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Switching from EPA + DHA (Omega-3-acid Ethyl Esters) to High-Purity EPA (Icosapent Ethyl) in a Statin-Treated Patient with Persistent Dyslipidemia and High Cardiovascular Risk: A Case Study.

ABSTRACT: Cardiovascular (CV) risk may remain despite statin treatment, and there is a need to address this risk with add-on therapy. The lipid effects of two different prescription omega-3 fatty acid therapies are described in a 55-year-old statin- and niacin-treated female with severe dyslipidemia and high CV risk. The patient was initially treated with omega-3-acid ethyl esters (eicosapentaenoic acid [EPA] and docosahexaenoic acid) 4 g/day. Due to persistently elevated low-density lipoprotein cholesterol (LDL-C), she was switched to icosapent ethyl (high-purity EPA ethyl ester) 4 g/day. Approximately 28 months after switching to icosapent ethyl, her LDL-C decreased by 69% to 52 mg/dL, triglycerides decreased by 35% to 119 mg/dL, non-high-density lipoprotein cholesterol (non-HDL-C) decreased by 63% to 76 mg/dL, total cholesterol decreased by 44% to 137 mg/dL, and HDL-C increased by 45% to 61 mg/dL. Total and small dense LDL particle concentrations decreased by 60 and 59%, respectively. Treatment was well tolerated, with improvements maintained over two years.

SUBMITTER: Crandell JR

PROVIDER: S-EPMC4957603 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Switching from EPA + DHA (Omega-3-acid Ethyl Esters) to High-Purity EPA (Icosapent Ethyl) in a Statin-Treated Patient with Persistent Dyslipidemia and High Cardiovascular Risk: A Case Study.

Crandell James R JR

Clinical Medicine Insights. Cardiology 20160721

Cardiovascular (CV) risk may remain despite statin treatment, and there is a need to address this risk with add-on therapy. The lipid effects of two different prescription omega-3 fatty acid therapies are described in a 55-year-old statin- and niacin-treated female with severe dyslipidemia and high CV risk. The patient was initially treated with omega-3-acid ethyl esters (eicosapentaenoic acid [EPA] and docosahexaenoic acid) 4 g/day. Due to persistently elevated low-density lipoprotein cholester ...[more]

PMID: 27478390

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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:Background & aimsIncreasing dietary intake of n-3 EPA+DHA and lowering dietary n-6 LA is under investigation as a therapeutic diet for improving chronic pain syndromes as well as other health outcomes. Herein we describe the diet methodology used to modulate intake of n-3 and n-6 PUFA in a free living migraine headache population and report on nutrient intake, BMI and diet acceptability achieved at week 16 of the intensive diet intervention and week 22 follow-up time-point.MethodsA total of 178 participants were randomized and began one of three diet interventions: 1) a high n-3 PUFA, average n-6 PUFA (H3) diet targeting 1500 mg EPA+DHA/day and 7% of energy (en%) from n-6 linoleic acid (LA), 2) a high-n-3 PUFA, low-n-6 PUFA (H3L6) targeting 1500 mg EPA+DHA/day and <1.8 en% n-6 LA or 3) a Control diet with typical American intakes of both EPA+DHA (<150 mg/day) and 7 en% from n-6 LA. Methods used to achieve diet change to week 16 include diet education, diet counseling, supply of specially prepared foods, self-monitoring and access to online diet materials. Only study oils and website materials were provided for the follow-up week 16 to week 22 periods. Diet adherence was assessed by multiple 24 h recalls administered throughout the trial. Diet acceptability was assessed in a subset of participants at 4 time points by questionnaire.ResultsAt week 16 H3 and H3L6 diet groups significantly increased median n-3 EPA+DHA intake from 48 mg/2000 kcals at baseline to 1484 mg/2000 kcals (p < 0.0001) and from 44 mg/2000 kcals to 1341 mg/2000 kcals (p < 0.0001), respectively. In the Control group, EPA+DHA intake remained below the typical American intake with baseline median at 60 mg/2000 kcals and 80 mg/2000 kcals (p = 0.6) at week 16. As desired, LA intake was maintained in the H3 and Control group with baseline median of 6.5 en% to 7.1 en% (p = 0.4) at week 16 and from 6.5 en% to 6.8 en% (p = 1.0) at week 16, respectively. In the H3L6 group, n-6 LA decreased from 6.3 en% at baseline to 3.2 en% (p < 0.0001) at week 16. There were no significant changes in BMI or diet acceptability throughout the trial or between diet groups.ConclusionsWe find this diet method to be acceptable to research participants and successful in altering dietary n-3 EPA+DHA with and without concurrent decreases in n-6 LA. If n-6 LA of less than 3 en% is desired, additional techniques to limit LA may need to be employed.

Dataset Information

Switching from EPA + DHA (Omega-3-acid Ethyl Esters) to High-Purity EPA (Icosapent Ethyl) in a Statin-Treated Patient with Persistent Dyslipidemia and High Cardiovascular Risk: A Case Study.

Publications

Switching from EPA + DHA (Omega-3-acid Ethyl Esters) to High-Purity EPA (Icosapent Ethyl) in a Statin-Treated Patient with Persistent Dyslipidemia and High Cardiovascular Risk: A Case Study.

Similar Datasets

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