Original ArticleAdd-on therapy for hypercholesterolemia: a pilot comparison of two gastrointestinally-acting agents in statin-treated patients
Section snippets
Methods
Patients with type IIA hypercholesterolemia (n = 12) or type IIB mixed hyperlipidema (n = 6) on a stable regimen of low- to moderate-dose statin therapy for at least 45 consecutive days were enrolled and randomized in this open-label crossover study to receive either oral colesevelam HCl 1.875 g twice daily (total 3.8 g/day) or oral ezetimibe 10 mg once daily as an AOT. After completion of 6 weeks of initial AOT, each patient was crossed over to the alternative AOT for an additional 6 weeks.
Results
Eighteen patients were originally enrolled. Two patients developed intolerable pyrosis on colesevelam HCl and were subsequently dropped from the study. One patient developed headache on ezetimibe and could not complete that phase of the study. An additional patient was lost to follow-up before completion of study protocol. “On-treatment” analysis was, therefore, limited to 14 patients (9 type 2A, 5 type 2B) who tolerated both AOTs and in whom all necessary follow-up data were available. Patient
Discussion
In a national survey of compliance with the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III guidelines, 75% of patients with coronary heart disease met the definition of “very high risk,” yet only 18% had reached the recommended optional LDL-C level of < 70 mg/dL and only 4% had reached both the recommended optional LDL-C level < 70 mg/dL and non–HDL-C level < 100 mg/dL, when triglycerides were >200 mg/dL.22 As statins remain the backbone of cholesterol-lowering
Financial disclosures
No financial support to conduct the study was provided by any pharmaceutical company or any other outside agency.
Dr. Zema has been a consultant to Daiichi-Sankyo Ltd, Merck & Co. and Merck/Schering-Plough, Astra-Zeneca and has received honoraria as a speaker from Daiichi-Sankyo Ltd., Merck & Co. and Merck/Schering-Plough, and Astra-Zeneca.
Acknowledgment
Grateful acknowledgement is extended to Dr. Mary Hanson, Merck & Co, Inc, for her invaluable assistance in manuscript preparation.
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