Efficacy, safety and tolerability of ongoing statin plus ezetimibe versus doubling the ongoing statin dose in hypercholesterolemic Taiwanese patients: an open-label, randomized clinical trial.

Abstract

BACKGROUND:

Reducing low-density lipoprotein cholesterol (LDL-C) is associated with reduced risk for major coronary events. Despite statin efficacy, a considerable proportion of statin-treated hypercholesterolemic patients fail to reach therapeutic LDL-C targets as defined by guidelines. This study compared the efficacy of ezetimibe added to ongoing statins with doubling the dose of ongoing statin in a population of Taiwanese patients with hypercholesterolemia.

METHODS:

This was a randomized, open-label, parallel-group comparison study of ezetimibe 10 mg added to ongoing statin compared with doubling the dose of ongoing statin. Adult Taiwanese hypercholesterolemic patients not at optimal LDL-C levels with previous statin treatment were randomized (N = 83) to ongoing statin + ezetimibe (simvastatin, atorvastatin or pravastatin + ezetimibe at doses of 20/10, 10/10 or 20/10 mg) or doubling the dose of ongoing statin (simvastatin 40 mg, atorvastatin 20 mg or pravastatin 40 mg) for 8 weeks. Percent change in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C) and triglycerides, and specified safety parameters were assessed at 4 and 8 weeks.

RESULTS:

At 8 weeks, patients treated with statin + ezetimibe experienced significantly greater reductions compared with doubling the statin dose in LDL-C (26.2% vs 17.9%, p = 0.0026) and total cholesterol (20.8% vs 12.2%, p = 0.0003). Percentage of patients achieving treatment goal was greater for statin + ezetimibe (58.6%) vs doubling statin (41.2%), but the difference was not statistically significant (p = 0.1675). The safety and tolerability profiles were similar between treatments.

CONCLUSION:

Ezetimibe added to ongoing statin therapy resulted in significantly greater lipid-lowering compared with doubling the dose of statin in Taiwanese patients with hypercholesterolemia. Studies to assess clinical outcome benefit are ongoing.

TRIAL REGISTRATION:

Registered at ClinicalTrials.gov: NCT00652327.

• Authors: Chih-Chieh Yu, Wen-Ter Lai, Kuang-Chung Shih, Tsung-Hsien Lin, Chieh-Hua Lu, Hung-Jen Lai, Mary E Hanson, Juey-Jen Hwang
• Journal: BMC research notes (BMC Res Notes) Vol. 5 Pg. 251 (May 23 2012) ISSN: 1756-0500 [Electronic] England
• PMID: 22621316 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Azetidines
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Lipids
• Ezetimibe

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anticholesteremic Agents (administration & dosage, adverse effects, therapeutic use)
• Azetidines (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Ezetimibe
• Female
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Hypercholesterolemia (blood, drug therapy)
• Intention to Treat Analysis
• Lipids (blood)
• Male
• Middle Aged
• Taiwan
• Treatment Outcome
• Young Adult