Outcomes and cost comparison of three therapeutic approaches to allergic rhinitis.

BACKGROUND: Allergic rhinitis (AR) is a global health problem because of its increasing impact on economics, society, and the individual's quality of life. This study compares the outcomes and cost of three intranasal therapeutic approaches to the treatment of AR. METHODS: This was a retrospective cohort study using propensity scores to achieve balanced cohorts. The study population included patients ≥16 years of age with at least one intranasal prescription claim, without concurrent nasal polyps or sinusitis. Health care use and costs, airway infections, pharmacy costs, and indicators of unsatisfactory treatment (i.e., treatment augmentation or switching) were evaluated in the 1-year follow-up period using a claims database. RESULTS: Data from 141,190 patients in intranasal antihistamines (INA) therapy, intranasal steroids (INS) therapy, and intranasal combination therapy (ICT) cohorts were analyzed. The INA cohort showed the lowest rate of change in treatment (switching or augmentation). Switching rates were lowest in the INS therapy cohort, whereas augmentation was lowest in the INA cohort. AR- and asthma-related medication costs were significantly lower in the INA cohort. No differences were observed in airway infections and overall health care costs. Concurrent chronic obstructive pulmonary disorder and asthma were the strongest predictors of health care cost and respiratory infection in the follow-up period. CONCLUSION: A change in treatment was noted in ∼⅓ of the entire study population. None of the treatments had a remarkable effect on health care costs or the occurrence of airway infections. The INA treatment cohort had lower AR- and asthma-related medication costs.

Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis.

Allergic rhinitis (AR) is highly prevalent in children. Olopatadine, 0.6% nasal spray (olopatadine) is approved for the relief of seasonal allergic rhinitis (SAR) symptoms in children 6 years of age and older. The objective of this study is to provide a comprehensive report of all clinical studies conducted with olopatadine in children with SAR. A pooled analysis was conducted of 2 randomized, double-blind, 2-week, IRB-approved studies that compared olopatadine with placebo (1 spray/nostril twice-daily) in patients 6-11 years of age with SAR. Assessments included the reflective total nasal symptom score (rTNSS) and total ocular symptom score (rTOSS), the Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire (PRQLQ), and the Caregiver Treatment Satisfaction Questionnaire for Allergic Rhinitis (CGTSQ-AR). Safety results were reported for these studies in combination with a pediatric pharmacokinetic study. Olopatadine was superior to placebo for mean decrease in rTNSS (p = 0.0012) and rTOSS (p = 0.0094), mean decrease in overall PRQLQ score (p = 0.0003), and mean summary CGTSQ AR score (p = 0.0013); (n = 944). The most frequently reported treatment-related events in the olopatadine group were epistaxis and dysgeusia (bad taste) (n = 1,046). For SAR treatment in patients 6-11 years of age, olopatadine was superior to placebo in reducing the symptoms of SAR, improving quality of life, and satisfying caregivers. Olopatadine is a safe and effective treatment for SAR patients as young as 6 years of age and it has been demonstrated to reduce disease impact on the lives of these children and their families.

The economic burden of dry eye disease in the United States: a decision tree analysis.

PURPOSE: The aim of this study was to estimate both the direct and indirect annual cost of managing dry eye disease (DED) in the United States from a societal and a payer's perspective. METHODS: A decision analytic model was developed to estimate the annual cost for managing a cohort of patients with dry eye with differing severity of symptoms and treatment. The direct costs included ocular lubricants, cyclosporine, punctal plugs, physician visits, and nutritional supplements. The indirect costs were measured as the productivity loss because of absenteeism and presenteeism. The model was populated with data that were obtained from surveys that were completed by dry eye sufferers who were recruited from online databases. Sensitivity analyses were employed to evaluate the impact of changes in parameters on the estimation of costs. All costs were converted to 2008 US dollars. RESULTS: Survey data were collected from 2171 respondents with DED. Our analysis indicated that the average annual cost of managing a patient with dry eye at $783 (variation, $757-$809) from the payers' perspective. When adjusted to the prevalence of DED nationwide, the overall burden of DED for the US healthcare system would be $3.84 billion. From a societal perspective, the average cost of managing DED was estimated to be $11,302 per patient and $55.4 billion to the US society overall. CONCLUSIONS: DED poses a substantial economic burden on the payer and on the society. These findings may provide valuable information for health plans or employers regarding budget estimation.

United States cost-effectiveness study of two dry eye ophthalmic lubricants.

PURPOSE: Dry eye is thought to be the most common ocular problem in the United States. However, it is only recently that it has been recognized as a disease with significant economic burden and impact on quality of life. This article presents an economic model of cost-effectiveness of two ophthalmic lubricants commonly used in the treatment of dry eye-Systane and Refresh Tears. METHOD: We conducted a meta-analysis, pooling the results of two clinical trials of patients with dry eye treated with Systane and Refresh Tears which presented response rates for improvements in ocular dryness, the key symptom of dry eye. An economic model was used to estimate the incremental cost-effectiveness ratio (ICER) for Systane versus Refresh Tears over a 12 month treatment period. RESULTS: Systane is significantly more effective than Refresh Tears at improving symptoms of "dryness" (75% vs 41%). Systane costs on average $57.79 per year more than Refresh Tears. Assigning a quality-adjusted life year (QALY) gain of 0.03 to responders results in an incremental cost per QALY gain of $5,837. CONCLUSION: Both Refresh Tears and Systane are effective and cost-effective interventions. Systane costs more than Refresh Tears, however clinical trial evidence shows it to be more effective. The ICER for Systane versus Refresh Tears is well below the generally accepted $50,000 per QALY threshold.

Clinically important difference in dry eye: change in IDEEL-symptom bother.

PURPOSE: The impact of dry eye on everyday living (IDEEL) is a valid, reliable questionnaire with 3 modules; symptom bother (SB), quality of life, and treatment satisfaction. This study tests the utility of the 20-item IDEEL-SB to discrimate self-assessed severity in dry eye subjects and to determine the clinically important difference (CID) in IDEEL-SB score that relates to a self-report of global change in dry eye condition after treatment. METHODS: After randomization to 1 of 3 marketed tear replacements, dry eye subjects completed the IDEEL-SB at baseline, 1 and 4 wk and global change questionnaire on status of general health and dry eye at 1 and 4 wk (5-point Likert scale; "much better" to "much worse"). The IDEEL-SB score was the unweighted mean score x 25. CID was initially estimated by receiver-operator curve analysis (ROC) and global change questionnaire. Various IDEEL-SB change criteria were tested to maximize % agreement, kappa score, and effect size. RESULTS: The 74 subjects were 54.0 +/- 17.2 years old and 52 (70.3%) were female. At baseline, 56.3% rarely/never used replacement tears. Subjects rated their dry eye severity as mild (41%), moderate (50%), or severe (9%). IDEEL-SB discriminated dry eye severity well; average baseline scores were mild: 40.0 (SD = 7.5), moderate: 50.6 (SD = 11.0) and severe 64.3 (SD = 8.0) (p = 0.001). After 4 wk of drops usage, IDEEL-SB dropped among "improved" subjects by -13.3 (SD = 10.9), "same" shifted by -4.7 (SD = 9.4), "worsened" changed by 1.4 (SD = 11.1). ROC results show that a 12-point change in IDEEL-SB is a clinically significant change in symptoms. CONCLUSIONS: 12-Point shift in the IDEEL-SB module is a CID based on ROC and the distribution across self-assessed severity groups compared with their global assessment of change in condition with treatment.

Medication compliance and persistence: terminology and definitions.

OBJECTIVE: The aim of the study is to provide guidance regarding the meaning and use of the terms "compliance" and "persistence" as they relate to the study of medication use. METHODS: A literature review and debate on appropriate terminology and definitions were carried out. RESULTS: Medication compliance and medication persistence are two different constructs. Medication compliance (synonym: adherence) refers to the degree or extent of conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency. It may be defined as "the extent to which a patient acts in accordance with the prescribed interval, and dose of a dosing regimen." Medication persistence refers to the act of continuing the treatment for the prescribed duration. It may be defined as "the duration of time from initiation to discontinuation of therapy." No overarching term combines these two distinct constructs. CONCLUSIONS: Providing specific definitions for compliance and persistence is important for sound quantitative expressions of patients' drug dosing histories and their explanatory power for clinical and economic events. Adoption of these definitions by health outcomes researchers will provide a consistent framework and lexicon for research.

Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis.

Seasonal allergic rhinitis (SAR) treatment should reduce symptoms and help patients resume normal function. This study was performed to determine the effect of olopatadine (Olo) nasal spray on symptoms, quality of life (QoL), work, and activities of SAR patients. A pooled analysis was conducted of two Institutional Review Board-approved, randomized, double-blind clinical trials that compared 2-week treatment with Olo 0.6% and Olo 0.4% to placebo. Symptoms were assessed with the Total Nasal Symptom Score (TNSS) from daily diaries. Health outcomes were measured by the Work Productivity and Activity Impairment Questionnaire-Allergy Specific (WPAI-AS) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). The studies included 1240 SAR patients with a mean age of 37 years; 64% were women. TNSS and RQLQ improvements were significantly different from placebo: TNSS, Olo 0.6% (p < 0.0001) and Olo 0.4% (p < 0.0037); RQLQ, Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). WPAI-AS improvements also were significant for overall work impact and activity impairment in the Olo 0.6% (p < 0.001) and Olo 0.4% (p < 0.05). Correlations between Olo 0.6% TNSS scores and work impact were r = 0.45 (p < 0.0001); activities, r = 0.55 (p < 0.0001); and RQLQ score, r = 0.61 (p < 0.0001), indicating that symptom reduction with Olo therapy was associated with improvements in function and QoL. Adverse events were nonserious and infrequent in all treatment groups. The most frequent adverse events were unpleasant taste and headache. This analysis indicates that Olo is a safe and effective intranasal treatment and is associated with significant improvement in QoL and ability to perform work and conduct usual activities of SAR patients.

Improved quality of life among seasonal allergic rhinitis patients treated with olopatadine HCl nasal spray 0.4% and olopatadine HCl nasal spray 0.6% compared with vehicle placebo.

Seasonal allergic rhinitis (SAR) exerts a significant adverse impact on health-related quality of life (QoL) and productivity of those who suffer from it. Unfortunately, some therapies for SAR also have a negative impact. Therefore, it is important to scrutinize the influence of new SAR therapies on patients' QoL and ability to function. The purpose of this study was to evaluate the effect of a new nasal antihistamine, olopatadine, on QoL in SAR patients. In a multicenter, randomized, double-blind SAR study comparing olopatadine 0.6 and 0.4% to placebo nasal spray, patients completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at baseline and after 2 weeks of treatment. The RQLQ is a validated questionnaire that addresses overall QoL and 7 domains of impairment associated with rhinoconjunctivitis (activities, sleep, non--nose/eye allergy symptoms, practical problems, nasal symptoms, eye symptoms, and emotional impairment). The overall RQLQ mean changes from baseline with olopatadine 0.6% (-1.1 +/- 1.4) and 0.4% (-1.1 +/- 1.3) nasal sprays were superior (p < 0.05) to placebo (-0.8 +/- 1.2). Olopatadine spray 0.6% was superior to placebo in six of the seven RQLQ domains and olopatadine 0.4% was superior to placebo in five RQLQ domains (p < 0.05). The correlation between the olopatadine 0.6% mean total symptom scores and mean RQLQ score was r = 0.66 (p < 0.0001), indicating that the enhancement in QoL derived from olopatadine therapy was significantly associated with symptom reduction. Olopatadine nasal spray is an effective antiallergy medication that significantly improves the QoL of patients suffering from SAR.

The economic impact of blue-light filtering intraocular lenses on age-related macular degeneration associated with cataract surgery: a third-party payer's perspective.

OBJECTIVES: Epidemiological data support an association between age-related macular degeneration (AMD) and cataract surgery that may be attributed to post-operative blue light exposure. By limiting the retina's blue light exposure, new blue-light filtering intraocular lenses (BLF IOLs) have the potential to reduce the development of AMD following cataract surgery. In the current economic healthcare environment, there is increased interest in the cost impact of new medical technologies. The objective of this analysis was to evaluate the cost impact of a BLF IOL versus a non-BLF IOL in cataract surgery. METHODS: An economic model was developed to emulate three age-specific cohorts and to assess the clinical and economic outcomes over 5 years. Data from the published literature was supplemented with clinical expert opinion. Key literature inputs involved the risk of AMD after cataract surgery as well as laboratory and animal data on the effectiveness of the BLF IOL in reducing the risk of AMD. Clinical experts provided information on the management of AMD. Direct medical costs including the cost of the IOL, monitoring, and AMD prophylaxis and treatment were incorporated into the model. All costs were standardized to 2004 US dollars. Age-stratified sensitivity analyses were conducted. RESULTS: In the BLF IOL group, the 5-year age-stratified incidence of AMD ranged from 0.58 to 9.23 per 100 eyes, compared with 1.69 to 24.55 per 100 eyes in the non-BLF IOL group. The incremental cost of the BLF was offset by reduced costs associated with averted AMD treatment. Estimated savings with BLF IOLs per 100 eyes were $4275, $29 997, and $111 734 in the 55 to 64 year-old, 65 to 74 year-old, and >or= 75-year-old cohorts, respectively; these findings remained robust throughout the sensitivity analyses. CONCLUSION: Limitations of this analysis include the lack of prospective clinical trial data that definitively demonstrate the efficacy of a BLF IOL in preventing AMD. Moreover, the efficacy data used to populate the model were derived from laboratory and animal studies. Thus, based on preliminary data, this study suggests that the economic benefits of implanting BLF IOLs during cataract surgery are observed in all patients over a 5-year timeframe although cost savings are greatest in patients >or= 75 years.

Cardiovascular disease in U.S. patients with metabolic syndrome, diabetes, and elevated C-reactive protein.

OBJECTIVE: C-reactive protein (CRP) independently predicts cardiovascular disease (CVD); whether it can stratify risk in those with metabolic syndrome and diabetes is not well documented. We evaluated whether elevated CRP levels modify the relationship of metabolic syndrome and diabetes with CVD in U.S. adults. RESEARCH DESIGN AND METHODS: In a cross-sectional study of 3,873 subjects (weighted to 156 million) aged >/=18 years participating in the National Health and Nutrition Examination Survey 1999-2000, subjects were classified as having diabetes, metabolic syndrome according to modified National Cholesterol Education Program criteria, or neither condition by low (<1 mg/l), intermediate (1-3 mg/l), or high (>3 mg/l) CRP levels. Logistic regression examined the odds of CVD by disease condition and CRP group. RESULTS: After adjusting for age, sex, smoking, and total cholesterol, compared with those with neither metabolic syndrome nor diabetes and low CRP levels, the odds of CVD were 1.99 (95% CI 1.10-3.59) for those with no disease and high CRP levels and 2.67 (1.30-5.48) for those with metabolic syndrome and intermediate CRP. Persons with metabolic syndrome but high CRP had an odds ratio (OR) of 3.33 (1.80-6.16), similar to those with diabetes and low CRP (3.21 [1.27-8.09]). The likelihood of CVD was highest in those with diabetes who had intermediate CRP levels (6.01 [2.54-14.20]) and in those with diabetes and high CRP (7.73 [3.99-14.95]). CONCLUSIONS: In this cross-sectional analysis, CVD is more common in those with metabolic syndrome or diabetes who have elevated CRP. Stratification by CRP may add prognostic information in patients with metabolic syndrome or diabetes.