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Is a treat-to-target approach to lipid-lowering therapy appropriate in patients with chronic kidney disease? A prospective French cohort study.
Massy, ZA, Kolla, E, Ferrières, J, Bruckert, E, Lambert, O, Mansencal, N, Laville, M, Frimat, L, Fouque, D, Combe, C, et al
Journal of nephrology. 2021;(5):1467-1477
Abstract
BACKGROUND Whereas European guidelines recommend adjusting lipid-lowering therapy (LLT) to meet prespecified targets ('treat-to-target') for low-density lipoprotein cholesterol (LDL-C), other guidelines do not ('fire and forget'). In a large observational prospective cohort, we sought to evaluate which strategy could be associated with better cardiovascular outcomes in chronic kidney disease (CKD). METHODS In CKD-REIN, patients (CKD stages 3 and 4) on LLT were categorized according to achievement of LDL-C targets for high and very high cardiovascular risk (< 2.6 and < 1.8 mmol/L, respectively) at baseline. Primary outcome was fatal/non-fatal atheromatous cardiovascular disease (CVD). Secondary outcomes were non-atheromatous CVD, atheromatous or non-atheromatous CVD, and major adverse cardiovascular events. RESULTS The population comprised 1521 patients (68 ± 12 years, 31% women, mean estimated glomerular filtration rate [eGFR] 35 mL/min/1.73 m2). Overall, 523 (34%) met their LDL-C targets at baseline. Median follow-up was 2.9 years (interquartile range 2.2-3.0). Incidence rates per 100 patient-years were 6.2% (95% confidence interval [CI] 5.5-7.0) for atheromatous CVD, 9.2% (8.3-10.1) for non-atheromatous CVD, 15.2% (14.0-16.4) for atheromatous/non-atheromatous CVD, and 6.3% (5.5-7.1) for major adverse cardiovascular events. Corresponding rates in patients who achieved targets were 6.6%, 9.8%, 16.1%, and 6.3%, respectively. Target achievement was not associated with risk of fatal/non-fatal atheromatous CVD (adjusted hazard ratio 1.04, 95% CI 0.76-1.44, p = 0.77) or fatal/non-fatal atheromatous or non-atheromatous CVD (0.98, 0.78-1.23, p = 0.91). CONCLUSIONS These findings do not appear to support a treat-to-target approach in CKD patients on LLT, and may favor the hypothesis of an advantage of fire-and-forget. Randomized trials are needed to confirm this theory.
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[Effects of changing the appearance of medications in safety and adherence in chronic patients over 65 years of age in primary care. CAMBIMED Study].
Arancón-Monge, JM, de Castro-Cuenca, A, Serrano-Vázquez, Á, Campos-Díaz, L, Rodríguez Barrientos, R, Del Cura-González, I, , , ,
Atencion primaria. 2020;(2):77-85
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Abstract
OBJECTIVE To study whether the changes in bioequivalent drugs with different appearances are associated with an increase in lack of adherence and medication use errors, in patients >65years old treated with antihypertensive and lipid-lowering medications. DESIGN Observational longitudinal prospective cohort study with a one-year follow-up period between 1 January 2013 and 31 December 2014. LOCATION Primary Healthcare Centres in the Community of Madrid. PARTICIPANTS Patients ≥65years-old with a diagnosis of hypertension and/or dyslipidaemia receiving treatment with Enalapril and/or Amlodipine and/or Simvastatin. MAIN MEASUREMENTS Variables collected during a Primary Care consultation by means of a personal interview were: sociodemographic (age, gender, level of education), clinical variables, adherence (Morisky-Green test and direct counting), medication errors (number and type), medication changes and number, analytical (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) and combined variable (error and/or adherence). There were 1 baseline and 4 quarterly visits. RESULTS The study included 274 patients with a mean age 72 (6.6) years, of whom 47.8% were female. Some medication changes were observed in 134 patients (48.9%), with a median of 3 (IQR 1-5) and a maximum of 11 changes. The risk of presenting with a medication use error or decreased adherence was increased in patients exposed to changes in all visits with RR 1.14 (1.16-1.69) at one year of follow-up. The most frequent error was the loss of dose. For each change in medication, the probability of a combined event increases by 41%. CONCLUSIONS The changes made in bioequivalent drugs with different appearance could increase the number of medication use errors and decrease the adherence. More studies should be carried out to assess how much this affects the control of the disease. The intervention section is not considered because it is an observational study.
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PRavastatin Versus FlUVastatin After Statin Intolerance: The PRUV-Intolerance Study With Propensity Score Matching.
Roh, JW, Chun, KH, Kang, M, Lee, CJ, Oh, J, Shim, CY, Ahn, CM, Kim, JS, Kim, BK, Park, S, et al
The American journal of medicine. 2019;(11):1320-1326.e1
Abstract
BACKGROUND Limited data are available on the relapse of statin intolerance after resumption of statins. We aimed to evaluate the relapse rates of statin intolerance in patients who subsequently received pravastatin or fluvastatin and to identify associated factors. METHODS This retrospective, propensity score-matched cohort study screened data obtained from a tertiary university hospital between 2006 and 2015. Of 8073 patients screened, 488 with statin intolerance who received pravastatin or fluvastatin with regular follow-up were enrolled. After propensity score matching of patients, 384 were finally analyzed. The primary outcome variables were relapse of statin intolerance and stopping (ie, discontinuation or switching to other statins) rate for the 2 statins. RESULTS During the median follow-up period of 37 months, the rate of relapse of intolerance was 10.4% and 18.2% among users of pravastatin and fluvastatin, respectively (P = 0.04). However, the log-rank test showed no difference in the relapse-free rates between the 2 groups (P = 0.34). The stopping rates of the 2 statins were 36.5% and 42.2% (P = 0.30), respectively, for various reasons, including low efficacy of the drugs. After adjustment, chronic kidney disease (hazard ratio [HR] 1.83, P = 0.03) and previous creatine kinase elevation (HR 3.13, P = 0.001) were identified as independent determinants of relapse. Older age (HR 1.03, P = 0.057) and female sex (HR 1.70, P = 0.059) were associated, but not significantly, with relapse. CONCLUSION Although a small proportion of patients taking pravastatin or fluvastatin experienced a relapse of intolerance, many patients eventually discontinued or changed these agents. Chronic kidney disease and history of creatine kinase elevation were independent determinants of relapse.
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Are the Levels of Lipid Parameters Associated with Biometeorological Conditions?
Skutecki, R, Cymes, I, Dragańska, E, Glińska-Lewczuk, K, Buciński, A, Drozdowski, M, Romaszko, J
International journal of environmental research and public health. 2019;(23)
Abstract
Lipid disorders, especially hypercholesterolemia, are one of the most thoroughly investigated cardiovascular risk factors. Their correlation with biometeorological conditions has been reported, with authors stressing seasonal increases of total cholesterol (TC) levels, mostly occurring in winter. This study aims at determining the correlation between the level of lipid parameters (LP) and meteorological conditions, analyzing seasonal variations in LP levels, and attempting to answer the following questions: do changes in LP levels result from the organism's response to cold or heat stress, or are they secondary to seasonal dietary variations? An observational study comprised ambulatory patients from the city of Olsztyn (Poland), for whom laboratory test were performed in 2016-2018, with 106,325 records of TC, high-density lipoprotein (HDL), and triglycerides (TG). LP levels were matched with atmospheric conditions on the day when the test was conducted and expressed by the universal thermal climate index (UTCI). We demonstrated seasonal increases of TC in cold stress (in wintertime) and of TG in heat stress (summer). The analysis of LP levels in specific periods revealed the increase of TC levels after holidays (i.e., Christmas and Easter) in men by 4.56%, and the increase of TG levels in women by 13.46% in the same period. Our results suggest the secondary, diet-dependent underlying cause of the observed changes. This work contributes to the discussion concerning the impact of biometeorological factors on LP levels and may be of significance when planning population-dedicated preventive activities.
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High exposure to statins decrease the risk of new-onset dementia: A nationwide population-based longitudinal cohort study.
Chang, CF, Liou, YS, Lin, TK, Ma, S, Hu, YR, Chen, HY, Jong, GP
Medicine. 2019;(34):e16931
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Several studies have shown that statin users have a lower risk of new-onset dementia (NOD) compared nonusers. However, other studies have shown opposite results. In this study, we investigated the association between the use of statins and the development of NOD.This was a longitudinal cohort study using data from claim forms submitted to the Taiwanese Bureau of National Health Insurance. The study included patients with NOD and non-NOD subjects from January 2002 to December 2013. We estimated the hazard ratios (HRs) of NOD associated with statin use, whereas nonuser subjects were used as a reference group.A total of 19,522 NOD cases were identified in 100,610 hyperlipidemic patients during the study period. The risk of NOD, after adjusting for sex, age, comorbidities, and concurrent medication, was lower among statin users than nonusers (HR 0.95, 95% CI [confidence interval] 0.94-0.96; P < .001). The adjusted HRs for NOD were 1.53 (95% CI, 1.45-1.62), 0.63 (95% CI, 0.57-0.71), and 0.34 (95% CI, 0.30-0.38) when the cumulative defined daily doses ranged from 28 to 365, 366 to 730, and more than 730 relative to nonusers, respectively.We concluded that statin use is associated with a decreased NOD risk. The protective effect of statins for NOD seemed to be related to high exposure to statins. This study also highlights that high exposure to statins has a dose-response effect on lowering NOD risk.
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Plasma Phospholipid Fatty Acids and Coronary Heart Disease Risk: A Matched Case-Control Study within the Women's Health Initiative Observational Study.
Liu, Q, Matthan, NR, Manson, JE, Howard, BV, Tinker, LF, Neuhouser, ML, Van Horn, LV, Rossouw, JE, Allison, MA, Martin, LW, et al
Nutrients. 2019;(7)
Abstract
BACKGROUND AND AIMS The association of fatty acids with coronary heart disease (CHD) has been examined, mainly through dietary measurements, and has generated inconsistent results due to measurement error. Large observational studies and randomized controlled trials have shown that plasma phospholipid fatty acids (PL-FA), especially those less likely to be endogenously synthesized, are good biomarkers of dietary fatty acids. Thus, PL-FA profiles may better predict CHD risk with less measurement error. METHODS We performed a matched case-control study of 2428 postmenopausal women nested in the Women's Health Initiative Observational Study. Plasma PL-FA were measured using gas chromatography and expressed as molar percentage (moL %). Multivariable conditional logistic regression was used to calculate odds ratios (95% CIs) for CHD associated with 1 moL % change in PL-FA. RESULTS Higher plasma PL long-chain saturated fatty acids (SFA) were associated with increased CHD risk, while higher n-3 polyunsaturated fatty acids (PUFA) were associated with decreased risk. No significant associations were observed for very-long-chain SFA, monounsaturated fatty acids (MUFA), PUFA n-6 or trans fatty acids (TFA). Substituting 1 moL % PUFA n-6 or TFA with an equivalent proportion of PUFA n-3 were associated with lower CHD risk. CONCLUSIONS Higher plasma PL long-chain SFA and lower PUFA n-3 were associated with increased CHD risk. A change in diet by limiting foods that are associated with plasma PL long-chain SFA and TFA while enhancing foods high in PUFA n-3 may be beneficial in CHD among postmenopausal women.
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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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Clinical Management of High and Very High Risk Patients with Hyperlipidaemia in Central and Eastern Europe: An Observational Study.
Petrov, I, Dumitrescu, A, Snejdrlova, M, Zafrir, B, Wożakowska-Kapłon, B, Fabryova, L, Pintarić, H, Bridges, I, Petkova, R
Advances in therapy. 2019;(3):608-620
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INTRODUCTION A retrospective/prospective observational study was conducted to explore the current management of hyperlipidaemia in high-risk (HR) and very high risk (VHR) patients in central/eastern Europe and Israel. METHODS The study enrolled adult patients who were receiving lipid-lowering therapy and attending a specialist (cardiologist/diabetologist/lipidologist) or internist for a routine visit at 57 sites (including academic/specialist/internal medicine centres) across Bulgaria, Croatia, Czech Republic, Israel, Poland, Romania and Slovakia. Data were collected from medical records, for the 12 months before enrolment, with/without ≤ 6 months' additional prospective follow-up. RESULTS A total of 1244 patients, mean (SD) age 63.3 (11.3) years were included (307 with familial hypercholesterolaemia (FH), 943 secondary prevention patients). Almost all patients (98.1%) were receiving statins (76.7% monotherapy/21.4% combined therapy), with 53.1% receiving high-intensity statin therapy: 127 patients (10.2%) had adverse events attributed to statin intolerance. Mean (SD) low density lipoprotein cholesterol (LDL-C) levels were 3.3 (1.7) mmol/L at the first, and 2.7 (1.3) mmol/L at the last, visit of the retrospective phase of observation, with little change during the prospective phase. Less than one-quarter (23.8%; 95% CI 17.29-31.45%) of HR patients and less than half (42.0%; 39.05-44.98%) of VHR patients achieved their risk-based LDL-C targets of < 2.5 and < 1.8 mmol/L, respectively. Less than 15% of FH patients reached these targets (10.9% (5.6-18.7%) of HR and 12.1% (8.0-17.4%) of VHR patients). The revised 2016 ESC/EAS target for HR patients (2.6 mmol/L) was met by 28.5% (21.44-36.38%) of HR patients overall. Almost one-half of patients (42.1%) experienced one or more cardiovascular events during observation. CONCLUSION Our findings confirm that, despite widespread statin use, a substantial proportion of patients treated for hyperlipidaemia in central/eastern Europe and Israel, particularly those with FH, do not reach recommended LDL-C targets, thus remaining at risk of cardiovascular events. FUNDING Amgen (Europe) GmbH.
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Characterizing hair loss in the elderly: an observational study of 163 patients.
Conic, RRZ, Juhasz, M, Rambhia, P, Damiani, G, Atanaskova-Mesinkovska, N, Piliang, M, Bergfeld, W
Journal of the European Academy of Dermatology and Venereology : JEADV. 2019;(5):e226-e228
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Hyperlipidaemia and incident osteoarthritis of the hand: a population-based case-control study.
Frey, N, Hügle, T, Jick, SS, Meier, CR, Spoendlin, J
Osteoarthritis and cartilage. 2017;(7):1040-1045
Abstract
OBJECTIVE Preclinical evidence suggests that increased cholesterol levels might be involved in the pathophysiology of osteoarthritis of the hand (HOA), but evidence from observational studies remains scarce. We aimed to analyse the association between hyperlipidaemia and incident HOA. DESIGN We conducted a matched (1:1) case-control study using the UK-based Clinical Practice Research Datalink (CPRD). Cases were patients aged 30-89 years with an incident diagnosis of HOA between 1995 and 2014. In multivariable conditional logistic regression analyses, we calculated odds ratios (OR) for incident HOA in patients with hyperlipidaemia, categorized by gender, age, previous duration of hyperlipidaemia, and recent statin treatment. RESULTS Among 19,590 cases and 19,590 controls, we observed an increased risk of HOA in patients with hyperlipidaemia (OR 1.37, 95% confidence intervals (CI) 1.28-1.47), when compared to patients without hyperlipidaemia. Thus, of all HOA cases in our study population, 3.6% may have been attributable to the presence of hyperlipidaemia (population attributable risk). Most patients with HOA were elderly, but the strength of the association between HOA and hyperlipidaemia inversely correlated with increasing age, with the highest OR of 1.72 (95% CI 1.24-2.38) in patients aged 29-49 years. Categorization by previous hyperlipidaemia duration, as well as sub-classification of patients with hyperlipidaemia into those with and without recent statin use did not meaningfully change the effect estimate. CONCLUSIONS Our results suggest that hyperlipidaemia may be an independent risk factor for new onset HOA.