Ubrogepant users' real-world experience: Patients on ubrogepant, characteristics and outcomes (UNIVERSE) study.

Objective: To assess the real-world effectiveness of ubrogepant by evaluating self-reported satisfaction with pain relief, ability to think clearly, and return to normal function in individuals who had used ubrogepant to treat a migraine episode within the preceding 14 days.

Background: Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Few studies have evaluated the real-world effectiveness of ubrogepant.

Health care resource utilization and costs associated with diagnosed medication overuse headache and potential acute medication overuse in individuals with migraine.

Objective: Estimate health care resource utilization and costs associated with medication overuse headache and potential acute medication overuse.

Methods: A retrospective analysis was conducted with Clinformatics Data Mart data (1 January 2019-31 December 2019) that included continuously enrolled commercially insured adults with migraine (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] code G43.xxx).

Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials.

Background: Triptans are the first-line option for the acute treatment of migraine attacks; however, triptans are contraindicated in people with certain underlying cardiovascular risk factors and are associated with inadequate efficacy or poor tolerability in some individuals. Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine.

Methods: This post hoc analysis of the phase 3 ACHIEVE trials examined the impact of ubrogepant on the Functional Disability Scale (FDS), satisfaction with medication, and Patient Global Impression of Change (PGIC) in participants who were self-reported triptan insufficient responders (TIRs), defined as those who are unable to take triptans due to contraindications, tolerability issues, or insufficient efficacy.

Geographic variation in the use of triptans and opioids for the acute treatment of migraine attacks.

Objective: To assess the geographic variations in triptan and opioid prescribing patterns for patients with migraine.

Background: Numerous guidelines recommend triptans as the standard of care for migraine attacks, yet opioids are still widely used for migraine treatment. Variation in the use of opioids and triptans for the treatment of migraine by geographic location is not well known.

Migraine Patients With Cardiovascular Disease and Contraindications: An Analysis of Real-World Claims Data.

Introduction: Triptans, the most commonly prescribed acute treatments for migraine attacks are, per FDA labeling, contraindicated in cardiovascular (CV) disease patients and have warnings and precautions for those with CV risk factors.

Methods: Headache specialists, cardiologists, and health economics and outcomes researchers convened to identify diagnostic codes for: (1) CV diseases contraindicating triptans based on FDA labeling; (2) conditions comprising "other significant underlying CV disease"; and (3) CV risk factors included as warnings and precautions for triptans. A retrospective, cross-sectional analysis of commercially insured adult US migraine patients in the 2017 Optum Clinformatics Data Mart (CDM) and the 2017 IBM Watson Health MarketScan Commercial Claims database was used to estimate the proportion of migraine patients with CV contraindications and warnings and precautions to triptans.

Comparison of healthcare resource utilization and costs among patients with migraine with potentially adequate and insufficient triptan response.

Background: Triptans are the most commonly prescribed acute treatments for migraine; however, not all triptan users experience adequate response. Information on real-world resource use and costs associated with triptan insufficient response are limited.

Methods: A retrospective claims analysis using US commercial health plan data between 2012 and 2015 assessed healthcare resource use and costs in adults with a migraine diagnosis newly initiating triptans.

Acute treatment patterns in patients with migraine newly initiating a triptan.

Background: Triptans are the most commonly used acute treatment for migraine. This study evaluated real-world treatment patterns following an initial triptan prescription to understand refill rates and use of non-triptan medications for the acute treatment of migraine.

Methods: Commercially-insured adult patients over 18 years of age with a triptan prescription between 1/1/2013 to 31/12/2013 were identified from the Optum Clinformatics™ Data Mart database, with date of the first triptan fill designated as index date.

Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II.

Objective: To evaluate the efficacy of ubrogepant on patient-reported functional disability, satisfaction with study medication, and global impression of change.

Background: Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine. In 2 phase 3 trials (ACHIEVE I and II), ubrogepant demonstrated efficacy vs placebo on the 2 co-primary endpoints of headache pain freedom and absence of the most bothersome migraine-associated symptom at 2 hours post dose for the 50 and 100 mg doses.

Development of a claims-based algorithm to identify potentially undiagnosed chronic migraine patients.

Objective: To develop a claims-based algorithm to identify undiagnosed chronic migraine among patients enrolled in a healthcare system.

Methods: An observational study using claims and patient survey data was conducted in a large medical group. Eligible patients had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) migraine diagnosis, without a chronic migraine diagnosis, in the 12 months before screening and did not have a migraine-related onabotulinumtoxinA claim in the 12 months before enrollment.

A Multicenter, Prospective, Observational Study to Determine Predictive Factors for Multidrug-Resistant Pneumonia in Critically Ill Adults: The DEFINE Study.

Objective: This study was conducted to describe the prevalence, epidemiology, and clinical outcomes of multidrug-resistant (MDR) organism (MDRO) pneumonia in critically ill patients.

Methods: A multicenter, prospective, observational study of patients admitted to 60 intensive care units (ICUs), from 34 hospitals, in the United States from November to December 2016. Adults (> 18 yrs) receiving antimicrobial therapy at least 5 days for pneumonia were included.

Long term outcomes of new generation drug eluting stents versus coronary artery bypass grafting for multivessel and/or left main coronary artery disease. A Bayesian network meta-analysis of randomized controlled trials.

Background: Most data guiding revascularization of multivessel disease (MVD) and/or left main disease (LMD) favor coronary artery bypass grafting (CABG) over percutaneous coronary intervention (PCI). However, those data are based on trials comparing CABG to bare metal stents (BMS) or old generation drug eluting stents (OG-DES). Hence, it is essential to outcomes of CABG to those of new generation drug eluting stents (NG-DES).

Adherence to Rivaroxaban, Dabigatran, and Apixaban for Stroke Prevention for Newly Diagnosed and Treatment-Naive Atrial Fibrillation Patients: An Update Using 2013-2014 Data.

Background: Few studies have assessed adherence to non-vitamin K antagonist oral anticoagulants (NOACs), especially using contemporary data now that multiple NOACs are available.

Objective: To compare adherence and treatment patterns among NOACs for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).

Methods: Incident and treatment-naive NVAF patients were identified during 2013-2014 from a large claims database in this retrospective cohort study.

Comparative Effectiveness of Intra-Articular Hyaluronic Acid and Corticosteroid Injections on the Time to Surgical Knee Procedures.

Background: Use of intra-articular hyaluronic acid (HA) injections to manage knee osteoarthritis (OA) remains controversial because of weak and conflicting evidence. The objective was to evaluate the effectiveness of intra-articular HA injections for knee OA management.

Methods: A nested cohort of persons with knee OA seeing a specialist was created using a 10% random sample of LifeLink Plus claims (2010-2015) to compare the risk of composite (any) knee surgical interventions, total (TKA)/unicompartmental knee arthroplasty (UKA) and TKA only among HA users and 2 comparison groups: corticosteroid (CS) users and HA/CS nonusers.

Comparison of Low-, Moderate-, and High-Molecular-Weight Hyaluronic Acid Injections in Delaying Time to Knee Surgery.

Background: We compared the effectiveness of low-molecular-weight (MW) hyaluronic acid (HA) injections (LMWHA), moderate-MW HA injections (MMWHA), and high-MW HA injections (HMWHA) for prevention or delay of knee surgery in patients with knee osteoarthritis.

Methods: An observational cohort study using LifeLink Plus claims (2006-2015) was used. The primary outcome measure of the study included all surgical interventions of the knee.

Adherence to Rivaroxaban, Dabigatran, and Apixaban for Stroke Prevention in Incident, Treatment-Naïve Nonvalvular Atrial Fibrillation.

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used for prevention of stroke secondary to nonvalvular atrial fibrillation (NVAF). Increased use of NOACs is partially a result of simplified regimens compared with warfarin, which has been associated with poor adherence and persistence to therapy. Few studies have assessed adherence to NOACs, especially using contemporary data now that multiple NOACs are available.

A Comparison of Oral Anticoagulant Use for Atrial Fibrillation in the Pre- and Post-DOAC Eras.

Introduction: Direct oral anticoagulants (DOACs) have seen rapid uptake for the prevention of stroke associated with non-valvular atrial fibrillation (NVAF). It is unclear whether use of DOACs represents direct therapeutic substitution over warfarin or if this coincides with an increase in overall treatment rates. This study sought to describe the difference in oral anticoagulant (OAC) use in the pre-DOAC and post-DOAC eras.

Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.

Background And Purpose: The objective of the study is to compare the cost-effectiveness of oral anticoagulants among atrial fibrillation patients at an increased stroke risk.

Methods: A Markov model was constructed to project the lifetime costs and quality-adjusted survival (QALYs) of oral anticoagulants using a private payer's perspective. The distribution of stroke risk (CHADS2 score: congestive heart failure, hypertension, advanced age, diabetes mellitus, stroke) and age of the modeled population was derived from a cohort of commercially insured patients with new-onset atrial fibrillation.

Net Clinical Benefits of Guidelines and Decision Tool Recommendations for Oral Anticoagulant Use among Patients with Atrial Fibrillation.

Background: The 2012 American College of Chest Physicians' Evidence-Based Clinical Practice (CHEST), the 2012 European Society of Cardiology, and the 2014 American Heart Association guidelines and published decision tools by LaHaye and Casciano offer oral anticoagulant (OAC) recommendations for patients with atrial fibrillation (AF). The aim of our study was to compare the net clinical benefit (NCB) of OAC prescribing that was concordant with these decision aids.

Methods: A cohort study of the 2001-2013 LifeLink claims data was used.

Mental health status of varenicline and bupropion users during a quit attempt compared to current smokers, other quitters, and non-smokers.

Background: Varenicline and bupropion are commonly prescribed non-nicotine containing smoking cessation agents. Post-marketing reports suggest an increased incidence of psychiatric disturbances associated with varenicline and bupropion. However, pre-existing psychiatric disorders may confound the association between these smoking cessation agents and psychiatric disturbances.

Variation in Anticoagulant Recommendations by the Guidelines and Decision Tools among Patients with Atrial Fibrillation.

Published atrial fibrillation (AF) guidelines and decision tools offer oral anticoagulant (OAC) recommendations; however, they consider stroke and bleeding risk differently. The aims of our study are: (i) to compare the variation in OAC recommendations by the 2012 American College of Chest Physicians guidelines, the 2012 European Society of Cardiology (ESC) guidelines, the 2014 American Heart Association (AHA) guidelines and two published decision tools by Casciano and LaHaye; (ii) to compare the concordance with actual OAC use in the overall study population and the population stratified by stroke/bleed risk. A cross-sectional study using the 2001-2013 Lifelink claims data was used to contrast the treatment recommendations by these decision aids.