No abstract

Objective-8-Hydroxy-2,2,14,14-tetramethylpentadecanedioic acid (ETC-1002) is a small molecule with a unique mechanism of action shown in nonclinical studies to modulate pathways of cholesterol, fatty acid, and carbohydrate metabolism. In previous phase 2 clinical trials, once daily oral treatment with ETC-1002 significantly reduced low-density lipoprotein-cholesterol in patients with hypercholesterolemia. In this trial, the lipid-lowering efficacy of ETC-1002 was evaluated in patients with type 2 diabetes mellitus and hypercholesterolemia. Additional cardiometabolic biomarkers, including glycemic measures, were also assessed. Approach and Results-A single-center, double-blind, placebo-controlled trial evaluated 60 patients with type 2 diabetes mellitus and elevated low-density lipoprotein-cholesterol. Patients discontinued all diabetes mellitus and lipid-regulating drugs and were randomized to receive ETC-1002 80 mg QD for 2 weeks followed by 120 mg QD for 2 weeks or placebo for 4 weeks. ETC-1002 lowered low-density lipoprotein-cholesterol levels by 43±2.6% (least squares mean±SE), compared with a reduction of 4±2.5% by placebo at day 29 (P<0.0001; primary end point). Non-high-density lipoproteincholesterol and total cholesterol were also significantly lowered by ETC-1002 compared with placebo (P<0.0001). Highsensitivity C-reactive protein was reduced by 41% (median) compared with a placebo reduction of 11% (P=0.0011). No clinically meaningful safety findings were observed. Conclusions-ETC-1002 lowered low-density lipoprotein-cholesterol and other lipids and demonstrated improvement inhigh-sensitivity C-reactive protein in patients with type 2 diabetes mellitus and hypercholesterolemia without worsening glycemic control. ETC-1002 was well tolerated in this population.

Objective SENTINEL1 characterized U.S. preterm infants 29 to 35 weeks' gestational age (wGA) < 12 months old hospitalized for laboratory-confirmed respiratory syncytial virus (RSV) disease and not receiving RSV immunoprophylaxis during the 2014 to 2015 RSV season. Study Design This is a noninterventional, observational, cohort study. Results A total of 702 infants were hospitalized with community-acquired RSV disease, of whom an estimated 42% were admitted to the intensive care unit (ICU) and 20% required invasive mechanical ventilation (IMV). Earlier gestational age and younger chronologic age were associated with an increased frequency of RSV-confirmed hospitalization (RSVH), ICU admission, and IMV. Among infants 29 to 32 wGA and < 3 months of age, 68% required ICU admission and 44% required IMV. One death occurred of an infant 29 wGA. Among the 212 infants enrolled for in-depth analysis of health care

ETC-1002 appears to be effective at reducing LDL-C and was well tolerated in patients with statin-associated muscle complaints. Longer and larger studies are required to confirm the absence of muscle side effects.

Breast cancer mortality rates remain disproportionately high among black women despite recent improvements in mammography screening utilization. We conducted a telephone survey among a sample of women (N = 202) participating in a randomized controlled trial investigating the effectiveness of a mammography reminder letter that was one component of a breast cancer control intervention strategy. The objectives of the survey were to ascertain the extent to which the letter reminder was received and acted upon, and to determine attitudes and breast cancer control practices in the target population. The study was conducted among members of a large health maintenance organization serving predominantly black women in Detroit, Michigan. Forty-eight percent of the participants completed a mammogram during the year after the letter was sent. While 72% of the women remembered receiving the letter reminder, only 5% responded to the recommendations in the letter. Important predictors of mammography completion included past mammogram utilization (OR: 2.49; 95% CI: 1.05-5.93), a prior physician recommendation for a mammogram (OR: 1.99; 95% CI: 1.00-3.95) and subject's knowledge of her primary physician's name (OR: 2.05; 95% CI: 0.91-4.60). Letter reminders promoting primary care visits were relatively ineffective since few women reported being prompted by the letter recommendation. Strategies which target physician mammography referral behavior may have an important impact on mammography utilization among inner-city women.