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Safety and Efficacy of Pitavastatin in Patients With Impaired Fasting Glucose and Hyperlipidemia: A Randomized, Open-labeled, Multicentered, Phase IV Study.
Lee, HY, Han, KH, Chung, WB, Her, SH, Park, TH, Rha, SW, Choi, SY, Jung, KT, Park, JS, Kim, PJ, et al
Clinical therapeutics. 2020;(10):2036-2048
Abstract
PURPOSE Although the role of high-intensity lipid-lowering therapy in cardiovascular protection has broadened, concerns still exist about new-onset diabetes mellitus (NODM), especially in vulnerable patients. This study aimed to compare the effect of high-dose (4 mg/d) and usual dose (2 mg/d) pitavastatin on glucose metabolism in patients with hyperlipidemia and impaired fasting glucose (IFG). METHODS In this 12-month study, glucose tolerance and lipid-lowering efficacy of high-dose pitavastatin (4 mg [study group]) was compared with that of usual dose pitavastatin (2 mg [control group]) in patients with hyperlipidemia and IFG. The primary end point was the change of glycosylated hemoglobin (HbA1c) after 24 weeks of treatment. The secondary end points were as follows: (1) NODM within 1 year after treatment, (2) change of lipid parameters, (3) changes of adiponectin, and (4) change of blood glucose and insulin levels. FINDINGS Of the total 417 patients screened, 313 patients with hypercholesterolemia and IFG were randomly assigned into groups. The mean (SD) change in HbA1c was 0.06% (0.20%) in the study group and 0.03% (0.22%) in the control group (P = 0.27). Within 1 year, 27 patients (12.3%) developed NODM, including 12 (10.6%) of 113 patients in the study group and 15 (14.2%) of 106 in the control group (P = 0.43). The study group had a significantly higher reduction of total cholesterol and LDL-C levels and a higher increase in apolipoprotein A1/apolipoprotein B ratio (0.68 [0.40] vs 0.51 [0.35], P < 0.01). IMPLICATIONS The high-dose pitavastatin therapy did not aggravate glucose metabolism compared with the usual dose therapy. Moreover, it had a better effect on cholesterol-lowering and apolipoprotein distribution in the patients with hyperlipidemia and IFG.
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Efficacy and safety of coenzyme A versus fenofibrate in patients with hyperlipidemia: a multicenter, double-blind, double-mimic, randomized clinical trial.
Chen, YQ, Zhao, SP, Ye, HJ
Current medical research and opinion. 2020;(6):941-945
Abstract
Background: We investigated the lipid-lowering efficacy and safety of coenzyme A (CoA) versus fenofibrate in Chinese patients with moderate dyslipidemia.Methods: A total of 417 subjects (aged 18-75 years) diagnosed with moderate dyslipidemia (triglyceride 2.3-6.5 mmol/L) from 13 large cardiovascular centers in China were recruited and randomly divided into a fenofibrate group (n = 207), which received 200 mg of fenofibrate orally once daily, and a CoA group (n = 210), which received 400 mg of CoA orally once a day. Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose were measured at baseline, and after 4 and 8 weeks of treatment.Results: The baseline triglyceride (TG) level in the fenofibrate group and the CoA group was 3.39 ± 0.99 mmol/L and 3.60 ± 1.11 mmol/L, respectively. After treatment for 4 and 8 weeks with fenofibrate, TG was reduced by 31.62% and 33.13%. In the CoA group, TG was reduced by 17.29% and 23.80%. Compared with baseline, total cholesterol (TC) was significantly decreased in both groups after either 4 or 8 weeks of treatment (p < .05). CoA increased high-density lipoprotein cholesterol (HDL-C) after 4 weeks of treatment, whereas it had no significant effect on HDL-C after 8 weeks of treatment. Low-density lipoprotein cholesterol (LDL-C) was not modified in either group. The incidence of side effects was significantly lower in the CoA group compared with the fenofibrate group (p < .05).Conclusions: Compared with fenofibrate, CoA has less effect on reducing plasma TG levels in subjects with moderate dyslipidemia. However, it has fewer adverse effects.
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Usefulness of Calculation of Cardiovascular Risk Factors to Predict Outcomes in Patients With Acute Myocardial Infarction.
Kim, CY, Lee, JH, Jang, SY, Bae, MH, Yang, DH, Park, HS, Cho, Y, Jeong, MH, Park, JS, Kim, HS, et al
The American journal of cardiology. 2019;(6):857-863
Abstract
Cardiovascular risk factors contribute differently to short-term prognosis of acute myocardial infarction (AMI); hypertension and diabetes increase adverse outcomes, whereas hyperlipidemia, smoking, and obesity seem to paradoxically decrease these in post-MI patients. We aimed to investigate whether a simple calculation of conventional risk factors, PARADOCS (Pressure of ARtery elevAtion, Diabetes, Obesity, Cholesterol, Smoking) score, would improve the ability to predict major adverse cardiac and cerebrovascular events (MACCEs) in post-MI patients. Between November 2011 and December 2015, 13,104 patients with diagnosis of AMI were analyzed in this study from Korean AMI Registry - National Institute of Health database. PARADOCS score was calculated as follows: (number of nonparadoxical risk factors - number of paradoxical risk factors) + 3 where nonparadoxical risk factors are hypertension and diabetes, and paradoxical risk factors are hyperlipidemia, smoking, and obesity. PARADOCS score was significantly greater in patients with 1-year MACCEs compared with those without MACCEs (3.43 ± 1.03 vs 2.88 ± 1.11, p <0.001). In Cox proportional hazards model, PARADOCS score was an independent predictor of 1-year MACCEs (hazards ratio 1.23, 95% confidence interval 1.16 to 1.30; p <0.001) after adjusting for confounding variables. In Kaplan-Meier survival curve, patients with greater PARADOCS score had worse clinical outcome. In conclusion, although it needs more validation, a simple calculation of risk factors, PARADOCS score, could provide useful prognostic information of MI patients to clinicians.
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Effect of a Remotely Delivered Tailored Multicomponent Approach to Enhance Medication Taking for Patients With Hyperlipidemia, Hypertension, and Diabetes: The STIC2IT Cluster Randomized Clinical Trial.
Choudhry, NK, Isaac, T, Lauffenburger, JC, Gopalakrishnan, C, Lee, M, Vachon, A, Iliadis, TL, Hollands, W, Elman, S, Kraft, JM, et al
JAMA internal medicine. 2018;(9):1182-1189
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Abstract
IMPORTANCE Approximately half of patients with chronic conditions are nonadherent to prescribed medications, and interventions have been only modestly effective. OBJECTIVE To evaluate the effect of a remotely delivered multicomponent behaviorally tailored intervention on adherence to medications for hyperlipidemia, hypertension, and diabetes. DESIGN, SETTING, AND PARTICIPANTS Two-arm pragmatic cluster randomized controlled trial at a multispecialty group practice including participants 18 to 85 years old with suboptimal hyperlipidemia, hypertension, or diabetes disease control, and who were nonadherent to prescribed medications for these conditions. INTERVENTIONS Usual care or a multicomponent intervention using telephone-delivered behavioral interviewing by trained clinical pharmacists, text messaging, pillboxes, and mailed progress reports. The intervention was tailored to individual barriers and level of activation. MAIN OUTCOMES AND MEASURES The primary outcome was medication adherence from pharmacy claims data. Secondary outcomes were disease control based on achieved levels of low-density lipoprotein cholesterol, systolic blood pressure, and hemoglobin A1c from electronic health records, and health care resource use from claims data. Outcomes were evaluated using intention-to-treat principles and multiple imputation for missing values. RESULTS Fourteen practice sites with 4078 participants had a mean (SD) age of 59.8 (11.6) years; 45.1% were female. Seven sites were each randomized to intervention or usual care. The intervention resulted in a 4.7% (95% CI, 3.0%-6.4%) improvement in adherence vs usual care but no difference in the odds of achieving good disease control for at least 1 (odds ratio [OR], 1.10; 95% CI, 0.94-1.28) or all eligible conditions (OR, 1.05; 95% CI, 0.91-1.22), hospitalization (OR, 1.02; 95% CI, 0.78-1.34), or having a physician office visit (OR, 1.11; 95% CI, 0.91-1.36). However, intervention participants were significantly less likely to have an emergency department visit (OR, 0.62; 95% CI, 0.45-0.85). In as-treated analyses, the intervention was associated with a 10.4% (95% CI, 8.2%-12.5%) increase in adherence, a significant increase in patients achieving disease control for at least 1 eligible condition (OR, 1.24; 95% CI, 1.03-1.50), and nonsignificantly improved disease control for all eligible conditions (OR, 1.18; 95% CI, 0.99-1.41). CONCLUSIONS AND RELEVANCE A remotely delivered multicomponent behaviorally tailored intervention resulted in a statistically significant increase in medication adherence but did not change clinical outcomes. Future work should focus on identifying which groups derive the most clinical benefit from adherence improvement efforts. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02512276.
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Effect of Evolocumab on Lipoprotein Particles.
Toth, PP, Sattar, N, Blom, DJ, Martin, SS, Jones, SR, Monsalvo, ML, Elliott, M, Davis, M, Somaratne, R, Preiss, D
The American journal of cardiology. 2018;(3):308-314
Abstract
The level of low-density lipoprotein cholesterol (LDL-C) reflects the cholesterol carried mainly by low-density lipoprotein particles (LDL-P). LDL-C, however, does not always correlate with LDL-P because of the variable amounts of cholesterol per particle. Consideration of LDL-P concentrations in addition to LDL-C may help guide therapeutic decisions in a select number of patients. Evolocumab is a fully human monoclonal antibody directed against proprotein convertase subtilisin-kexin type 9 that lowers both LDL-C and cardiovascular events. To evaluate the effect of evolocumab on serum levels and size of lipoprotein particles, we conducted a post hoc subanalysis of 619 patients from the Durable Effect of PCSK9 Antibody Compared with Placebo Study or DESCARTES trial, a 52-week, randomized, double-blind, placebo-controlled, global study of patients with hyperlipidemia. At baseline, mean LDL-P concentration was 1077 nmol/L for the placebo group and 1100 nmol/L for the evolocumab group. In patients receiving evolocumab, week 52 total LDL-P concentration decreased to 610 nmol/L, a treatment difference of 50% versus placebo. Evolocumab also reduced concentrations of medium very low-density lipoprotein particles (VLDL-P), small VLDL-P, and intermediate-density lipoprotein particle: median (Q1, Q3) changes were -15.2% (-48, 48), -29% (-54, 18), and -36% (-70, 22), respectively. Mean (95% confidence interval) % changes in total LDL particle size in the evolocumab group was -1.7 (-2.0, -1.4); % changes in HDL and VLDL particle sizes were 1.1 (0.7, 1.5) and 8.7 (7.0, 10.5), respectively. Changes in total LDL, HDL, and VLDL particle sizes (vs placebo) were all significant (p <0.001). In conclusion, evolocumab significantly lowers atherogenic lipoprotein particles including low-density and remnant lipoproteins.
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Clinical implications of carotid artery intima media thickness assessment on cardiovascular risk stratification in hyperlipidemic Korean adults with diabetes: the ALTO study.
Hong, EG, Ohn, JH, Lee, SJ, Kwon, HS, Kim, SG, Kim, DJ, Kim, DS
BMC cardiovascular disorders. 2015;:114
Abstract
BACKGROUND The primary objective was to investigate prevalence of subclinical atherosclerosis in Korean individuals with diabetes and hyperlipidemia. Association of subclinical atherosclerosis with cardiovascular risk was assessed. METHODS Assessments of carotid artery intima media thickness (cIMT) and atheromatous plaque were done using B-mode ultrasonography. Subclinical atherosclerosis was diagnosed based on presence of plaque, and/or increased cIMT versus mean cIMT reference values for Korean healthy controls. Atherosclerosis risk factors were analyzed using United Kingdom Prospective Diabetes Study (UKPDS) risk engine and Framingham Risk Score. RESULTS In total, 355 patients were included; increased mean cIMT was observed in 15.3 % of patients, 69 % had >1 carotid artery plaque, and 72.7 % were diagnosed with subclinical atherosclerosis. In total, 60 % of subjects were taking statins, with low-density lipoprotein cholesterol level maintained ~80 mg/dL at enrollment. Carotid artery measures were well correlated with UKPDS and Framingham risk scores. Prevalence of subclinical atherosclerosis in the low risk group (<15 % 10-year UKPDS-predicted coronary heart disease risk) was 64.7 %; higher than predicted in previous studies. In multivariate analysis, advanced age was a significant risk factor for subclinical atherosclerosis in men and women, while increased waist circumference and longer diabetes duration were independent predictors only in women. CONCLUSION Subclinical atherosclerosis is more prevalent among individuals with both diabetes and hyperlipidemia than in diabetic patients without additional cardiovascular risk factors. As conventional risk engines, based on modifiable risk factors may underestimate cardiovascular risk, early non-invasive carotid artery imaging screening may be warranted for patients with diabetes and hyperlipidemia, especially if they are elderly, have central obesity or have long duration of diabetes. TRIAL REGISTRATION www.clinicaltrials.gov NCT01264263.
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Which lipid measurement should we monitor? An analysis of the LIPID study.
Glasziou, PP, Irwig, L, Kirby, AC, Tonkin, AM, Simes, RJ
BMJ open. 2014;(2):e003512
Abstract
OBJECTIVES To evaluate the optimal lipid to measure in monitoring patients, we assessed three factors that influence the choice of monitoring tests: (1) clinical validity; (2) responsiveness to therapy changes and (3) the size of the long-term 'signal-to-noise' ratio. DESIGN Longitudinal analyses of repeated lipid measurement over 5 years. SETTING Subsidiary analysis of a Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study-a clinical trial in Australia, New Zealand and Finland. PARTICIPANTS 9014 patients aged 31-75 years with previous acute coronary syndromes. INTERVENTIONS Patients were randomly assigned to 40 mg daily pravastatin or placebo. PRIMARY AND SECONDARY OUTCOME MEASURES We used data on serial lipid measurements-at randomisation, 6 months and 12 months, and then annually to 5 years-of total cholesterol; low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and their ratios; triglycerides; and apolipoproteins A and B and their ratio and their ability to predict coronary events. RESULTS All the lipid measures were statistically significantly associated with future coronary events, but the associations between each of the three ratio measures (total or LDL cholesterol to HDL cholesterol, and apolipoprotein B to apolipoprotein A1) and the time to a coronary event were better than those for any of the single lipid measures. The two cholesterol ratios also ranked highly for the long-term signal-to-noise ratios. However, LDL cholesterol and non-HDL cholesterol showed the most responsiveness to treatment change. CONCLUSIONS Lipid monitoring is increasingly common, but current guidelines vary. No single measure was best on all three criteria. Total cholesterol did not rank highly on any single criterion. However, measurements based on cholesterol subfractions-non-HDL cholesterol (total cholesterol minus HDL cholesterol) and the two ratios-appeared superior to total cholesterol or any of the apolipoprotein options. Guidelines should consider using non-HDL cholesterol or a ratio measure for initial treatment decisions and subsequent monitoring.
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Slovak trial on cardiovascular risk reduction following national guidelines with CaDUET® (the STRONG DUET study).
Fedacko, J, Pella, D, Jarcuska, P, Sabol, F, Kmec, J, Lopuchovsky, T, Merkovska, L, Jedlickova, L, Janicko, M, Sajty, M
Advances in therapy. 2013;(1):60-70
Abstract
INTRODUCTION The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe. METHODS This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk. RESULTS Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe. CONCLUSION Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.
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A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.
Fiscella, K, Volpe, E, Winters, P, Brown, M, Idris, A, Harren, T
Journal of the National Medical Association. 2010;(12):1231-6
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Abstract
OBJECTIVE Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. METHODS We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. RESULTS One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. CONCLUSIONS Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.
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Effects of a standardized oral fat load on vascular remodelling markers in healthy subjects.
Derosa, G, Ferrari, I, D'Angelo, A, Salvadeo, SA, Fogari, E, Gravina, A, Mereu, R, Palumbo, I, Maffioli, P, Randazzo, S, et al
Microvascular research. 2010;(1):110-5
Abstract
The most adequate way to experimentally reproduce the post-prandial lipemia condition appears to be the administration of a standardized oral fat load (OFL) to fasting patients. We studied the effects of a standardized OFL on markers of vascular remodelling in healthy subjects. We enrolled 286 Caucasians aged >or= 18 of either sex. The OFL was given after a 12-h fast. Blood samples were drawn before and 3, 6, 9 and 12h after the fat load. The following parameters were evaluated: body mass index (BMI), blood glucose (BG), systolic blood pressure (SBP), diastolic blood pressure (DBP), lipid profile, nitrites and nitrates, adiponectin (ADP), metalloproteinase-2 (MMP-2) and metalloproteinase-9 (MMP-9). High density lipoprotein-cholesterol (HDL-C) decrease was present in subjects after 6h. Triglycerides (Tg) change was observed after 6h. Nitrites/nitrates variation was observed after 6 and 9h during OFL. Adiponectin level was decreased after 6 and 9h during OFL. Both MMP-2 and MMP-9 levels were higher after 6h during OFL. We observed that nitrites/nitrates and ADP significantly decreased and MMP-2 and MMP-9 significantly increased after a standardized OFL. Other studies need to confirm the direct acute effects of post-prandial lipemia on vascular damage.