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Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia.
Arch Intern Med. 1994 Feb 28; 154(4):441-9.AI

Abstract

BACKGROUND

Few studies have been performed to compare fenofibrate, a second-generation fibrate, and simvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. This study was aimed to compare the efficacy of both drugs in reducing atherogenic risk factors in type IIa or IIb hyperlipidemia.

METHODS

Sixty-three patients entered this single-center, double-blind, crossover trial. Sixty patients (32 with type IIa and 28 with type IIb hyperlipidemia) were randomized to treatment for 3 months with a single daily 200-mg dose of micronized fenofibrate or 20 mg of simvastatin and then changed to the alternative treatment for a further 3-month period.

RESULTS

After the first treatment period, in both types IIa and IIb, fenofibrate and simvastatin produced similar significant reductions in levels of total cholesterol and low-density lipoprotein cholesterol; high-density lipoprotein cholesterol levels were increased with both drugs in type IIb. Only fenofibrate decreased total triglyceride levels in type IIb, Lp(a) lipoprotein levels in patients with high baseline values, and fibrinogen. After the second period of treatment, in both types IIa and IIb, switching from fenofibrate to simvastatin resulted in a further reduction in total cholesterol and low-density lipoprotein cholesterol levels. The difference in the response of the two treatments on levels of total triglycerides, Lp(a) lipoprotein, and fibrinogen was confirmed after changing over to the alternative treatment. This short-term study showed few adverse effects for both drugs.

CONCLUSIONS

Fenofibrate and simvastatin provide similar variations on total cholesterol and low-density lipoprotein cholesterol levels after a 3-month treatment period, with simvastatin having the capacity to decrease these measures further when administered after fenofibrate. However, fenofibrate exhibits a significant effect on other established risk factors, such as total triglyceride, fibrinogen, and Lp(a) lipoprotein levels, and accordingly has a broader spectrum of activity than simvastatin.

Authors+Show Affiliations

Point Médical, Dijon, France.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

8117177

Citation

Farnier, M, et al. "Comparative Efficacy and Safety of Micronized Fenofibrate and Simvastatin in Patients With Primary Type IIa or IIb Hyperlipidemia." Archives of Internal Medicine, vol. 154, no. 4, 1994, pp. 441-9.
Farnier M, Bonnefous F, Debbas N, et al. Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia. Arch Intern Med. 1994;154(4):441-9.
Farnier, M., Bonnefous, F., Debbas, N., & Irvine, A. (1994). Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia. Archives of Internal Medicine, 154(4), 441-9.
Farnier M, et al. Comparative Efficacy and Safety of Micronized Fenofibrate and Simvastatin in Patients With Primary Type IIa or IIb Hyperlipidemia. Arch Intern Med. 1994 Feb 28;154(4):441-9. PubMed PMID: 8117177.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type IIa or IIb hyperlipidemia. AU - Farnier,M, AU - Bonnefous,F, AU - Debbas,N, AU - Irvine,A, PY - 1994/2/28/pubmed PY - 1994/2/28/medline PY - 1994/2/28/entrez SP - 441 EP - 9 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 154 IS - 4 N2 - BACKGROUND: Few studies have been performed to compare fenofibrate, a second-generation fibrate, and simvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor. This study was aimed to compare the efficacy of both drugs in reducing atherogenic risk factors in type IIa or IIb hyperlipidemia. METHODS: Sixty-three patients entered this single-center, double-blind, crossover trial. Sixty patients (32 with type IIa and 28 with type IIb hyperlipidemia) were randomized to treatment for 3 months with a single daily 200-mg dose of micronized fenofibrate or 20 mg of simvastatin and then changed to the alternative treatment for a further 3-month period. RESULTS: After the first treatment period, in both types IIa and IIb, fenofibrate and simvastatin produced similar significant reductions in levels of total cholesterol and low-density lipoprotein cholesterol; high-density lipoprotein cholesterol levels were increased with both drugs in type IIb. Only fenofibrate decreased total triglyceride levels in type IIb, Lp(a) lipoprotein levels in patients with high baseline values, and fibrinogen. After the second period of treatment, in both types IIa and IIb, switching from fenofibrate to simvastatin resulted in a further reduction in total cholesterol and low-density lipoprotein cholesterol levels. The difference in the response of the two treatments on levels of total triglycerides, Lp(a) lipoprotein, and fibrinogen was confirmed after changing over to the alternative treatment. This short-term study showed few adverse effects for both drugs. CONCLUSIONS: Fenofibrate and simvastatin provide similar variations on total cholesterol and low-density lipoprotein cholesterol levels after a 3-month treatment period, with simvastatin having the capacity to decrease these measures further when administered after fenofibrate. However, fenofibrate exhibits a significant effect on other established risk factors, such as total triglyceride, fibrinogen, and Lp(a) lipoprotein levels, and accordingly has a broader spectrum of activity than simvastatin. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/8117177/Comparative_efficacy_and_safety_of_micronized_fenofibrate_and_simvastatin_in_patients_with_primary_type_IIa_or_IIb_hyperlipidemia_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/vol/154/pg/441 DB - PRIME DP - Unbound Medicine ER -