10 research outputs found

    Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

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    BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

    Treatment (Tx) patterns and overall survival (OS) in patients (pts) with NSCLC in Sweden : A SCAN-LEAF study analysis from the I-O Optimise initiative

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    Background: As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, the SCAN-LEAF study aims to describe the epidemiology, clinical care and outcomes for pts with NSCLC in Scandinavia. We report initial Tx and OS for pts with NSCLC prior to the availability of immunotherapies in Sweden. Methods: The analysis includes all adult pts diagnosed with NSCLC at Uppsala and Karolinska (Stockholm) University Hospitals from 2012 to 2015 (follow-up to Dec 2016). Electronic medical record data were extracted using Pygargus CXP software and linked with national registries. Bespoke rule-based algorithms were applied to describe Tx patterns; Kaplan–Meier methods were used to estimate OS. Results: 2779 pts were diagnosed with incident NSCLC (median age, 70 yrs [range: 22–96; 14.2% ≥80]; male, 48.5%; histology: non-squamous (NSQ), 70.9%, squamous (SQ), 17.7%, other, 11.4%; stage distribution: I, 19.3%; II, 7.7%; IIIA, 12.3%; IIIB, 7.2%; IV, 51.2%). Initial Tx (≤6 months from diagnosis) by stage and yr of diagnosis is shown in the table. Median OS (months) for NSQ and SQ pts: not reached and 52.8 in stage I, 43.2 and 23.6 in stage II, 26.7 and 20.4 in stage IIIA, 12.5 and 12.9 in stage IIIB, and 7.6 and 6.1 in stage IV, respectively. Among stage IIIB–IV pts, 60.7% (NSQ) and 53.5% (SQ) had ≥1 line of systemic anti-cancer therapy (SACT); median OS was 12.2 (NSQ) and 10.4 (SQ) months in pts on SACT, and 3.1 (NSQ) and 3.7 (SQ) months in pts not on SACT. Ongoing analyses will assess factors associated with SACT receipt in stage IIIB–IV pts. Conclusions: Swedish pts with NSCLC had a high burden of disease, with most diagnosed at stage IV and a median OS of 1 yr in late-stage pts receiving SACT. There is also scope for improved prognosis in pts diagnosed at early stages, particularly in SQ pts. Future analyses will assess the potential impact of recent improvements in diagnostics and therapeutics on Tx patterns and OS in Swedish NSCLC pts

    Evolution of overall survival (OS) in patients (pts) with incident NSCLC in Denmark and Sweden : A SCAN-LEAF study analysis from the I-O Optimise initiative

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    Background: As part of I-O Optimise, a multinational research platform providing real-world insights into the management of lung cancers, the SCAN-LEAF study aims to describe the epidemiology, clinical care, and outcomes for pts with NSCLC in Scandinavia. Here, we report temporal OS trends among pts diagnosed with incident NSCLC from 2005 to 2015 in Denmark and Sweden. Methods: The SCAN-LEAF Danish and Swedish cohorts were established by linking respective national registries and include all adult pts diagnosed with incident NSCLC from Jan 2005 to Dec 2015 (follow-up to Dec 2016). The Kaplan–Meier method was used to estimate OS at 1, 3, and 5 yrs by histology (non-squamous cell [NSQ] or squamous cell [SQ]), TNM stage, and yr of diagnosis; changes in OS over time were assessed using the Cochrane–Armitage test. Results: 31,939 pts in Denmark and 30,067 pts in Sweden were diagnosed with NSCLC from 2005 to 2015. Most were diagnosed at stage IV (51.6% and 48.4%, respectively) and had NSQ histology (54.4% and 60.4%). Statistically significant trends (P 5% over the analysis period were seen for NSQ pts at 1 yr for all stages in both countries (Table); at 3 yrs for stages I–IIIB in Denmark (P ≤ 0.027), and stages I–II (P ≤ 0.0013) in Sweden; and at 5 yrs for stages I–II (P ≤ 0.026) in both countries. For SQ pts, this was seen only at 1 yr for stage IIIA in Denmark and stage I in Sweden (Table), and at 5 yrs for stage IIIA in Denmark (p = 0.02). Conclusions: Despite some improvements between 2005 and 2015, mainly in the short-term survival of pts with early-stage NSCLC, long-term OS rates for pts with late-stage disease did not change significantly and remained low. Even in pts with early-stage disease, OS outcomes were suboptimal, with a particular unmet need in the SQ population. Future analyses including data after 2015 will evaluate the potential impact on OS of increased use of new TKIs and immune checkpoint inhibitors

    Nordic Monitoring of diet, physical activity and overweight : Validation of indicators

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    In 2007, a Nordic working group was established with the aim to describe a future Nordic monitoring system on diet, physical activity and overweight. The monitoring system should be simple and at relatively low cost. Therefore it has been decided to conduct the moni-toring as a telephone interview. In 2009, the indicator questions were validated against an objective method (physical activity) or existing survey methods (diet) and the present report mainly describes the validation studies.  On basis of the validation studies the working group suggests that the indicators are used in a future monitoring system. In 2011 and 2013 the first collection of data in all Nordic countries will take place

    Traffic air pollution and mortality from cardiovascular disease and all causes: a Danish cohort study

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    <p>Abstract</p> <p>Background</p> <p>Traffic air pollution has been linked to cardiovascular mortality, which might be due to co-exposure to road traffic noise. Further, personal and lifestyle characteristics might modify any association.</p> <p>Methods</p> <p>We followed up 52 061 participants in a Danish cohort for mortality in the nationwide Register of Causes of Death, from enrollment in 1993–1997 through 2009, and traced their residential addresses from 1971 onwards in the Central Population Registry. We used dispersion-modelled concentration of nitrogen dioxide (NO<sub>2</sub>) since 1971 as indicator of traffic air pollution and used Cox regression models to estimate mortality rate ratios (MRRs) with adjustment for potential confounders.</p> <p>Results</p> <p>Mean levels of NO<sub>2</sub> at the residence since 1971 were significantly associated with mortality from cardiovascular disease (MRR, 1.26; 95% confidence interval [CI], 1.06–1.51, per doubling of NO<sub>2</sub> concentration) and all causes (MRR, 1.13; 95% CI, 1.04–1.23, per doubling of NO<sub>2</sub> concentration) after adjustment for potential confounders. For participants who ate < 200 g of fruit and vegetables per day, the MRR was 1.45 (95% CI, 1.13–1.87) for mortality from cardiovascular disease and 1.25 (95% CI, 1.11–1.42) for mortality from all causes.</p> <p>Conclusions</p> <p>Traffic air pollution is associated with mortality from cardiovascular diseases and all causes, after adjustment for traffic noise. The association was strongest for people with a low fruit and vegetable intake.</p
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