the 365-day periods before (preindex period) and after (postindex period) the study index date from patients with mild asthma aged 12 to 65 years who began treatment with MF or FPS. Asthma-related inpatient, outpatient, pharmaceutical, and total charges; exacerbations; short-acting beta(2)-agonist (SABA) canister claims; and adherence to therapy were assessed. Matched cohorts of MF and FPS patients were compared using multivariate generalized linear regression models.

Results: Among matched MF (n = 4094) and FPS (n = 4094) cohorts, MF patients had significantly lower postindex asthma-related total charges ($2136 vs $2315, respectively; P = 0.0003), lower pharmaceutical charges ($727 vs $925, respectively; P < 0.0001), fewer exacerbations (0.14 vs 0.16, respectively; P = 0.0306), fewer SABA canister claims (0.9 vs 1.0, respectively; P < 0.0001), and greater adherence measured by prescription fills (3.0 vs 2.8, respectively; P < 0.0001). Asthma-related inpatient charges, outpatient charges, and adherence measured by percent of days covered were not significantly different between treatment cohorts. Limitations included a lack of additional ICS and ICS/LABA therapies, a lack of pediatric patients, and the general limitations associated with retrospective database analyses (e.g., no patient records).

Conclusions: These data suggest that MF may be more cost-effective than FPS for the treatment of mild asthma. To effectively and efficiently manage asthma, it is important for clinicians to follow current NAEPP guidelines, which indicate ICS monotherapy as preferred treatment for mild persistent asthma.
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December 2009