The efficacy and safety of long-term PCSK9 inhibition remain uncertain. Koren and coauthors studied 1255 patients treated with 420 mg of evolocumab monthly in the open-label OSLER-1 extension trial. The mean follow-up time of patients receiving therapy was 44 months, with 543 patients treated longer than 4 years, representing the longest clinical trial exposure to a PCSK9 inhibitor to date. Substantial low-density lipoprotein cholesterol (LDL-C) lowering was sustained (57% reduction), no neutralizing antibodies were detected with cumulative drug exposure, and neurocognitive event rates were 0.4%. In an editorial, Stone notes that the lack of neutralizing antibodies with this fully human PCSK9 inhibitor is reassuring but that open-label studies may overstate benefits, as only responders typically continue with therapy.
Trans-fatty acids (TFAs) have deleterious cardiovascular effects, but clinical outcomes of TFA restrictions have not been studied. Brandt and coauthors used the New York State Department of Health Statewide Planning and Research Cooperative System and census population estimates to evaluate hospitalizations for myocardial infarction (MI) and stroke before and after TFA restrictions were initiated in 11 New York counties between 2007 and 2011. The population with TFA restrictions experienced significant decline in MI and combined MI and stroke events beyond temporal trends compared with populations in the 25 counties without restrictions. These data are noteworthy, as the US Food and Drug Administration plans a nationwide restriction in 2018.
Age-specific transitions between categories of blood pressure (BP) in multiracial/multiethnic populations have not been well studied. Hardy and coauthors examined 17 747 participants aged 8 to 80 years enrolled in the National Health and Nutrition Examination Survey to characterize ages at which populations transition between ideal BP, prehypertension, and hypertension across the life course. The largest prehypertension to hypertension net transitions occurred at young ages in white boys (age 8 years) and African American men (age 25 years), while net transitions increased for white women after age 40 years and Mexican American women after age 60 years. In a commentary, Taylor and coauthors emphasize the pressing need for greater cognizance of the risk of undetected and unattended BP elevations in young individuals.
Women with congenital heart disease (CHD) have increased risk for adverse events during pregnancy and delivery. Using the Healthcare Cost and Utilization Project California State Inpatient Database, Hayward and coauthors examined maternal and fetal outcomes in 3 642 041 women from 2014 to 2017, including 3189 with noncomplex and 262 with complex CHD. Congenital heart disease was associated with higher risk of incident congestive heart failure, atrial arrhythmias, and fetal growth restriction, and complex CHD was associated with ventricular arrhythmias and maternal in-hospital mortality. However, these adverse outcomes were rare, each occurring in less than 10 women with noncomplex or complex CHD. Davidson notes in a commentary that these data provide reassuring news for many women with CHD desiring to bear children.
Highlights. JAMA Cardiol. 2017;2(6):585. doi:10.1001/jamacardio.2016.3649