BACKGROUND: For patients who have above-target low-density lipoprotein cholesterol (LDL-C) levels while on statin monotherapy, coadministration of a cholesterol absorption inhibitor with the statin may decrease serum LDL-C levels and improve overall lipid profiles. OBJECTIVES: To assess the effectiveness and safety of ezetimibe 10 mg/day coadministered with a statin in patients with primary hypercholesterolemia who have higher than recommended LDL-C levels while on statin monotherapy. METHODS: A six-week, prospective, multicentre study of eligible patients who had above-target LDL-C levels while on monotherapy with any statin, regardless of dose, for a minimum of four weeks. All patients were treated for six weeks with 10 mg ezetimibe daily coadministered with their current statins. RESULTS:A total of 1141 patients were screened, 953 (83.5%) fulfilled the study inclusion criteria and 837 (87.8%) completed the study. Reasons for withdrawal included: lost to follow-up (50 patients [5.2%]); protocol violations (45 patients [4.7%]); adverse events (19 patients [2.0%]); and withdrawal of consent (two patients [0.2%]). After six weeks of treatment, statistically significant (P = 0.001) mean reductions were observed in LDL-C (30.05%), total cholesterol (20.84%), triglycerides (10.16%), apolipoprotein B (19.84%) and the total cholesterol to high-density lipoprotein cholesterol ratio (19.88%). At six weeks, 674 patients (80.5%) achieved target LDL-C levels. Fifty predominantly mild, nonserious adverse events related to ezetimibe were reported by 32 patients (3.4%). Frequently reported adverse events included constipation (n = 7 [0.7% of patients]), diarrhea (n = 4 [0.4%]) and dizziness (n = 4 [0.4%]). CONCLUSION:Ezetimibe coadministered with statins is effective in reducing LDL-C in patients who do not attain target LDL-C levels while on statin monotherapy.
RCT Entities:
BACKGROUND: For patients who have above-target low-density lipoprotein cholesterol (LDL-C) levels while on statin monotherapy, coadministration of a cholesterol absorption inhibitor with the statin may decrease serum LDL-C levels and improve overall lipid profiles. OBJECTIVES: To assess the effectiveness and safety of ezetimibe 10 mg/day coadministered with a statin in patients with primary hypercholesterolemia who have higher than recommended LDL-C levels while on statin monotherapy. METHODS: A six-week, prospective, multicentre study of eligible patients who had above-target LDL-C levels while on monotherapy with any statin, regardless of dose, for a minimum of four weeks. All patients were treated for six weeks with 10 mg ezetimibe daily coadministered with their current statins. RESULTS: A total of 1141 patients were screened, 953 (83.5%) fulfilled the study inclusion criteria and 837 (87.8%) completed the study. Reasons for withdrawal included: lost to follow-up (50 patients [5.2%]); protocol violations (45 patients [4.7%]); adverse events (19 patients [2.0%]); and withdrawal of consent (two patients [0.2%]). After six weeks of treatment, statistically significant (P = 0.001) mean reductions were observed in LDL-C (30.05%), total cholesterol (20.84%), triglycerides (10.16%), apolipoprotein B (19.84%) and the total cholesterol to high-density lipoprotein cholesterol ratio (19.88%). At six weeks, 674 patients (80.5%) achieved target LDL-C levels. Fifty predominantly mild, nonserious adverse events related to ezetimibe were reported by 32 patients (3.4%). Frequently reported adverse events included constipation (n = 7 [0.7% of patients]), diarrhea (n = 4 [0.4%]) and dizziness (n = 4 [0.4%]). CONCLUSION:Ezetimibe coadministered with statins is effective in reducing LDL-C in patients who do not attain target LDL-C levels while on statin monotherapy.
Authors: Claude Gagné; Harold E Bays; Stuart R Weiss; Pedro Mata; Katherine Quinto; Michael Melino; Meehyung Cho; Thomas A Musliner; Barry Gumbiner Journal: Am J Cardiol Date: 2002-11-15 Impact factor: 2.778
Authors: Carlos A Dujovne; Mark P Ettinger; J Frederick McNeer; Leslie J Lipka; Alexandre P LeBeaut; Ramachandran Suresh; Bo Yang; Enrico P Veltri Journal: Am J Cardiol Date: 2002-11-15 Impact factor: 2.778
Authors: Boris Kerzner; John Corbelli; Stephan Sharp; Leslie J Lipka; Lorenzo Melani; Alexandre LeBeaut; Ramachandran Suresh; Pabak Mukhopadhyay; Enrico P Veltri Journal: Am J Cardiol Date: 2003-02-15 Impact factor: 2.778
Authors: R H Knopp; H Gitter; T Truitt; H Bays; C V Manion; L J Lipka; A P LeBeaut; R Suresh; B Yang; E P Veltri Journal: Eur Heart J Date: 2003-04 Impact factor: 29.983
Authors: Michael H Davidson; Thomas McGarry; Robert Bettis; Lorenzo Melani; Leslie J Lipka; Alexandre P LeBeaut; Ramachandran Suresh; Steven Sun; Enrico P Veltri Journal: J Am Coll Cardiol Date: 2002-12-18 Impact factor: 24.094