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Switching statin-treated patients from fenofibrate to the prescription omega-3 therapy icosapent ethyl: a retrospective case series.

ABSTRACT: INTRODUCTION:Patients receiving statin therapy for dyslipidaemia often require treatment with an additional agent to control triglyceride levels. Options for add-on therapy include fibrates and omega-3 fatty acids. This case series describes the effects of switching add-on therapy from fenofibrate to icosapent ethyl (the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on patient lipid profiles. METHODS:This was a retrospective analysis of patient records from a private medical practice in western New York. Statin-treated patients with dyslipidaemia who had been treated with fenofibrate and later switched to icosapent ethyl were selected for analysis. Lipid profiles before and after the switch to icosapent ethyl were compared. RESULTS:The records of five patients were analysed. All patients had hypertension and were overweight, male, and at high cardiovascular risk. After the switch to icosapent ethyl (treatment duration 3.9-5.8 months), triglyceride levels decreased in four patients, and low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and total cholesterol levels decreased in all patients. High-density lipoprotein levels increased in four patients. Icosapent ethyl was well tolerated. CONCLUSIONS:Switching from fenofibrate to icosapent ethyl as add-on to a statin therapy due to clinical need may provide an option for patients to maintain or improve lipid parameters.

SUBMITTER: Castaldo RS

PROVIDER: S-EPMC4801984 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Switching statin-treated patients from fenofibrate to the prescription omega-3 therapy icosapent ethyl: a retrospective case series.

Castaldo Richard S RS

Drugs & therapy perspectives : for rational drug selection and use 20160308

<h4>Introduction</h4>Patients receiving statin therapy for dyslipidaemia often require treatment with an additional agent to control triglyceride levels. Options for add-on therapy include fibrates and omega-3 fatty acids. This case series describes the effects of switching add-on therapy from fenofibrate to icosapent ethyl (the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on patient lipid profiles.<h4>Methods</h4>This was a retrospective analysis of patient records from a priva ...[more]

PMID: 27065746

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Project description:IntroductionPatients with diabetes and prediabetes are at increased risk of dyslipidemia and cardiovascular disease. To reduce this risk, statins and additional therapies may be considered. Omega-3 fatty acids offer an option to reduce triglycerides (TG) and potentially improve other lipid parameters, although products that contain docosahexaenoic acid (DHA) may increase low-density lipoprotein cholesterol (LDL-C) while eicosapentaenoic acid (EPA) does not. Prescription formulations include omega-3-acid mixtures (combination of predominantly EPA and DHA), and icosapent ethyl (high-purity prescription form of EPA ethyl ester); prescription omega-3 products are indicated as an adjunct to diet to reduce TGs in adult patients with severe hypertriglyceridemia at a dose of 4 g/day.MethodsThis was a retrospective analysis of records from a private endocrinology practice of patients who received omega-3-acid ethyl esters (OM3EE) (4 g/day) and were subsequently switched to icosapent ethyl (IPE; 4 g/day) due to the potential of OM3EE to raise LDL-C and/or cause gastrointestinal upset. Patient records were analyzed for LDL-C, TG, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and non-HDL-C measured before and after the switch to IPE.ResultsThe records of ten patients met the criteria for this analysis and were included. All patients had taken OM3EE for ≥1 year prior to their last lipid measurement before switching to IPE, and all had been taking IPE for >3 months at the time of their subsequent lipid measurement. Nine of the ten patients were on concomitant statin therapy throughout. Reductions in LDL-C, TC, and non-HDL-C were observed in eight patients, reductions or no changes in TG were observed in eight patients, and increases or no changes in HDL-C were observed in eight patients. No gastrointestinal adverse events were observed.ConclusionIn most patients with prediabetes or diabetes who switched from OM3EE to IPE, LDL-C and other lipid parameters improved. IPE was well tolerated.

Project description:ImportanceThe Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated the efficacy of icosapent ethyl (IPE) for high-risk patients with hypertriglyceridemia and known cardiovascular disease or diabetes and at least 1 other risk factor who were treated with statins.ObjectiveTo estimate the cost-effectiveness of IPE compared with standard care for high-risk patients with hypertriglyceridemia despite statin treatment.Design, setting, and participantsAn in-trial cost-effectiveness analysis was performed using patient-level study data from REDUCE-IT, and a lifetime analysis was performed using a microsimulation model and data from published literature. The study included 8179 patients with hypertriglyceridemia despite stable statin therapy recruited between November 21, 2011, and May 31, 2018. Analyses were performed from a US health care sector perspective. Statistical analysis was performed from March 1, 2018, to October 31, 2021.InterventionsPatients were randomly assigned to IPE, 4 g/d, or placebo and were followed up for a median of 4.9 years (IQR, 3.5-5.3 years). The cost of IPE was $4.16 per day after rebates using SSR Health net cost (SSR cost) and $9.28 per day with wholesale acquisition cost (WAC).Main outcomes and measuresMain outcomes were incremental quality-adjusted life-years (QALYs), total direct health care costs (2019 US dollars), and cost-effectiveness.ResultsA total of 4089 patients (2927 men [71.6%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive IPE, and 4090 patients (2895 men [70.8%]; median age, 64.0 years [IQR, 57.0-69.0 years]) were randomly assigned to receive standard care. Treatment with IPE yielded more QALYs than standard care both in trial (3.34 vs 3.27; mean difference, 0.07 [95% CI, 0.01-0.12]) and over a lifetime projection (10.59 vs 10.35; mean difference, 0.24 [95% CI, 0.15-0.33]). In-trial, total health care costs were higher with IPE using either SSR cost ($18 786) or WAC ($24 544) than with standard care ($17 273; mean difference from SSR cost, $1513 [95% CI, $155-$2870]; mean difference from WAC, $7271 [95% CI, $5911-$8630]). Icosapent ethyl cost $22 311 per QALY gained using SSR cost and $107 218 per QALY gained using WAC. Over a lifetime, IPE was projected to be cost saving when using SSR cost ($195 276) compared with standard care ($197 064; mean difference, -$1788 [95% CI, -$9735 to $6159]) but to have higher costs when using WAC ($202 830) compared with standard care (mean difference, $5766 [95% CI, $1094-$10 438]). Compared with standard care, IPE had a 58.4% lifetime probability of costing less and being more effective when using SSR cost and an 89.4% probability of costing less than $50 000 per QALY gained when using SSR cost and a 72.5% probability of costing less than $50 000 per QALY gained when using WAC.Conclusions and relevanceThis study suggests that, both in-trial and over the lifetime, IPE offers better cardiovascular outcomes than standard care in REDUCE-IT participants at common willingness-to-pay thresholds.

Project description:ImportancePatients with type 2 diabetes are at high risk of cardiovascular disease (CVD) in part owing to hypertriglyceridemia and low high-density lipoprotein cholesterol. It is unknown whether adding triglyceride-lowering treatment to statin reduces this risk.ObjectiveTo determine whether fenofibrate reduces CVD risk in statin-treated patients with type 2 diabetes.Design, setting, and participantsPosttrial follow-up of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Study between July 2009 and October 2014; 5 years of follow-up were completed for a total of 9.7 years at general community and academic outpatient research clinics in the United States and Canada. Of the original 5518 ACCORD Lipid Trial participants, 4644 surviving participants were selected based on the presence of type 2 diabetes and either prevalent CVD or CVD risk factors and high-density lipoprotein levels less than 50 mg/dL (<55 mg/dL for women and African American individuals).InterventionsPassive follow-up of study participants previously treated with fenofibrate or masked placebo.Main outcomes and measuresOccurrence of cardiovascular outcomes including primary composite outcome of fatal and nonfatal myocardial infarction and stroke in all participants and in prespecified subgroups.ResultsThe 4644 follow-on study participants were broadly representative of the original ACCORD study population and included significant numbers of women (n = 1445; 31%), nonwhite individuals (n = 1094; 21%), and those with preexisting cardiovascular events (n = 1620; 35%). Only 4.3% of study participants continued treatment with fenofibrate following completion of ACCORD. High-density lipoprotein and triglyceride values rapidly equalized among participants originally randomized to fenofibrate or placebo. Over a median total postrandomization follow-up of 9.7 years, the hazard ratio (HR) for the primary study outcome among participants originally randomized to fenofibrate vs placebo (HR, 0.93; 95% CI, 0.83-1.05; P = .25) was comparable with that originally observed in ACCORD (HR, 0.92; 95% CI, 0.79-1,08; P = .32). Despite these overall neutral results, we continued to find evidence that fenofibrate therapy effectively reduced CVD in study participants with dyslipidemia, defined as triglyceride levels greater than 204 mg/dL and high-density lipoprotein cholesterol levels less than 34 mg/dL (HR, 0.73; 95% CI, 0.56-0.95).Conclusions and relevanceExtended follow-up of ACCORD-lipid trial participants confirms the original neutral effect of fenofibrate in the overall study cohort. The continued observation of heterogeneity of treatment response by baseline lipids suggests that fenofibrate therapy may reduce CVD in patients with diabetes with hypertriglyceridemia and low high-density lipoprotein cholesterol. A definitive trial of fibrate therapy in this patient population is needed to confirm these findings.Trial registrationclinicaltrials.gov Identifier: NCT00000620.

Project description:Although low-density lipoprotein cholesterol lowering is effective in atherosclerotic cardiovascular disease (ASCVD) prevention, considerable 'lipid-associated' residual risk remains, particularly in patients with mild-to-moderate hypertriglyceridaemia (2-10 mmol/L; 176-880 mg/dL). Triglyceride (TG)-rich lipoproteins carry both TGs and cholesterol (remnant-cholesterol). At TG levels >5 mmol/L (440 mg/dL) vs. <1 mmol/L (88 mg/dL) or remnant-cholesterol >2.3 mmol/L (89 mg/dL) vs. <0.5 mmol/L (19 mg/dL), risk is ∼1.5-fold elevated for aortic stenosis, 2-fold for all-cause mortality, 3-fold for ischaemic stroke, 5-fold for myocardial infarction (MI), and 10-fold for acute pancreatitis. Furthermore, Mendelian randomization studies indicate that elevated TG-rich lipoproteins are causally related to increased risk of ASCVD and even all-cause mortality. While genetic and epidemiological data strongly indicate that TG-rich lipoproteins are causally linked to ASCVD, intervention data are ambiguous. Fibrates, niacin and low-dose omega-3 fatty acids have all been used in outcome trials, but have failed to demonstrate clear benefit in combination with statins. Whether the lack of additional benefit relates to methodological issues or true failure is indeterminate. Importantly, a recent intervention trial evaluating a high dose of eicosapentaenoic-acid showed clear benefit. Thus, REDUCE-IT evaluated the effect of icosapent ethyl (4 g/day) on cardiovascular outcomes in 8179 high-risk patients with moderate TG elevation on statin therapy. Over a median duration of 4.9 years, the relative risk for the primary endpoint (composite of cardiovascular death, non-fatal MI, non-fatal stroke, coronary revascularization, or unstable angina) was reduced by 25% (absolute risk 17.2% vs. 22.0%; P < 0.0001; number needed to treat 21). High-dose icosapent ethyl intervention therefore confers substantial cardiovascular benefit in high-risk patients with moderate hypertriglyceridaemia on statin therapy.

Dataset Information

Switching statin-treated patients from fenofibrate to the prescription omega-3 therapy icosapent ethyl: a retrospective case series.

Publications

Switching statin-treated patients from fenofibrate to the prescription omega-3 therapy icosapent ethyl: a retrospective case series.

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