Abstract 14687: Achieved Eicosapentaenoic Acid (EPA) Levels Predicts Regression of Coronary Plaque Volumes by Coronary Computed Tomography Angiography (CCTA) in the EVAPORATE Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Suvasini Lakshmanan ◽  
Chandana Shekar ◽  
April Kinninger ◽  
Ilana Golub ◽  
Suraj Dahal ◽  
...  
Keyword(s):  
Coronary Computed Tomography Angiography ◽  
Controlled Trial ◽  
Coronary Plaque ◽  
Intervention Trial ◽  
Beneficial Effects ◽  
Icosapent Ethyl ◽  
Point Analysis ◽  
Calcified Plaque ◽  
Fatty Plaque

Background: Despite the beneficial effects of statins on progression of coronary atherosclerosis and cardiovascular (CV) events, significant CV risk persists in patients with hypertriglyceridemia. In REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial), icosapent ethyl (IPE) added to statins reduced initial and total CV events by 25% and 30%, but the mechanisms of benefit are unclear. In a follow-up analysis, degree of CV benefit from IPE was predominantly related to achieved serum EPA levels. Methods: EVAPORATE is a randomized, placebo-controlled trial, using CCTA to evaluate the effects of IPE as an adjunct to statins on coronary plaque volumes in a cohort with elevated triglycerides. Here, we present the 18-month, pre-specified secondary end-point analysis on association of achieved serum EPA levels, and change in coronary plaque volumes in the pooled cohort. Results: 80 patients were enrolled, and 68 completed the 18-month visit. Median (IQR) level of serum EPA for the pooled cohort was 20.6 (13.8) ug/ml at baseline and 25.3 (55.5) ug/ml at follow up. At 18 months, EPA levels > 26 ug/ml predicted regression of fibro-fatty plaque (logβ: - 0.75± 0.36), total non-calcified plaque (TNCP) (logβ: - 0.77± 0.33), and total plaque (TP) (logβ: - 0.63± 0.28) volumes (mm3), after adjustment for age, sex, diabetes, hypertension, and baseline TGL levels (p < 0.05 for all). Conclusions: Higher serum EPA levels predict regression of prognostically relevant coronary plaque volumes, TNCP, and TP on CCTA. This provides important mechanistic correlation to the CV benefits of IPE.

scholarly journals POS0216 GREATER HIGH-DENSITY LIPOPROTEIN LEVELS OVER TIME ARE LINKED TO DECREASED CORONARY PLAQUE FORMATION AND REGRESSION AND STABILIZATION OF HIGH-RISK LESIONS IN RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 325.2-326
Author(s):  
G. Karpouzas ◽  
S. Ormseth ◽  
E. Hernandez ◽  
M. Budoff
Keyword(s):  
Coronary Atherosclerosis ◽  
Density Lipoprotein ◽  
Coronary Plaque ◽  
Plaque Formation ◽  
Prednisone Dose ◽  
Calcified Plaque ◽  
Plaque Regression ◽  
Mixed Plaque ◽  
Over Time

Background:The relationship between serum lipoproteins and cardiovascular disease risk in rheumatoid arthritis (RA) is complex1. Their levels and function may vary based on disease activity and medication use. Beneficial effects on high-density lipoprotein (HDL-C) levels, structure and behavior, in response to treatment have been described. However, the impact of HDL-C levels over time on coronary atherosclerosis progression in RA is unknown.Objectives:We here evaluated the influence of HDL-C levels over time on long-term coronary plaque formation and progression in patients with RA.Methods:One hundred one RA patients without symptoms or history of cardiovascular disease who participated in a computed tomography angiography study of coronary atherosclerosis had repeat assessments after 6.9±0.3 years to evaluate plaque progression. Clinical, laboratory and medication data were recorded at baseline and regular outpatient follow-up visits thereafter. Time-averaged HDL-C was calculated for each patient using available consecutive HDL measurements between baseline and follow-up. Robust logistic regression assessed the association between time-averaged HDL-C and likelihood of new plaque formation in segments without plaque at baseline, and transition of prevalent mixed plaque to calcified plaque. Robust multinomial logistic regression evaluated the effect of time-averaged HDL-C on likelihood of new non-calcified, mixed or calcified plaque formation in segments without plaque (compared to remaining without plaque), and non-calcified plaque regression or transition to mixed or calcified plaque at follow-up (compared to remaining non-calcified). All models accounted for clustering of coronary segments within patients and adjusted for Framingham D’Agostino risk score, proximal segment location, time-averaged CRP, cumulative prednisone dose, bDMARD duration, statin duration, waist-to-height ratio, and time-averaged triglycerides.Results:Participants were mostly female (n=87, 86.1%), with a mean ± standard deviation (SD) age of 51.5±10.3 years and time-averaged HDL-C of 51.7±13.9. Ninety-seven new plaques formed in segments without plaque at baseline; 20 were noncalcified, 21 were mixed, and 56 were calcified. Time-averaged HDL-C had no effect on new total plaque formation (adjusted odds ratio-OR 0.88 [95% CI 0.64-1.21]). However, each 1-SD increase in time-averaged HDL-C associated with a 44% reduced likelihood of new non-calcified plaque formation at follow-up (adjusted OR 0.56 [95% CI 0.35-0.92], Figure 1). In contrast, there was no effect of time-averaged HDL-C on new mixed or calcified plaque formation. Of 98 non-calcified plaques at baseline, 42 did not change at follow-up, 32 regressed (disappeared), 16 transitioned to mixed and 8 to calcified plaques. Each SD increase in time-averaged HDL-C yielded a 2.2-fold greater likelihood of non-calcified plaque regression (adjusted OR 2.21 [95% CI 1.02-4.83]). Sixteen of 52 mixed plaques present at baseline transitioned to more stable calcified lesions, and time-averaged HDL-C (per 1-SD increment) predicted a 3.5-fold increased likelihood of transition of mixed to fully calcified plaque (adjusted OR 3.56 [95% CI 1.25-10.17]).Conclusion:Higher HDL-C over time predicted regression of existing and decreased formation of new higher-risk non-calcified plaque. It also associated with transition of vulnerable mixed plaque to more stable fully calcified plaque. These effects were independent of RA treatment duration, prednisone dose and statin exposure.References:[1]Toms TE et al. Curr Vasc Pharmacol. 2010;8:301–326.Figure 1.Impact of HDL-C over time on coronary plaque progression in RADisclosure of Interests:George Karpouzas Speakers bureau: Sanofi/Genzyme/Regeneron, Consultant of: Sanofi/Genzyme/Regeneron, Grant/research support from: Pfizer, Sarah Ormseth: None declared, Elizabeth Hernandez: None declared, Matthew Budoff: None declared

scholarly journals Usefulness of MCP-1 Chemokine in the Monitoring of Patients with Coronary Artery Disease Subjected to Intensive Dietary Intervention: A Pilot Study

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3047
Author(s):  
Magdalena Makarewicz-Wujec ◽  
Jan Henzel ◽  
Cezary Kępka ◽  
Mariusz Kruk ◽  
Łukasz Wardziak ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Dietary Intervention ◽  
Coronary Plaque ◽  
Control Group ◽  
Dash Diet ◽  
Plaque Component ◽  
Calcified Plaque ◽  
Atheroma Volume ◽  
Artery Disease

Monocyte chemotactic protein-1 (MCP-1) plays an important role in the entire atherosclerotic process, from atherogenesis to destabilisation of the atherosclerotic plaque. The purpose of this study is to evaluate the effect of the dietary approaches to stop hypertension (DASH) diet in patients with coronary artery disease on the MCP-1 plasma concentration and to evaluate the potential usefulness of this chemokine as a marker of change in the volume and composition of coronary plaque. Material and method. As part of the dietary intervention to stop coronary atherosclerosis in computed tomography (DISCO-CT) study, patients were randomised to an intervention group (n = 40) in which the DASH diet was introduced, and to a control group (n = 39) with no dietary intervention. In the DASH group, dietary counselling was provided at all follow-up visits within 12 months of the follow-up period. MCP-1 plasma concentration was determined using enzyme-linked immunosorbent assay (ELISA). Coronary plaque analysis was performed using a semi-automated plaque analysis software system (QAngioCT, Medis, the Netherlands). Results. In the DASH group, MCP-1 plasma concentration significantly decreased by 34.1 pg/mL (p = 0.01), while in the control group, the change in MPC-1 was not significant. Significant inverse correlations were revealed for the change in MCP-1 plasma concentration and change in the consumption of vitamin C and dietary fibre both in the DASH (r = −0.519, p = 0.0005; r = −0.353, p = 0.025, respectively) and in the control group (r = −0.488 p = 0.001; r = −0.502, p = 0.001, respectively). In patients with the highest decrease in percent atheroma volume (PAV), a significant positive correlation was observed between the change in MCP-1 plasma concentration and changes in PAV (r = 0.428, p = 0.033) and calcified plaque component (r = 0.468, p = 0.018), while the change in noncalcified plaque component correlated inversely with change in MCP1 (r = −0.459, p = 0.021). Conclusion. Dietary intervention based on the DASH diet model reduces the MCP-1plasma concentration, mostly due to an increased intake of plant-derived, fibre-rich foods and antioxidants. The change in MCP-1 plasma concentration seems to reflect changes in the atheroma volume and proportions between the calcified and non-calcified plaque elements.

scholarly journals Pericoronary adipose tissue attenuation in low-risk asymptomatic individuals, sex-differences and association with markers of cardiovascular disease

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
N Shanmuganathan ◽  
R Ramanathan ◽  
D Dey ◽  
M Goeller ◽  
MW Kusk ◽  
...  
Keyword(s):  
Density Lipoprotein ◽  
Coronary Plaque ◽  
Low Risk ◽  
Low Density ◽  
Ct Attenuation ◽  
Calcified Plaque ◽  
Blood Pressures ◽  
Asymptomatic Individuals ◽  
Pai 1

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Pericoronary adipose tissue (PCAT) attenuation by coronary computed tomography angiography (CCTA) is a marker of coronary inflammation and predicts clinical outcomes in symptomatic patients undergoing CCTA. Sex-differences in PCAT CT attenuation among asymptomatic individuals are not previously described. Purpose To evaluate PCAT CT attenuation according to sex and markers of cardiovascular disease (CVD). Methods Cross-sectional cohort study including asymptomatic individuals, 50- or 60-year of age, not taking any medicine and without known CVD or type-2 diabetes. At baseline and 5-year follow-up smoking habits, blood pressures and biochemistry (lipids, CRP, fibrinogen, D-dimer, t-PA, PAI-1, vWF) were recorded and Agatston Score measured. At follow-up, CCTA was achieved. Quantitative coronary plaque analysis was performed and PCAT CT attenuation within a radial distance of 3 mm from the outer vessel wall 10–50 mm distal to the origin of the right coronary artery measured. A validated PCAT CT attenuation threshold (high vs low risk) of -70.1 Hounsfield units was applied. Results Included were 123 participants (60 women). Independent of co-variation, PCAT CT attenuation (median, [IQR]) was lower in women (-71.0, [-77.2- -67.0]) vs men (-64.5, [-69.9- -57.4]), p &lt; 0.001. No associations between PCAT CT attenuation (high vs low) and risk factors of CVD, CAC or coronary plaque volumes were demonstrated (Table). Variations in blood pressures, biochemical markers and CAC over five years were not associated with PCAT CT attenuation. Conclusion In low-risk asymptomatic individuals, PCAT CT attenuation was lower in women compared to men, irrespective of markers of CVD. Table. Patient characteristics stratified by PCAT CT attenuation PCAT CT attenuation ≤ -70.1 HU (n = 49) PCAT CT attenuation &gt; -70.1 HU (n = 74) p-value Risk factors Age65-years55-years 2623 3143 0.32 SexMenWomen 1534 4826 &lt;0.001 TobaccoNeverCurrent/previous 1732 3737 0.10 Systolic BP, mmHgDiastolic BP, mmHgTotal cholesterol, mmol/lLDL-cholesterol, mmol/lHDL-cholesterol, mmol/lTriglycerides, mmol/l 137 (17)76 (10)5.61 (0.92)3.50 (0.93)1.41 (0.30)1.65 (0.99 - 2.22) 136 (16)77 (10)5.42 (0.82)3.30 (0.82)1.45 (0.35)1.35 (1.03 - 2.11) 0.660.590.230.220.570.52 Biochemistry CRP, mg/lFibrinogen, μmol/lD-dimer, mg/lvWFt-PAPAI-1 1.16 (0.99 - 2.22)9.5 (8.5 - 10.7)0.40 (0.30 - 0.49)128 (102 - 154)7.1 (5.8 - 8.8)20.5 (16.2 - 31.8) 0.61 (0.30 - 1.14)9.0 (7.8 - 10.0)0.32 (0.24 - 0.47)116 (92 - 146)6.3 (5.1 - 8.8)20.3 (14.7 - 26.3) &lt;0.010.10&lt;0.050.110.200.34 Coronary plaque data Agatston ScoreTotal plaque volume, mm&sup3;NCP volume, mm&sup3;CP volume, mm&sup3;LD-NCP volume, mm&sup3; 1 (0 - 36)15.7 (0 - 143.3)0 (0 - 128.1)0 (0 - 14.6)0.5 (0 - 18.7) 8 (0 - 115)15.6 (0 - 268.2)13.5 (0 - 220.5)1.7 (0 - 31.7)1.8 (0 - 21.8) 0.300.450.490.360.74 Values are n (%), mean (SD) or median (IQR).Abbreviations: HU =Hounsfield unit; LDL =low-density lipoprotein; HDL =high-density lipoprotein; BP =blood pressure; CRP = c-reactive protein: vWF =von-Willebrand Factor; t-PA =tissue plasminogen activator; PAI-1 =plasminogen activator inhibitor -1; NCP =non-calcified plaque; CP =calcified plaque; LD-NCP =low-density non-calcified plaque.

scholarly journals Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection among individuals diagnosed with melanoma

2021 ◽  
Author(s):  
Sharon L Manne ◽  
Carolyn J Heckman ◽  
Deborah A Kashy ◽  
Lee M Ritterband ◽  
Frances P Thorndike ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Sun Protection ◽  
Web Based ◽  
Participant Engagement ◽  
Beneficial Effects ◽  
Core Components ◽  
Self Examination ◽  
The Impact ◽  
Univariate Analyses

Abstract Adherence to regular, thorough skin self-examination (SSE) and consistent sun protection behaviors among melanoma survivors is relatively low. This study reports on the impact of an online intervention, called mySmartSkin (MSS), on engagement in SSE and sun protection behaviors among melanoma survivors, as well as the mediators of the intervention effects. The intervention was compared with usual care (UC), and primary outcomes were assessed at 24 and 48 weeks. Short-term outcomes were also evaluated at 8 weeks postbaseline. Results demonstrate a significant effect on SSE and sun protection. At all three follow-up assessments, the proportion of participants reporting conducting a thorough SSE in the time since the previous assessment was significantly greater in MSS than in UC. In addition, both multivariate and univariate analyses indicated that engagement in sun protection behaviors was significantly higher in MSS than UC at 24 weeks, but the effect on sun protection at 48 weeks was significant only in multivariate analyses. Beneficial effects of MSS were significantly mediated by knowledge about melanoma and characteristics of suspicious lesions, as well as self-efficacy. Participant engagement in MSS was satisfactory, with approximately two-thirds of participants completing at least two of the three core components. Content was rated as highly trusted, easy to understand, easy to navigate, and helpful. In conclusion, MSS illustrated significant and durable effects on SSE and mixed results on sun protection. Future studies should consider ways to further enhance treatment effects and engagement in MSS.

scholarly journals OP0120 BIOLOGICS MAY PREVENT CARDIOVASCULAR EVENTS IN RHEUMATOID ARTHRITIS BY INHIBITING CORONARY PLAQUE FORMATION AND STABILIZING HIGH-RISK LESIONS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 79.1-80
Author(s):  
G. Karpouzas ◽  
S. Ormseth ◽  
E. Hernandez ◽  
M. Budoff
Keyword(s):  
Rheumatoid Arthritis ◽  
High Risk ◽  
Coronary Plaque ◽  
Plaque Formation ◽  
Cvd Risk ◽  
Calcified Plaque ◽  
Lower Likelihood ◽  
Low Attenuation Plaque

Background:Biologic disease-modifying antirheumatic drugs (bDMARDs) effectively control inflammation and may improve cardiovascular outcomes in Rheumatoid arthritis.Objectives:To evaluate if bDMARDs decrease long-term cardiovascular disease (CVD) risk in rheumatoid arthritis and whether potential benefits might be rendered by impacting coronary plaque formation or progression.Methods:In this single-center observational cohort study, 150 patients underwent computed tomography angiography for evaluation of coronary atherosclerosis (total, non-calcified, mixed/calcified and low-attenuation or high-risk plaque); 101 had repeat assessments within 6.9±0.3 years to evaluate plaque progression. All CVD events were prospectively recorded, including cardiac death, myocardial infarction, unstable angina, revascularization, stroke, claudication, and heart failure hospitalization. The Framingham-D’Agostino score assessed clinical risk. Segment stenosis score (cumulative stenosis) measured plaque burden. The effect of bDMARD treatment on CVD events was assessed using marginal structural models. The inverse probability of treatment and censoring weights were used in a weighted pooled logistic regression with current bDMARD use and time since study entry included in the model to approximate a Cox proportional hazards model allowing for time-varying weights. Robust logistic regression evaluated the effect of bDMARD exposure (>50 percent of follow-up period) on likelihood of new plaque formation or change in plaque composition in per-segment models adjusted for Framingham-D’Agostino score, time between scans, statin duration, cumulative prednisone dose and time-averaged CRP.Results:Sixteen patients incurred 19 CVD events. Current bDMARD use associated with lower CVD risk (OR=0.20 [95%CI=0.05-0.75], p=0.018, Figure 1). However, the effect of bDMARDs was no longer significant when a 6-month exposure extension was applied (OR=0.42 [95% CI 0.13-1.38], p=0.15). The effect of bDMARD use on CVD risk was moderated by non-calcified plaque and low-attenuation plaque presence (Figure 1); specifically, bDMARDs were associated with lower CVD risk only in patients with non-calcified plaque (p=.048) or low-attenuation plaque (p=0.036) at baseline. Per-segment plaque progression analyses showed no main effect of bDMARD exposure on likelihood of new plaque formation (Figure 2). However, bDMARD exposure predicted lower likelihood of new plaque forming in segments without plaque among patients without mixed/calcified plaque in other coronary segments (OR=0.40 [95%CI=0.17-0.93]), but not among those with mixed/calcified plaque elsewhere in their arteries (OR=1.60 [95%CI=0.71-3.62]). Moreover, transition of non-calcified to mixed/calcified plaque associated with bDMARD exposure (OR=4.00 [95%CI=1.05-15.32]). bDMARD use also predicted low-attenuation plaque loss (p=0.042).Figure 1.Effect of bDMARD use on cardiovascular disease risk stratified by coronary plaque presenceFigure 2.Effect of bDMARD exposure on plaque formation and transition from baseline to follow-upConclusion:In rheumatoid arthritis, bDMARD use associated with reduced long-term CVD risk, lower likelihood of new plaque formation in patients with early atherosclerosis, stabilization of high-risk plaque and protective calcification of non-calcified lesions.Disclosure of Interests:George Karpouzas Grant/research support from: Pfizer, Consultant of: Sanofi-Genzyme-Regeneron, Janssen, Speakers bureau: Sanofi-Genzyme-Regeneron, BMS, Sarah Ormseth: None declared, Elizabeth Hernandez: None declared, Matthew Budoff: None declared

scholarly journals Effects of canagliflozin are mostly observed at first follow-up, within 6 months of commencement: results for the ABCD canagliflozin audit

2020 ◽  
Vol 20 (2) ◽  
pp. 113-116
Author(s):  
Thomas SJ Crabtree ◽  
Peter Winocour ◽  
Ken Darzy ◽  
Suzanne Phillips ◽  
Alison Evans ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Trial Data ◽  
Randomised Control Trial ◽  
Baseline Hba1c ◽  
Beneficial Effects ◽  
Randomised Controlled ◽  
The Uk ◽  
Minimum Dataset ◽  
Trial Evidence

Introduction: Canagliflozin was initially approved for use in the UK in March 2013. Randomised control trial evidence has demonstrated multiple beneficial effects. Many of these are present at initial follow-up and within 26 weeks of randomised control trial data. Our aim was to assess whether the beneficial effects of canagliflozin on multiple clinical and biochemical parameters occurred prior to first follow-up and, if so, whether these continued to improve or simply persisted at second follow-up.Methods: Data were extracted from the ABCD nationwide canagliflozin audit to include a minimum dataset of a baseline value and one (or two) follow-ups for each value.Results: A total of 1,214 patient datasets were identified and used in the analysis: mean±SD age 60.1±10.6 years; median duration of diabetes 8 (IQR 2.4–12.6 years); baseline HbA1c 75.1±17.4 mmol/mol (9.0±1.59%) and weight 97.8±22.0 kg. 68.3% of the patients were Caucasian where this was known (n=183). At first follow-up (median 0.7 years) from baseline: change in HbA1c −9.3 mmol/mol (95% CI −8.2 to −10.4; p<0.0001), weight −2.3 kg (95% CI −1.9 to −2.5; p<0.0001); BMI −0.7 kg/m2 (95% CI −0.6 to −0.8; p<0.0001); alanine aminotransferase −2 U/L (95% CI −1.3 to −2.7; p<0.0001); eGFR −0.9 mL/min/1.73 m2 (95% CI −0.4 to −1.4; p<0.001); systolic blood pressure (BP) −2.6 mmHg (95% CI −1.6 to −3.5; p<0.0001) and diastolic BP −0.9 mmHg (95% CI −0.2 to −1.6; p<0.001). Significant differences persisted comparing second follow-up (median 1.2 years) to baseline, but no further significant changes were noted between first follow-up and second follow-up other than in weight and BMI with further change in weight −0.65 kg (95% CI −0.2 to −1.1; p=0.047).Conclusion: The improvements following canagliflozin in this real-world cohort seem to occur within the first 0.7 years of treatment, which is similar to randomised controlled trial data. These improvements seem to be maintained over the next 6 months, with significant further weight loss occurring between 0.7 years and 1.2 years, although the mechanism of this is unclear and might be due to confounders. More evidence on this point is needed.

scholarly journals Effect of icosapent ethyl on progression of coronary atherosclerosis in patients with elevated triglycerides on statin therapy: a prospective, placebo-controlled randomized trial (EVAPORATE): interim results

2020 ◽  
Author(s):  
Matthew J Budoff ◽  
Joseph B Muhlestein ◽  
Deepak L Bhatt ◽  
Viet T Le Pa ◽  
Heidi T May ◽  
...  
Keyword(s):  
Statin Therapy ◽  
Coronary Atherosclerosis ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
Fibrous Plaque ◽  
Double Blind ◽  
Atherosclerosis Progression ◽  
Icosapent Ethyl ◽  
Calcified Plaque ◽  
High Triglyceride

Abstract Aims Though statin therapy is known to slow coronary atherosclerosis progression and reduce cardiovascular (CV) events, significant CV risk still remains. In the REDUCE-IT study, icosapent ethyl (IPE) added to statin therapy reduced initial CV events by 25% and total CV events by 30%, but its effects on coronary atherosclerosis progression have not yet been fully investigated. Therefore, this study is to determine whether IPE 4 g/day will result in a greater change from baseline in plaque volume measured by serial multidetector computed tomography than placebo in statin-treated patients. Methods and results EVAPORATE is a randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis by coronary computed tomographic angiography (CCTA) (≥1 angiographic stenoses with ≥20% narrowing), on stable statin therapy with low-density lipoprotein cholesterol levels 40–115 mg/dL, and persistently high triglyceride levels (135–499 mg/dL). Patients underwent an interim scan at 9 months and were followed for an additional 9 months with CCTA at 0, 9, and 18 months. Here, we present the protocol-specified interim efficacy results. A total of 80 patients were enrolled, with 67 completing the 9-month visit and having interpretable CCTA at baseline and at 9 months (age = 57 ± 6 years, male = 36, 63%). At the 9-month interim analysis, there was no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs. 94%, P = 0.469). However, there was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque) (35% vs. 43%, P = 0.010), total plaque (non-calcified + calcified plaque) (15% vs. 26%, P = 0.0004), fibrous plaque (17% vs. 40%, P = 0.011), and calcified plaque (−1% vs. 9%, P = 0.001), after adjustment by baseline plaque, age, sex, diabetes, baseline triglyceride levels, and statin use. Conclusion EVAPORATE is the first study using CCTA to evaluate the effects of IPE as an adjunct to statin therapy on atherosclerotic plaque characteristics in a high-risk CV population with persistently high triglyceride levels. It provides important mechanistic data in regards to the reduction in CV events in the REDUCE-IT clinical trial. ClinicalTrials. govIdentifier NCT029226027.

scholarly journals A 10-year follow-up of tailored behavioural treatment and exercise-based physiotherapy for persistent musculoskeletal pain

2016 ◽  
Vol 31 (2) ◽  
pp. 186-196 ◽  
Author(s):  
Christina Emilson ◽  
Ingrid Demmelmaier ◽  
Stefan Bergman ◽  
Per Lindberg ◽  
Eva Denison ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Medicine ◽  
Behavioural Treatment ◽  
Beneficial Effects ◽  
Maximum Pain ◽  
Secondary Outcomes ◽  
Randomised Controlled

Objective: To study the long-term outcomes of two interventions targeting patients with sub-acute and persistent pain in a primary care physiotherapy setting. Design: A 10-year follow-up of a two-armed randomised controlled trial, initially including 97 participants. Interventions: Tailored behavioural medicine treatment, applied in a physiotherapy context (experimental condition), and exercise-based physiotherapy (control condition). Main measures: Pain-related disability was the primary outcome. The maximum pain intensity, pain control, fear of movement, sickness-related absence (register data) and perceived benefit and confidence in coping with future pain problems were the secondary outcomes. Results: Forty-three (44%) participants responded to the follow-up survey, 20 in the tailored behavioural medicine treatment group and 23 in the exercise-based physiotherapy group. The groups did not differ in terms of the change in the scores for the primary outcome ( p=0.17) of pain-related disability between the experimental group (median: 2.5, Q1-Q3: -2.5-14.25), and the control group (median: 0, Q1-Q3: -5-6). Further, there were also no significant differences found for the secondary outcomes except for sickness-related absence, where the exercise-based physiotherapy group had more days of sickness-related absence three months before treatment ( p= 0.02), and at the 10-year follow-up ( p=0.03). Discussion: The beneficial effects favouring tailored behavioural medicine treatment that observed post-treatment and at the two-year follow-up were not maintained 10 years after treatment.

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