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The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.

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.

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).

Adverse drug events (ADEs) led to the treatment of an estimated 701,547 patients in US emergency departments (EDs) in 2004 and 2005, according to a recent study in the Journal of the American Medical Association (JAMA). Significantly, those patients ?65 years of age were 2 times more likely to have ED treatment for an ADE and approximately 7 times more likely to need hospitalization than their younger counterparts.

Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations

Infliximab

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pramipexole

Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Telbivudine

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

A change in resting heart rate in healthy middle-aged men is tied to mortality risk, with those who experience a long-term rise in resting heart rate having an increased risk of mortality and those with a long-term decrease in resting heart rate having a reduced risk of mortality.

After years of minimal results, stem cell research is forging ahead. "This is a new appetizer for what may be an excellent meal in years to come," said former AHA president Valentin Fuster, MD, PhD, at a press briefing Tuesday morning. "Reports the past couple of years have been equivocal at best."

The practice of late reperfusion-percutaneous coronary intervention (PCI) performed 2 to 28 days after myocardial infarction (MI)-in patients who are stable does not lead to improved clinical outcomes compared with medical therapy, said Judith S. Hochman, MD, lead investigator of the Occluded Artery Trial (OAT).

The thiazolidinedione pioglitazone has a beneficial effect on carotid intima media thickness (CIMT) compared with glimepiride in patients with type 2 diabetes, said Theodore Mazzone, MD, lead investigator of the CHICAGO (Carotid Intima Media Thickness in Atherosclerosis Using Pioglitazone) study.

A series of analyses offers no consensus on the safety of drug-eluting stents (DES) compared with bare metal stents. Depending on the study, DES either result in an increase in major adverse coronary events (MACE) or a decrease in subsequent need for coronary artery bypass graft (CABG) surgery and repeat percutaneous coronary intervention without an excess of adverse clinical events.

Screening for coronary calcium may provide an impetus for physicians to initiate preventive cardiovascular therapies in patients who have coronary calcium, but persistence with the medications is no better than in patients who are started on therapies without a coronary calcium test, said Allen J. Taylor, MD

Healthcare is a disaster in progress. That was the stark warning from AHA president Raymond Gibbons, MD, during his presidential address yesterday at the American Heart Association (AHA) Scientific Sessions.

A cost-effectiveness analysis suggests that restricting the use of drug-eluting stents (DES) is prudent. In the analysis, the substitution of DES for bare metal stents appears to be cost-effective only when the target vessel revascularization (TVR) rate with bare metal stents is high, which is typically the case in small vessels and longer stenoses, said Sanjay Kaul, MD, MPH.

Two studies confirm that chronic kidney disease (CKD) is associated with coronary heart disease (CHD) and its severity. In one of the studies, anemia was also a predictor of CHD and its severity.