Drugs Real World Outcomes
September 2019
Background: Several lipid guidelines recommend that proprotein convertase subtilisin/kexin type 9 inhibitors should be considered for patients with atherosclerotic cardiovascular disease who are inadequately treated with maximally tolerated lipid-lowering treatment.
Objectives: The PEARL study assessed the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab in patients with hypercholesterolemia in a real-world setting.
Methods: PEARL was an open, prospective, multicenter, non-interventional study conducted in Germany.
Aim: To evaluate the effect of alirocumab on frequency of standard apheresis treatments [weekly or every 2 weeks (Q2W)] in heterozygous familial hypercholesterolaemia (HeFH).
Methods And Results: ODYSSEY ESCAPE (NCT02326220) was a double-blind study in 62 HeFH patients undergoing regular weekly or Q2W lipoprotein apheresis. Patients were randomly assigned (2:1, respectively) to receive alirocumab 150 mg (n = 41) or placebo (n = 21) Q2W subcutaneously for 18 weeks.
Background: Many patients with heterozygous familial hypercholesterolemia (HeFH) fail to reach optimal low-density lipoprotein cholesterol (LDL-C) levels with available lipid-lowering medications, including statins, and require treatment using alternative methods such as lipoprotein apheresis.
Objective: To evaluate the efficacy of alirocumab 150 mg every 2 weeks (Q2W) compared with placebo in reducing the frequency of lipoprotein apheresis treatments in patients with HeFH.
Methods: ODYSSEY ESCAPE is a randomized, double-blind, placebo-controlled, parallel-group, 18-week, phase 3 study being conducted in the United States and Germany.
The management of atrial fibrillation (AF) has seen marked changes in past years, with the introduction of new oral anticoagulants, new antiarrhythmic drugs, and the emergence of catheter ablation as a common intervention for rhythm control. Furthermore, new technologies enhance our ability to detect AF. Most clinical management decisions in AF patients can be based on validated parameters that encompass type of presentation, clinical factors, electrocardiogram analysis, and cardiac imaging.
View Article and Find Full Text PDFAims: We aimed to assess the increased risk of death and severe vascular events in elderly individuals with subclinical or manifest peripheral arterial disease (PAD), evidenced by low ankle brachial index (ABI < 0.9) in primary care.
Methods And Results: In this monitored prospective observational study, 6880 representative unselected patients aged >or=65 years were followed up over 3 years by 344 primary care physicians.
Objective: To investigate the relationship between various lipid parameters and the presence of peripheral arterial disease (PAD).
Methods: Cross-sectional analysis of the observational epidemiological getABI study (German epidemiological trial on Ankle Brachial Index) with 6,880 unselected elderly patients in 344 primary care centers.
Results: In the multivariate analysis, the strength of the association between the various lipid parameters and PAD was found to be generally limited, when accounting for other risk factors.
Previous studies in selected patient samples suggested a high risk for total mortality and cardiovascular (CV) morbidity associated not only with symptomatic, but also with asymptomatic peripheral arterial disease (PAD). Our aim was to assess the 1-year risk of death and CV morbidity associated with PAD in primary care. Furthermore, we quantified the strength of association between low ankle-brachial index (ABI, as indicator for PAD), plasma homocysteine (HC) levels, and various accepted PAD risk factors, and death and outcomes.
View Article and Find Full Text PDFWe aimed to obtain reliable data on the epidemiology, co-morbidities and risk factor profile of peripheral arterial disease (PAD) in general medical practise. In the cross-sectional part of the observational German Epidemiological Trial on Ankle Brachial Index (getABI study), 344 general practitioners throughout Germany determined the ABI of consecutive, unselected patients aged 65 years or older with bilateral Doppler ultrasound measurements. Additional assessments comprised patient history with the focus on atherothrombotic diseases, physical examination, and the WHO questionnaire on intermittent claudication.
View Article and Find Full Text PDF