BackgroundThe American Heart Association recognizes high triglycerides as a cardiovascular risk factor.Methods and ResultsThis retrospective observational administrative claims analysis (Optum Research Database) included statin‐treated patients ≥45 years old with diabetes mellitus and/or atherosclerotic cardiovascular disease, triglycerides 2.26 to 5.64 mmol/L, and a propensity‐matched comparator cohort with triglycerides <1.69 mmol/L and high‐density lipoprotein cholesterol >1.04 mmol/L. In the high‐triglycerides cohort versus comparators (both n=10 990, 49% women), mean age was 61.7 versus 62.2 years and follow‐up was 41.3 versus 42.1 months, respectively. Multivariate analysis of composite major cardiovascular events demonstrated significantly increased risk in the high‐triglycerides (n=13 411 patients) versus comparator (n=32 506 patients) cohorts (hazard ratio [HR], 1.35; 95% confidence interval [CI], 1.225–1.485; P<0.001), with significantly higher risk for nonfatal myocardial infarction (HR, 1.35; 95% CI, 1.19–1.52; P<0.001), nonfatal stroke (HR, 1.27; 95% CI, 1.14–1.42; P<0.001), and need for coronary revascularization (HR, 1.51; 95% CI, 1.34–1.69; P<0.001), but not unstable angina or cardiovascular death. Increased cardiovascular risk in the high‐triglycerides versus comparator cohort was maintained, even with addition of non–high‐density lipoprotein cholesterol to the multivariate model and when analyzing high and low high‐density lipoprotein cholesterol subgroups. Average total healthcare cost per patient per month (cost ratio, 1.15; 95% CI, 1.084–1.210; P<0.001) and rate of occurrence of inpatient hospital stay (HR, 1.17; 95% CI, 1.113–1.223; P<0.001) were also significantly greater in the high‐triglycerides cohort.ConclusionsIn this real‐world analysis, patients with high cardiovascular risk and high triglycerides had worse composite cardiovascular and health economic outcomes than patients with well‐managed triglycerides and high‐density lipoprotein cholesterol >1.04 mmol/L.
Objective: To retrospectively investigate the real-world impact of elevated triglyceride (TG) levels on cardiovascular (CV) outcomes, medical resource utilization, and medical costs using observational administrative claims data from the Optum Research Database. Methods: Patients with one or more claims for statin therapy between January 1, 2010, and December 31, 2010, and 6 months or more of baseline data prior to the index date were eligible for inclusion in the study. Patients aged 45 years or older with diabetes and/or atherosclerotic CV disease were included and analyzed in an elevated TG cohort (!150 mg/dL) vs a comparator cohort with TG levels less than 150 mg/dL and high-density lipoprotein cholesterol (HDL-C) levels greater than 40 mg/dL. Results: In the elevated TG vs propensity-matched comparator cohorts (both N¼23,181 patients), the mean age was 62.2 vs 62.6 years, mean follow-up was 41.4 vs 42.5 months, 49.7% (11,518) vs 49.5% (11,467) were female, 83.7% (19,392) vs 84.0% (19,478) had diabetes, and 29.8% (6915) vs 29.3% (6800) had atherosclerotic CV disease. In the elevated TG (N¼27,471 patients) vs comparator (N¼32,506 patients) cohorts, multivariate analysis revealed significantly greater risk of composite major CV events (hazard ratio [HR], 1.26; 95% CI, 1.19-1.34; P<.001), nonfatal myocardial infarction (HR, 1.32; 95% CI, 1.20-1.45; P<.001), nonfatal stroke (HR, 1.14; 95% CI, 1.04-1.24; P¼.004), and need for coronary revascularization (HR, 1.46; 95% CI, 1.33-1.61; P<.001) but not unstable angina (P¼.53) or CV death (P¼.23). Increased CV risk was maintained with the addition of noneHDL-C to the multivariate model and with high and low HDL-C subgroup analysis. Total direct health care costs (cost ratio, 1.12; 95% CI, 1.08-1.16; P<.001) and inpatient hospital stays (HR, 1.13; 95% CI, 1.10-1.17; P<.001) were significantly higher in the elevated TG cohort vs the comparator cohort. Conclusion: Statin-treated patients with TG levels of 150 mg/dL or greater had worse CV and health economic outcomes than those with well-managed TG (<150 mg/dL) and HDL-C (>40 mg/dL) levels.
Background: Magnetic Resonance Imaging (MRI) of patients with implanted cardiac devices is currently considered hazardous due to potential for electromagnetic interference to the patient and pacemaker system. With approximately 60 million MRI scans performed worldwide per year, an estimated majority of pacemaker patients may develop an indication for an MRI during the lifetime of their pacemakers, suggesting that safe use of pacemakers in the MRI environment would be clinically valuable. A new pacing system (Medtronic EnRhythm MRI™ SureScan™ and CapSureFix MRI™ leads) has been designed and pre-clinically tested for safe use in the MRI environment. The EnRhythm MRI study is designed to confirm the safety and efficacy of this new pacing system.
Several new medications for pulmonary arterial hypertension (PAH) have recently been introduced; however, current real-world data regarding US patients with PAH are limited. We conducted a retrospective administrative claims study to examine PAH treatment patterns and summarize healthcare utilization and costs among patients with newly diagnosed PAH treated in US clinical practice. Patients newly treated for PAH from 1 January 2010 to 31 March 2015 were followed for ≥12 months. Patient characteristics, treatment patterns, healthcare resource utilization, and costs were described. Adherence (proportion of days covered), persistence (months until therapy discontinuation/modification), and the probability of continuing the index regimen were analyzed by index regimen cohort (monotherapy versus combination therapy). Of 1637 eligible patients, 93.8% initiated treatment with monotherapy and 6.2% with combination therapy. The most common index regimen was phosphodiesterase type 5 inhibitor (PDE-5I) monotherapy (70.0% of patients). A total of 581 patients (35.5%) modified their index regimen during the study. Most patients (55.4%) who began combination therapy did so on or within six months of the index date. Endothelin receptor agonists (ERAs) and combination therapies were associated with higher adherence than PDE-5Is and monotherapies, respectively. Healthcare utilization was substantial across the study population, with costs in the combination therapy cohort more than doubling from baseline to follow-up. The majority of patients were treated with monotherapies (most often, PDE-5Is), despite combination therapies and ERAs being associated with higher medication adherence. Index regimen adjustments occurred early and in a substantial proportion of patients, suggesting that inadequate clinical response to monotherapies may not be uncommon.
Rhizomes of butterbur, Petasites hybridus L. (Asteraceae), have been used since ancient times for the treatment of inflammatory diseases. In the present study, the effects of lipophilic extracts from rhizomes of Petasites hybridus on the formation and release of prostaglandin E2 were investigated. The extracts had different contents of petasin and isopetasin: A: 2.1 % and 0.4 %, B: 0.2 % and 0.1 %, C: 12.1 % and 6.1 % and D: 21.9 % and 9.4 %, respectively. Direct inhibition of cyclooxygenase (COX) -1 and -2 isoenzymes and inhibition of the expression of COX-2 and p42/44 MAP kinase in rat primary microglial cells were tested. All extracts were found to be only weak direct inhibitors of COX-1 (IC50> 400 microg/mL). However, most extracts revealed a strong inhibitory activity against the inducible isoform COX-2 ( A: IC50=30.4 microg/mL; B: IC50=60.6 microg/mL; C: IC50=22.6 microg/mL; D: IC50=20.0 microg/mL). This activity was not correlated to the content of petasin and isopetasin. Pure petasin and isopetasin neither inhibited COX-1 nor COX-2 (IC50 > 400 microM for both compounds and enzymes). Petasites extracts dose-dependently inhibited LPS-induced and thus COX-2-mediated PGE2 release in primary rat microglial cells (A: IC50= 2.4 microg/mL; C: IC50=5.8 microg/mL and D: IC50=4.6 microg/mL). Also this effect was independent from the petasin and isopetasin content. COX-2 synthesis in microglia was totally blocked with 5 microg/mL of C whereas COX-1 synthesis was not influenced. C and D did not affect the LPS-induced activation of p38 MAPK and IkappaBalpha, but they prevented the LPS-induced activation of p42/44 MAPK. Therefore, these Petasites hybridus extracts can be regarded as natural selective inhibitors of COX-2 and its expression, an effect which is independent from the petasin content.
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