Redefining Blood Pressure Assessment - The Role of the Ambulatory Blood Pressure Monitoring Study for Drug Safety.

According to models developed from large epidemiological studies, mean increases in systolic blood pressure of 2-3 mmHg can increase the risk of cardiovascular (CV) adverse events, especially in patients with a high risk for CV disease. There are new regulatory recommendations for the use of a safety ambulatory blood pressure monitoring (ABPM) study to assess the blood pressure (BP) effects of drugs used chronically. The ABPM study collects BP measurements over 24 hours at baseline and during treatment in patients with underlying CV risk.

Correction to: FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock.

The author name that previously read.

FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock.

Distributive shock is a subset of shock marked by decreased systemic vascular resistance, organ hypoperfusion and altered oxygen extraction. Despite the use of intravenous fluids and either higher dose of catecholamines or other additional exogenous vasopressors to maintain blood pressure in the target range, the rate of mortality remains higher in patients with septic shock. Therefore, there is clearly an unmet need for additional safe and effective treatments.

Relationship between International Normalized Ratio and Outcomes in Modern Trials with Warfarin Controls.

Introduction: A target international normalized ratio (INR) of 2-3 has been recommended for patients with atrial fibrillation (AF) and risk factors for thromboembolism. This recommendation is largely based on evidence from observational studies a decade ago. This study utilized collective data from modern trials with warfarin controls to examine the relationship of warfarin anticoagulation, as assessed by INR, on the clinical outcome events of interest.

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.

Background: Concerns exist that women are underrepresented in trials of cardiovascular medications.

Objectives: The authors sought to examine women's participation and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S.

Sun exposure, vitamin D intake and progression to disability among veterans with progressive multiple sclerosis.

Background: Early life events have been suggested to influence multiple sclerosis (MS) susceptibility, and to potentially modulate its clinical course. We assessed vitamin D-related exposures from childhood to disease onset and their associations with MS progression.

Methods: Among veterans in the Multiple Sclerosis Surveillance Registry, 219 reported having the progressive form and met the inclusion criteria.

Sun exposure, vitamin D and age at disease onset in relapsing multiple sclerosis.

Background: Current evidence suggests that sun exposure and vitamin D intake, during childhood and adolescence, are associated with a reduced risk of multiple sclerosis (MS). However, the role of these environmental agents in the timing of disease symptom onset remains to be investigated.

Methods: Using a cross-sectional study design, we recruited participants from the Veterans Health Administration-Multiple Sclerosis Surveillance Registry.

Using geographic information system tools to improve access to MS specialty care in Veterans Health Administration.

Access to appropriate and timely healthcare is critical to the overall health and well-being of patients with chronic diseases. In this study, we used geographic information system (GIS) tools to map Veterans Health Administration (VHA) patients with multiple sclerosis (MS) and their access to MS specialty care. We created six travel-time bands around VHA facilities with MS specialty care and calculated the number of VHA patients with MS who resided in each time band and the number of patients who lived more than 2 hours from the nearest specialty clinic in fiscal year 2007.

Time of birth, residential solar radiation and age at onset of multiple sclerosis.

Unlabelled: BACKGROUNDS/AIM: Gestational and early life events have been suggested to contribute to multiple sclerosis (MS) susceptibility. We assessed the effects of time and place of birth on the age at onset of MS symptoms.

Methods: We selected a national cohort of 967 veterans from the Multiple Sclerosis Surveillance Registry for whom month and season (time) of birth, and birthplace (city and state) were available.