Retrospective comparison of the effectiveness of a fenofibrate 145 mg formulation compared with the standard 160 mg tablet.
OBJECTIVE
To compare changes in lipid levels (total cholesterol [total-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG], and high-density lipoprotein cholesterol [HDL-C]) for patients who switched from standard fenofibrate 160 mg (requiring dosing with food) to fenofibrate 145 mg with no food effect (NFE).


METHODS
The analyses were performed using an electronic medical records dataset from 1 January 2003 to 31 July 2005. Patients were eligible for the analysis if they had a diagnosis of hypertension, dyslipidaemia or diabetes mellitus, were written a prescription for standard fenofibrate 160 mg during the period 1 May 2004 to 30 April 2005, and were written a subsequent prescription for fenofibrate 145 mg NFE at least 60 days after first receiving the 160 mg dose. The outcomes measured were lipid levels: total-C, LDL-C, HDL-C and TG.


RESULTS
491 patients who switched from standard fenofibrate 160 mg to fenofibrate 145 mg NFE met all of the inclusion criteria. Patients who changed therapy to fenofibrate 145 mg NFE from standard fenofibrate 160 mg showed a beneficial response in lipid levels. Statistically significant patient-specific changes in lipid levels were observed for the change from baseline to standard fenofibrate 160 mg for three lipid levels (total-C, HDL-C and TG). Statistically significant changes were observed for the switch to fenofibrate 145 mg NFE for three lipid levels (total-C, LDL-C and TG).


CONCLUSIONS
More patients treated in an outpatient clinical practice had better lipid results when prescribed fenofibrate 145 mg NFE than those prescribed standard fenofibrate 160 mg, suggesting that a less restrictive dosing regimen improves lipid outcomes.
Davidson
Michael H
MH
University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA. michaeldavidson@radiantresearch.com
Jones
Peter H
PH
D000368:Aged; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy; D005260:Female; D011345:Fenofibrate / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D016347:Medical Records Systems, Computerized / Q000706:statistics & numerical data*; D008875:Middle Aged; D012189:Retrospective Studies; D013607:Tablets; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D000960:Hypolipidemic Agents; D013607:Tablets; D014280:Triglycerides; D002784:Cholesterol; D011345:Fenofibrate
Int J Clin Pharmacol Ther. 2006 Feb;44(2):64-70
16502765
Fam Pract. 2007 Sep;24(4):380-7
17630270
Pharmacotherapy. 2008 May;28(5):570-5
18447655
Int J Clin Pract. 2008 Jan;62(1):76-87
17983433
Drugs. 2007;67(1):121-53
17209672
Diab Vasc Dis Res. 2007 Sep;4 Suppl 3:S15-20
17935056
Arch Intern Med. 2005 May 23;165(10):1147-52
15911728
Am J Med. 1987 Nov 27;83(5B):21-5
3318449
Circulation. 1998 Nov 10;98(19):2088-93
9808609
Clin Pharmacokinet. 2006;45(4):425-32
16584288
Cardiology. 1990;77 Suppl 4:50-7
2073672
Drugs. 1997 Oct;54(4):615-33
9339964
Postgrad Med J. 1993;69 Suppl 1:S34-41
8497455
Drugs. 1990 Aug;40(2):260-90
2226216
Am J Cardiol. 1998 Apr 1;81(7):912-7
9555782
Int J Nanomedicine. 2006;1(2):129-47
17722529
J Cardiovasc Pharmacol. 1999 Jul;34(1):60-3
10413068
Arch Fam Med. 2000 Nov-Dec;9(10):1169-75
11115225
Curr Vasc Pharmacol. 2005 Jan;3(1):87-98
15638786
Br J Clin Pharmacol. 2007 Mar;63(3):346-55
17096681
Am J Cardiovasc Drugs. 2002;2(2):125-32; discussion 133-4
14727988
J Clin Pharm Ther. 2000 Dec;25(6):445-51
11123498
Circulation. 2006 Jan 17;113(2):203-12
16401776