Dataset Information

New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study.

ABSTRACT: The objective of this study was to analyse persistence to lipid-lowering drug use for primary prevention of cardiovascular disease (CVD) in a new users cohort, to explore all-cause and cardiovascular related morbidity, comorbidity and mortality in this group and, finally, to study the relationship between persistence and morbimortality. We selected subjects who started lipid-lowering treatment for primary prevention of CVD between 1 January 2010 and 31 December 2017 (N = 1424), and classified them as treatment-persistent or -nonpersistent. Bivariate analyses were performed to compare sociodemographic and clinical variables, morbimortality and time to event between groups. The association between morbidities was explored using comorbidity network analysis. The effect of persistence was analysed using logistic regression and Cox survival analyses. Only 38.7% of users were persistent with treatment. Persistent and nonpersistent users had similar sociodemographic and clinical profiles, although differed in age, smoking status, and glycemia. Comorbidity networks revealed that the number of co-occurring diagnoses was higher in nonpersistent than persistent users. Adjusted analyses indicated a protective effect of treatment persistence, especially against major adverse cardiovascular events (MACE), but this effect was not statistically significant. Observational studies are crucial to characterize real-world effectiveness.

SUBMITTER: Aguilar-Palacio I

PROVIDER: S-EPMC7593937 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study.

Aguilar-Palacio Isabel I Rabanaque María José MJ Maldonado Lina L Chaure Armando A Abad-Díez José María JM León-Latre Montse M Casasnovas José Antonio JA Malo Sara S

International journal of environmental research and public health 20201020 20

The objective of this study was to analyse persistence to lipid-lowering drug use for primary prevention of cardiovascular disease (CVD) in a new users cohort, to explore all-cause and cardiovascular related morbidity, comorbidity and mortality in this group and, finally, to study the relationship between persistence and morbimortality. We selected subjects who started lipid-lowering treatment for primary prevention of CVD between 1 January 2010 and 31 December 2017 (N = 1424), and classified th ...[more]

PMID: 33092211

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Project description:The management of low-density lipoprotein cholesterol (LDL-C) levels is a central strategy for the prevention of atherosclerotic cardiovascular disease. Current United States (2018 American Heart Association/American College of Cardiology/Multisociety) and European (2019 European Society of Cardiology/European Atherosclerosis Society) guidelines endorse statin therapy as the first-line therapy for pharmacologic LDL-C lowering. However, in clinical practice up to 30% of patients report partial or complete intolerance to statin therapy. While the nocebo effect with statins is well described, perceived statin intolerance prevents many patients from achieving LDL-C thresholds associated with clinical benefit. Bempedoic acid is a novel, oral, non-statin lipid-l owering therapy that works by inhibiting adenosine triphosphate-citrate lyase, an enzymatic reaction upstream of 3-hydroxy-3-methylglutaryl coenzyme A reductase in the hepatic cholesterol synthesis pathway. Bempedoic acid confers reduction in LDL-C of ~18% on background statin therapy,~21% in patients with statin intolerance, and ~38% when given in fixed-dose combination with ezetimibe. The CLEAR Outcomes trial, which enrolled high-risk primary and secondary prevention patients with reported statin intolerance and LDL-C levels ≥100 mg/dL, showed that bempedoic acid compared with placebo reduced 4-component major adverse cardiovascular events (MACE) by 13% (hazard ratio 0.87, 95% confidence interval 0.79-0.96). Bempedoic acid also reduced 3-component MACE by 15%, myocardial infarction by 23% and coronary revascularization by 19%. The benefit was even greater in the primary prevention cohort (hazard ratio 0.70, 95% confidence interval 0.55-0.89) for 4-component MACE. Bempedoic acid was associated with increases in uric acid levels and cholelithiasis, but numerically fewer events of myalgia and new-onset diabetes. These findings confirm that bempedoic acid is an effective approach to reduce cardiovascular outcomes in high-risk patients with statin intolerance who require further reduction in LDL-C.

Project description:PurposeNovel pharmaceutical treatments reducing cardiovascular events in dyslipidaemia patients must demonstrate clinical efficacy and cost-effectiveness to promote long-term adoption by patients, physicians, and insurers.ObjectiveTo assess the cost-effectiveness of statin monotherapy compared to additive lipid-lowering therapies for primary and secondary cardiovascular prevention from the perspective of Germany's healthcare system.MethodsTransition probabilities and hazard ratios were derived from cardiovascular outcome trials for statin combinations with icosapent ethyl (REDUCE-IT), evolocumab (FOURIER), alirocumab (ODYSSEY), ezetimibe (IMPROVE-IT), and fibrate (ACCORD). Costs and utilities were retrieved from previous literature. The incidence of major adverse cardiovascular events was simulated with a Markov cohort model. The main outcomes were the incremental cost-effectiveness ratios (ICER) per quality adjusted life year (QALY) gained.ResultsFor primary prevention, the addition of icosapent ethyl to statin generated 0.81 QALY and €14,732 costs (ICER: 18,133), whereas fibrates yielded 0.63 QALY and € - 10,516 costs (ICER: - 16,632). For secondary prevention, the addition of ezetimibe to statin provided 0.61 QALY at savings of € - 5,796 (ICER: - 9,555) and icosapent ethyl yielded 0.99 QALY and €14,333 costs (ICER: 14,485). PCSK9 inhibitors offered 0.55 and 0.87 QALY at costs of €62,722 and €87,002 for evolocumab (ICER: 114,639) and alirocumab (ICER: 100,532), respectively. A 95% probability of cost-effectiveness was surpassed at €20,000 for icosapent ethyl (primary and secondary prevention), €119,000 for alirocumab, and €149,000 for evolocumab.ConclusionsFor primary cardiovascular prevention, a combination therapy of icosapent ethyl plus statin is a cost-effective use of resources compared to statin monotherapy. For secondary prevention, icosapent ethyl, ezetimibe, evolocumab, and alirocumab increase patient benefit at different economic costs.

Project description:ObjectiveTo assess the benefits and harms of lipid-lowering therapies used to prevent or manage cardiovascular disease including bile acid sequestrants (BAS), ezetimibe, fibrates, niacin, omega-3 supplements, proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, and statins.Data sourcesMEDLINE, the Cochrane Database of Systematic Reviews, and a grey literature search.Study selectionSystematic reviews of randomized controlled trials published between January 2017 and March 2022 looking at statins, ezetimibe, PCSK9 inhibitors, fibrates, BAS, niacin, and omega-3 supplements for preventing cardiovascular outcomes were selected. Outcomes of interest included major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, and adverse events.SynthesisA total of 76 systematic reviews were included. Four randomized controlled trials were also included for BAS because no efficacy systematic review was identified. Statins significantly reduced MACE (6 systematic reviews; median risk ratio [RR]=0.74; interquartile range [IQR]=0.71 to 0.76), cardiovascular mortality (7 systematic reviews; median RR=0.85, IQR=0.83 to 0.86), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.88 to 0.92). Major adverse cardiovascular events were also significantly reduced by ezetimibe (3 systematic reviews; median RR=0.93, IQR=0.93 to 0.94), PCSK9 inhibitors (14 systematic reviews; median RR=0.84, IQR=0.83 to 0.87), and fibrates (2 systematic reviews; mean RR=0.86), but these interventions had no effect on cardiovascular or all-cause mortality. Fibrates had no effect on any cardiovascular outcomes when added to a statin. Omega-3 combination supplements had no effect on MACE or all-cause mortality but significantly reduced cardiovascular mortality (5 systematic reviews; median RR=0.93, IQR=0.93 to 0.94). Eicosapentaenoic acid ethyl ester alone significantly reduced MACE (1 systematic review, RR=0.78) and cardiovascular mortality (2 systematic reviews; RRs of 0.82 and 0.82). In primary cardiovascular prevention, only statins showed consistent benefits on MACE (6 systematic reviews; median RR=0.75, IQR=0.73 to 0.78), cardiovascularall-cause mortality (7 systematic reviews, median RR=0.83, IQR=0.81 to 0.90), and all-cause mortality (8 systematic reviews; median RR=0.91, IQR=0.87 to 0.91).ConclusionStatins have the most consistent evidence for the prevention of cardiovascular complications with a relative risk reduction of about 25% for MACE and 10% to 15% for mortality. The addition of ezetimibe, a PCSK9 inhibitor, or eicosapentaenoic acid ethyl ester to a statin provides additional MACE risk reduction but has no effect on all-cause mortality.

Project description:IntroductionAccurate risk assessment is critical in cardiovascular (CV) prevention, yet physicians often underestimate CV risk, leading to inadequate preventive measures.AimThis study evaluates the concordance between physician-perceived CV risk and calculated CV risk in a primary prevention setting.MethodsThis cross-sectional study included primary prevention patients from the Cardiology Outpatient Clinic of Caserta Hospital, Italy. Two independent cardiologists evaluated the physician-perceived risk, and a third resolved discrepancies. CV risk was calculated using SCORE2 for patients with 70 years or less and SCORE2-OP for those with more than 70 years. The concordance between perceived and calculated risks was assessed using Cohen's kappa coefficient. Multivariate logistic regression analysis was performed to examine the influence of risk estimation on achieving low-density lipoprotein cholesterol (LDL-C) targets recommended by the ESC.Results389 patients had complete data for CV risk calculation. Physician-perceived risk categorized 8.7% of patients as low/moderate, 37.8% as high, and 53.5% as very-high risk. In contrast, calculated CV risk according to the SCORE2/SCORE2-OP classified 8% as low/moderate, 5.7% as high, and 86.4% as very-high risk. The concordance between perceived and calculated CV risk was poor (Cohen's kappa 0.208, p < 0.001). Underestimated patients reached LDL-C targets in 16% of cases, well-estimated in 34.5%, and overestimated in 76.9%. Statin use was significantly lower in patients with underestimated CV risk (29.2%) compared to well-estimated (50%) and overestimated (76.9%) groups (p < 0.001). Multivariate analysis showed that patients with overestimated risk were more likely to achieve LDL-C targets (OR 5.33, CI 1.33-21.42, p = 0.018), whereas underestimated patients were 47% less likely (OR 0.53, CI 0.3-0.93, p = 0.027).ConclusionsA significant discrepancy exists between physician-perceived and calculated CV risk, leading to risk underestimation in over one-third of patients. This underestimation is associated with lower LDL-C target achievement and reduced statin use.

Dataset Information

New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study.

Publications

New Male Users of Lipid-Lowering Drugs for Primary Prevention of Cardiovascular Disease: The Impact of Treatment Persistence on Morbimortality. A Longitudinal Study.

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