Efficacy and safety of fluvastatin ER 80 mg compared with fluvastatin IR 40 mg in the treatment of primary hypercholesterolaemia

William Insull, Adrian D. Marais, Ronnie Aronson, Sheryl Manfreda, Jacques Bedard, Steven Bowman, Hillary Browne, L. J. Burgess, Albert Carr, Lydia G. Corn, Ian Hamilton Craig, David Cross, Salah El Hafi, Thomas G. Elliot, Jean Firth, Jonathan L. Isaacsohn, Charlotte A. Jones, Sezer Karcier, Jon LeLevier, Robert S. LipetzLeif A. Lohrbauer, Albert Oberman, Richard O'Brien, Terry L. Poling, M. C. Rajput, Cindy Jo Richard, Russell Scott, Sirri Kes, Diane K. Smith, Inan Soydan, J. Terblanche, Karen Wolmarans

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

The efficacy and safety of once- or twice-daily immediate-release (IR) fluvastatin 40 mg were compared with those of the extended-release (XL) formulation of fluvastatin 80 mg every night (qpm), which facilitates sustained drug delivery. Patients (n=442) with primary hypercholesterolaemia (Fredrickson types IIa and IIb) were randomised to the three treatment groups in the ratio 1:1:1. Active treatment was administered for 24 weeks, following a four-week placebo/dietary lead-in period. At week 24, the mean reduction in low density lipoprotein cholesterol levels in patients treated with fluvastatin XL 80 mg every night (qpm) (-33.5%) was significantly greater than in the fluvastatin IR 40 mg every night (qpm) group (-23.2%; p<0.001), and similar to the reduction for patients treated with fluvastatin IR 40 mg twice-daily (bid) (-31.4%). Significant and dose-related alterations in other lipid variables were also apparent, particularly for high density lipoprotein cholesterol (10.2% increase) and apolipoprotein A1 and B levels (+11.5% and -24.2%, respectively) in the fluvastatin XL 80 mg qpm group compared with the fluvastatin IR 40 mg qpm group (all p<0.001). Mean triglyceride levels decreased by 14.6% in the fluvastatin XL 80 mg qpm group. Adverse events were generally mild, with no differences in frequency across the groups. Fluvastatin XL 80 mg qpm is a safe and effective lipid-lowering treatment for patients with type II hypercholesterolaemia.

Original languageEnglish (US)
Pages (from-to)148-155
Number of pages8
JournalBritish Journal of Cardiology
Volume11
Issue number2
StatePublished - Mar 2004

Keywords

  • Fluvastatin
  • Hypercholesterolaemia
  • Low density lipoprotein cholesterol
  • Sustained-release formulation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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