PIII‐51

BACKGROUND Since HMG‐CoA reductase inhibitors (statins) are widely used for the treatment of hyperlipidemia in women of childbearing age, the pregnancy safety data regarding statins are urgently needed. Recent case series based on voluntary reports described cases of malformations including central nervous system defects and unilateral limb defects. This raised concerns about the fetal safety of statins. The objective of this study is to determine whether gestational use of statins poses substantial fetal toxicity. METHODS Pregnancy outcome of 45 exposed to statins and 45 matched comparison group were followed. There was no significant difference in the rate of major malformations between cases (1/45) and controls (3/45) ( p=0.38 ). The pregnancy outcomes, such as live birth ( p=0.10 ), spontaneous abortion ( p=0.72 ), and therapeutic abortion were not statistically different between the exposed and control groups. CONCLUSION Our pilot cohort did not demonstrate the malformation patterns reported in a case series based on voluntary reports. Clinical Pharmacology & Therapeutics (2005) 79 , P72–P72; doi: 10.1016/j.clpt.2005.12.259