Gaps in Guideline-Based Lipid-Lowering Therapy for Secondary Prevention in the United States: A Retrospective Cohort Study of 322†153 Patients.

BACKGROUND: Many patients with atherosclerotic cardiovascular disease (ASCVD) are not on guideline-recommended statin therapy. We evaluated utilization of statins and other lipid-lowering therapy (LLT), and changes in low-density lipoprotein cholesterol (LDL-C), among patients with ASCVD over a 1-year period. METHODS: LLT and LDL-C levels at the first outpatient visit (January 1, 2017-December 31, 2018) and 1-year follow-up were evaluated using data from Cerner Real-World Data, an electronic health record-derived data set from 92 US health systems. Logistic regression was used to evaluate factors associated with high-intensity statin use. RESULTS: We identified 322 153 patients with ASCVD (median age 69 years, 58.8% men, 81.8% White). Overall, 76.1% of patients were on statins, with only 39.4% on high-intensity statins. Men were more likely to receive high-intensity statins than women (multivariable-adjusted odds ratio, 1.34 [95% CI, 1.30-1.38]). Increasing age was associated with lower odds of statin use (odds ratio, 0.79 per 5-year increase at 60 years [95% CI, 0.78-0.81]). Patients with peripheral artery disease (odds ratio, 0.40 [95% CI, 0.37-0.42]) and cerebrovascular disease (odds ratio, 0.75 [95% CI, 0.70-0.80]) had lower odds of using high-intensity statins than those with coronary artery disease. At baseline, most patients (61.3%) had elevated LDL-C (≥70 mg/dL), including 59.8% of those on low/moderate-intensity statins and 76.1% on no statin; only 45.3% achieved an LDL-C <70 mg/dL at 1 year. Nonstatin LLT use was low (ezetimibe, 4.4%; proprotein convertase subtilisin/kexin type 9 inhibitors, 0.7%). Among patients on no statin or low/moderate-intensity statin at baseline, 14.8% and 13.4%, respectively, were on high-intensity statins at 1 year. CONCLUSIONS: Among patients with ASCVD in routine care, high-intensity statins are underutilized, and uptitration and use of nonstatin therapy are uncommon. Women, older adults, and individuals with noncardiac ASCVD are particularly undertreated. Concerted efforts are needed to address therapeutic inertia for lipid management in patients with ASCVD.

Cost-effectiveness of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis.

AIMS: Primary axillary hyperhidrosis (PAHH) is a condition characterized by excessive sweating that negatively impacts health-related quality of life, with significant psychological and social impacts. Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the United States for treatment of PAHH in patients 9 years of age and older. Our objective was to assess the cost-effectiveness of GT as first-line topical therapy compared to topical aluminum chloride from a United States commercial perspective. MATERIALS AND METHODS: A Markov model was developed consisting of four health states based on the Hyperhidrosis Disease Severity Scale (HDSS) over a time horizon of 5 years with discount rates of 3% for both costs and outcomes. Transitions between health states were driven by HDSS response, defined as an improvement of ≥2 points. Non-responders and those who discontinue could switch to later line treatments or no treatment. Health utility scores were based on HDSS scores, supported by published literature. RESULTS: Over 5 years, GT yielded 0.12 greater QALYs and 0.93 greater LYs with response compared to treatment with prescription aluminum chloride at an incremental cost of $10,584. Relative to prescription aluminum chloride, GT resulted in an incremental cost-effectiveness ratio (ICER) of $87,238 per QALY gained, $11,349 per LY with response. The ICER fell below $100,000 for 66% of probabilistic sensitivity analysis simulations and below $150,000 for 82% of simulations. LIMITATIONS: This analysis represents a simplified scenario of a hypothetical PAHH patient. Due to sparse data, assumptions were required for treatment patterns, efficacy, and persistence. CONCLUSION: Based on the analysis of incremental cost per QALY gained, GT may be cost-effective relative to prescription aluminum chloride at commonly accepted willingness to pay thresholds.

Treatment Patterns, Depression, and Anxiety Among US Patients Diagnosed with Hyperhidrosis: A Retrospective Cohort Study.

INTRODUCTION: Hyperhidrosis is associated with social and emotional stress due to limitations on health-related quality of life. This study examined real-world treatment patterns and concomitant depression and/or anxiety in patients with hyperhidrosis. METHODS: Commercial health plan members in the US with ≥ 2 hyperhidrosis diagnosis codes and/or antiperspirant prescription claims were identified from January 2010 through November 2017. A control cohort (CC) of patients without hyperhidrosis was matched to the hyperhidrosis cohort on demographic characteristics. Depression and/or anxiety were identified by ≥ 1 relevant diagnosis code or pharmacy claim. A multivariable logistic regression model estimated odds of treatment in the hyperhidrosis cohort, and depression/anxiety in the hyperhidrosis cohort and CC, adjusting for patient characteristics. RESULTS: A total of 44,484 patients with hyperhidrosis were identified, of whom 58.5% were female, with a mean (± standard deviation) age of 36.5 ± 16.5 years (83.5% ≥ 18 years). A small majority of patients (51.6%, 0.69/person-year) received treatment with prescription antiperspirants. Post-index oral systemic therapies, medical procedures, and surgical options were uncommon. At 12 months post-index, 48.4% of the sample had not filled a prescription for extra- or prescription-strength antiperspirants. Compared with the CC (n = 137,451), a higher percentage of patients with hyperhidrosis had depression or anxiety reported during follow-up (41.1 vs. 28.2%, p < 0.001); this corresponded to higher adjusted odds of depression/anxiety in patients with hyperhidrosis [odds ratio (OR) 1.76, 95% confidence interval (CI) 1.72-1.80, p < 0.001]. Baseline depression and/or anxiety were associated with lower odds of receiving hyperhidrosis treatment (OR 0.77, 95% CI 0.73-0.80), as was increasing age and male gender. Patients with hyperhidrosis also had more frequent incident depression/anxiety during follow-up (18.2 vs. 10.6%, p < 0.001). CONCLUSION: In this real-world analysis, hyperhidrosis was associated with increased odds of depression and/or anxiety. However, relatively low percentages of patients received prescription topical or oral treatments or underwent surgery, suggesting that tolerability, efficacy, and provider awareness may be limiting factors in the effective treatment of hyperhidrosis.

A systematic evidence-based review of treatments for primary hyperhidrosis.

OBJECTIVE: Hyperhidrosis (excessive sweating) is associated with significant quality-of-life burden yet is often undertreated. With limited FDA-approved treatments, health care providers must determine optimal treatment among approved and off-label options. Key objectives of this review were to reassess, update, and expand a previous systematic review of commonly used treatment options for primary hyperhidrosis, including consideration of aluminum and zirconium compounds. METHODS: We performed a qualitative systematic review of efficacy, health-related quality of life, satisfaction, and safety of interventions, replicating and expanding the strategy outlined in a previous systematic review, with the addition of studies utilizing a within-patient design. We performed a critical appraisal of identified studies to determine risk of bias (RoB) and strength of evidence (SOE). RESULTS: A total of 32 studies were eligible for critical appraisal. Only three studies - two clinical trials of glycopyrronium cloth (2.4%) and one trial of botulinum toxin A injections in axillary hyperhidrosis were rated as "low" RoB; both had SOE ratings of "moderate" for use in axillary hyperhidrosis - the highest rating included in this review. CONCLUSIONS: Optimal treatment choice depends on several factors, including understanding the quality of evidence regarding each treatment's efficacy and safety (considerations of convenience and cost are beyond the scope of this review). In hyperhidrosis, as in other clinical conditions, treatment decisions should be patient centered. At this time, because of the quality of evidence, only imprecise estimates of effect are possible for hyperhidrosis treatments included in this review, and statements about comparative effectiveness are not possible.

Cost-effectiveness of overactive bladder treatments: from the US payer perspective.

AIM: To assess the cost-effectiveness of onabotulinumtoxinA (onabotA), implantable sacral nerve stimulation devices, percutaneous tibial nerve stimulation, anticholinergic medications and mirabegron compared with best supportive care (BSC) for management of refractory overactive bladder (OAB). METHODS: A Markov model was developed to compare the cost-effectiveness of treatment options with BSC over a 10-year time horizon. Resource utilization, discontinuation rates and costs were derived from unpublished and published sources. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios were reported. RESULTS: Treatment with onabotA 100U produced the largest gain in QALYs (7.179) and lowest estimated incremental cost-effectiveness ratio ($32,680/QALY) of all assessed treatments compared with BSC. CONCLUSION: Compared with BSC, onabotA 100U was the most cost-effective treatment option for patients with refractory OAB.

Development of a new patient-reported outcome (PRO) measure on the Impact of Nighttime Urination (INTU) in patients with nocturia-Psychometric validation.

AIMS: To psychometrically evaluate the Impact of Nighttime Urination (INTU) questionnaire, a new patient-reported outcome measure developed to assess the impact of nocturia on health and functioning in a multicenter, behavioral modification (fluid restriction) study. METHODS: Participants aged 50-95 years with at least two voiding episodes/night for ≥6 months completed voiding diaries and the INTU on 3 consecutive days during weeks 1 and 2 (same day recall) and completed the Pittsburgh Sleep Quality Index (PSQI) and Nocturia Quality of Life Questionnaire (N-QOL) at baseline and days 8 and 15. Psychometric evaluations of the INTU were conducted. RESULTS: Rasch analysis showed the INTU to be a unidimensional construct, with most items located on the severe end of the symptom severity continuum. In addition to an Overall Impact Score (10 items), exploratory factor analysis affirmed by confirmatory factor analysis identified two domains: Daytime (six items) and Nighttime (four items) Impact Scores (comparative fit index = 0.968; root mean square error of approximation = 0.08). Concurrent validity met prespecified hypotheses, indicating similarity of concepts with the PSQI (correlation [r] = 0.627) and N-QOL (r = -0.784) total scores. The INTU differentiated among patients with different nocturic episode frequencies (P < 0.05 for all three summary scores). Statistically significant decreases were observed in mean Overall and Nighttime Impact Scores at week 2 versus week 1 in responders, indicating that the instrument can detect changes in response to symptom improvements. CONCLUSIONS: The INTU questionnaire demonstrated robust measurement properties and is a suitable tool for assessing the patient-reported impact of nocturia on health and functioning.