Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study.

Background: Proprotein convertase subtilisin/kexin type 9 (PCSK9) increases serum LDL-cholesterol (LDL-C) concentrations. We assessed the effects of AMG 145, a human monoclonal antibody against PCSK9, in patients with hypercholesterolaemia in the absence of concurrent lipid-lowering treatment.

Methods: In a phase 2 trial done at 52 centres in Europe, the USA, Canada, and Australia, patients (aged 18-75 years) with serum LDL-C concentrations of 2·6 mmol/L or greater but less than 4·9 mmol/L were randomly assigned equally through an interactive voice response system to subcutaneous injections of AMG 145 70 mg, 105 mg, or 140 mg, or placebo every 2 weeks; subcutaneous AMG 145 280 mg, 350 mg, or 420 mg or placebo every 4 weeks; or oral ezetimibe 10 mg/day.

Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia.

Purpose: The efficacy and safety of conivaptan administered via 30-minute i.v. infusion to patients with euvolemic or hypervolemic hyponatremia were evaluated.

Impact of high-dose atorvastatin in coronary heart disease patients age 65 to 78 years.

Background: High-dose statin therapy may be underutilized in aged patients due to doubts about efficacy and safety.

Hypothesis: To investigate outcomes and safety in patients aged 65-78 years compared with patients aged < 65 years in the ALLIANCE study.

Methods: A total of 2,442 stable coronary heart disease (CHD) patients with dyslipidemia were randomized to either aggressive treatment (low-density lipoprotein cholesterol titration goal of < 80 mg/dL or maximum 80 mg/d of atorvastatin) or usual care (continuation of baseline lipid-lowering therapy, with changes and laboratory analyses directed by treating physicians).

Focused atorvastatin therapy in managed-care patients with coronary heart disease and CKD.

Background: This post hoc analysis of the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) Study investigates the effect of focused atorvastatin therapy versus usual care on cardiovascular outcomes in patients with coronary heart disease (CHD) with and without chronic kidney disease (CKD).

Study Design: Prospective randomized open-label; median follow-up, 54.3 months.

Long-term safety of a novel antianginal agent in patients with severe chronic stable angina: the Ranolazine Open Label Experience (ROLE).

Objectives: This report describes safety and tolerability data from 746 chronic angina patients treated in the ROLE (Ranolazine Open Label Experience) program.

Background: Ranolazine treats angina without depressing hemodynamic status. The long-term safety and tolerability of ranolazine have not been previously reported.

Statin use in a "real-world" clinical setting: aggressive lipid lowering compared with usual care in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial.

Clinical trials that incorporate elements of "real-world" experience are of great value to practicing physicians. Using a trial design adapted to approximate clinical settings, the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial compared a focused treatment strategy using atorvastatin with usual medical care. Patients eligible for study participation were predefined based on diagnosis codes for coronary heart disease from US managed care database records; 66% of these patients were taking lipid-lowering medications at study entry.

Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study.

Objectives: This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings.

Background: Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a "real-world" setting.

The cost of reaching National Cholesterol Education Program (NCEP) goals in hypercholesterolaemic patients. A comparison of atorvastatin, simvastatin, lovastatin and fluvastatin.

Objective: Recognising the importance of treating hyperlipidaemia, the National Cholesterol Education Program (NCEP) has established widely accepted treatment goals for low density lipoprotein cholesterol (LDL-C). Medications used most commonly to achieve these LDL-C goals are HMG-CoA reductase inhibitors. The relative resource utilisation and cost associated with the use of reductase inhibitors of different LDL-C lowering efficacy are unknown, but are major health and economic concerns.