Treatment patterns of galcanezumab versus standard of care preventive migraine medications over 24 months: a US retrospective claims study.

OBJECTIVE: To describe long-term (24-month) treatment patterns of patients initiating galcanezumab versus standard of care (SOC) preventive migraine treatments including anticonvulsants, beta-blockers, antidepressants, and onabotulinumtoxinA using administrative claims data. METHODS: This retrospective cohort study, which used Optum de-identified Market Clarity data, included adults with migraine with ≥1 claim for galcanezumab or SOC preventive migraine therapy (September 1, 2018 - March 31, 2020) and continuous database enrollment for 12 months before (baseline) and 24 months after (follow-up) the index date (date of first claim). Baseline patient demographics, clinical characteristics, and treatment patterns were analyzed after 24-month follow-up, including adherence (measured as the proportion of days covered [PDC]), persistence, discontinuation (≥60-day gap), restart, and treatment switch. Propensity score matching (1:1) was used to balance the galcanezumab and SOC cohorts. RESULTS: The study included 2307 matched patient pairs with 24-month follow-up. The mean age across cohorts was 44.5 years (females: ∼87%). Patients in the galcanezumab versus SOC cohort demonstrated greater treatment adherence (PDC: 48% vs. 38%), with more patients considered adherent (PDC ≥80%: 26.6% vs. 20.7%) and persistent (322.1 vs. 236.4 d) (all p < .001). After 24-month follow-up, fewer galcanezumab-treated patients had discontinued compared with SOC-treated patients (80.1% vs. 84.7%; p < .001), of which 41.3% and 39.6% switched to a non-index medication, respectively. The most prevalent medication patients switched to in both cohorts was erenumab. Significantly greater proportions of patients who initiated galcanezumab versus SOC medications switched to fremanezumab (p < .001) and onabotulinumtoxinA (p = .016). CONCLUSION: Patients who initiated galcanezumab for migraine prevention had higher treatment adherence and persistence compared with those who initiated SOC medications after 24-month follow-up.

Only few patients (3 − 13%) with migraine, who qualify for preventive treatment, are using them. Conventional preventive treatments have not been developed specifically for migraine treatment, and more than half of the patients stop using them prematurely. Calcitonin gene-related peptide monoclonal antibodies such as galcanezumab, fremanezumab, and erenumab are newer treatments that provide migraine-specific preventive treatment. Prior studies have compared 6- to 12-month migraine medication use by patients starting galcanezumab versus those starting traditional standard of care (SOC) migraine preventive medications. We compared long-term (24-month) migraine medication use in patients starting galcanezumab versus those starting SOC migraine preventive medications to confirm if the results are sustained over a longer period. Over 24 months, patients who used galcanezumab followed the prescribed treatment regimen to a greater extent compared with those who used SOC medications (48% vs. 38%, respectively). Additionally, patients using galcanezumab continued treatment for a longer time compared with those using SOC. Over 24 months, about 85% of patients stopped taking SOC medications, while around 80% of patients stopped taking galcanezumab. Our findings indicate that patients with migraine are more likely to continue using galcanezumab as a preventive treatment for a longer period compared with SOC medications. This study helps identify gaps in the preventive treatment of migraine and provides insights on how they are not being used enough.

Type 2 Diabetes Comorbidity and Cognitive Decline in Patients with Alzheimer's Disease.

BACKGROUND: Although insulin dysregulation and resistance likely participate in Alzheimer's disease (AD) etiologies, little is known about the correlation between type 2 diabetes mellitus (T2DM) and the progression of cognitive decline in patients with AD. OBJECTIVE: To determine whether AD patients with T2DM experience more rapid cognitive decline than those without T2DM. METHODS: All cognitive performance data and the presence or absence of T2DM comorbidity in patients with AD were derived from the US National Alzheimer's Coordinating Center's (NACC) Uniform Data Set (UDS). A search of the UDS identified 3,055 participants with AD who had more than one epoch completed. The data set culled clinically diagnosed AD dementia patients who were assessed for diabetes type identified during at least 1 visit. These patients were divided into 2 groups based on whether they had a diagnosis of T2DM. The data from these groups were then analyzed for differences in cognitive decline based on neuropsychological test battery scores and a Clinician Dementia Rating using a general linear model. RESULTS: Comparisons of the mean scores for 16 selected tests from the neuropsychological test battery showed no significant differences in baseline scores and scores at subsequent visits between the T2DM and nondiabetic groups. CONCLUSIONS: The results revealed no differences in cognitive decline metrics over the course of 5 visits in either study group. These data indicate that the presence of T2DM does not increase the rate of cognitive decline in AD. This finding contradicts expected disease burden and will need to be explored further.

Pediatric Trauma Arrival Times and the Swing Shift.

BACKGROUND: Trauma center staff and trainees are often assigned to a day and night shift. However, for adult trauma, the swing shift has been found to offer superior clinical exposure compared with a standard day or night shift for trainees. We characterized patterns in pediatric trauma arrival times based on the hour, weekday, and month and studied whether or not the swing shift also maximizes exposure to hands-on experiences in managing pediatric trauma. METHODS: We performed a retrospective review of the trauma database at our urban, level 2 pediatric trauma center. We identified all the pediatric trauma activations in the last 13 years (2006-2018). A retrospective shift log was created, which included day (7:00 am to 7:00 pm), night (7:00 pm to 7:00 am), and swing (noon to midnight) shifts. The shifts were compared using the Wilcoxon match-pairs signed rank test. Weekends data were also compared with weekdays, and comparisons were also made for pediatric patients with Injury Severity Scores (ISS) >15. RESULTS: There were 3532 pediatric patients identified for our study. The swing shift had 1.98 times more activations than the night shift, and 1.33 more than the day shift (P < 0.001). The swing shift was also superior to both the day and night shifts for exposure to patients with Injury Severity Score greater than 15 (P < 0.001). Weekend days had 1.28 times more trauma than the weekdays (P < 0.001). Peak arrival time was between the hours of 3:00 pm and 9:00 pm, and patient age did not have an effect on this trend. CONCLUSIONS: Experience in managing pediatric trauma patients will improve for trainees who utilize the swing shift. In addition, the hours between 3:00 pm and 9:00 pm on weekends may represent a time of particularly high likelihood of pediatric trauma arrivals, which may require extra staff and hospital resources.Level of Evidence: Therapeutic Study, Level IV.

Comparison of injuries among motorcycle, moped and bicycle traffic accident victims.

OBJECTIVE: Motorcycles, moped scooters and bicycles are commonly involved in traffic accidents and riders often suffer significant morbidity and mortality. The aim of this study is to compare and categorize the different injury patterns and fractures suffered by riders of each vehicle type after a traffic accident. METHODS: Data from a level 1 trauma center in Las Vegas, Nevada were analyzed. Traffic accident victims riding a motorcycle, moped, or bicycle from 2013 to 2017 were included. Injury location and fracture location were assigned to six and sixteen categorical locations, respectively. Descriptive statistics, including frequency counts for categorical data and mean for continuous data, were calculated for the full sample and for each of the vehicle types. Logistic regression was performed on race, categorized age, vehicle type and helmet use to calculate adjusted odds ratios for injury type between the three groups. RESULTS: Of the 2115 patients, 1372 were motorcyclists, 356 were moped scooter riders and 387 were bicyclists. Overall the vast majority of injuries reported were of the extremities or pelvic girdle (62.2%), and this was true regardless of vehicle type. Head and neck injuries were significantly more common in bicyclists (39.5%) and moped riders (34.6%), than in motorcyclists (22.7%). Helmet use was substantially lower in the moped (34%) and bicycle (20%) groups compared to the motorcycle group (85%). The most common fractures regardless of vehicle type were of the skull/face, rib, vertebral, and tibia/fibula with slight variations between vehicle groups. CONCLUSION: Similarities were seen in the most common fracture and injury patterns between the three groups. Head and neck injuries were much more common in moped and bicycle riders compared to motorcyclists. This is most likely due to the significantly higher percentage of motorcycle riders who wore a helmet. Counseling regarding helmet and protective equipment use, especially among moped and bicycle riders is essential to reduce head injuries.

Effect of Statewide Social Distancing and Stay-At-Home Directives on Orthopaedic Trauma at a Southwestern Level 1 Trauma Center During the COVID-19 Pandemic.

OBJECTIVES: To compare orthopaedic trauma volume and mechanism of injury before and during statewide social distancing and stay-at-home directives. DESIGN: Retrospective. SETTING: Level 1 trauma center. PATIENTS/PARTICIPANTS: One thousand one hundred thirteen patients sustaining orthopaedic trauma injuries between March 17 and April 30 of years 2018, 2019, and 2020. INTERVENTION: Statewide social distancing and stay-at-home directives. MAIN OUTCOME MEASUREMENTS: Number of consults, mechanism of injury frequency, and type of injury frequency. RESULTS: During the COVID-19 pandemic, orthopaedic trauma consult number decreased. Injuries due to gunshot wounds increased and those due to automobile versus pedestrian accidents decreased. Time-to-presentation increased and length of stay decreased. Operative consults remained unchanged. CONCLUSIONS: Orthopaedic trauma injuries continued to occur during the COVID-19 pandemic at an overall decreased rate, however, with a different distribution in mechanism and type of injury. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Relationship Between Oral Health and Clinical Osteoporosis Among Hospitalized Patients with and Without Diabetes.

Objective Diabetes mellitus (DM) is associated with poor oral health and osteoporosis (OP). The aim of this study was to assess the relationship between OP, periodontal disease (PD), and other dental and health outcomes in a cohort of hospitalized patients with and without DM. Method Using a cross-sectional study design, we enrolled consecutive hospitalized patients. We administered a questionnaire to gather demographic information, oral health history, smoking history, and history of OP. We inspected their dentition and reviewed their charts. Data were analyzed using t-tests, chi-square tests, and logistic regression models. Result  Out of 301 patients enrolled, 275 had PD, 102 had DM, and 30 had OP. In univariate analyses, factors associated with OP included older age (p<0.001), female gender (p=0.046), presence of DM (p=0.049), and having more discharge medications (p=0.01). There was no significant relationship between PD and OP. In logistic regression analyses, age remained significantly associated with having OP among all hospitalized patients and in the non-DM populations. In the DM population, female gender was the only significant predictor for having OP. Conclusion Although we found no significant relationship between having PD and OP in our population, we found that among patients with DM, female gender predicted OP, whereas in patients without DM, age was a stronger predictor. Earlier screening for OP in female patients with DM may be useful in identifying and treating OP sooner in this population.

Eosinophilic esophagitis: comorbidities and atopic disease in Nevada.

Eosinophilic esophagitis (EoE) is a rare, immune-mediated illness. We aimed to examine the comorbidities and sensitization patterns associated with an EoE diagnosis in Nevada. The study goal was two-fold: to determine the most common EoE comorbidities and sequela in the state of Nevada using healthcare utilization records across all settings and to determine the most common food and aeroallergens in histologically positive EoE pediatric patients using clinical sensitization data. Esophageal obstruction/stricture was the most frequently reported diagnosis in adults with EoE (29.5%). Among pediatrics, the highest ranking comorbidities included asthma (13.4%); diseases of the stomach, duodenum, and intestine (7.26%); allergies (7.01%); and gastroesophageal reflux disease (GERD) (3.69%). Additionally, the top sensitizations reported in histologically positive EoE patients were largely pollen related (82.9%). Atopic disease and specifically food allergens are commonly reported as comorbid conditions with EoE in the literature. However, our clinical pediatric data set from this study revealed that aeroallergen sensitizations far exceeded that of food allergens (82.9% aero-positive vs. 17.1% dood positive). The high presence of esophageal stricture/obstruction in adults could be indicative of late diagnosis; in addition, the aeroallergen sensitization in children could suggest different clinical management techniques necessary may be needed for this disease. Education among healthcare providers regarding the presence of aeroallergen sensitization in this population may result in earlier diagnoses and help reduce morbidity and the cost from this disease.

Relationship between dental loss and health outcomes among hospitalized patients with and without diabetes.

There is mixed evidence regarding the impact of poor dental health on cardiovascular disease and other health outcomes. Our objective was to determine the outcomes associated with poor dental health among hospitalized patients with and without diabetes mellitus (DM) at our institution. We enrolled a consecutive sample of adult patients admitted to an academic medical center. We gathered demographic, health and dental information, reviewed their medical records and then examined their teeth. We analyzed data using SPSS V.24. There was a high prevalence of dental loss among all hospitalized patients. Older age (p<0.001), smoking (p=0.034), having DM (p=0.001) and lower frequency of teeth brushing (p<0.001) were predictors of having a lower number of healthy teeth. Among DM and non-DM patients, fewer remaining healthy teeth was associated with presence of heart disease (p=0.025 and 0.003, respectively). Patients with diabetes mellitus (DM) had a higher prevalence of stroke (p=0.006) while patients without DM had a higher number of discharge medications (p=0.001) associated with having fewer number of healthy teeth. There was no correlation between number of healthy teeth and the length or frequency of hospitalization. Patients with DM are more likely to have fewer number of healthy teeth compared with non-DM patients. Fewer number of healthy teeth was associated with higher prevalence of heart disease in both DM and non-DM patients and with more discharge medications in non-DM patients.

Significance of inferior wall ischemia in non-dominant right coronary artery anatomy.

AIM: To investigate the relationship of inferior wall ischemia on myocardial perfusion imaging in patients with non-dominant right coronary artery anatomy. METHODS: This was a retrospective observational analysis of consecutive patients who presented to the emergency department with primary complaint of chest pain. Only patients who underwent single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) were included. Patients who showed a reversible defect on SPECT MPI and had coronary angiography during the same hospitalization was analyzed. Patients with prior history of coronary artery disease (CAD) including history of percutaneous coronary intervention and coronary artery bypass graft surgerys were excluded. True positive and false positive results were identified on the basis of hemodynamically significant CAD on coronary angiography, in the same territory as identified on SPECT MPI. Coronary artery dominance was determined on coronary angiography. Patients were divided into group 1 and group 2. Group 1 included patients with non-dominant right coronary artery (RCA) (left dominant and codominant). Group 2 included patients with dominant RCA anatomy. Demographics, baseline characteristics and positive predictive value (PPV) were analyzed for the two groups. RESULTS: The mean age of the study cohort was 57.6 years. Sixty-one point seven percent of the patients were males. The prevalence of self-reported diabetes mellitus, hypertension and dyslipidemia was 36%, 71.9% and 53.9% respectively. A comparison of baseline characteristics between the two groups showed that patients with a non-dominant RCA were more likely to be men. For inferior wall ischemia on SPECT MPI, patients in study group 2 had a significantly higher PPV, 32/42 (76.1%), compared to patients in group 1, in which only 3 out of the 29 patients (10.3%) had true positive results (P value < 0.001 Z test). The difference remained statistically significant even when only patients with left dominant coronary system (without co-dominant) were compared to patients with right dominant system (32/40, 76.1% in right dominant group, 3/19, 15.8% in left dominant group, P value < 0.001 Z test). There was no significant difference in mean hospital stay, re-hospitalization, and in-hospital mortality between the two groups. CONCLUSION: The positive predictive value of SPECT MPI for inferior wall ischemia is affected by coronary artery dominance. More studies are needed to explain this phenomenon.

ST-segment elevation myocardial infarction, systems of care. An urgent need for policies to co-ordinate care in order to decrease in-hospital mortality.

BACKGROUND: Regional trends for ST-segment elevation myocardial infarction (STEMI) treatment is not known in the state of Nevada. HYPOTHESIS: Great disparity exists for treatment for STEMI in different geographical areas of Nevada. There is a great potential to improve treatment and outcomes of STEMI patients in the State of Nevada. METHODS: Admissions to non-federal hospitals in the state of Nevada, using 2011 to 2013 discharge data from the Nevada State Inpatient Data Base (acquired from Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality), were analyzed. Outpatient-onset STEMI patients were identified. The state of Nevada was divided into three divisions based on population densities, defined as population per square mile. Division A included counties with population density of <50 per square mile, Division B included counties with population density of 50 to 200 per square mile, and Division C included counties with population density of >200 per square mile. Trends in use of STEMI-related therapies and the impact on in-hospital mortality rates were compared. RESULTS: Almost 20% of the patients with outpatient-onset STEMI do not get any STEMI-related therapy and have significantly higher mortality rate. Patients from Division A do not have direct access to percutaneous coronary intervention (PCI) centers. These patients receive less STEMI-related therapies. Low-volume PCI centers had equivalent mortality rates for STEMI patients who got PCI, compared to high-volume PCI centers. CONCLUSIONS: Policies must be created and processes streamlined so all STEMI patients in Nevada receive appropriate treatment.

Mesh complications and failure rates after transvaginal mesh repair compared with abdominal or laparoscopic sacrocolpopexy and to native tissue repair in treating apical prolapse.

OBJECTIVE: Our objective was to quantitate the extent of complications and failure rate for apical prolapse repair with transvaginal mesh (TVM) use versus sacrocolpopexy over a minimum of 2 years of follow-up. METHODS: Truven CCAE and Medicare Supplemental databases 2008-2013 were used for analysis. Patients with apical prolapse repair via transvaginal mesh (TVMR), abdominal sacrocolpopexy (ASCP), laparoscopic sacrocolpopexy (LSCP), or native tissue repair (NTR) and continuously enrolled for years were in the study cohort. Surgical failures were identified by reoperation for any prolapse or subsequent use of pessary. SAS® 9.3 was used for analysis. RESULTS: Mesh removal/revision was reported highest in TVMR (5.1 %), followed by LSCP (1.7 %) and ASCP (1.2 %). In those with concomitant sling, combined rates for mesh/sling revision were high, at 9.0 % in TVMR + sling, 5.6 % in ASCP + sling, and 4.5 % LSCP + sling. Sling-alone cases reported a 3.5 % revision rate. Pelvic pain (16.4-22.7 %) and dyspareunia (5.6-7.5 %) were high in all three approaches for apical prolapse repairs. Reoperation for apical prolapse was more common for TVMR (2.9 %) compared with NTR (2.3 %) [odds ratio (OR) 1.27; confidence interval (CI) 1.1-1.47; p 0.002]. Both ASCP and LSCP were superior to NTR (ASCP 1.5 %, OR 0.63, CI 0.46-0.86; p 0.003) and LSCP 1.8 % (OR 0.79, CI 0.62-1.01; p 0.07). Overall prolapse recurrence, as indicated by any compartment surgery for prolapse and/or pessary use, was also noted highest in TVMR (5.9 % OR 1.23, CI 1.11-1.36; p <0.0001). Laparoscopic sacrocolpopexies were slightly superior at 4.0 % overall recurrence (OR 0.83, CI 0.7-0.98); p 0.03). Failure of incontinence surgery was higher when the initial procedure combined prolapse and sling surgery (1.97 %) versus sling alone (1.6 %). CONCLUSIONS: Reoperation for apical prolapse is more common with TVMR than with sacrocolpopexies and NTR. Incontinence procedures are more likely to fail when performed along with prolapse repair than when performed alone. When mesh is used for repair, mesh revision is highest with TVMR and lowest with ASCP.

Current practice patterns for management of vulvodynia in the United States.

PURPOSE: To evaluate the current practice patterns for the management of vulvodynia in the United States (US) and to estimate healthcare costs related to this condition. METHODS: Truven MarketScan Commercial Claims and Encounters databases for years 2009-2013 were utilized for analysis. The study cohort included women, 18 years or older, with a diagnosis of vulvodynia (ICD-9 625.70), who had been continuously enrolled for 360 days from the date of diagnosis. Measures included the most common prescriptions, primary procedures, associated diagnoses, as well as net healthcare costs. Statistical Analysis Software 9.3 was used for statistical analysis. RESULTS: Among 24,122 subjects with vulvodynia, 12,584 met enrollment criteria. Mean age was 41.0 ± 12.9 years. Vulvar biopsy (29.6%), urinalysis (27.8%), urine culture (27.5%) and wet mount for infectious agents (25.5%) were commonly performed primary procedures. The most common prescriptions were antidepressants (32.4%), followed by opiates (27.6%), antifungals (26.1%), and steroidal agents (22.7%). Vulvodynia was frequently associated with vulvovaginitis (32.0%), urinary tract infection (20.6%), and chronic fatigue (18.6%). The mean net cost per patient including pharmacy claims during the follow-up period was $9591.80 (SD $14,595.52; 95% CI $9333.45-$9850.13). CONCLUSIONS: Our findings confirm great variation in the current management of vulvodynia. The variety of treatment approaches is a reflection of the poor current understanding of the etiology and pathophysiology of vulvodynia. Further research is needed to determine which treatments are most effective in the management of each subtype of vulvodynia.

Changes in Inflammatory and Bone Turnover Markers After Periodontal Disease Treatment in Patients With Diabetes.

BACKGROUND: The underlying mechanisms for increased osteopenia and fracture rates in patients with diabetes are not well understood, but may relate to chronic systemic inflammation. We assessed the effect of treating periodontal disease (POD), a cause of chronic inflammation, on inflammatory and bone turnover markers in patients with diabetes. MATERIALS AND METHODS: Using an investigator-administered questionnaire, we screened a cross-section of patients presenting for routine outpatient diabetes care. We recruited 22 subjects with POD. Inflammatory and bone turnover markers were measured at baseline and 3 months following POD treatment (scaling, root planing and subantimicrobial dose doxycycline). RESULTS: There were nonsignificant reductions in high-sensitivity C-reactive protein (6.34-5.52mg/L, P = 0.626) and tumor necrosis factor-alpha (10.37-10.01pg/mL, P = 0.617). There were nonsignificant increases in urinary C-terminal telopeptide (85.50-90.23pg/mL, P = 0.684) and bone-specific alkaline phosphatase (7.45-8.79pg/mL, P = 0.074). Patients with >90% adherence with doxycycline were 6.4 times more likely to experience reduction in tumor necrosis factor-alpha (P = 0.021) and 2.8 times more likely to experience reductions in high-sensitivity C-reactive protein (P = 0.133). CONCLUSIONS: Treatment of POD in patients with diabetes resulted in nonsignificant lowering of inflammatory markers and nonsignificant increase in bone turnover markers. However, adherence to doxycycline therapy resulted in better treatment effects.

DENTAL LOSS AMONG AMBULATORY PATIENTS WITH DIABETES.

AIMS: There is a high prevalence of dental loss among patients with diabetes. Understanding the factors that impact dental loss in this population will aid with developing new strategies for its prevention. METHODS: Using a cross-sectional study design, diabetes patients presenting for routine clinic visit were evaluated with an investigator-administered questionnaire. Data was collected on demographics, dental history, duration, control and complications of diabetes. RESULTS: Among 202 subjects, 100 were female, mean age: 58.9 ± 13.2 years, duration of diabetes: 15.8 ± 11.0 years, and hemoglobin A1c: 7.7 ± 1.6%. Thirty-one patients (15.3%) had lost all their teeth and only 13 (6.4%) had all 32 of their natural teeth. Using multiple linear regression, older age (ß= - 0.146; 95% CI: - 0.062 to - 0.230), not flossing (ß= - 3.462; 95% CI: - 1.107 to - 5.817), and presence of diabetic retinopathy (ß= - 4.271; 95% CI: - 1.307 to - 7.236) were significant predictors of dental loss. CONCLUSIONS: Dental loss is common in patients with diabetes and is associated with older age, diabetic retinopathy and not flossing. In order to reduce dental loss among patients with diabetes, regular flossing should be emphasized as an important component of dental care.