Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: A pooled analysis from two controlled phase III clinical studies

Robert H. Knopp, C. A. Dujovne, A. Le Beaut, L. J. Lipka, R. Suresh, E. P. Veltri, J. Alderman, J. E. Angelo, W. Beliveau, R. J. Bettis, R. Broker, F. Brosco, J. Caldwell, J. Capo, J. Cavenaugh, S. Christiansen, J. Colton, D. R. Crow, C. de la Garza, G. DoddsM. A. Drehobl, S. Duckor, S. El Hafi, W. T. Ellison, R. Emkey, M. Ettinger, W. Fathauer, J. Feldstein, R. Fleischmann, R. Gaona, R. Gaona, A. J. Garber, W. T. Garland, H. Geisberg, R. Gilman, R. Gilmore, S. Gilmour, H. Gitter, G. Gladstein, J. Glassman, A. C. Goldberg, S. Gottlieb, R. Grimshaw, M. Hagan, J. Hamilton, R. Havlicek, J. Held, A. Heller, A. Herd, R. Hutchins, R. Jain, T. Jeppson, M. Kaufmann, R. Kaufmann, R. H. Knopp, S. Kulback, J. LaSalle, P. Levy, R. Lipetz, T. W. Littlejohn, P. Lodewick, C. V. Manion, A. Marcadis, J. S. Matlock, D. McCluskey, F. A. McGrew, R. McInroy, J. F. McNeer, R. Mills, B. Miskin, J. D. Mumper, B. Nasser, R. Nett, M. Noss, T. O'Barr, H. Offenberg, R. Oskoui, T. Parker, P. Peters, T. Poling, M. C. Portz, S. Promisloff, J. F. Quigley, D. Riff, O. Robinson, S. Rosenblatt, P. Sandall, J. Schmidt, H. G. Schrott, G. Sellers, G. Shockey, R. Siegel, J. O. Smith, L. K. Smith, W. Spisak, J. M. Stafford, T. W. Starz

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129 Scopus citations

Abstract

Ezetimibe is a novel cholesterol absorption inhibitor that blocks intestinal absorption of dietary and biliary cholesterol. Data from 1719 patients who participated in two multicentre, double-blind studies of ezetimibe were pooled to evaluate the drug's efficacy and safety in patients with primary hypercholesterolaemia. Following dietary stabilisation, a two- to 12-week washout period, and a four-week, single-blind, placebo lead-in period, patients were randomised to ezetimibe 10 mg or placebo once daily in the morning for 12 consecutive weeks. The primary efficacy endpoint was percent reduction in plasma low-density lipoprotein (LDL)-cholesterol from baseline at endpoint. Ezetimibe reduced LDL-cholesterol by a mean of 18.2% compared with an increase of 0.9% with placebo (P<0.01) and resulted in favourable, statistically siqnificant chanqes in HDL-cholesterol, triglycerides and apo B. The response to ezetimibe was consistent across all subgroups analysed. Ezetimibe was well tolerated, with a safety profile similar to placebo.

Original languageEnglish
Pages (from-to)363-368
Number of pages6
JournalInternational Journal of Clinical Practice
Volume57
Issue number5
StatePublished - Jun 1 2003
Externally publishedYes

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    Knopp, R. H., Dujovne, C. A., Le Beaut, A., Lipka, L. J., Suresh, R., Veltri, E. P., Alderman, J., Angelo, J. E., Beliveau, W., Bettis, R. J., Broker, R., Brosco, F., Caldwell, J., Capo, J., Cavenaugh, J., Christiansen, S., Colton, J., Crow, D. R., de la Garza, C., ... Starz, T. W. (2003). Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: A pooled analysis from two controlled phase III clinical studies. International Journal of Clinical Practice, 57(5), 363-368.