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Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study.
Am Heart J 2009; 157(1):195-203AH

Abstract

BACKGROUND

Patients with mixed dyslipidemia often require combination therapy to effectively control lipid abnormalities. This study compared the effects of combination therapy with ABT-335 (a new formulation of fenofibric acid) and simvastatin to ABT-335 and simvastatin monotherapies on lipid and nonlipid parameters in patients with mixed dyslipidemia.

METHODS

This was a phase 3, multicenter, randomized, double-blind, active-controlled study. A total of 657 patients with mixed dyslipidemia (low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL, triglycerides [TGs] > or =150 mg/dL, and high-density lipoprotein cholesterol [HDL-C]<40 mg/dL [men] or <50 mg/dL [women]) were randomized to 12 weeks of treatment with ABT-335 + simvastatin (20 or 40 mg) combination therapy, ABT-335 monotherapy (135 mg), or simvastatin monotherapy (20, 40, or 80 mg).

RESULTS

Combination therapy resulted in significantly greater increases in HDL-C and decreases in TGs compared to the corresponding simvastatin monotherapy dose (P < .001) and decreases in LDL-C compared to ABT-335 monotherapy (P < .001). HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335). HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335). Twelve-week treatment with combination therapy was generally well tolerated with a safety profile consistent with ABT-335 and simvastatin monotherapies. No cases of rhabdomyolysis were reported.

CONCLUSION

For patients with mixed dyslipidemia, combination therapy provided more effective control of multiple lipid parameters than either monotherapy alone, with a safety profile similar to both monotherapies.

Authors+Show Affiliations

The Creighton Cardiac Center, Omaha, NE 68131, USA. smm@creighton.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19081418

Citation

Mohiuddin, Syed M., et al. "Efficacy and Safety of ABT-335 (fenofibric Acid) in Combination With Simvastatin in Patients With Mixed Dyslipidemia: a Phase 3, Randomized, Controlled Study." American Heart Journal, vol. 157, no. 1, 2009, pp. 195-203.
Mohiuddin SM, Pepine CJ, Kelly MT, et al. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J. 2009;157(1):195-203.
Mohiuddin, S. M., Pepine, C. J., Kelly, M. T., Buttler, S. M., Setze, C. M., Sleep, D. J., & Stolzenbach, J. C. (2009). Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. American Heart Journal, 157(1), pp. 195-203. doi:10.1016/j.ahj.2008.08.027.
Mohiuddin SM, et al. Efficacy and Safety of ABT-335 (fenofibric Acid) in Combination With Simvastatin in Patients With Mixed Dyslipidemia: a Phase 3, Randomized, Controlled Study. Am Heart J. 2009;157(1):195-203. PubMed PMID: 19081418.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. AU - Mohiuddin,Syed M, AU - Pepine,Carl J, AU - Kelly,Maureen T, AU - Buttler,Susan M, AU - Setze,Carolyn M, AU - Sleep,Darryl J, AU - Stolzenbach,James C, Y1 - 2008/11/20/ PY - 2008/05/02/received PY - 2008/08/20/accepted PY - 2008/12/17/entrez PY - 2008/12/17/pubmed PY - 2009/1/23/medline SP - 195 EP - 203 JF - American heart journal JO - Am. Heart J. VL - 157 IS - 1 N2 - BACKGROUND: Patients with mixed dyslipidemia often require combination therapy to effectively control lipid abnormalities. This study compared the effects of combination therapy with ABT-335 (a new formulation of fenofibric acid) and simvastatin to ABT-335 and simvastatin monotherapies on lipid and nonlipid parameters in patients with mixed dyslipidemia. METHODS: This was a phase 3, multicenter, randomized, double-blind, active-controlled study. A total of 657 patients with mixed dyslipidemia (low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL, triglycerides [TGs] > or =150 mg/dL, and high-density lipoprotein cholesterol [HDL-C]<40 mg/dL [men] or <50 mg/dL [women]) were randomized to 12 weeks of treatment with ABT-335 + simvastatin (20 or 40 mg) combination therapy, ABT-335 monotherapy (135 mg), or simvastatin monotherapy (20, 40, or 80 mg). RESULTS: Combination therapy resulted in significantly greater increases in HDL-C and decreases in TGs compared to the corresponding simvastatin monotherapy dose (P < .001) and decreases in LDL-C compared to ABT-335 monotherapy (P < .001). HDL-C increased 17.8% versus 7.2% and TGs decreased -37.4% versus -14.2% (ABT-335 + simvastatin 20 vs simvastatin 20); LDL-C decreased -24.0% versus -4.0% (ABT-335 + simvastatin 20 vs ABT-335). HDL-C increased 18.9% versus 8.5% and TGs decreased -42.7% versus -22.4% (ABT-335 + simvastatin 40 vs simvastatin 40); LDL-C decreased -25.3% versus -4.0% (ABT-335 + simvastatin 40 vs ABT-335). Twelve-week treatment with combination therapy was generally well tolerated with a safety profile consistent with ABT-335 and simvastatin monotherapies. No cases of rhabdomyolysis were reported. CONCLUSION: For patients with mixed dyslipidemia, combination therapy provided more effective control of multiple lipid parameters than either monotherapy alone, with a safety profile similar to both monotherapies. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/19081418/Efficacy_and_safety_of_ABT_335__fenofibric_acid__in_combination_with_simvastatin_in_patients_with_mixed_dyslipidemia:_a_phase_3_randomized_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(08)00748-5 DB - PRIME DP - Unbound Medicine ER -