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PREAMI trial

The ACE inhibitor perindopril significantly reduced left ventricular remodeling in a well-treated population of older patients with acute myocardial infarction (MI) and preserved ejection fraction, said Roberto Ferrari, MD, PhD, lead investigator of the Perindopril Remodeling in Elderly with Acute Myocardial Infarction (PREAMI).

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Ranolazine: An update on the novel antianginal agent

Ranolazine (Ranexa, CV Therapeutics) is a partial fatty acid oxidase inhibitor that increases the amount of ATP produced from glucose and increases the ability of the myocardium to retain functionality despite a reduced oxygen supply. Ranolazine is under FDA review for the treatment of chronic stable angina (CSA). Ranolazine was first reviewed in the August 2003 issue of Formulary. Since the initial review of ranolazine by FDA, additional data have emerged that merit an update in this journal. Clinical trials have demonstrated the efficacy of ranolazine as both monotherapy and combination therapy in patients with CSA. Recently published clinical trials (MARISA and CARISA) have shown an improvement in symptom-limited exercise duration. The results of the ERICA trial demonstrated a reduction in weekly anginal attacks when ranolazine was added to maximum-dose amlodipine therapy. Headache and generalized weakness were the most commonly reported adverse events in clinical trials. Prolongation of the QT interval has raised concerns; however, a lack of development of ventricular tachyarrhythmias-specifically Torsade de Pointes-remains an important safety finding. (Formulary. 2005;40:323–328.)

Imagine Trial

Initiating therapy with the ACE inhibitor quinapril within the first 7 days after coronary artery bypass graft (CABG) surgery does not lead to better outcomes among patients already receiving optimal therapy, said Wiek H. van Gilst, MD, lead investigator of IMAGINE (Ischemia Management with Accupril Post Bypass Graft via Inhibition of Angiotensin Converting Enzyme).

PCI-Clarity trial

Early use of clopidogrel, started prior to rather than at the time of angioplasty, reduces the risk of death, MI, or stroke by nearly half, reported Marc S. Sabatine, MD, MPH, lead investigator of PCI-CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy).

ASCOT-BLPA

An antihypertensive regimen of amlodipine with added perindopril significantly reduces all-cause mortality and most major adverse cardiovascular outcomes compared with a regimen of atenolol with the addition of a diuretic, according to the final results of ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial Blood Pressure Lowering Arm).

OASIS-5 trial

The factor Xa inhibitor fondaparinux prevents death, MI, and refractory ischemia at 9 days as well as the low-molecular-weight heparin enoxaparin in patients with acute coronary syndromes (ACS), while reducing the incidence of bleeding.

CIBIS III trial

A beta blocker first strategy appears to be as safe and effective as an ACE inhibitor first strategy for the treatment of older patients with heart failure, and may confer an early survival advantage.

PREAMI trial

The ACE inhibitor perindopril significantly reduced left ventricular remodeling in a well-treated population of older patients with acute myocardial infarction (MI) and preserved ejection fraction, said Roberto Ferrari, MD, PhD, lead investigator of the Perindopril Remodeling in Elderly with Acute Myocardial Infarction (PREAMI).

FDA actions in brief

FDA approved a new influenza vaccine (Fluarix, GlaxoSmith-Kline) for adults aged 18 years and older.

First-time generic approvals

Clonazepam orally disintegrating tablets 0.125, 0.25, 0.5, 1, and 2 mg (equiv to Klonopin rapidly disintegrating tablets).

Pipeline Preview

Nelarabine (Arranon, GlaxoSmithKline) injection for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.

Ambien CR

This non-benzodiazepine hypnotic is delivered in 2 stages through the use of a bi-layered tablet.

Remicade

Infliximab, a chimeric monoclonal antibody, exerts its effect through inhibition of human tumor necrosis factor alpha (TNF alpha).

Celebrex

This NSAID is believed to exert its therapeutic effect through inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib was approved on July 29, 2005, for the relief of the signs and symptoms of ankylosing spondylitis (AS).

Muraglitazar: A dual peroxisome proliferator-activated receptor agonist

Muraglitazar (Bristol-Myers Squibb/Merck) is a new agent under investigation for the treatment of patients with type 2 diabetes. It belongs to a novel class of drugs that target the peroxisome proliferator-activated receptors, both alpha and gamma subtypes. Available clinical data describe improvements in glycemic parameters similar to available thiazolidinediones. In addition to improvements in blood glucose and hemoglobin A (HbA 1c), muraglitazar treatment is associated with a substantial reduction in triglycerides (TGs), an increase in HDL-C, and a modest decrease in LDL-C levels. Safety data are limited, but in available abstracts, there are reports of moderately elevated rates of edema, weight gain, and hypoglycemia with muraglitazar compared with placebo or pioglitazone. When used in combination with metformin or glyburide, chronic heart failure events have been reported with muraglitazar. If approved, muraglitazar will provide a convenient alternative for the treatment of type 2 diabetes. (Formulary. 2005;40:285–293.)

Safety labeling updates and new warnings

Revised labeling was issued for tadalafil (Cialis, Lilly ICOS), vardenafil (Levitra, Bayer/GlaxoSmithKline/Schering-Plough), and sildenafil (Viagra, Pfizer) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non-arteritic ischemic optic neuropathy (NAION).

Bisphosphonate maintains BMD gains achieved with parathyroid hormone

One year of bisphosphonate therapy maintains the gains in bone mineral density (BMD) experienced after 1 year of full-length parathyroid hormone (1–84) in postmenopausal women at risk of osteoporotic fracture. The findings were published in the New England Journal of Medicine (2005;353:555–565).

Cost-effectiveness of 4 empiric antimicrobial regimens in patients with community-acquired pneumonia

This study compares the cost-effectiveness of the 4 most common empiric antimicrobial regimens used for the treatment of adults with community-acquired pneumonia (CAP) at a community health system during a 6-month period. Associations between initial antimicrobials and total hospital costs were determined. Cost-effectiveness ratios were determined by dividing the total hospital costs by the percent survival. A total of 415 patients met criteria for the Pneumonia Severity Index (PSI) risk class IV or V. Costs (adjusted for inflation) were as follows (median, 25th and 75th percentile): total hospital costs ($5,078 [$3,218–$8,144]), pharmacy costs ($753 [$455–$1,357]), and antibiotic costs ($139 [$82–$229]). The most favorable cost-effectiveness ratio was observed for patients who received levofloxacin monotherapy ($4,635 per life saved), followed by ceftriaxone plus a macrolide ($5,278), ceftriaxone monotherapy ($5,368), and ceftriaxone plus levofloxacin ($6,317).

Actoplus Met

Pioglitazone acts primarily by decreasing insulin resistance, while metformin improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose.

FDA actions in brief

Valsartan (Diovan, Novartis) received an expanded indication for reducing cardiovascular mortality in patients who are at high risk due to left ventricular failure or dysfunction after myocardial infarction.

Celebrex

This NSAID is believed to exert its therapeutic effect through inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2). Celecoxib was approved on July 29, 2005, for the relief of the signs and symptoms of ankylosing spondylitis (AS).

Dual peroxisome proliferator-activated receptor agonist demonstrates significant lipid benefits

Phase 3 clinical trial results have demonstrated that the dual alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist muraglitazar achieves significant beneficial lipid effects compared with pioglitazone, and the agent also provides long-term glycemic control in type 2 diabetics. The results were reported during the American Diabetes Association (ADA) 65th Annual Meeting in San Diego, Calif.