The tolerability and efficacy of low-dose simvastatin in statin-intolerant patients

Degreef, L.E.; Opdam, F.L.; Teepe-Twiss, I.M.; Jukema, J.W.; Guchelaar, H.J.; Tamsma, J.T.

doi:10.1016/j.ejim.2010.03.015

« Previous Next »European Journal of Internal Medicine
Volume 21, Issue 4 , Pages 293-296, August 2010

The tolerability and efficacy of low-dose simvastatin in statin-intolerant patients☆

L.E. Degreef
- Section of Vascular Medicine, Department of Endocrinology & General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
F.L. Opdam
- Section of Vascular Medicine, Department of Endocrinology & General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
I.M. Teepe-Twiss
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands
J.W. Jukema
- Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
H.J. Guchelaar
- Department of Clinical Pharmacy & Toxicology, Leiden University Medical Center, Leiden, The Netherlands
J.T. Tamsma
- Section of Vascular Medicine, Department of Endocrinology & General Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands
- Corresponding author. Section of Vascular Medicine, Department of Endocrinology & General Internal Medicine, Leiden University Medical Center, Albinusdreef 2, PO box 9600, 2300 RC Leiden, The Netherlands. Tel.: +31 715262998; fax: +31 715248140.

Received 8 January 2010; received in revised form 25 March 2010; accepted 28 March 2010. published online 13 May 2010.

Abstract

Background/aim

Statin intolerance is increasingly recognized as a therapy limiting factor in the primary and secondary prevention of cardiovascular disease. Since vulnerability to dose related adverse events differ between subjects treated with statins we hypothesized low-dose simvastatin would be tolerated and effective in statin-intolerant patients.

Method

A single center open label prospective observational study was performed assessing tolerability and efficacy of low-dose simvastatin treatment in 35 statin-intolerant patients. Statin intolerance was defined as not being able to tolerate a registered dose statin due to myalgia–myopathy, myositis, or elevation of serum liver enzyme levels. These statin-intolerant patients were treated with simvastatin with an initial dose of 2.5mg every other day. The dose was titrated upwards if possible. Tolerability was defined as remaining on treatment. Efficacy was defined as change of LDL-cholesterol compared to baseline.

Results

The reached simvastatin dose ranged from 0.825 to 8.75mg/day with a mean dose of 4mg/day. Fifty-seven percent of the patients tolerated low-dose therapy and remained on treatment. Of these patients, 30% noted recurrent myalgia. Low-dose simvastatin significantly decreased mean(SD) LDL-cholesterol levels with 25.9(12.1)% (p<0.001). Eleven percent of the patients reached LDL-cholesterol target levels (<2.6mmol/l) in an intention to treat analysis and in 20% of patients that tolerated low-dose simvastatin.

Conclusion

Low-dose simvastatin therapy is tolerated in a considerable proportion of statin-intolerant patients with significant lipid lowering efficacy. Low-dose statin therapy can be considered in multidrug regimens in statin-intolerant patients.

Keywords: Statin intolerance, Low-dose statin, Simvastatin, LDL-cholesterol, Cardiovascular prevention