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

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.

How much effect of different antihypertensive medications on cardiovascular outcomes is attributable to their effects on blood pressure?

The debate over whether certain antihypertensive medications have benefits beyond what would be expected from their blood pressure lowering spurred the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, which randomized 42,418 participants to chlorthalidone (15,255), amlodipine (9048), lisinopril (9054), or doxazosin (9061). We compared chlorthalidone, the active control, with each of the other three agents with respect to the primary outcome, fatal coronary heart disease or nonfatal myocardial infarction, and several other clinical endpoints. The arms were similar with respect to the primary endpoint, although some differences were found for other endpoints, most notably heart failure. Although the desire was to achieve similar blood pressure reductions in the four arms, we found some systolic blood pressure and diastolic blood pressure differences. A natural question is to what degree can observed treatment group differences in cardiovascular outcomes be attributed to these blood pressure differences. The purpose of this paper was to delineate the problems inherent in attempting to answer this question, and to present analyses intended to overcome these problems.

A comparison of 5-day courses of dirithromycin and azithromycin in the treatment of acute exacerbations of chronic obstructive pulmonary disease.

BACKGROUND: Short-term use of antibiotics has become a common component of the management of acute exacerbations of chronic bronchitis (AECB), particularly in complex cases with productive cough or purulent phlegm. The macrolide antibiotics, particularly second-generation agents such as dirithromycin and azithromycin, are among the antibiotic classes frequently recommended and used to treat upper and lower respiratory infections, including AECB. OBJECTIVE: This study compared the clinical efficacy and tolerability of 5-day courses of dirithromycin and azithromycin given once daily for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD). METHODS: This randomized, investigator-blinded, parallel-group clinical trial was conducted at 5 centers in the United States. Eligible patients were adult (age >35 years) smokers or ex-smokers (smoking history of at least 10 pack-years) with chronic bronchitis and an acute exacerbation, defined by the occurrence of increased dyspnea and/or productive cough and feverishness within 48 hours of enrollment. Before randomization, an attempt was made to obtain a sputum specimen from each patient for Gram's staining and culture. Patients were randomized to receive dirithromycin 500 mg QD for 5 days or azithromycin 500 mg QD on day 1 and 250 mg QD on days 2 to 5. Clinical efficacy was assessed separately by patients and physicians at early (days 7-10) and late (days 25-35) posttreatment visits. RESULTS: Eighty-six patients (48 women, 38 men; mean age, 55 years) with a mean smoking history of 31 pack-years were included in the intent-to-treat analysis. Forty-six (54%) patients were randomized to dirithromycin and 40 (47%) patients to azithromycin. Clinical efficacy was reported in a high proportion of patients in both treatment groups, both at the early posttreatment visit (84.8% dirithromycin, 75.7% azithromycin; difference dirithromycin - azithromycin, 9.1%; 95% CI, -8.2 to 26.4) and the late posttreatment visit (95.5% and 86.5%, respectively; difference dirithromycin - azithromycin, 9.0%; 95% CI, -3.7 to 21.6). A similar proportion of patients required a second course of antibiotics over the study period (20.5% dirithromycin, 27.0% azithromycin; difference dirithromycin - azithromycin, -6.6%; 95% CI, -25.2 to 12.1). Only 42 (48.8%) patients were able to produce a sputum sample before receiving study treatment, and of these, only 20 (47.6%) demonstrated a preponderance of neutrophils on Gram's staining. Both treatments were well tolerated. CONCLUSIONS: The results of this study suggest comparable clinical efficacy between 5-day courses of once-daily dirithromycin and azithromycin in acute exacerbations of COPD. There were insufficient data to permit meaningful comparison of the bacteriologic efficacy of these macrolide antibiotics.

A retrospective case series of the lipid effects of switching from omega-3 fatty acid ethyl esters to icosapent ethyl in hyperlipidemic patients.

BACKGROUND: Western New York is among the regions with the highest rate of heart disease and stroke in the United States. Multifactorial causes include hypertriglyceridemia and dyslipidemia, and additional therapies may be needed to reduce residual risk that remains even after treatment with statins or other lipid-lowering medications. The purpose of this study was to evaluate the effects of a switch from omega-3 fatty acid ethyl esters (OM3EE) to icosapent ethyl (IPE) on lipid profiles in patients with hyperlipidemia. METHODS: This was a retrospective chart review of patient records extracted from multiple medical practices throughout Western New York (4 locations). Randomly selected patients (N = 15) were eligible if they were aged ≥ 18 years with diagnosis codes for high triglyceride (TG) levels or hyperlipidemia and were receiving OM3EE. They were switched from OM3EE to IPE, and lipid parameters were measured after ≥ 2 months. RESULTS: The records of 15 patients were analyzed and lipid measurements were available for 14 patients; 10 were on statins and 4 were on ezetimibe. At ≥ 2 months after the switch to IPE, 13 patients experienced decreases in total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) levels; 12 experienced a decrease in TG and low-density lipoprotein cholesterol (LDL-C) levels; and changes in HDL-C levels were varied, with no change in 1 patient, decreases in 9 patients, and increases in 4 patients. CONCLUSION: The results of this real-world retrospective analysis of 14 patients with hyperlipidemia demonstrated reductions in TG, LDL-C, TC, and non-HDL-C levels, with mixed results in HDL-C levels, after switching from OM3EE to IPE.