Efficacy and tolerability of a "suprabioavailable" formulation of fenofibrate in patients with dyslipidemia: a pooled analysis of two open-label trials.
BACKGROUND
Newer fibrates such as micronized fenofibrate lower triglyceride (TG) levels, raise high-density lipoprotein cholesterol (HDL-C) levels, and lower fibrinogen levels, in addition to markedly lowering levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). A new microcoated "suprabioavailable" formulation of fenofibrate has demonstrated a superior pharmacokinetic profile compared with micronized fenofibrate 200 mg/d and may effectively reduce cardiovascular risk factors at the lower dose of 160 mg/d.


OBJECTIVE
The goal of this study was to assess the efficacy and tolerability of the suprabioavailable" formulation of fenofibrate in patients with type IIa, type IIb, or type IV dyslipidemia.


METHODS
This was a pooled analysis of data from 2 unpublished multicenter, open-label trials with a common protocol. After a 4-week washout period, patients with dyslipidemias not corrected by diet alone were assigned to receive microcoated fenofibrate 160 mg/d for 12 weeks. Changes in lipid profiles and safety variables (vital signs, body weight, and laboratory measures) were monitored throughout the study, and adverse events occurring between visits 1 and 5 were recorded by the study investigators.


RESULTS
The 2 trials included 375 men and women (mean age, 55.2 years) with type IIa (n = 158), type IIb (n = 195), type IV (n = 21), or other (n = 1) dyslipidemias. At end point. HDL-C levels in patients with type IIa, IIb, or IV dyslipidemia were increased by a respective 10.9% (P < 0.001), 16.1% (P < 0.001), and 12.1% (P < 0.05), whereas TG levels were decreased by a respective 27.7% (P < 0.001), 46.4% (P < 0.001), and 40.2% (P < 0.05). In patients with type IIa or IIb dyslipidemia, TC decreased (-14.3% in each group), LDL-C decreased (-20.6% and -13.2%, respectively), and the LDL-C/HDL-C ratio decreased (-26.7% and -22.0%) (all, P < 0.001). Overall, 121 of 375 (32.3%) patients experienced > or = adverse event (AE) (202 nonserious, 8 serious). Of these, 10.1% were judged to be possibly drug related. The most common nonserious AEs were those affecting the body as a whole (2.7% of patients) and the digestive system (5.3% of patients). No serious AE was considered drug related.


CONCLUSIONS
The new "suprabioavailable" microcoated, micronized formulation of fenofibrate appears to maintain the good efficacy and safety profile of micronized fenofibrate. In the study population with moderate dyslipidemia (types IIa and IIb), it promoted beneficial changes in major lipid risk factors for cardiovascular disease.
Ramjattan
Brian R
BR
First Line Medical Services Ltd, Saint John 's, Newfoundland, Canada.
Callaghan
Denis J G
DJ
Theiss
Uwe
U
D000293:Adolescent; D000328:Adult; D000368:Aged; D001682:Biological Availability; D008076:Cholesterol, HDL / Q000097:blood / Q000378:metabolism; D002986:Clinical Trials as Topic; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy* / Q000378:metabolism; D006938:Hyperlipoproteinemia Type II / Q000188:drug therapy / Q000378:metabolism; D006953:Hyperlipoproteinemia Type IV / Q000188:drug therapy / Q000378:metabolism; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood / Q000378:metabolism
D008076:Cholesterol, HDL; D000960:Hypolipidemic Agents; D014280:Triglycerides; D011345:Fenofibrate