M. Chris Runken

Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine

BACKGROUND: Treatment of adolescent migraine remains a significant unmet medical need. We compared the efficacy and safety of 3 doses of sumatriptan and naproxen sodium (suma/nap) combination tablets to placebo in the acute treatment of adolescent migraine. METHODS: This randomized, parallel group study in 12 to 17 year olds required 2 to 8 migraines per month (typically lasting >3 hours untreated) for ≥6 months. Subjects entered a 12-week run-in phase, treating 1 moderate-to-severe migraine (attack 1) with single-blind placebo. Subjects reporting headache pain 2 hours after dosing were randomly assigned into a 12-week double-blind phase, treating 1 moderate-to-severe migraine (attack 2) with placebo (n = 145), suma/nap 10/60 mg (n = 96), 30/180 mg (n = 97), or 85/500 mg (n = 152). The primary end point was the percentage of subjects pain-free at 2 hours. RESULTS: The attack 2 adjusted (age; baseline pain severity) 2-hour pain-free rates were higher with suma/nap 10/60 mg (29%; adjusted P = .003), 30/180 mg (27%; adjusted P = .003), and 85/500 mg (24%; adjusted P = .003) versus placebo (10%). Posthoc primary end-point analyses did not demonstrate differences among the 3 doses or an age-by-treatment interaction. Statistically significant differences were found for 85/500 mg versus placebo for sustained pain-free 2 to 24 hours (23% vs 9%; adjusted P = .008), 2-hour photophobia-free (59% vs 41%; adjusted P = .008), and 2-hour phonophobia-free (60% vs 42%; adjusted P = .008). Analyses of other pain, associated symptoms, rescue medication use, and health outcome end points supported higher efficacy for active doses versus placebo. All active doses were well tolerated. CONCLUSIONS: All doses of suma/nap were well tolerated, providing similarly effective acute treatment of adolescent migraine pain and associated symptoms, as compared with placebo.

Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents.

Objectives.— To evaluate the long‐term safety, tolerability, effectiveness, impact on quality of life, and medication satisfaction of sumatriptan/naproxen sodium in the acute treatment of migraine headache in adolescents.

Impact of NSAID and Triptan use on developing chronic migraine: results from the American Migraine Prevalence and Prevention (AMPP) study.

To assess the influence of triptan or nonsteroidal anti‐inflammatory drug (NSAID) use on the likelihood of developing chronic migraine (CM) among persons with episodic migraine (EM).

Assessing the impact of migraine onset on work productivity.

Objective: Examine the impact of migraine on work productivity, and particularly the association between time of migraine onset and lost productivity as measured by absenteeism and presenteeism. Methods: A total of 509 people with migraine completed one online baseline survey and a diary survey after each of their next three migraines. All subjects were 18 or older and employed full time. Results: Sixty-four percent of migraines occurred on a workday. Of these, 68% resulted in some work productivity impact in the form of absenteeism or presenteeism. Migraines occurring during usual sleeping hours or prior to the start of work had the greatest impact on productivity. Conclusions: Findings indicate that absenteeism and presenteeism are both substantial contributors to work productivity loss. Primary factors associated with lost productivity include pain severity, migraine symptoms, and sleep disturbance.

Estimating the prevalence and economic burden of overactive bladder among Medicare beneficiaries prior to Medicare Part D coverage

ABSTRACT Objective: The goal of this study is to provide annual estimates for the treated prevalence and expenditures attributable to overactive bladder (OAB) in the elderly prior to Medicare Part D drug coverage. Research design and methods: All Medicare claims were extracted for beneficiaries over 65 with continuous coverage for Medicare Parts A and B during 2003–2004. Two OAB definitions were created: (1) the base case included diagnosis codes that narrowly defined OAB, and (2) the sensitivity variant included additional codes indicative of OAB. Descriptive comparisons of baseline characteristics, annual expenditures, and events and procedures were performed for OAB vs. non-OAB subjects meeting the inclusion criteria. CMS expenditures (2004 US dollars) for individuals were totaled and multiple regression techniques were used to estimate costs attributable to OAB after adjusting for demographic characteristics and comorbid conditions. Results: The prevalence of subjects with an OAB diagnosis ranged from 8.8 to 13.6% for the base and sensitivity definitions, respectively. While mean total annual expenditures ranged from

Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes.

9331 to

Longitudinal change in migraine headache-days and indirect cost consequences.

9655, mean annual expenditures attributable to OAB ranged from

Multi-Center Comparison of Response to a Single Tablet of Sumatriptan 85 mg and Naproxen 500 mg vs Usual Therapy Treating Multiple Migraine Attacks as Measured by the Completeness of Response Survey

825 to

The dilemma of diabetes in chronic inflammatory demyelinating polyneuropathy.

1184 per subject (9–12% of total medical expenditures for OAB subjects), with aggregate total OAB-attributable expenditures of

Consistency of return to normal function, productivity, and satisfaction following migraine attacks treated with sumatriptan/naproxen sodium combination.

1.8–3.9 billion per year. Conclusions: The treated prevalence of individuals seeking treatment for OAB in the elderly Medicare population is comparable to some common chronic conditions in that population, and OAB-attributable CMS expenditures are considerable. However, due to study limitations this is a conservative estimate of the direct cost of OAB in the elderly population. The reported estimates exclude pharmacy and out-of-pocket costs, are extrapolated to only two-thirds of the elderly Medicare population, and do not include expenditures by Medicaid for long-term care. Additionally, claims data limits detection of chronic conditions to patients who receive treatment or consultation for OAB; diagnosis codes used were based on expert opinion rather than a review of medical records to identify OAB patients; and long-term care costs are not included.