Changes In Intima-media Thickness Research Articles

Association Between Air Pollution and Coronary Artery Calcification Within Six Metropolitan Areas in the USA (the Multi-Ethnic Study of Atherosclerosis and Air Pollution): A Longitudinal Cohort Study

Background Long-term exposure to fi ne particulate matter less than 2·5 μm in diameter (PM2·5) and traffi c-related air pollutant concentrations are associated with cardiovascular risk. The disease process underlying these associations remains uncertain. We aim to assess association between long-term exposure to ambient air pollution and progression of coronary artery calcium and common carotid artery intima-media thickness. Methods In this prospective 10-year cohort study, we repeatedly measured coronary artery calcium by CT in 6795 participants aged 45–84 years enrolled in the Multi-Ethnic Study of Atherosclerosis and Air P ollution (MESA Air) in six metropolitan areas in the USA. Repeated scans were done for nearly all participants between 2002 and 2005, for a subset of participants between 2005 and 2007, and for half of all participants between 2010 and 2012. Common carotid artery intima-media thickness was measured by ultrasound in all participants at baseline and in 2010–12 for 3459 participants. Residence-specifi c spatio-temporal pollution concentration models, incorporating communityspecifi c measurements, agency monitoring data, and geographical predictors, estimated concentrations of PM2·5 and nitrogen oxides (NOX) between 1999 and 2012. The primary aim was to examine the association between both progression of coronary artery calcium and mean carotid artery intima-media thickness and long-term exposure to ambient air pollutant concentrations (PM2·5, NOX, and black carbon) between examinations and within the six metropolitan areas, adjusting for baseline age, sex, ethnicity, socioeconomic characteristics, cardiovascular risk factors, site, and CT scanner technology. Findings In this population, coronary calcium increased on average by 24 Agatston units per year (SD 58), and intimamedia thickness by 12 μm per year (10), before adjusting for risk factors or air pollutant exposures. Participantspecifi c pollutant concentrations averaged over the years 2000–10 ranged from 9·2–22·6 μg PM2·5/m³ and 7·2–139·2 parts per billion (ppb) NOX. For each 5 μg PM2·5/m³ increase, coronary calcium progressed by 4·1 Agatston units per year (95% CI 1·4–6·8) and for each 40 ppb NOX coronary calcium progressed by 4·8 Agatston units per year (0·9–8·7). Pollutant exposures were not associated with intima-media thickness change. The estimate for the eff ect of a 5 μg/m³ higher long-term exposure to PM2·5 in intima-media thickness was –0·9 μm per year (95% CI –3·0 to 1·3). For 40 ppb higher NOX, the estimate was 0·2 μm per year (–1·9 to 2·4). Interpretation Increased concentrations of PM2·5 and traffi c-related air pollution within metropolitan areas, in ranges commonly encountered worldwide, are associated with progression in coronary calcifi cation, consistent with acceleration of atherosclerosis. This study supports the case for global eff orts of pollution reduction in prevention of cardiovascular diseases.

Visit-to-visit blood pressure variability, average BP level and carotid arterial stiffness in the elderly: a prospective study.

In a cross-sectional study, visit-to-visit blood pressure (BP) variability was shown to be associated with artery remodelling. Here, we investigated the impact of visit-to-visit BP variability and average BP on the carotid artery remodelling progression in high-risk elderly according to different classes of antihypertension medication use/non-use. BP measurements and carotid ultrasound were performed in the common carotid artery in 164 subjects (mean age 79.7 years at baseline, 74.7% females) with one or more cardiovascular risk factors. Based on 12 visits (1 × /month for 1 year), we calculated visit-to-visit BP variability expressed as the standard deviation (s.d.), coefficient of variation (CV), maximum BP, minimum BP and delta (maximum-minimum) BP. We measured mean intima-media thickness (IMT) as well as stiffness parameter β were measured at baseline and at the mean 4.2-year follow-up. In a multiple regression analysis, the maximum, minimum, s.d. and average of systolic BP (SBP) were significantly associated with a change in β-values between the baseline and follow-up after adjustment for age, smoking, lower high-density lipoprotein level, baseline β-value and follow-up period. There were no significant associations between the visit-to-visit BP variability measures and the change in mean IMT. Significant associations of maximum, minimum, s.d. and average SBP were found with increased β-values in the subjects without calcium channel blocker (CCB) use and in the subjects using renin-angiotensin system inhibitors (RASIs). Thus, exaggerated visit-to-visit SBP variability and a high average SBP level were significant predictors of progression in carotid arterial stiffness in high-risk elderly without CCBs use and in those using a RASI.

SUN-P212: Changes in Intima-Media Thickness (IMT) after Exercise in a group of Children with Overweight and Obesity in Murcia, Southeast of Spain

SUN-P212: Changes in Intima-Media Thickness (IMT) after Exercise in a group of Children with Overweight and Obesity in Murcia, Southeast of Spain

RELATONSHIP BETWEEN SERUM LIPOPROTEIN-ASSOCIATED PHOSPHOLIPSAE A2 AND CAROTD INTMAMEDIA THICKNESS WITH CEREBRAL INFARCTON

Background and Purpose: Cerebral atherosclerosis is the leading cause of mechanical obstruction of blood flow that final event is cerebral infarction. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is an inflammatory biomarkers specific for blood vessels, is an important factor predicted extent of atherosclerosis. The study aimed to assess the association between serum Lp-PLA2 concentration with carotid intimamedia thickness (IMT). Materials andMethod: The cross – sectional study, in 37 patients who presented to Department of Cardiology - Hue University Hospital and Hue Central Hospital. Vulnerability asessment of the external carotid artery into the skull through ultrasound by measuring carotid intima-media thickness. Testing serum Lp-PLA2 concentration, lipid profile, blood glucose. Results: Group of patients with thickness of carotid IMT levels of serum Lp-PLA2 was 27.73 IU/ml higher than the group with thickness normal carotid IMT was 14.35 IU/ml; p < 0.05. Total cholesterol, LDL cholestrol, triglycerid and Lp-PLA2 are the factors capable of predict the changes in size IMT; (p <0.05). There is moderate correlation between Lp-PLA2 levels and carotid intima-media thickness (r = 0.47; p < 0.05). Conclusion: Higher Lp-PLA2 levels is significantly associated with carotid intimamedia thickness in patients who have cerebral infarction. Key words: Stroke, atherosclerosis, inflammation, biomarker.

Association between air pollution and coronary artery calcification within six metropolitan areas in the USA (the Multi-Ethnic Study of Atherosclerosis and Air Pollution): a longitudinal cohort study

Long-term exposure to fine particulate matter less than 2.5 μm in diameter (PM2.5) and traffic-related air pollutant concentrations are associated with cardiovascular risk. The disease process underlying these associations remains uncertain. We aim to assess association between long-term exposure to ambient air pollution and progression of coronary artery calcium and common carotid artery intima-media thickness. In this prospective 10-year cohort study, we repeatedly measured coronary artery calcium by CT in 6795 participants aged 45-84 years enrolled in the Multi-Ethnic Study of Atherosclerosis and Air Pollution (MESA Air) in six metropolitan areas in the USA. Repeated scans were done for nearly all participants between 2002 and 2005, for a subset of participants between 2005 and 2007, and for half of all participants between 2010 and 2012. Common carotid artery intima-media thickness was measured by ultrasound in all participants at baseline and in 2010-12 for 3459 participants. Residence-specific spatio-temporal pollution concentration models, incorporating community-specific measurements, agency monitoring data, and geographical predictors, estimated concentrations of PM2.5 and nitrogen oxides (NOX) between 1999 and 2012. The primary aim was to examine the association between both progression of coronary artery calcium and mean carotid artery intima-media thickness and long-term exposure to ambient air pollutant concentrations (PM2.5, NOX, and black carbon) between examinations and within the six metropolitan areas, adjusting for baseline age, sex, ethnicity, socioeconomic characteristics, cardiovascular risk factors, site, and CT scanner technology. In this population, coronary calcium increased on average by 24 Agatston units per year (SD 58), and intima-media thickness by 12 μm per year (10), before adjusting for risk factors or air pollutant exposures. Participant-specific pollutant concentrations averaged over the years 2000-10 ranged from 9.2-22.6 μg PM2.5/m(3) and 7.2-139.2 parts per billion (ppb) NOX. For each 5 μg PM2.5/m(3) increase, coronary calcium progressed by 4.1 Agatston units per year (95% CI 1.4-6.8) and for each 40 ppb NOX coronary calcium progressed by 4.8 Agatston units per year (0.9-8.7). Pollutant exposures were not associated with intima-media thickness change. The estimate for the effect of a 5 μg/m(3) higher long-term exposure to PM2.5 in intima-media thickness was -0.9 μm per year (95% CI -3.0 to 1.3). For 40 ppb higher NOX, the estimate was 0.2 μm per year (-1.9 to 2.4). Increased concentrations of PM2.5 and traffic-related air pollution within metropolitan areas, in ranges commonly encountered worldwide, are associated with progression in coronary calcification, consistent with acceleration of atherosclerosis. This study supports the case for global efforts of pollution reduction in prevention of cardiovascular diseases. US Environmental Protection Agency and US National Institutes of Health.

Carotid Atherosclerosis Progression and Risk of Cardiovascular Events in a Community in Taiwan.

The authors investigated the association between progression of carotid atherosclerosis and incidence of cardiovascular disease in a community cohort in Taiwan. Data has rarely been reported in Asian populations. Study subjects were 1,398 participants who underwent ultrasound measures of common carotid artery intima-media thickness (IMT) and extracranial carotid artery plaque score at both 1994–1995 and 1999–2000 surveys. Cox proportional hazards model was used to assess the risk of incident cardiovascular disease. During a median follow-up of 13 years (1999–2013), 71 strokes and 68 coronary events occurred. The 5-year individual IMT change was not associated with development of cardiovascular events in unadjusted and adjusted models. Among subjects without plaque in 1994–1995, we observed elevated risk associated with presence of new plaque (plaque score >0 in 1999–2000) in a dose-response manner in unadjusted and age- and sex- adjusted models. The associations attenuated and became statistically non-significant after controlling for cardiovascular risk factors (hazard ratio [95% confidence interval] for plaque score >2 vs. 0: stroke, 1.61 [0.79–3.27], coronary events, 1.13 [0.48–2.69]). This study suggested that carotid plaque formation measured by ultrasound is associated increased risk of developing cardiovascular disease, and cardiovascular risk factors explain the associations to a large extent.

경동맥초음파에서 죽상경화반을 예측하는 혈액학적 수치의 분석

ABSTRACT In this study, we performed the carotid artery ultrasound targeting 140 subjects who have conducted to evaluate the changes in intima-media thickness(IMT) and plaque correlated with the presence or absence of a hematological test of the carotid artery. Considering that the IMT thickness more than 1mm is abnormal based on the carotid artery ultrasound to assess the presence or absence of plaque, and examined the correlation by classifying the blood lipid value and the fasting blood glucose level through the serum test. Consequently, the fasting blood glucose level is being analyzed as independent predictors of causing dental plaque(p=0.033), cut off value was determined as 126 mg/dL(sensitivity 56.25%, specificity 68.38%) in ROC curve analysis. Furthermore, the odds ratio appeared 1.01 times the value in the Logistic regression. Therefore, it seemed that the necessity to prospective studies in a number of subjects are considered, and also taking into account a number of blood test values along with the sonography of the carotid artery as a valuable part for effective primary prevention and follow-up observation of the cardiac and brain vascular disease is highly recommended.

Effects of biphasic, basal-bolus or basal insulin analogue treatments on carotid intima-media thickness in patients with type 2 diabetes mellitus: the randomised Copenhagen Insulin and Metformin Therapy (CIMT) trial

ObjectiveTo assess the effect of 3 insulin analogue regimens on change in carotid intima-media thickness (IMT) in patients with type 2 diabetes.Design and settingInvestigator-initiated, randomised, placebo-controlled trial with a 2×3...

Metformin versus placebo in combination with insulin analogues in patients with type 2 diabetes mellitus—the randomised, blinded Copenhagen Insulin and Metformin Therapy (CIMT) trial

ObjectiveTo assess the effect of metformin versus placebo both in combination with insulin analogue treatment on changes in carotid intima-media thickness (IMT) in patients with type 2 diabetes.Design and settingInvestigator-initiated,...

Lower the Low-density Lipoprotein Cholesterol to the Level When You Born

Lower the Low-density Lipoprotein Cholesterol to the Level When You Born

Clinical and therapeutic value of carotid intima-media thickness

Carotid Intima Media Thickness (IMT) has been widely used to predict cardiovascular events in primary and secondary prevention studies. Yet, the power of IMT to reclassify risk level on top of conventional risk assessment based on classical risk factors remains unsettled. In fact, recent data indicate that the prognostic power of IMT is lower than that provided by the identification of carotid plaques. The role of IMT as surrogate endpoint to assess the efficacy of cardiovascular protective therapies is also still debated. In fact, no studies have ever been designed and powered to show a relationship between changes in carotid IMT during follow-up and cardiovascular events. Recently, two meta-analysis of trials using IMT as surrogate endpoint failed to demonstrate an association between IMT regression and cardiovascular events. The reasons for the lack of predictive role for changes in IMT are uncertain. It has been shown that IMT is not a pure atherosclerotic index, being substantially affected by age and hemodynamic factors including blood pressure and vessel wall shear stress. In addition, the status of carotid vessels does not strictly reflect that of coronary arteries. Finally, intra and inter-observer variability of measurements may further limit the association between IMT changes in individual patients and cardiovascular risk. Thus, IMT represents a valuable risk marker in population studies but its role for tailoring cardiovascular therapy in clinical practice remains currently uncertain.

Risk factors of atherosclerosis during systemic therapy targeting vascular endothelial growth factor.

The aim of the present study was to examine the changes in intima-media thickness (IMT) and myocardial perfusion in association with other laboratory risk factors for atherosclerosis in patients treated with therapy that targeted vascular endothelial growth factor (VEGF). IMT, myocardial perfusion and laboratory risk factors of atherosclerosis were studied in 58 patients with metastatic colorectal carcinoma or metastatic renal cell carcinoma prior to and at 3-monthly intervals during anti-VEGF treatment. Compared with the pretreatment IMT, the results indicated that the IMT was consistently increased during therapy in the two patient groups. Patient blood pressure and concentration of troponin T increased transiently. An increase in the concentration of high-density lipoprotein cholesterol and decrease in the concentrations of C-reactive protein and homocysteine were also observed. Novel myocardial ischemia was evident in individual patients. In conclusion, anti-VEGF therapy affects the laboratory risk factors of atherosclerosis and results in an acceleration of atherosclerosis, as demonstrated by increased IMT.

Abstract 15947: Machine Learning to Predict Rapid Progression of Carotid Atherosclerosis in Patients With Impaired Glucose Tolerance in the ACT NOW Study

Impaired glucose tolerance (IGT) is associated with increased cardiovascular disease. Identifying IGT patients with rapid atherosclerosis progression will help in early risk-stratification. Machine learning (ML) involves algorithms that can learn complex relationships from data to make accurate predictions. Unlike traditional low-dimensional statistical approaches, ML can handle high dimensional datasets to make accurate predictions. Aim: To test the performance of ML in identifying IGT patients who will develop rapid carotid plaque progression. Methods: In the ACT NOW study (IGT patients were randomized to receive either pioglitazone or placebo), 382 subjects had carotid intima-media thickness (IMT) measured at baseline and at 15-18 months. Patients with IMT change in the top 10 percentile (n=39) were classified as rapid progressors (RP) and the rest (n=343) considered non-rapid progressors (NRP). ML using Naïve Bayes model was performed using 115 clinical/laboratory variables to develop a model to fit the true value of the class label (RP, NRP). Experiments were conducted with 10-fold cross validation in training/validation sets. Class prediction was also performed using traditional logistic regression model using 5 variables found different between RP and NRP by univariate analyses. Model performance was assessed using area under receiver operating characteristic curve. Results: Mean±SD IMT change was 0.011±0.026 mm overall; 0.058±0.018 for RP and 0.006±0.02 for NRP. Area under the curve (AUC) for ML (0.855) was higher versus traditional logistic regression model (0.73) (Fig.). ML correctly classified 78% of instances with κ statistic of 0.32. Conclusions: ML using naïve Bayes method provided good predictive ability in identifying IGT patients who had the most rapid plaque progression. ML may improve clinical prediction over traditional low-dimensional biostatistical approaches.

The effect of smoking on carotid intima–media thickness progression rate and rate of lumen diameter reduction

ObjectiveThe purpose of the study was to investigate the long-term associations between smoking habits, environmental tobacco smoke exposure (ETS), carotid intima–media thickness (IMT) progression rate, and rate of lumen diameter reduction in the carotid artery during a 16-year follow-up. Another objective was to investigate if an effect of smoking on progression rate could be explained by increased low grade inflammation. MethodsThe study population included 2992 middle-aged men and women in the 1991–1994 (baseline) and the 2007–2012 (re-examination) investigation of the Malmö Diet and Cancer Study cardiovascular cohort. Associations between smoking, progression of carotid IMT and lumen diameter reduction due to plaque protrusion were assessed by linear regression. ResultsIMT progression rates and rate of lumen diameter reduction increased from never smokers with no ETS through former, moderate and heavy smokers, even after adjustment for traditional risk factors (e.g., differences in yearly progression rates (mm/year) of maximal IMT in the carotid bifurcation compared to never smokers; former smokers 0.0074 (95% CI: 0.0018–0.0129), moderate smokers 0.0106 (95% CI: 0.0038–0.0175), and heavy smokers 0.0146 (95% CI: 0.0061–0.0230)). Former smokers showed distinct lowering of progression rates after more than five years since smoking cessation. Smoking and former smoking was associated with increased low grade inflammation, however, the effect of smoking on atherosclerotic progression rate remained fairly unchanged after such adjustment. ConclusionThe effect of smoking and former smoking on carotid IMT progression rates and change in lumen reduction due to plaque protrusion could not be explained by differences in traditional risk factors or low grade inflammation.

Nuclear magnetic resonance-determined lipoprotein subclasses and carotid intima-media thickness in type 1 diabetes

BackgroundDyslipidemia has been linked to vascular complications of Type 1 diabetes (T1DM). We investigated the prospective associations of nuclear magnetic resonance-determined lipoprotein subclass profiles (NMR-LSP) and conventional lipid profiles with carotid intima-media thickness (IMT) in T1DM. MethodsNMR-LSP and conventional lipids were measured in a subset of Diabetes Control and Complications Trial (DCCT) participants (n = 455) at study entry (‘baseline’, 1983–89), and were related to carotid IMT determined by ultrasonography during the observational follow-up of the DCCT, the Epidemiology of Diabetes Interventions and Complications (EDIC) study, at EDIC Year 12 (2004–2006). Associations were defined using multiple linear regression stratified by gender, and following adjustment for HbA1c, diabetes duration, body mass index, albuminuria, DCCT randomization group, smoking status, statin use, and ultrasound devices. ResultsIn men, significant positive associations were observed between some baseline NMR-subclasses of LDL (total IDL/LDL and large LDL) and common and/or internal carotid IMT, and between conventional total- and LDL-cholesterol and non-HDL-cholesterol and common carotid IMT, at EDIC Year 12; these persisted in adjusted analyses (p < 0.05). Large LDL particles and conventional triglycerides were positively associated with common carotid IMT changes over 12 years (p < 0.05). Inverse associations of mean HDL diameter and large HDL concentrations, and positive associations of small LDL with common and/or internal carotid IMT (all p < 0.05) were found, but did not persist in adjusted analyses. No significant associations were observed in women. ConclusionNMR-LSP-derived LDL particles, in addition to conventional lipid profiles, may help in identifying men with T1DM at highest risk for vascular disease.

Effects of comprehensive intensive therapies on the change of intima-media thickness of carotid arteries in type 2 diabetic patients: A report of 4-year follow-up with a literature review.

The aim was to evaluate the effect of comprehensive intensive therapy on the carotid and femoral arteries of intima-media thickness in patients with type 2 diabetes mellitus after 4-year follow-up. In this prospective 4-year study, patients (N = 210) with newly diagnosed type 2 diabetes received either comprehensive intensive therapy (n = 110) or conventional therapy (n = 100). Blood pressure, blood glucose and lipid levels were monitored every 3-6 months, and carotid and femoral arteries of intima-media thickness were monitored with ultrasonography. For the literature review, various databases were searched until 20 December 2014 for studies that evaluated effects of intensive multi-factorial therapies on comprehensive intensive therapy in type 2 diabetes mellitus patients. The comprehensive intensive therapy group had a smaller rate of carotid intima-media thickness increase than the conventional therapy (control) group (p < 0.05). The carotid intima-media thickness in comprehensive intensive therapy group remained stable while the adjusted rate of carotid intima-media thickness increase was 12.55% in the control group. The femoral intima-media thickness change was also smaller in comprehensive intensive therapy group but the difference over time did not reach significance. The carotid intima-media thickness remained stable in type 2 diabetes mellitus patients who received comprehensive intensive therapy, suggesting that multi-factorial intensive therapies might have potential in reducing macro-vascular events in these patients.

Changes in intima media thickness, ankle brachial index and flow mediated dilation in pre hypertensive individuals

Introduction: Prehypertension (PH) is a state being on the frontier between the physiological referent arterial pressure values and pathological ones. The opinion concerned with its treatment is contradictory. Vascular alteration is an object of interest. Material and methods: Intima Media Thickness (IMT), Ankle Brachial Index (ABI) and Flow Mediated Dilation (FMD) indices were examined in 103 individuals with PH and 45 normotensives. Anthropometric and clinical chemical methods were also applied. The statistical processing was carried out by ÐœS Excel 2000 and SPSS 11.0. Results: The pre hypertensives` metabolic profile was unfavorable, they are overweight and have bigger waist size, reflecting in higher cardiovascular risk. The percentage of FMD is reduced as an expression of endothelial function. Structural vascular alterations are not registered - ITM and ABI values are of no significant difference in the two followed up groups. Conclusion: The therapeutic approach in prehypertensives should be directed to reestablishment of the endothelial function.

Effects of bariatric surgery on markers of subclinical atherosclerosis and endothelial function: a meta-analysis of literature studies.

Several studies confirmed a significantly increased carotid intima-media thickness (IMT) and impaired flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) in obese subjects, but few data are available on the effects of bariatric surgery on these markers of cardiovascular (CV) risk. We performed a meta-analysis of studies evaluating changes in IMT, FMD and NMD in obese patients after bariatric surgery. A systematic search was performed in the PubMed, Web of Science, Scopus and EMBASE databases without any language or publication year restriction. The last search was performed in January 2015. In addition, the reference lists of all retrieved articles were manually reviewed. Prospective studies evaluating the impact of bariatric surgery on the markers of CV risk were included. Changes in IMT, FMD and NMD after bariatric surgery were expressed as mean differences (MD) with pertinent 95% confidence intervals (95% CIs). IMT has been expressed in millimeters (mm); FMD and NMD as percentage (%). Impact of clinical and demographic features on effect size was assessed by meta-regression. Ten articles (314 obese patients) were included in the analysis. Six studies contained data on IMT (7 data sets; 206 patients), 8 studies on FMD (9 data sets; 269 patients) and 4 on NMD (4 data sets; 149 patients). After bariatric surgery, there was a significant reduction of IMT (MD: -0.17 mm; 95% CI: -0.290, -0.049; P=0.006) and a significant improvement in FMD (MD: 5.65%; 95% CI: 2.87, 8.03; P<0.001), whereas NMD did not change (MD: 2.173%; 95% CI: -0.796, 5.142; P=0.151). Interestingly, percentage of changes in the body mass index were associated with changes in IMT (Z=11.52, P<0.001), FMD (Z=-4.26, P<0.001) and NMD (Z=-3.81, P<0.001). Despite heterogeneity among studies, bariatric surgery is associated with improvement of subclinical atherosclerosis and endothelial function. These effects may significantly contribute to the reduction of the CV risk after bariatric surgery.

Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels

ImportanceTestosterone use in older men is increasing, but its long-term effects on progression of atherosclerosis are unknown.ObjectiveTo determine the effect of testosterone administration on subclinical atherosclerosis progression in older men with low or low-normal testosterone levels.Design, Setting, and ParticipantsTestosterone’s Effects on Atherosclerosis Progression in Aging Men (TEAAM) was a placebo-controlled, double-blind, parallel-group randomized trial involving 308 men 60 years or older with low or low-normal testosterone levels (100-400 ng/dL; free testosterone <50 pg/mL), recruited at 3 US centers. Recruitment took place between September 2004 and February 2009; the last participant completed the study in May 2012.InterventionsOne hundred fifty-six participants were randomized to receive 7.5 g of 1% testosterone and 152 were randomized to receive placebo gel packets daily for 3 years. The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL.Main Outcomes and MeasuresCoprimary outcomes included common carotid artery intima-media thickness and coronary artery calcium; secondary outcomes included sexual function and health–related quality of life.ResultsBaseline characteristics were similar between groups: patients were a mean age of 67.6 years; 42% had hypertension; 15%, diabetes; 15%, cardiovascular disease; and 27%, obesity. The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group (mean difference adjusted for age and trial site, 0.0002 mm/year; 95% CI, −0.003 to 0.003, P = .89). The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group (adjusted mean difference, −10.8 Agatston units/year; 95% CI, −45.7 to 24.2; P = .54). Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone. Sexual desire, erectile function, overall sexual function scores, partner intimacy, and health-related quality of life did not differ significantly between groups. Hematocrit and prostate-specific antigen levels increased more in testosterone group.Conclusions and RelevanceAmong older men with low or low-normal testosterone levels, testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life. Because this trial was only powered to evaluate atherosclerosis progression, these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men.Trial Registrationclinicaltrials.gov Identifier: NCT00287586

Effects of lanthanum carbonate versus calcium carbonate on vascular stiffness and bone mineral metabolism in hemodialysis patients with type 2 diabetes mellitus: a randomized controlled trial

BackgroundVascular calcification contributes to cardiovascular disease in hemodialysis (HD) patients with diabetes. The randomized controlled trial reported here compared the effects of lanthanum carbonate (LC) and calcium carbonate (CC) on vascular stiffness assessed using brachial-ankle pulse wave velocity (ba-PWV), intima-media thickness (IMT), bone mineral density (BMD), and serum markers of chronic kidney disease – mineral and bone disorder in such patients.MethodsBa-PWV, IMT, BMD, and the biomarkers osteocalcin (OC) and bone alkaline phosphatase (BAP) were examined in 43 type 2 diabetes HD patients treated with LC (n=21) or CC (n=22) for 2 years.ResultsForty-one patients completed the study (19, LC; 22, CC). The mean ba-PWV significantly increased only in the CC group (median: 2,280.5 to 2,402.5 cm/s, P<0.05), after 24-month treatment; it remained unchanged in the LC group (median: 1,830.5 to 2,018.3 cm/s). However, the difference between the groups did not reach statistical significance. Changes in IMT and BMD were not different between the two groups. Changes in serum phosphorus, corrected calcium, and intact parathyroid hormone levels were similar between the groups. The incidence of fracture was 0% (0/19) in the LC group, and 13.6% (3/22) in the CC group (P=0.2478). The OC/BAP ratio increased significantly in the LC group (median: 0.83 to 2.47), compared with in the CC group (median: 0.77 to 1.40) (P=0.036).ConclusionFrom this study, in Japanese type 2 diabetes HD patients, we conclude that 2-year treatment with LC might have slowed the progression of ba-PWV; however, it did not cause a difference in ba-PWV, IMT, BMD, or fracture, compared with CC. Further, LC increased the OC/BAP ratio to a greater extent than CC.