We assessed the relationship between GnRH agonists and the risk of clinical fractures in men with prostate cancer.
Using a database of medical claims from 16 large American companies we identified a ...study group of 3,779 men with prostate cancer who received treatment with a GnRH agonist and a control group of 8,341 with prostate cancer who were not treated with a GnRH agonist. Men with 1 or more medical claims for bone metastases were excluded. The rates of any clinical fracture, hip fracture and vertebral fracture were compared between the groups.
The rate of any fracture was 7.91/100 vs 6.55/100 person-years at risk in men who received vs did not receive a GnRH agonist (relative risk 1.21, 95% CI 1.09 to 1.34). The rates of hip fracture (relative risk 1.76, 95% CI 1.33 to 2.33) and vertebral fracture (relative risk 1.18, 95% CI 0.94 to 1.48) were also higher in men who received a GnRH agonist. GnRH agonist treatment was independently associated with fracture risk on multivariate analyses.
GnRH agonists increase the risk of clinical fracture in men with prostate cancer.
The aims of this study were to assess glycemic control, weight loss, and durability of glycemic control in patients initiated on canagliflozin (CANA) versus sitagliptin (SITA).
Adults with type II ...diabetes mellitus initiated on CANA or SITA (index date) were identified from IQVIA™ Real-World Data Electronic Medical Records – US database (03/29/2012–04/30/2016). Inverse probability of treatment weighting accounted for baseline differences between cohorts. Outcomes were compared using weighted Cox regression and Kaplan-Meier curves and included time to reaching HbA1c thresholds (<7%53 mmol/mol, <8%64 mmol/mol, <9%75 mmol/mol), weight loss ≥5%, failure to maintain HbA1c below threshold, new antihyperglycemic (AHA) prescription, and failure to maintain HbA1c/new AHA prescription.
Weighted cohorts were well balanced (NCANA = 14,542; NSITA = 15,151). CANA patients were 12–15% more likely to reach the HbA1c thresholds, 47% more likely to lose ≥5% of body weight, 31% less likely to have a new AHA prescription, 10–15% less likely to fail to maintain HbA1c, and 13–26% less likely to fail to maintain HbA1c or have a new AHA, versus SITA patients.
CANA patients were more likely to reach HbA1c and weight loss thresholds and maintain HbA1c below threshold versus SITA patients, while being less likely to have a prescription for a new AHA, suggesting more durable glycemic control with CANA.
Introduction
Dolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen for HIV-1 treatment with long-term efficacy and good tolerability comparable to 3- or 4-drug regimens. This study evaluated DTG/3TC ...cost versus other standard single-tablet regimens during its first year of approval.
Methods
This retrospective study analyzed US claims data from adults with HIV-1. Eligibility criteria included ≥ 1 dispensing of DTG/3TC, DTG/abacavir (ABC)/3TC, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF, and darunavir (DRV)/COBI/FTC/TAF (index date was first dispensing) and ≥ 6 months of continuous eligibility before index date (baseline period). All-cause and HIV-related healthcare costs were evaluated during the observation period (index date until earliest of end of continuous eligibility or data availability). Adjusted cost differences and adjusted cost ratios were estimated using multivariable regression models controlling for differences in baseline characteristics between cohorts.
Results
Overall, 22,061 individuals with HIV-1 and dispensed treatment with DTG/3TC (
n
= 590), DTG/ABC/3TC (
n
= 4355), BIC/FTC/TAF (
n
= 9068), EVG/COBI/FTC/TAF (
n
= 7081), or DRV/COBI/FTC/TAF (
n
= 967) were included. Most claims data were from men (mean age ~ 46 years). Mean unadjusted all-cause total healthcare costs per patient per month were significantly lower for DTG/3TC versus BIC/FTC/TAF and DRV/COBI/FTC/TAF, and mean unadjusted HIV-related healthcare costs per patient per month were significantly lower for DTG/3TC versus DRV/COBI/FTC/TAF. Cost differences were primarily driven by significantly lower pharmacy costs for DTG/3TC versus other regimens (
P
< 0.001), while medical costs were similar across cohorts. Results were similar among treatment-naive and treatment-experienced individuals. After adjusting for baseline covariates, significant adjusted cost differences were generally consistent with unadjusted findings. Adjusted cost ratios generally favored DTG/3TC for all-cause healthcare and HIV-related costs, with all pharmacy cost ratios favoring DTG/3TC (
P
< 0.001).
Conclusion
Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.
Introduction
For many, atopic dermatitis (AD) is not adequately controlled with topical regimens. This analysis examined treatment using advanced therapies and associated costs.
Methods
The IQVIA ...Health Plan Claims data set was analyzed. Patients aged ≥ 12 years with AD who newly initiated advanced therapy after the availability of dupilumab (March 28, 2017) and had ≥ 6 months continuous enrollment before and after their first advanced therapy claim (index date) were included. Advanced therapies included dupilumab, systemic corticosteroids (SCSs), systemic immunosuppressants (SISs), and phototherapy. A multivariate regression model was used to predict annualized follow-up healthcare costs.
Results
In total, 1980 patients were included (61.1% female; mean age, 41.2 years SD, 17.4; 11.3% < 18 years). Pre-index date, 65.2% of patients used topical corticosteroids (TCSs; 40.7% and 32.1% used medium and high potency, respectively). The most common advanced therapy was SCSs (
N
= 1453 73.4%; 69.2% prednisone) followed by dupilumab (
N
= 265 13.4%), SISs (
N
= 99 5.0%; 47.5% methotrexate), and phototherapy (
N
= 163 8.2%). Of patients treated with dupilumab, SISs, and phototherapy, 17.4%, 26.3%, and 14.1%, respectively, were prescribed SCSs post-index date. Overall, 62.6% of patients initiating SCSs, 49.1% initiating dupilumab, 64.6% initiating SISs, and 36.2% initiating phototherapy were prescribed TCSs post-index date. Mean annualized total costs (SD) post-index date were $20,722 ($47,014): $11,196 ($41,549) in medical costs ($7973 $35,133 in outpatient visit costs) and $9526 ($21,612) in pharmacy costs. Mean annualized total cost (SD) varied significantly (
P
< 0.05) by index treatment: dupilumab, $36,505 ($14,028); SCSs, $17,924 ($49,019); SISs, $24,762 ($47,583); phototherapy, and $17,549 ($57,238).
Conclusions
Switching to combination therapy with SCSs and TCSs was common within 6 months of initiating advanced therapy in patients with AD. Patients also incurred significant pharmacy and outpatient costs. These results highlight the difficulty of managing AD with these existing treatment options.
Achievement of MR4.5 (BCR-ABL1 ≤ 0.0032% on international scale) is an important goal of tyrosine kinase inhibitor (TKI) treatment for patients with chronic myeloid leukemia (CML). This study ...describes treatment patterns by region and assesses time to achieve MR4.5 in patients with CML - chronic phase (CP) treated with second-line nilotinib or dasatinib in 10 countries. A multivariate Cox proportional hazards model was used to assess time to MR4.5 for nilotinib versus dasatinib. The model accounted for the competing-risk event of TKI resistance, included random effects for country clustering, and was adjusted for baseline covariates. The study included 280 patients treated with either nilotinib (N = 135 48%) or dasatinib (N = 145 52%) as second-line TKI with median treatment durations of 19.1 and 18.7 months, respectively. Nilotinib was observed to be better in achieving MR4.5 than dasatinib (adjusted hazard ratio = 1.37, 95% CI 1.11, 1.69) suggesting second-line nilotinib may perform better in achieving MR4.5 than dasatinib.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
To quantify the clinical and economic burden of uncontrolled epilepsy in patients requiring emergency department (ED) visit or hospitalization.
Health insurance claims from a 5-state Medicaid ...database (1997Q1-2009Q2) and 55 self-insured US companies ("employer," 1999Q1 and 2008Q4) were analyzed. Adult patients with epilepsy receiving antiepileptic drugs (AED) were selected. Using a retrospective matched-cohort design, patients were categorized into cohorts of "uncontrolled" (≥ 2 changes in AED therapy, then ≥ 1 epilepsy-related ED visit/hospitalization within 1 year) and "well-controlled" (no AED change, no epilepsy-related ED visit/hospitalization) epilepsy. Matched cohorts were compared for health care resource utilization and costs using multivariate conditional regression models and nonparametric methods.
From 110,312 (Medicaid) and 36,529 (employer) eligible patients, 3,454 and 602 with uncontrolled epilepsy were matched 1:1 to patients with well-controlled epilepsy, respectively. In both populations, uncontrolled epilepsy cohorts presented about 2 times more fractures and head injuries (all p values < 0.0001) and higher health care resource utilization (ranges of adjusted incidence rate ratios IRRs all-cause utilization: AEDs = 1.8-1.9, non-AEDs = 1.3-1.5, hospitalizations = 5.4-6.7, length of hospital stays = 7.3-7.7, ED visits = 3.7-5.0, outpatient visits = 1.4-1.7, neurologist visits = 2.3-3.1; all p values < 0.0001) than well-controlled groups. Total direct health care costs were higher in patients with uncontrolled epilepsy (adjusted cost difference 95% confidence interval (CI) Medicaid = $12,258 $10,482-$14,083; employer = $14,582 $12,019-$17,097) vs well-controlled patients. Privately insured employees with uncontrolled epilepsy lost 2.5 times more work days, with associated indirect costs of $2,857 (95% CI $1,042-$4,581).
Uncontrolled epilepsy in patients requiring ED visit or hospitalization was associated with significantly greater health care resource utilization and increased direct and indirect costs compared to well-controlled epilepsy in both publicly and privately insured settings.
Abstract Background In metastatic castration-resistant prostate cancer (mCRPC), optimal treatment sequences are unknown. We assessed second-line taxane (TT) versus androgen receptor-targeted therapy ...(ART), after initial ART failure, in US oncology community practices. Patients and methods Using electronic medical records, mCRPC patients receiving first-line ART and second-line therapy (TT, ART) were identified. Response and overall survival (OS) were evaluated from second-line therapy initiation. Multivariate analyses were adjusted for year, age, metastases, opioid use, prostate-specific antigen (PSA), hemoglobin, alkaline phosphatase (ALP) and albumin levels. Results Of 546 patients receiving first-line ART, 206 and 340 received second-line TT and ART. Compared with patients receiving second-line ART, patients receiving TT were younger (median: 74 vs. 79 years), more had intermediate-high Halabi risk scores (59% vs. 35%), had higher opioid use (42% vs. 22%), median PSA (116 vs. 48 ng/mL), ALP (112 vs. 87 U/L), and lactate dehydrogenase (254 vs. 201 U/L), and had lower hemoglobin (11.2 vs. 12.3 g/dL) and albumin levels (3.8 vs. 4.0 g/dL); all P <0.001. Response rates were higher with second-line TT versus ART (clinical response: 44.2% vs. 24.7%; P =0.006; PSA response: 44.5% vs. 28.7%; P =0.004). OS did not differ between cohorts (hazard ratio HR=0.90; P =0.511). Among poor prognosis patients (hemoglobin <11 g/d; albumin <LLN), those receiving second-line TT versus ART showed improved OS (HR=0.52; P =0.004; HR=0.36; P =0.003, respectively). Conclusions Despite more severe disease profiles, mCRPC patients receiving second-line TT versus ART achieved higher response rates after initial ART. Poor prognosis patients had improved OS with second-line TT versus ART.
The present meta-analysis was undertaken to (1) assess erythroid response rates in myelodysplastic syndromes (MDS) patients treated with epoetin alfa as a monotherapy, (2) gain further insights into ...predictors of response rates, and (3) compare the erythroid response rates observed with epoetin alfa and darbepoetin alfa. A systematic review of studies from 1990 to 2006 in MDS patients treated with epoetin alfa or darbepoetin alfa was performed and yielded 30 studies evaluating a total of 1,314 patients (epoetin alfa: 22 studies, 925 patients; darbepoetin alfa: eight studies, 389 patients). Pooled estimates of erythroid response rates, stratified by the International Working Group criteria (IWGc) and treatment group, were calculated using random-effects meta-analysis methods. Univariate meta-regression analyses were further conducted to identify study characteristics associated with erythroid response rate. The pooled estimate of erythroid response rate was significantly higher for epoetin alfa IWGc studies (57.6%) as compared to non-IWGc studies (31.6%;
p
< 0.001). Study factors predictive of higher response rate in the epoetin alfa IWGc studies included higher proportion of patients with RA/RARS (
p
< 0.001), lower mean baseline serum erythropoietin level (
p
= 0.007), and fixed dosing regimen (
p
< 0.001). There was no significant difference in the pooled erythroid response rates between the two agents (epoetin alfa: 57.6% vs. darbepoetin alfa: 59.4%;
p
= 0.828). The current study reported significantly higher erythroid response rates predominantly in the more recent studies that primarily utilized IWGc to define response. With the use of standardized patient selection and response evaluation methods, epoetin alfa and darbepoetin alfa yielded comparable erythroid response rates in MDS patients.
Background
The cost of pregnancy is increasing over time despite the decline in pregnancy rates.
Objective
To fully elucidate and evaluate the cost drivers of pregnancy in the US for payers, a ...systematic review was conducted to understand the main cost components and primary factors that contribute to the direct costs of pregnancy, pregnancy-related complications and unintended pregnancy among women of childbearing age (15–44 years).
Data Sources
We performed electronic searches in the PubMed database from January 2000 to December 2012, and major women’s health and pharmacoeconomics conference proceedings from 2011 to 2012.
Study Selection
The systematic review is comprised of studies that reported pregnancy, pregnancy-related complications, unplanned pregnancy, and pregnancy-induced monetary costs. The review excluded narrative reports, systematic reviews, model-derived cost of pregnancy papers, non-US-based studies, and reports based solely on expert opinions.
Study Appraisal and Synthesis Methods
Two reviewers independently applied the inclusion criteria and assessed the quality of the data collected. Disagreements between reviewers were resolved by consensus or by arbitration through a third party, with reference to the original sources. We collected information on the study design and outcomes for each included study. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines in designing, performing, and reporting of the systematic review.
Results
We identified 40 studies from electronic and handsearching methods. We classified studies based on the primary research topic focusing on the overall cost of pregnancy (
N
= 10), cost of pregnancy-related complications (
N
= 26), cost of unintended pregnancy (
N
= 2), cost of planned pregnancy (
N
= 1), or cost of pregnancy by facilities (
N
= 1). In the quality assessment, randomized, non-randomized, and retrospective database studies had low to moderate risk of bias. We determined primary cost drivers based on the highest cost reported in each study. The identified cost drivers were inpatient care, pregnancy delivery, multiple births, complicated cesarean sections, high-risk pregnancy, preterm birth, low birth weight, complications due to conditions such as hypertension, diabetes, anemia, and cancer, and in vitro fertilization. In 2008, the overall mean cost per hospital stay for pregnancy-related incidence ranged from $3,306 to $9,234 in 2012 dollars. The mean cost of pregnancy-related complications that led to preterm birth was as high as $326,953 for an infant born at 25 weeks. It is estimated that over 50 % of live births were unintended in the US. The difference in the cost of unintended pregnancy and intended pregnancy was approximately $536 million.
Limitations
One limitation of the systematic review was the exclusion of model-based cost studies which were excluded because of the high level of variation and heterogeneity across sources of reported cost. Another limitation of the review is that the cost of pregnancy perspective is restricted to the US.
Conclusion
Preventing pregnancy-related complications and reducing unintended pregnancies may lower the overall economic burden of pregnancy on the US health care system.
As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many ...prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media.
To evaluate compliance among licensed firms with the Cannabis Act and analyze trends among violations regarding promotional material.
This cross-sectional study evaluated cannabis-licensed firms after cannabis legalization. Data were extracted from online public platforms, including company websites, Facebook, Instagram, and Twitter, from October 1, 2019, to March 31, 2020. Descriptive statistics, Poisson regression, and logistic regression were used to analyze the associations of covariates with promotion violations.
The primary outcome was characterization of type and prevalence of promotion violations. Secondary outcomes were the role of various covariates (namely, licensed firm characteristics and online platforms) in the frequency and probability of violations. Hypotheses were formulated before data collection.
Among 261 licensed firms, 211 (80.8%) had an online platform, including 204 (96.7%) with websites, 128 (60.7%) with Facebook, 123 (58.3%) with Instagram, and 123 (58.3%) with Twitter. Of all licensed firms with an online platform, 182 (86.3%) had at least 1 violation. Compared with websites, the risk of violations was significantly higher on Facebook (rate ratio RR, 1.24; 95% CI, 1.11-1.39) and Instagram (RR, 1.19; 95% CI, 1.05-1.34). The most common violations included lack of age restrictions, brand glamorization, and omission of risk information. With websites as the reference group, lack of age restrictions was approximately 15 times more likely to occur on Facebook (odds ratio OR, 14.76; 95% CI, 8.06-27.05); the odds of an age restriction violation were also higher on Instagram (OR, 2.48; 95% CI, 1.43-4.32) and Twitter (OR, 4.03; 95% CI, 2.29-7.09). For unsubstantiated claims, the odds of violations were significantly decreased on Facebook (OR, 0.23; 95% CI, 0.11-0.48) and Instagram (OR, 0.28; 95% CI, 0.14-0.57). The odds of glamorization were associated with an increase on Instagram (OR, 2.90; 95% CI, 1.72-4.88).
In this cross-sectional study, widespread violations were observed in online Canadian cannabis promotion. To protect public health and safety amid legalization, decision-makers should make explicit federal regulation and enforcement regarding promotional activities of cannabis retailers. These results suggest that policy and enforcement of cannabis promotion in Canada would have an international impact, from ease of access to online media and downstream consequences of unregulated promotion.
PDF
