A patient perspective of the impact of medication side effects on adherence: results of a cross-sectional nationwide survey of patients with schizophrenia.

BACKGROUND: Antipsychotic medications often have a variety of side effects, however, it is not well understood how the presence of specific side effects correlate with adherence in a real-world setting. The aim of the current study was to examine the relationship between these variables among community-dwelling patients with schizophrenia. METHODS: Data were analyzed from a 2007-2008 nationwide survey of adults who self-reported a diagnosis of schizophrenia and were currently using an antipsychotic medication (N = 876). The presence of side effects was defined as those in which the patient reported they were at least "somewhat bothered". Adherence was defined as a score of zero on the Morisky Medication Adherence Scale. To assess the relationship between side effects and adherence, individual logistic regression models were fitted for each side effect controlling for patient characteristics. A single logistic regression model assessed the relationship between side effect clusters and adherence. The relationships between adherence and health resource use were also examined. RESULTS: A majority of patients reported experiencing at least one side effect due to their medication (86.19%). Only 42.5% reported complete adherence. Most side effects were associated with a significantly reduced likelihood of adherence. When grouped as side effect clusters in a single model, extra pyramidal symptoms (EPS)/agitation (odds ratio (OR) = 0.57, p = 0.0007), sedation/cognition (OR = 0.70, p = 0.033), prolactin/endocrine (OR = 0.69, p = 0.0342), and metabolic side effects (OR = 0.64, p = 0.0079) were all significantly related with lower rates of adherence. Those who reported complete adherence to their medication were significantly less likely to report a hospitalization for a mental health reason (OR = 0.51, p = 0.0006), a hospitalization for a non-mental health reason (OR = 0.43, p = 0.0002), and an emergency room (ER) visit for a mental health reason (OR = 0.60, p = 0.008). CONCLUSIONS: Among patients with schizophrenia, medication side effects are highly prevalent and significantly associated with medication nonadherence. Nonadherence is significantly associated with increased healthcare resource use. Prevention, identification, and effective management of medication-induced side effects are important to maximize adherence and reduce health resource use in schizophrenia.

Clinical and economic outcomes of the Cincinnati Pharmacy Coaching Program for diabetes and hypertension.

PURPOSE: Value-based insurance designs (VBID) have been developed by health insurance companies and used by employers to allocate health care resources appropriately and to lower patients' out-of-pocket costs for services related to chronic conditions. The purpose of this study was to evaluate the effect of the Cincinnati Pharmacy Coaching Program (CPCP) on clinical and economic outcomes. The CPCP is a VBID implemented by Anthem Blue Cross & Blue Shield in Ohio. It provided tailored pharmacist-based educational services and financial incentives to participants. METHODS: This was a quasi-experimental pre/post longitudinal study in which patients were identified as they enrolled in the CPCP between Jan. 1, 2008, and Dec. 31, 2009. Patients could participate in a Diabetes Coaching Program (DCP) or a Heart Healthy Coaching Program (HHCP). Control subjects were selected from patients who were invited but did not choose to participate. Control subjects were matched to intervention cohorts using propensity score matching. Clinical (blood pressure, lipid levels, and hemoglobin A1c) and economic (all-cause and disease-attributable) outcomes were evaluated using within-subject (pre-post) and between-subject comparison (intervention-control) design. RESULTS: A total of 607 patients were enrolled in intervention groups, and 557 control subjects were selected after matching. Significant reductions were found in blood pressure, lipid levels, and hemoglobin A1c after enrollment, and a significantly greater proportion of patients, compared with controls, achieved their clinical goals according to national guidelines in both programs. Hypertension-related cost trends were favorable for HHCP relative to the control cohort. Diabetes-related costs increased for all groups from pre- to post-index, largely driven by office visits and medication costs in the DCP and inpatient/ER visits in the control cohort. CONCLUSION: Results showed significant improvements in all diabetes- and hypertension-related clinical measures. This study shows the effect of a comprehensive VBID on the health of patients with chronic disease.

Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis.

OBJECTIVE: To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. STUDY DESIGN AND SETTING: Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. RESULTS: Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. CONCLUSIONS: Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. EBM RATING: B-20.

Economic impact and quality-of-life burden of allergic rhinitis.

Allergic rhinitis can be a debilitating condition which, if untreated, can result in considerable health-related and economic consequences. A review of the published literature was conducted, with quantitative/qualitative analysis as appropriate, to explore the direct, indirect, and hidden costs of allergic rhinitis, as well as the quality-of-life burdens that the disease presents to patients and to the healthcare system. Lack of treatment, undertreatment, or nonadherence to treatment in allergic rhinitis were seen to increase direct and indirect costs, reinforcing the need for patient education and for physicians to implement existing evidence-based guidelines for prevention and treatment. It was concluded that greater awareness of the total economic burden of allergic rhinitis should encourage appropriate intervention and ultimately ensure clinically favorable and cost-effective outcomes.

Assessment of intranasal corticosteroid use in allergic rhinitis: benefits, costs, and patient preferences.

Current medical guidelines for allergic rhinitis, a highly prevalent disorder, recommend an intranasal corticosteroid as a safe and effective pharmacotherapeutic option. The 6 intranasal corticosteroids available in the United States have approximately equivalent efficacy, although their formulations differ and patients express preferences for specific products. While they are all generally safe at recommended doses, patient preference may increase willingness to adhere to a treatment regimen, a major goal when long-term therapy is required. Another important factor involves the direct costs of treatment associated with each intranasal corticosteroid. This review presents comparative economic data from a retrospective study using a large managed care database as well as data from controlled clinical studies comparing patient preferences for specific attributes of 4 intranasal corticosteroids. When possible, comparative data from clinical trials that assess patient preference, potential treatment adherence, and costs, as well as their interrelationships, should be considered when evaluating intranasal corticosteroid use in the managed care setting.

Evaluation of patients' preferences for triamcinolone acetonide aqueous, fluticasone propionate, and mometasone furoate nasal sprays in patients with allergic rhinitis.

OBJECTIVE: To compare product attributes, preferences, and expected compliance associated with triamcinolone acetonide aqueous (TAA-AQ), fluticasone propionate (FP), and mometasone furoate (MF) nasal sprays in patients with allergic rhinitis. STUDY DESIGN AND SETTING: Data from 2 randomized, double-blind crossover studies with identical design were pooled (N = 215). Patients completed a 14-item sensory attributes questionnaire immediately after each product, and stated their preference and expected compliance with a prescription after receiving all products. RESULTS: Compared with FP and MF, TAA-AQ was associated with significantly less odor and greater liking of odor ( P < 0.001); and less taste, less dryness of nose/throat, less aftertaste, and greater overall liking ( P < 0.05). Significantly more patients preferred most a prescription of TAA-AQ (50.0%) versus FP (25.0%; P < 0.001) and MF (25.0%; P < 0.001), and would "definitely comply" with TAA-AQ (62.5%) versus FP (49.0%; P < 0.01) and MF (51.0%; P < 0.01). CONCLUSION: TAA-AQ was associated with significantly more positive sensory attributes, higher preference, and better expected compliance than FP and MF. SIGNIFICANCE: Patients' preferences for the sensory attributes of an intranasal corticosteroid may affect adherence to treatment.

Triamcinolone acetonide aqueous nasal spray and fluticasone propionate are equally effective for relief of nasal symptoms in patients with seasonal allergic rhinitis.

OBJECTIVE: We compared 220 microg daily intranasal aqueous triamcinolone acetonide (TAA AQ) with 200 microg daily fluticasone propionate (FP) for relief of seasonal allergic rhinitis symptoms. Study design and setting Randomized, parallel-group, investigator-blind study included patients with symptomatic seasonal allergic rhinitis. After a baseline period, TAA AQ or FP was taken for about 21 days. Nasal symptom (discharge, stuffiness, itching, sneezing) severity was recorded twice daily; total nasal symptom score was calculated. Health-related quality of life was assessed by Rhinoconjunctivitis Quality of Life Questionnaire. RESULTS: Reductions in individual symptoms and total nasal symptom score were statistically significant versus baseline and were equivalent between treatments: -3.15 +/- 0.19 with TAA AQ (n = 148) and approximately 3.17 +/- 0.18 with FP (n = 147) (95% confidence interval for the difference, -0.7391 to 0.3693). Clinically and statistically significant improvements in Rhinoconjunctivitis Quality of Life Questionnaire scores were comparable. CONCLUSION: TAA AQ and FP were equally efficacious in relieving seasonal allergic rhinitis symptoms and improving health-related quality of life. SIGNIFICANCE: Differences in molecular potency of intranasal steroids do not confer differences in efficacy.

Direct and indirect costs of sleep disturbances and residual symptoms in patients treated for depression: analysis of a nationwide cross sectional survey.

OBJECTIVE: To assess the relationship between inadequate response to depression treatment and sleep disturbances, work productivity loss, and resource utilization. METHODS: Adults reporting antidepressant use for more than 90 days (n = 6116) in the 2009 US National Health and Wellness Survey were categorized as non-, partial-, or complete responders to depression treatment. Multivariable analyses, adjusting for patient characteristics and comorbidities, examined the association of treatment response with sleep disturbances (including possible mediation), productivity, and resource use. RESULTS: Partial- and nonresponders, versus complete responders, experienced greater sleep disturbance, productivity loss, and resource use. Mediation results were consistent with the possibility that sleep disturbances predicted inadequate treatment response, which led to greater resource use. CONCLUSIONS: Sleep disturbances are prevalent in depression and associated with increased resource use. Appropriate management, including antidepressants that alleviate sleep disturbances, may improve functional and economic outcomes.

Real-world impact of reminder packaging on antihypertensive treatment adherence and persistence.

BACKGROUND: Patient medication adherence is multidimensional and poses significant concerns to health care professionals. One aspect of adherence is a patient forgetting to take their prescribed medication, which may be improved with reminder packaging (RP). The objective of this analysis was to assess the impact of RP on patient adherence to antihypertensive therapy. METHODS: This retrospective, propensity score-matched study evaluated patients switching to a single-pill combination of valsartan-hydrochlorothiazide in RP compared with patients remaining on the combination without reminder packaging (non-RP). Patients receiving combination therapy between April 1, 2009 and July 31, 2010 were eligible for inclusion. Patients were propensity score-matched on baseline adherence and background demographic variables, including comorbidities. Medication possession ratio, proportion of days covered, time to refill, and time to discontinuation were evaluated as primary measures of subsequent adherence and persistence. RESULTS: In a total of 9266 matched patients (4633 participants in both cohorts), adherence was significantly higher in the RP cohort compared with patients in the non-RP cohort (medication possession ratio, RP 80% versus non-RP 73%; proportion of days covered, RP 76% versus non-RP 63%; both P < 0.001). Refill timing was 10 days for RP patients versus 16 days for non-RP patients (P < 0.001). Similar trends were observed with respect to time to discontinuation (RP 196 days, non-RP 174 days; P < 0.001). A higher proportion of RP patients remained on therapy compared with non-RP patients, with patients in the RP group being 17% less likely to discontinue therapy compared with patients in the non-RP group (hazards ratio 0.833; 95% confidence interval 0.793-0.875). CONCLUSION: This real-world assessment of differences in adherence and persistence rates demonstrated that patients receiving RP were more adherent and persistent with their treatment regimens.

Retrospective claims database analysis to determine relationship between renin-angiotensin system agents, rehospitalization, and health care costs in patients with heart failure or myocardial infarction.

BACKGROUND: Heart failure (HF) and myocardial infarction (MI) cause considerable morbidity and mortality, but the outcomes and health care costs related to adherence to treatment guidelines for HF and MI are not fully understood. OBJECTIVES: The aims of this study were as follows: (1) to determine the proportion of patients discharged from the hospital with a primary diagnosis of HF or MI who subsequently received prescriptions for American Heart Association/American College of Cardiology-recommended angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), also referred to as renin-angiotensin system agents; (2) to investigate the relationship between adherence to and persistence with ACEIs/ARBs and risk of rehospitalization; and (3) to assess the relationship between adherence to and persistence with ACEIs or ARBs, cardiovascular-related health care costs, and total health care costs. METHODS: Using the prescription and medical service records of a large national pharmacy-benefit database, we conducted a retrospective analysis of patients discharged from the hospital with a primary diagnosis of HF or MI between July 1, 2003, and June 30, 2006. Medication adherence, persistence, rehospitalization risk, and health care costs during 1-year follow-up were measured. Logistic regression models were used to estimate the likelihood of rehospitalization for different levels of adherence and persistence. Generalized linear models were used to investigate the impact of adherence and persistence on total health care costs and cardiovascular-related health care costs. RESULTS: A total of 799 HF and 696 MI patients were included in the analysis; 57.20% of HF patients and 59.20% of MI patients were prescribed an ACEI or an ARB after discharge from the hospital. The mean (SD) age was 65.7 (13.7) years in the HF group and 60.6 (10.7) years in the MI group. In both groups, men accounted for a greater proportion of the patients than women. In the HF group, adherence and persistence were associated with a lower likelihood of rehospitalization compared with nonadherence and nonpersistence (P < 0.042 and P < 0.005, respectively). In the MI group, there was no significant difference in rehospitalization risk between those who were adherent and those who were not. However, among these patients, persistence was associated with a lower risk of rehospitalization than nonpersistence (P < 0.036). Adherence and persistence were associated with lower health care costs (HF: P < 0.001 for all comparisons; MI: P < 0.019 for adherence and total cost, P = NS for persistence and total cost, P < 0.012 for adherence and cardiovascular cost, P < 0.031 for persistence and cardiovascular cost). CONCLUSION: Adherence to and persistence with ACEIs or ARBs may reduce the risk of rehospitalization in patients with HF or MI, thereby potentially reducing health care costs.

Triamcinolone acetonide aqueous nasal spray improves nocturnal rhinitis-related quality of life in patients treated in a primary care setting: the Quality of Sleep in Allergic Rhinitis study.

BACKGROUND: Sleep disturbances due to allergic rhinitis can contribute to daytime fatigue, impair mood, and decrease daytime functioning. OBJECTIVE: To measure allergic rhinitis patients' nocturnal rhinitis-related quality of life using a new, validated disease-specific instrument, the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). METHODS: This open-label study was conducted in a primary care setting. Adult patients with seasonal or perennial allergic rhinitis rated nocturnal rhinitis-related quality of life using the NRQLQ and sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after 3 weeks of treatment with triamcinolone acetonide aqueous nasal spray (TAA AQ), 220 microg/d. Changes from baseline in overall and individual domain scores for both the NRQLQ and PSQI were evaluated using t tests for paired differences. RESULTS: The majority of the patients (N = 651) were female (58%), were white (85%), and shared a bed with a partner (63%). Mean +/- SD patient age was 45.7 +/- 15.5 years. TAA AQ treatment was associated with significant improvements in overall NRQLQ score (mean +/- SD change, -1.5 +/- 1.3; P < .001) and in individual domain scores (P < .001 for sleep problems, symptoms during sleep, symptoms upon waking in morning, and practical problems). Similarly, overall and individual PSQI domain scores were statistically significantly improved (P < .001). There were strong correlations between NRQLQ and PSQI scores (all comparisons P < .001). CONCLUSIONS: Treatment with TAA AQ for 3 weeks resulted in statistically significant improvements in nocturnal rhinitis-related quality of life and sleep quality in allergic rhinitis patients treated in a primary care setting.