Adherence to Oral Migraine Prophylaxis Medications in Patients with Chronic Migraine

Thesis (Master's)--University of Washington, 2013BACKGROUND Migraine is an episodic neurological disorder that affects 12% of Americans and millions worldwide. Chronic migraine (CM) as ≥15 headache days per month with ≥8 days per month that meet criteria for migraine, for more than three months, with each episode lasting greater than four hours. CM is a disabling disorder that has been shown to significantly reduce quality of life and leaves many patients unable to perform daily activities. Patients with frequent headaches, such as those suffering from CM, may benefit from prophylactic treatment. Oral prophylactic agents require adherence to various dosing regimens in order to adequately reduce the burden of migraine. Although adherence has been well studied among migraine patients, only one study has investigated adherence using claims databases in this population. To date, no study has examined adherence to prophylactic therapy among the chronic migraine population using real world data from large claims databases such as MarketScan. OBJECTIVE The aim of this study is to describe the chronic migraine population through a large US insurance claims database from 2008 to 2011 and to assess adherence, switching, and resource use among patients taking oral migraine prophylactics. METHODS Data were obtained from MarketScan® Research Databases, which contain inpatient, outpatient, and pharmacy claims for patients covered by commercial, Medicare, and Medicaid insurance plans in the US. Databases were queried for patients 18 years and older who were diagnosed with CM and who initiated an oral migraine prophylactic agent between January 1, 2008 and December 31, 2011. Drugs included in the analysis were those representative of the three main classes of medications used in migraine prophylaxis: antidepressants (amitriptyline, nortriptyline, citalopram, escitalopram, sertraline, fluoxetine, paroxetine), beta blockers (propranolol, metoprolol, nadolol, atenolol), and anti-seizure (gabapentin, topiramate, divalproex) medications. Adherence to migraine prophylactic agents among the CM patient population were calculated with both medication possession ratios (MPR) and proportion of days covered (PDC). Switch rate was reported as the proportion of patients for whom was recorded a pharmacy claim for one of the 13 medications of interest within 30 days prior to or 60 days post discontinuation of the initial prophylactic. Proportion of patients with one or more ER visits for migraine stratified by prophylactic medication and adherence rates (both MPR and PDC). Bivariate analyses were conducted to compare patient demographics among patients taking each medication; and separately between patients who were and were not adherent. T-tests and chi-2 tests were used to estimate means and standard deviations for continuous data and or proportions for categorical variables, respectively. Unadjusted and adjusted comparisons were made using logistic regression models for adherence and ER visits. RESULTS In the MarketScan Databases, we identified 47,555 patients who had a diagnosis of chronic migraine between 2008 and 2011. After applying inclusion/exclusion criteria there were 1,640 patients included in the analysis of the 6-month follow-up cohort and 861 patients in the 12-month follow-up cohort. The majority of patients were female with a mean age approximately 40 years old. Preferred provider organization (PPO) health insurance was the most common plan type and a large portion of patients were working full time. Approximately 30% of patients were adherent at the end of 6 months and 14% at 12 months when ≥80% MPR was used to measure adherence. Using PDC to calculate adherence provided even lower estimates of 24% and 14% for 6 and 12 months follow-up, respectively. The most common prophylactic switched to and from was topiramate. A large proportion of the patients who switched decided to replace amitriptyline and nortriptyline with another prophylactic, while an equally large proportion of patients who switched chose to convert to citalopram, gabapentin, or propranolol. At 6 months, the proportion in the non-adherent group who experienced an ER visit is smaller than the proportion who experienced an ER visit in the adherent group. At 12 months, the proportions are similar between the adherent and non-adherent groups. Regression models were not statistically significant for any of the outcomes. CONCLUSION Adherence to oral migraine prophylactics is low among the US chronic migraine population at both 6 and 12 months. A large proportion of patients switch between the prophylactics studied with the greatest switching occurring to and from topiramate. A significant proportion of chronic migraine patients experience ER visits but in our results we found that these visits were not associated with adherence

Adherence to thyroid hormone replacement therapy: a retrospective, claims database analysis

<p><b>Objective:</b> The objective of this analysis was to compare adherence at 6 months and 12 months across levothyroxine formulations for patients with hypothyroidism.</p> <p><b>Methods:</b> This retrospective analysis utilized insurance claims data from a commercially insured population from January 1, 2000 through March 31, 2016. Patients were included if they were diagnosed with hypothyroidism and initiated treatment with generic levothyroxine, Levoxyl, Synthroid, Unithroid, or Tirosint. Patients were excluded if they were younger than age 18, were diagnosed with thyroid cancer, received a prescription for liothyronine, or did not have continuous insurance coverage over the study period. Adherence, defined by the proportion of days covered (PDC) ≥ 80%, was examined using multivariable analyses for both 6 and 12 months post-initiation on therapy</p> <p><b>Results:</b> The study identified 580,331 patients who fit the study criteria. At 6 months, 40.3% of patients were found to be non-adherent, while 51.9% were non-adherent at 12 months. Synthroid was associated with significantly higher adherence compared to all other levothyroxine formulations at both 6 and 12 months. Compared to generic levothyroxine, the likelihood of being adherent at 12 months was highest for Synthroid (OR = 1.44; 95% CI = 1.43–1.46), followed by Levoxyl (OR = 1.20 95% CI = 1.17–1.23). Tirosint and Unithroid were associated with significantly lower adherence at 12 months compared to generic levothyroxine (OR = 0.65; 95% CI = 0.57–0.75 and OR = 0.79; 95% CI = 0.71–0.89, respectively).</p> <p><b>Conclusions:</b> This large, retrospective real-world study demonstrated that adherence to levothyroxine remains a concern among patients with hypothyroidism, and that differences in adherence may exist across levothyroxine formulations.</p

Understanding Treatment Patterns and Outcomes among Patients with De Novo Unresectable Locally Advanced or Metastatic Urothelial Cancer: A Population-Level Retrospective Analysis from Alberta, Canada

Despite a high disease burden, real-world data on treatment patterns in patients with unresectable locally advanced or metastatic urothelial carcinoma (la/mUC) in Canada are limited. This retrospective, longitudinal cohort study describes treatment patterns and survival in a population of patients with de novo unresectable la/mUC from Alberta, Canada, diagnosed between 1 January 2015 and 31 December 2019, followed until mid-2020. The outcomes of interest were systemic therapy treatment patterns and overall survival (OS). Of 206 patients, most (65.0%, n = 134) did not receive any systemic therapies. Of 72 patients (35.0%) who received first-line systemic therapy, the median duration of treatment was 2.8 months (IQR 3.3). Thirty-five patients (48.6% of those who received first-line therapy) received subsequent second-line therapy, for a median of 3.0 months (IQR 3.3). In all patients (n = 206), the median OS from diagnosis was 5.3 months (95% CI, 4.5&ndash;7.0). In patients who received treatment, the median OS from the initiation of first-line and second-line systemic therapy was 9.1 (6.4&ndash;11.6) and 4.6 months (3.9&ndash;19.2), respectively. The majority of patients did not receive first-line systemic therapy, and, in those who did, survival outcomes were poor. This study highlights the significant unmet need for safe and efficacious therapies for patients with la/mUC in Canada

Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.

PURPOSE: Locally advanced/metastatic urothelial cancer (la/mUC) affects patients quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la/mUC who were cisplatin-ineligible from EV-103 Cohort K. METHODS: In this phase Ib/II trial, patients were randomly assigned 1:1 to EV + P or EV monotherapy (mono). Exploratory patient-reported outcomes (PROs) were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) and Brief Pain Inventory Short Form (BPI-SF) at baseline, once per week for cycles 1-3, and then in every cycle through the end of treatment. Changes in scores from baseline to week 24, reported as least squares mean (standard error), were assessed by mixed models for repeated measures. There were no formal statistical comparisons between treatment arms. RESULTS: Of 149 patients treated, 65 (EV + P) and 63 (EV mono) comprised the PRO analysis set. For EV + P, EORTC QLQ-C30 QOL was maintained through week 24 with improvements in emotional functioning, pain, and insomnia. Clinically meaningful improvements were seen in EORTC QLQ-C30 pain after EV + P at weeks 12 (-14.41 [3.14]) and 24 (-14.99 [3.56]) and BPI-SF worst pain at week 24 (-2.07 [0.37]). For EV mono, EORTC QLQ-C30 QOL remained stable with clinically meaningful improvements in EORTC QLQ-C30 pain (-12.55 [4.27]), insomnia (-14.46 [4.69]), and constipation (-10.09 [4.35]) at week 24. There were small-to-moderate improvements in BPI-SF worst pain at week 24. CONCLUSION: EV + P in patients with la/mUC who were cisplatin-ineligible was associated with preservation or improvement of QOL/functioning/symptoms. Improvement in pain was seen in both PRO instruments and treatment arms. These data complement clinical outcomes of 1L EV + P