Tag: pubmed

J Manag Care Spec Pharm. 2022 Nov;28(11):1304-1315. doi: 10.18553/jmcp.2022.28.11.1304.

ABSTRACT

BACKGROUND: Direct oral anticoagulants (DOACs) have become widely used for the prevention of stroke in nonvalvular atrial fibrillation (AF) and for the treatment of venous thromboembolism (VTE). Warfarin, the standard of care prior to DOACs, requires monitoring and dose adjustment to ensure patients remain appropriately anticoagulated. DOACs do not require monitoring but are significantly more expensive. We sought to examine real-world effectiveness and costs of DOACs and warfarin in patients with AF and VTE. OBJECTIVE: To examine clinical and economic outcomes. The clinical objectives were to determine the bleeding and thrombotic event rates associated with DOACs vs warfarin. The economic objectives were to determine the cost associated with these events, as well as the all-cause medical and pharmacy costs associated with DOACs vs warfarin. METHODS: This analysis was an observational, propensity-matched comparison of retrospective medical and pharmacy claims data for members enrolled in an integrated health plan between October 1, 2015, and September 30, 2020. Members who were older than 18 years of age with at least 1 30-day supply of warfarin or a DOAC filled within 30 days of a new diagnosis of VTE or nonvalvular AF were eligible for the analysis. Cox hazard ratios were used to compare differences in clinical outcomes, where paired t-tests were used to evaluate economic outcomes. RESULTS: After matching, there were 893 patients in each group. Among matched members, warfarin was associated with increased risk of nonmajor bleeds relative to apixaban (hazard ratio [HR] = 1.526; P = 0.0048) and increased risk of pulmonary embolism relative to both DOACs (apixaban: HR = 1.941 [P = 0.0328]; rivaroxaban: HR = 1.833 [P = 0.0489]). No statistically significant difference was observed in hospitalizations or in length of stay between warfarin and either DOAC. The difference-in-difference (DID) in total costs of care per member per month for apixaban and rivaroxaban relative to warfarin were $801.64 (P = 0.0178) and $534.23 (P = 0.0998) more, respectively. DID in VTE-related cost for apixaban was $177.09 less, relative to warfarin (P = 0.0098). DID in all-cause pharmacy costs for apixaban and rivaroxaban relative to warfarin were $342.47 (P < 0.0001) and $386.42 (P < 0.001) more, respectively. CONCLUSIONS: Warfarin use was associated with a significant decrease in total cost of care despite a significant increase in VTE-related costs vs apixaban. Warfarin was also associated with a significant increase in other nonmajor bleeds relative to apixaban, as well as a significant increase in pulmonary embolism relative to both DOACs. Warfarin was associated with a significant reduction in all-cause pharmacy cost compared with either DOAC. DISCLOSURES: The authors of this study have nothing to disclose.

PMID:36282935 | DOI:10.18553/jmcp.2022.28.11.1304

J Manag Care Spec Pharm. 2022 Nov;28(11):1272-1281. doi: 10.18553/jmcp.2022.28.11.1272.

ABSTRACT

BACKGROUND: Migraineurs may be categorized as having episodic migraine (EM: < 15 headache days/month) or chronic migraine (CM: ≥ 15 days/month for > 3 months with ≥ 8 days/month having features of migraine). Opioid use has been linked to progression from EM to CM. OBJECTIVE: To describe the utilization of opioid prescriptions among patients with migraine, to determine the association between opioid use and migraine progression, and to explore demographic and clinical risk factors for migraine progression. METHODS: This retrospective cohort study used Optum’s deidentified Clinformatics Data Mart Database from January 2015 to December 2018. Adult patients with a migraine diagnosis and continuous health plan enrollment were included. Opioid use was measured by average daily morphine equivalent dose, also known as morphine milligram equivalent (MME). Descriptive statistics were used to summarize the opioid use by patient demographic and clinical characteristics. A Cox proportional hazards model with stepwise selection was used to determine the risk factors of new-onset CM. RESULTS: Overall, 35% of patients with migraine (27,331 of 78,134) received prescription opioids (> 0 MME/day) during the 12-month follow-up period. Higher opioid dosage was found in patients who had CM and comorbidities of interest. Compared with patients with EM, patients with CM were twice as likely to receive at least 20 MME/day (CM 3.8% vs EM 1.9%) and had a higher median opioid day supply (CM 20 vs EM 10) during follow-up. About 7% of patients with CM with at least 1 opioid prescription had at least 50 MME/day in any 90-day period during follow-up. A significant association was found between MME level and the likelihood of new-onset CM. Additional significant risk factors of migraine progression included younger age, female sex, South and West regions, and having a diagnosis of medication overuse headache, depression, back pain, or fibromyalgia (all P < 0.05). CONCLUSIONS: Despite guidelines and the availability of more migraine-specific treatments, opioids are still commonly prescribed to patients with migraines in real-world practice, especially for those with CM. In this study population, a higher risk of new-onset CM was associated with receiving higher opioid doses.

PMID:36282930 | DOI:10.18553/jmcp.2022.28.11.1272

J Manag Care Spec Pharm. 2022 Nov;28(11):1200-1206. doi: 10.18553/jmcp.2022.28.11.1200.

ABSTRACT

BACKGROUND: As new rare-disease drug therapy, gene therapies, and high-priced cancer drugs receive US Food and Drug Administration approval, there is an increasing potential for drug super spender individuals with more than $250,000 annual drug cost. OBJECTIVE: To categorize all members in a large, commercially insured population by their total annual combined drug costs from both medical and pharmacy benefits and to determine the trend in drug super spender prevalence. METHODS: Using a commercially insured population with integrated medical and pharmacy benefits, all unique members with any enrollment between January 2016 and December 2019 were identified. The sum of total cost for all pharmacy claims plus all medical benefit claim lines for drugs was determined for each member, for each calendar year. Cost was defined as the plan plus member liability at network-discounted price, with no further adjustment for any coupons or rebates. Descriptive statistics were used to describe the drug super spender growth. RESULTS: There was an average of 17.9 million members per year with at least 1 month of eligibility through the 4-year study period. In 2016, a total of 2,994 members with more than $250,000 drug cost per member accounted for $1,324 million drug spend. In 2019, there were 5,894 super spender members (97% increase), accounting for $2,579 million drug cost (95% increase), which was 9.6% of $26,618 million total drug spend. CONCLUSIONS: In this large, commercially insured population, a small (32 per 100,000) number of drug super spender members comprise a disproportionate portion of the total drug expenditures, at $1 of every $10 dollars of total drug expenditures. Health plans need to understand the drug super spender trend and develop strategies to maintain health care affordability. DISCLOSURES: This study was funded internally by Prime Therapeutics LLC. Drs Starner and Gleason are employees of Prime Therapeutics LLC, a pharmacy benefits management company. Dr Bowen is a former employee of Prime Therapeutics LLC.

PMID:36282927 | DOI:10.18553/jmcp.2022.28.11.1200

J Manag Care Spec Pharm. 2022 Nov;28(11):1321-1330. doi: 10.18553/jmcp.2022.28.11.1321.

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) imposes substantial health care and economic burden on health care systems and patients. Previous studies failed to examine health care resource utilization (HCRU) and costs among patients with incident AF and potential disparity with regard to geographic location. OBJECTIVES: To examine HCRU and costs among patients with incident AF compared with patients without AF and examine whether a geographic disparity exists. METHODS: This was a retrospective cohort study. We selected patients with AF and patients without AF from IBM/Watson MarketScan Research Databases 2014-2019. HCRU and costs were collected 12 months following an AF index date. We used 2-part models with bootstrapping to obtain the marginal estimates and CIs. Rural status was identified based on Metropolitan Statistical Area. We adjusted for age, sex, plan type, US region, and comorbidities. RESULTS: Among 156,732 patients with AF and 3,398,490 patients without AF, patients with AF had 9.04 (95% CI = 8.96-9.12) more outpatient visits, 0.82 (95% CI = 0.81-0.83) more emergency department (ED) visits, 0.33 (95% CI = 0.33-0.34) more inpatient admission, and $15,095 (95% CI = 14,871-15,324) higher total costs, compared with patients without AF. Among patients with AF, rural patients had 1.99 fewer (95% CI = -2.26 to -1.71) outpatient visits and 0.05 (95% CI = 0.02-0.08) more ED visits than urban patients. Overall, rural patients with AF had decreased total costs compared with urban patients (mean = $751; 95% CI = -1,227 to -228). CONCLUSIONS: Incident AF was associated with substantial burden of health care resources and an economic burden, and the burden was not equally distributed across patients in urban vs rural settings. DISCLOSURES: Dr Hansen reports grants from the National Science Foundation during the conduct of the study.

PMID:36282926 | DOI:10.18553/jmcp.2022.28.11.1321

J Manag Care Spec Pharm. 2022 Nov;28(11):1213-1218. doi: 10.18553/jmcp.2022.28.11.1213.

ABSTRACT

BACKGROUND: Early after the onset of the COVID-19 pandemic, concerns were raised that the use of psoriasis treatments, particularly biologic therapies because of their immunosuppressant effects, could be associated with a poor prognosis in the case of COVID-19 infection. OBJECTIVE: To examine changes in adherence to systematic biologic therapies for psoriasis after the onset of the COVID-19 pandemic. METHODS: Using IQVIA medical and pharmacy claims data from January 1, 2018, to October 31, 2020, we identified patients aged 18 years or older who had a diagnosis of plaque psoriasis in 2018 and who received systemic biologic therapies for psoriasis, including both provider-administered and pharmacy-dispensed therapies. We calculated the incidence of 14-day gaps without therapy per 1,000 study participants for each 30-day interval. We constructed interrupted time series analyses to test changes in the incidence of outcomes after the pandemic declaration. RESULTS: The sample included 15,890 study participants: 45.4% were female and 15.2% were aged 65 years or older. For patients using biologic therapies dispensed from the pharmacy, there was a 13.1% decrease in the incidence of 14-day gaps without biologic therapy immediately after pandemic declaration, from 92.4 gaps per 1,000 patients to 80.2 gaps per 1,000 patients, but this decrease was not statistically significant. However, for patients using provider-administered therapies, the incidence of 14-day gaps without biologic therapy increased by 55.1% after pandemic declaration, from 29.0 gaps per 1,000 patients to 44.9 gaps per 1,000 patients (P < 0.01). CONCLUSIONS: Following the onset of the COVID-19 pandemic, we found an increased incidence of gaps in biologic therapy for psoriasis among users of provider-administered treatments but not among users of pharmacy-dispensed therapies. DISCLOSURES: Dr Hernandez reports personal fees from Bristol Myers Squibb and personal fees from Pfizer outside the submitted work. Dr Hernandez is funded by the National Heart, Lung and Blood Institute (grant K01HL142847). The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The statements, findings, conclusions, views, and opinions expressed in this publication are based on data obtained under license from IQVIA as part of the IQVIA Institute’s Human Data Science Research Collaborative.

PMID:36282925 | DOI:10.18553/jmcp.2022.28.11.1213

Gut. 2022 Sep 5:gutjnl-2022-328188. doi: 10.1136/gutjnl-2022-328188. Online ahead of print.

NO ABSTRACT

PMID:36282906 | DOI:10.1136/gutjnl-2022-328188

Aesthet Surg J. 2022 Oct 25:sjac273. doi: 10.1093/asj/sjac273. Online ahead of print.

ABSTRACT

BACKGROUND: The main disadvantages of wearing a compression garment following abdominoplasty are the increase in intra-abdominal pressure and risk of venous stasis. On the one hand, the wearing of garments may increase the risk of venous thromboembolism. On the other hand, it may be beneficial in decreasing edema formation after surgery.

OBJECTIVES: To evaluate the effectiveness of compression garments in reducing subcutaneous edema after abdominoplasty.

METHODS: Thirty-two women aged from 19 to 50 years were selected and randomly allocated to either the garment (n = 16) or no-garment (n = 16) group. All patients underwent abdominoplasty and received 10 sessions of manual lymphatic drainage during the postoperative period. Postoperative edema formation was assessed by perimetry and bioimpedance, and seroma formation was assessed by ultrasound. The statistical tests included Student’s t test, mixed linear models, analysis of variance with repeated measures, and the Kolmogorov-Smirnov test, which were performed at a significance level α of 0.05 (p ≤ 0.05).

RESULTS: The no-garment group showed a trend toward lower mean waist circumference (WC) at 29 days following abdominoplasty and significantly lower WC after postoperative day 35 compared to values from the garment group (p < 0.001). The mean total body water was slightly lower in the no-garment group than in the garment group 7 days after surgery (p = 0.05).

CONCLUSIONS: Patients who did not wear a compression garment after abdominoplasty showed less subcutaneous edema formation after 24 days of surgery than those who wore the garment.

PMID:36282895 | DOI:10.1093/asj/sjac273

PLoS One. 2022 Oct 25;17(10):e0276444. doi: 10.1371/journal.pone.0276444. eCollection 2022.

ABSTRACT

To examine the effectiveness of a play-based intervention for improving social play skills of typically-developing playmates of children with ADHD. Children (5-11 years) were randomised to an intervention (n = 15) or waitlisted control group (n = 14). The Test of Playfulness was scored by a blinded rater. Between-group statistics compared the change of the intervention (10-week intervention) and waitlisted control (10-week wait) groups. Change in the intervention group following intervention was significantly greater than the change in the waitlisted control group. When combining data from the groups, playmates’ (n = 29) mean ToP scores improved significantly following intervention, with a large effect pre- to post-intervention and pre-intervention to follow-up. Typically-developing playmates of children with ADHD benefited from participation in a peer-mediated intervention.

PMID:36282854 | DOI:10.1371/journal.pone.0276444

Integr Environ Assess Manag. 2022 Oct 25. doi: 10.1002/ieam.4704. Online ahead of print.

ABSTRACT

The process of producing information about dynamic land use/land cover and ecosystem health in a short time with high accuracy and low cost is important. This information is one of the basic data used for sustainable land management. For this purpose, remote sensing technologies are generally used, and sampling points are mostly assigned. Determination of the optimum number of sampling points using the I-Tree Canopy Tool was the main focus of this study. The I-Tree Canopy Tool classifies land cover, revealing the effects of tree cover on ecosystem services, such as carbon sequestration and storage, temperature regulation, air pollutant filtering, and air quality improvement, with numerical data. It is used since it is practical, open source, and user-friendly. This software works based on sampling point assignment, but it is unclear how many sampling points should be assigned. Therefore, determining the optimum number of sample points by statistical methods will increase the effectiveness of this tool and will guide users. For this purpose, reference data were created for comparison. Then, 31 I-Tree Canopy reports were created with 100-point increments up to 3100. The data obtained from the reports were compared with the reference data, and statistical analysis based on Gaussian and a second-order polynomial fit was performed. At the end of the analysis, the following results were obtained; the results of this study showed that the optimum number of sample points for a 1-ha area is 760±32 from the comparison of the real area and I-Tree Canopy results. Similar results from the Gaussian fit of annually sequestered and stored carbon and CO₂ amounts in trees and the reduction of air pollution in grams were obtained as 714±16. Therefore, we may conclude that the sample points taken more than 800 will not create a statistically significant difference. This article is protected by copyright. All rights reserved. Integr Environ Assess Manag 2022;00:0-0. © 2022 SETAC.

PMID:36281815 | DOI:10.1002/ieam.4704

Brain. 2022 Oct 25:awac285. doi: 10.1093/brain/awac285. Online ahead of print.

ABSTRACT

Repetitive transcranial magnetic stimulation (rTMS) is emerging as a non-invasive therapeutic strategy in the battle against Alzheimer’s disease. Alzheimer’s disease patients primarily show alterations of the default mode network for which the precuneus is a key node. Here, we hypothesized that targeting the precuneus with TMS represents a promising strategy to slow down cognitive and functional decline in Alzheimer’s disease patients. We performed a randomized, double-blind, sham-controlled, phase 2, 24-week trial to determine the safety and efficacy of precuneus stimulation in patients with mild-to-moderate Alzheimer’s disease. Fifty Alzheimer’s disease patients were randomly assigned in a 1:1 ratio to either receive precuneus or sham rTMS (mean age 73.7 years; 52% female). The trial included a 24-week treatment, with a 2-week intensive course in which rTMS (or sham) was applied daily five times per week, followed by a 22-week maintenance phase in which stimulation was applied once weekly. The Clinical Dementia Rating Scale-Sum of Boxes was selected as the primary outcome measure, in which post-treatment scores were compared to baseline. Secondary outcomes included score changes in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, Mini-Mental State Examination and Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale. Moreover, single-pulse TMS in combination with EEG was used to assess neurophysiological changes in precuneus cortical excitability and oscillatory activity. Our findings show that patients that received precuneus repetitive magnetic stimulation presented a stable performance of the Clinical Dementia Rating Scale-Sum of Boxes score, whereas patients treated with sham showed a worsening of their score. Compared with the sham stimulation, patients in the precuneus stimulation group also showed also significantly better performances for the secondary outcome measures, including the Alzheimer’s Disease Assessment Scale-Cognitive Subscale, Mini-Mental State Examination and Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale. Neurophysiological results showed that precuneus cortical excitability remained unchanged after 24 weeks in the precuneus stimulation group, whereas it was significantly reduced in the sham group. Finally, we found an enhancement of local gamma oscillations in the group treated with precuneus stimulation but not in patients treated with sham. We conclude that 24 weeks of precuneus rTMS may slow down cognitive and functional decline in Alzheimer’s disease. Repetitive TMS targeting the default mode network could represent a novel therapeutic approach in Alzheimer’s disease patients.

PMID:36281767 | DOI:10.1093/brain/awac285