Two new studies presented during the American Hospital Association Scientific Sessions, Nov. 3-7, 2007, in Orlando, could speed the replacement of abciximab by eptifibatide in cardiac patients. EVA-AMI showed similar outcomes between the two drugs when used in percutaneous coronary intervention (PCI) and BRIEF-PCI showed that a two-hour infusion of eptifibatide can be as effective as the standard 18-hour course following uncomplicated PCI procedures.
Bystanders and automated external defibrillators (AEDs) are a life-saving combination.
Prasugrel, a new antiplatelet agent in Phase 3 clinical trials, is superior to clopidogrel in preventing major adverse cardiac events in patients undergoing percutaneous coronary intervention (pCI), but is associated with an increase in the risk of major bleeding.
Real-time pharmacogenetic-guided dosing of warfarin does not lead to a reduction in prothrombin time international normalized ratios (INRs) out of the therapeutic range compared with standard warfarin dosing, although it did lead to smaller and less frequent warfarin dosing changes, reported Jeffrey L. Anderson, MD.
In older patients with advanced systolic heart failure, rosuvastatin added to standard heart failure medications failed to significantly reduce incidence of a composite of cardiovascular death, nonfatal myocardial infarction (MI), and nonfatal stroke compared with placebo, although it did reduce the incidence of all-cause and cardiovascular-related hospitalizations.
Asymptomatic peripheral artery disease (PAD) is becoming more prevalent, and at least among women, is associated with a significantly higher prevalence of obesity, Andrew D. Sumner, MD, said.
Parkinson disease (PD) is a chronic, progressive neurodegenerative disorder affecting approximately 1% of people aged >60 years. Levodopa has long been the cornerstone of PD treatment, but many patients receiving long-term levodopa therapy experience dyskinesia and motor fluctuations. Dopamine agonists act directly on dopamine receptors and are associated with a lower incidence of dyskinesias. There are 2 subclasses of dopamine agonists: ergot-derived and nonergot-derived. The use of ergot-derived dopamine agonists has declined in recent years due to the agents' association with valvular heart disease. Nonergot-derived dopamine agonists such as ropinirole and pramipexole are used more widely in the treatment of PD. Rotigotine is a nonergot-derived dopamine agonist that was approved by FDA on May 9, 2007, for the treatment of early-stage idiopathic PD. Rotigotine is the first approved nonergot-derived dopamine agonist that is delivered continuously through a transdermal silicone-based patch that is replaced..
A summary of agents in late-stage development for the treatment of Alzheimer's disease (November 2007).
An investigational drug that combines niacin extended-release (ER) and laropiprant, a prostaglandin D2 receptor antagonist, reduces the flushing that often leads to niacin ER discontinuation while preserving the agent's beneficial effects on lipids, according to lead author Darbie Maccubbin, PhD, Merck Research Laboratories, Rahway, New Jersey, et al. The results of this research were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria, September 1 to 5, 2007. The drug is pending FDA approval.
In a randomized, controlled, open-label trial in patients with peripheral arterial disease (PAD), it was demonstrated that antiplatelet therapy plus an oral anticoagulant was no better at preventing major cardiovascular complications than antiplatelet therapy alone. The combination therapy was also associated with a significant increase in life-threatening bleeding complications compared with monotherapy.
In a prespecified secondary analysis of the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes (MERLIN)-TIMI 36 trial, ranolazine was associated with a reduction in the number of episodes of ventricular tachycardia and supraventricular tachycardia. The results of the analysis were presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.
Questions about the safety of drug-eluting stents (DES) versus bare metal stents (BMS) persisted after 2 studies presented at the European Society of Cardiology (ESC) Congress 2007 in Vienna, Austria, demonstrated varying effects of DES and BMS on long-term mortality.
In the Blue Mountains Eye Study published in the American Journal of Ophthalmology, statin use was demonstrated to be protective against the development of cataracts, reducing a patient's risk by nearly half.
In 2 large, case-control studies published in the New England Journal of Medicine (NEJM), researchers demonstrated that, overall, a woman's use of a selective serotonin-reuptake inhibitor (SSRI) in early pregnancy was not associated with significantly increased risks of congenital heart defects or most other types of birth defects.
Throughout 2007, Formulary's "Focus on" articles have examined 9 newly approved or investigational drugs of interest to pharmacy and therapeutics committee members. Because many readers have said that they frequently reference this column when making formulary decisions for their hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each. Of the 9 agents reviewed in 2007, 4 have received final FDA approval; the remaining 5 agents have not yet been approved by FDA.
FDA approval information regarding zoledronic acid (Reclast injection), somatropin (rDNA origin) injection (Norditropin), clopidogrel 300-mg loading dose (Plavix), IV and oral levofloxacin (Levaquin), thrombin, topical (human) (Evithrom), amlodipine/olmesartan (Azor), and docetaxel injection concentrate (Taxotere)
First-time generic approvals: oxcarbazepine tablets; risedronate tablets; clarithromycin for oral suspension
The latest FDA action (through November 2007) related to anecortave depot suspension (Retaane), lamotrigine extended-release (Lamictal XR), pramlintide injection (Symlin), frovatriptan (Frova), lumiracoxib (Prexige), PI-88, C1 inhibitor (Cinryze), Etravirine, IPI-504, Parathyroid hormone (rDNA origin) for injection (Preos), and pafuramidine
Raloxifene was approved on September 13, 2007, for the additional indication of the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.
FDA has approved doripenem, a carbapenem antibiotic, for the treatment of complicated intra-abdominal and urinary tract infections, including pyelonephritis
Patients with early-stage pulmonary arterial hypertension (PAH) and those with either inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or inoperable or post-pulmonary endarterectomy pulmonary hypertension can benefit from treatment with bosentan, according to study results presented at the European Society of Cardiology Congress 2007 in Vienna, Austria.
Thrombolytic therapy with reteplase/abciximab before percutaneous coronary intervention (PCI) (facilitated PCI) has no effect on post-myocardial infarction (MI) complications, including death, but the treatment significantly increases the risk of bleeding compared with primary PCI performed with in-lab abciximab in patients with ST-elevation MI, according to the results of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study.
In a multicenter, multinational, randomized controlled study, a fixed-dose combination of perindopril/ indapamide was associated with a reduced risk of death and vascular events in patients with type 2 diabetes, many of whom were already taking antihypertensive drugs.
The 2007 Congress of the European Society of Cardiology attracted nearly 30,000 attendees to Vienna, Austria, from September 1 to 5, 2007. The congress offered details of the latest research in various fields of cardiology
Maraviroc is the first CCR5 antagonist approved for the treatment of HIV-1 infection. The use of maraviroc is associated with significant decreases in HIV viral load and increases in CD4 counts in antiretroviral treatment-experienced patients with CCR5-tropic virus when used as an add-on to optimized antiretroviral treatment. In clinical trials, patients with dual- or mixed-tropic virus (which can infect cells using CXCR4 and/or CCR5 receptors) who were treated with maraviroc demonstrated no difference in HIV viral load compared with patients who received placebo. A recent study compared maraviroc plus lamivudine/zidovudine with efavirenz plus lamivudine/zidovudine; maraviroc did not demonstrate noninferiority when undetectable virus was defined as <50 copies/mL; however, maraviroc did meet noninferiority criteria when undetectable virus was defined as <400 copies/mL. Maraviroc is not recommended for patients with CXCR4-tropic, dual-tropic, or mixed-tropic virus; for antiretroviral-naive patients; or for..
