Cardiovascular Diseases

Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.

The duration of dual antiplatelet therapy (aspirin plus clopidogrel) following drug-eluting stent (DES) implantation has been a source of much recent debate. FDA currently recommends either 3 or 6 months of clopidogrel therapy following DES implantation, depending on the type of stent used.

A review of agents in late-stage development for the treatment of arrhythmia and heart failure (January 2007).

When used for their approved indications, drug-eluting stents (DES) probably do not increase the risk of death or myocardial infarction (MI) compared with bare metal stents (BMS), an FDA advisory panel concluded at a meeting in Gaithersburg, Md, last month.

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.

Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.

Men who suffer from migraines are at increased risk for cardiovascular events, according to researchers. The new findings follow similar reports that women with migraines are at higher risk for cardiovascular disease.

A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).

A comparison of the investigational COX-2 inhibitor etoricoxib and diclofenac found no increase in the risk of cardiovascular events over 3 years with etoricoxib.

A secondary analysis of data from the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial demonstrated that statin treatment can significantly reduce the severity of a second ischemic stroke in patients who had no history of coronary heart disease. With statin treatment, there were fewer fatal and severe strokes, fewer moderate and mild strokes, fewer transient ischemic attacks (TIAs), and more patients who had no events, said Larry B. Goldstein, MD, at the American Neurological Association (ANA) 131st Annual Meeting.

Two studies of the effects of famotidine in patients with chronic heart failure (CHF) have demonstrated that the treatment improves cardiac symptoms of CHF, including ventricular remodeling. Famotidine has not been approved by FDA for treatment of CHF.

An angiotensin receptor blocker (ARB) valsartan-based regimen offered advantages over a calcium channel blocker (CCB) amlodipine-based regimen in preventing heart failure (HF) and diabetes in patients with hypertension, according to results of an analysis published in Hypertension.

Disease-modifying antirheumatic drugs (DMARDs) reduce the risk of acute myocardial infarction (MI) in patients with rheumatoid arthritis (RA), according to results of an observational study published in the journal Arthritis & Rheumatism.

Drug-eluting stents (DES) represent an innovative application of pharmaceutical technology that has piqued the interest of hospital and managed care decision-makers. Since their introduction to the US market in 2004, the sirolimus- and paclitaxel-eluting stents have featured drugs employing different mechanisms of action to reduce the risk of restenosis following percutaneous coronary intervention (PCI) in an attempt to improve cardiovascular outcomes.

Review of agents in late-stage development for the treatment of acute coronary syndrome, angina, and myocardial infarction (October 2006).

Review of agents in late-stage development for the treatment of hypertension and stroke (September 2006).

Intensive therapy with atorvastatin 80 mg/d, in comparison with the same medication at 10 mg/d, significantly reduced the rate of major cardiovascular events by 25% in patients with clinically evident stable coronary heart disease (CHD) and diabetes, according to a study published in Diabetes Care.

Atorvastatin showed no statistically significant difference in the reduction of a composite cardiovascular disease (CVD) end point in type 2 diabetes patients, according to a randomized, double-blind, parallel-group study.

The tyrosine kinase inhibitor imatinib is cardiotoxic and can lead to severe left ventricular dysfunction and heart failure in humans, according to research involving humans, mice and cultured cardiomyocytes.

This antiplatelet agent exerts its effect through direct inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADP-mediated activation of the lipoprotein GPIIb/IIIa complex.

A meta-analysis of data from randomized, parallel-designed, placebo-controlled studies involving >44,000 patients demonstrated that those who had taken the cycloxygenase-2 (COX-2) inhibitor celecoxib (50–800 mg TDD) had a lower incidence of adverse cardiorenal events including hypertension, edema, or congestive heart failure than those taking nonselective non-steroidal anti-inflammatory drugs (NSAIDs), according to an oral and poster presentation at the 21st annual scientific meeting of the American Society of Hypertension (ASH) in New York, NY.

While the increased risk of vascular events associated with cyclooxygenase-2 (COX-2) inhibitors has been well established, new data are emerging that demonstrate similar risk increases associated with non-steroidal anti-inflammatory drugs (NSAIDs) that are not selective for COX-2. The data, published in the British Medical Journal (BMJ), were from a meta-analysis of published and unpublished randomized trials. The study comes more than a year after the withdrawals of the COX-2-selective NSAIDs rofecoxib and valdecoxib from the US market.

A meta-analysis of data from national hospital records in Denmark and from the country's national prescription registry showed that the use of selective cyclooxygenase-2 (COX-2) inhibitors in all doses and nonselective non-steroidal anti-inflammatory drugs (NSAIDs) in high doses raised the risk of death in patients who experienced first-time acute myocardial infarction (MI).

An observational cohort study found that the risk of major congenital malformations for infants who were exposed to angiotensin-converting enzyme (ACE) inhibitors during their first trimester increased by a factor of more than 2, while exposure to other antihypertensive medications did not demonstrate an increased risk.

A cohort study with a nested case-control analysis of first hospitalizations for heart failure (HF) associated the use of non-steroidal anti-inflammatory drugs (NSAIDs) with a 30% increase in the target end point among patients aged 60 to 84 years.