Search

Background The PCSK 9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low‐density lipoprotein‐cholesterol ( LDL ‐C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin‐associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone. Methods and Results Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL ‐C target levels were not met. The primary efficacy endpoint was LDL ‐C percentage change from baseline to W24. Mean baseline LDL ‐C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least‐squares mean LDL ‐C changes from baseline to W24 were −51.7% and −53.5%, respectively (placebo [+4.7%]; both groups P LDL ‐C targets at W24. Treatment‐emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection‐site reactions among the most common treatment‐emergent adverse events. Conclusions Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL ‐C. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02023879. more...

Background In the Determining the Efficacy and Tolerability of cholesteryl ester transfer protein (CETP) INhibition with AnacEtrapib (DEFINE) trial, anacetrapib added to statin produced robust low-density lipoprotein cholesterol (LDL-C)-lowering and high-density lipoprotein cholesterol (HDL-C)-raising vs placebo in patients with coronary heart disease (CHD). Predictors of the degree of LDL-C and HDL-C responses to anacetrapib, however, are poorly understood. Objective Lipid effects of anacetrapib in patient subgroups within the DEFINE trial (clinicaltrials.gov: NCT00685776) are reported. Methods The percent of placebo-corrected changes from baseline for LDL-C (estimated by Friedewald calculation [Fc-LDL-C]) and HDL-C after 24 weeks of anacetrapib 100 mg/day were compared among patients by age, gender, race, diabetes status, type of concomitant statin with or without other lipid therapies, and baseline HDL-C, Fc-LDL-C, and triglyceride (TG) levels. Results Percent decreases in Fc-LDL-C and increases in HDL-C with anacetrapib were similar (magnitude of difference generally more...

A 52-year-old woman suffering from breast cancer had a port-a-cath implanted to administer chemotherapy. A port-a-cath (a portmanteau of portal and catheter) consists of a reservoir compartment (the portal) which has a silicone bubble for needle insertion (the septum) mounted to the catheter. Six and a half months after implantation, she complained of palpitations. An ECG showed sinus rhythm with premature atrial complexes. An X-ray showed dislocation of the distal tip of the catheter with migration into the right atrium (RA) and right ventricle (RV). more...

Strain gauge plethysmography and impedance plethysmography are non-invasive diagnostic techniques for deep venous thrombosis. In 145 consecutive out-patients presented with suspected acute deep venous thrombosis we compared these two techniques. Venography was performed if one or both tests were positive. Both tests were repeatedly normal in 91 (63%) patients, while in 38 (26%) patients both tests were abnormal and venography confirmed the presence of venous thrombosis. In six other patients the impedance plethysmography test result and venography were positive while the result of the strain gauge plethysmography test was normal. This difference was statistically significant (p less than 0.001). Four of these six patients had acute proximal thrombosis of the deep leg veins. The impedance plethysmography was falsely positive in four patients while strain gauge plethysmography was falsely abnormal in one patient. We conclude that in the diagnostic management of patients with suspected deep venous thrombosis, impedance plethysmography is superior to strain gauge plethysmography. more...