Fenofibraat en niacine vergelijkbaar bij atherogene dyslipidemie

Nieuws - 14 sep. 2010

Fenofibrate, niacin ‘largely comparable’ in atherogenic dyslipidemia

14 September 2010

Fenofibrate and niacin are "largely comparable" as treatments for patients with hypertriglyceridemia and low levels of high-density lipoprotein (HDL) cholesterol, a randomized trial has found. However, the two treatments had different effects on glucose metabolism and inflammation, leading the authors to recommend an individualized approach to the pharmacologic treatment of atherogenic dyslipidemia.

A team led by Sang-Hak Lee (Severance Cardiovascular Hospital, Seoul, Republic of Korea) enrolled 201 patients with triglyceride levels of 150-499 mg/dl (1.69-5.63 mmol/l), HDL cholesterol levels of less than 45 mg/dl (1.16 mmol/l), and low-density lipoprotein (LDL) cholesterol levels of less than 130 mg/dl (3.36 mmol/l).Following an 8-week dietary run-in, the participants were randomly assigned to receive one of two treatments for 16 weeks: fenofibrate 160 mg/day or niacin extended-release 1500 mg/day.

The study, which is reported in the journal Atherosclerosis, found that the two regimens had similar effects on most lipid parameters.

For instance, the ratio of apolipoprotein B to apolipoprotein A-1 fell by 20% in the fenofibrate group and by 22% in the niacin group; HDL cholesterol fell by 24% with fenofibrate and by 20% with niacin; and triglycerides fell by 53% with fenofibrate and by 47% with niacin.

Other effects differed between the treatments, however. LDL cholesterol, lipoprotein (a), and C-reactive protein all fell significantly more with niacin than with fenofibrate. But niacin was also associated with a worsening in glycemic control, as indicated by a significant increase in fasting glucose and glycated hemoglobin, whereas these parameters were improved with fenofibrate.

Furthermore, niacin was less well-tolerated, being associated with a greater frequency of adverse events and a greater likelihood of treatment discontinuation. Pruritis, skin flushing, and nausea were all significantly more frequent with niacin than with fenofibrate.

Lee and colleagues say this is the first study to demonstrate that niacin and fenofibrate have equivalent effects on the apolipoprotein B/A-1 ratio, each reducing apolipoprotein B and raising apolipoprotein A-1.However, the two drugs had different effects on other parameters including glycemic control and tolerability."It is worth noting that there are currently no positive cardiovascular outcome studies for fenofibrate, while there are studies showing benefit of niacin," the authors remark.

This caveat notwithstanding, they conclude that the two treatments have "a largely comparable lipid-modifying effect in patients with hypertriglyceridemia and low HDL cholesterol," but note: "Their effects on glucose metabolism and inflammation, and their adverse events, need to be considered additionally."

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