A study assessing real-world experiences from a US-based healthcare institution is providing new insight into use of statin therapy during pregnancy.
Presented at the American Heart Association 2022 Scientific Sessions, the study, which leveraged data recorded at Intermountain Healthcare sites from 1997-2021, provide insight into patient characteristics and outcomes among women using statins for dyslipidemia during pregnancy.
Few agents have received the amount of acclaim from clinicians as statin therapies. For decades, statin therapy has solidified its role in the armamentariums of clinicians and treatment algorithms of patients with cholesterol disorders. As the body evidence surrounding use for statins has grown, so has the push to expand patient populations. However, one group that had been excluded from consideration in most instances is women who are pregnant or may become pregnant. For decades, a black box warning accompanied the labels for statin therapy outlining their contraindication for this patient population, but, in 2021, the US Food and Drug Administration removed this warning based on a growing body evidence demonstrating the safety of statin use.
Despite this, many remain skeptical about the use of statins in pregnant women. The current study was born out of the desire to learn more about the effects of statin therapy in this patient population. With this in mind, investigators designed their study as a retrospective analysis of electronic health record data recorded at 24 hospitals and 215 clinics within the Intermountain Health system from 1997-2021.
A total of 63 statin-user pregnancies were identified during this time period. For the purpose of analysis, these patients were matched 1:10 ratio by age with nonstatin patients. The primary outcomes of interest included differences in patient characteristics and outcomes.
Results of the investigators' analysis indicated statin users had greater rates of hyperlipidemia (100% vs 1.7%; P<.0001), hypertension (34.9% vs 2.2%; P <.0001), diabetes (41.3% vs 1.0%; P <.0001),smoking history (11.1% vs 1.4%; P <.0001), family history of heart failure (6.3% v 0%; P <.0001), ASCVD history (7.9% vs 0.2%; P <.0001), and familial hypercholesterolemia (25.4% vs 1.1%; P <.0001). When examining maternal and fetal outcomes, miscarriage (30.2% vs 15.7%; P=.005), preterm labor (29.5% vs 17.5%; P=.07), and congenital anomalies were more common among statin users than nonusers. Investigators pointed out statin use was discontinued during pregnancy by 39.7% among those with a live birth.
With an interest in learning more about the study, our editorial team caught up with study investigator Viet Le, PA-C, associate professor of research at Intermountain Healthcare, and that conversation is the subject of the following video.
This study, “Characteristics and Outcomes of Statin Use During Pregnancy: A US Real-World Experience,” was presented at AHA 22.