Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

Maternal Differences and Birth Outcome Disparities: Diversity Within a High-Risk Prenatal Clinic

BACKGROUND: We examined the influence of race/ethnicity on appointment attendance, maternal psychiatric and medical diagnoses, and birth outcomes within a diverse, low income, high risk pregnant population to determine whether birth outcome disparities would be lessened in a sample with high biopsychosocial risk across all groups METHODS: Data were retrospectively obtained on all women scheduled for appointments in the San Francisco Genera Hospital (SFGH) High-Risk Obstetrics (HROB) clinic during a three-month period. General linear model and logistic regression procedures were used to examine the associations of race/ethnicity with maternal characteristics, clinic attendance, and birth outcomes. RESULTS: Our sample included 202 maternal-infant pairs (Hispanic 57%, Black 16%, Asian 15%, White 12%). Racial/ethnic differences were seen in language (p < .001), gravidity (p < .001), parity (p = .005), appointment attendance (p < .001), diabetes (p = .005), psychiatric diagnosis (p = .02), illicit drug use (p < .001), smoking (p < .001). These maternal characteristics, including rate of attendance at specialized prenatal appointments, did not predict birth outcomes with the exception of an association between diabetes and earlier gestational age (p = .03). In contrast, Black maternal race/ethnicity was associated with earlier gestational age at birth (p = .004) and lower birth weight (p < .001) compared to Whites. CONCLUSIONS: Within a diverse maternal population of high biopsychosocial risk, racial/ethnic disparities in birth outcomes persist. These disparities have implications for infant health trajectory throughout the lifecourse and for intervention implementation in high risk groups