Formulary Watch |

Pipeline Preview, December 2007

FDA-related information through December 2007 on Guaifenesin/codeine extended-release, delayed-release valproic acid, telavancin, Endeavor, oral beclomethasone, and R7128

FDA actions in brief, December 2007

FDA-related information through December 2007 for nilotinib (Tasigna), sitagliptin (Januvia), SymlinPen120, SymlinPen60, terbinafine (Lamisil), diclofenac (Voltaren Gel), sevelamer (Renvela), brimonidine/timolol (Combigan), Zingo, Totect, Menactra, FluMist, ACAM2000, Afluria, palonosetron injection (Aloxi), bortezomib (Velcade), certuximab (Erbitux), alemtuzumab (Campath), fosamprenavir (Lexiva), and tipranavir (Aptivus)

Topotecan: Oral chemotherapy agent approved for the treatment of relapsed SCLC

This oral formulation of topotecan was approved on October 12, 2007, for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response who are ≥45 days from the end of first-line chemotherapy.

Ixabepilone: Antineoplastic agent approved in combination with capecitabine or as monotherapy for the treatment of advanced breast cancer in patients with cancer unresponsive to other treatments

Ixabepilone was approved on October 16, 2007, as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine; and in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

Raltegravir: Integrase inhibitor approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients

FDA approved raltegravir on October 12, 2007, for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication and HIV-1 strains that are resistant to multiple antiretroviral agents.

Prophylactic G-CSF associated with reduced risk of febrile neutropenia and early death in adult patients with cancer who are receiving chemotherapy

The use of prophylactic granulocyte colony-stimulating factors (G-CSF) in adult patients with cancer who are receiving chemotherapy is associated with a reduced risk of early death and febrile neutropenia, according to a systematic review and meta-analysis published in the Journal of Clinical Oncology.

Antibiotics justified to prevent pneumonia after chest infection, but not to prevent other serious complications after respiratory tract infection

In a retrospective cohort study of 162 primary care practices in the United Kingdom, the use of antibiotics was demonstrated to be effective in preventing serious complications following upper respiratory tract infection (URTI), sore throat, or otitis media; however, the authors stated that the number needed to treat (NNT) to prevent 1 such complication is too high to justify prescription of the drugs for this purpose.

FDAAA empowers FDA to have greater control over drug safety

Congress approved the FDA Amendments Act of 2007 (FDAAA) in September after a lengthy debate that resulted in compromises on many issues. The resulting law contains numerous provisions designed to better inform the public about drug safety and provides new tools for FDA to reduce risks and unsafe drug use.

FORMULARY ARTWORK - NEWS LETTER

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Childhood BMI key to later CVD risk

Primary care physicians and pediatricians who do not measure childhood body mass index (BMI) are missing a prime opportunity to prevent cardiovascular disease later in life.

Dark chocolate can boost coronary blood flow reserve

Researchers in Japan have found that dark chocolate can have a positive impact on coronary circulation.

Study: Side effects not major reason for statin discontinuation

Persistence with statins is only approximately 50% by 12 months after therapy is started, with Spanish-speaking patients at highest risk of discontinuing therapy, said Michael H. Davidson, MD, during the American Heart Association Scientific Sessions, Nov. 3-7, 2007, in Orlando.

Interventional indications can present confusion

Therapeutic choices in interventional cardiology are often complicated by factors, such as gastrointestinal (GI) bleeding, left anterior descending coronary artery stenosis, thrombocytopenia, and uncontrollable angina.

AHA challenged to work to end global inequalities in cardiovascular care

A leading expert on global inequalities in cardiovascular healthcare challenged the American Heart Association to take the lead in reducing the burden of cardiovascular disease worldwide.

Blood pressure levels can change by season

Antihypertensive treatment that works in the summer may not be sufficient for wintertime blood pressure (BP) control.

Anti-ischemic agent reduces HbA1c levels in patients with diabetes

Ranolazine extended-release significantly reduced the level of hemoglobin (Hb) A1c in patients with diabetes, allowing more of them to achieve the clinical HbA1c treatment target of less than 7.0%.

Eptifibatide use to increase

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 AEDs make for life-saving duo

Bystanders and automated external defibrillators (AEDs) are a life-saving combination.

Antiplatelet reduces cardiac events in PCI

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 genotype-based warfarin dosing feasible, but not linked to fewer out-of-range INRs

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.

Statin has no effect on cardiovascular outcomes in advanced systolic heart failure

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 PAD prevalence on rise; obese women at high risk

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.

Formulary November E-news art

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Rotigotine: The first transdermal nonergot-derived dopamine agonist for the treatment of Parkinson disease

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..

Drug Watch: Agents in late-stage development for the treatment of Alzheimer's disease (November 2007) (PDF)

A summary of agents in late-stage development for the treatment of Alzheimer's disease (November 2007).

Adding prostaglandin blocker to niacin ER reduces flushing without compromising effects on lipids

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.

Unfavorable risk:benefit ratio with antiplatelet plus anticoagulant therapy for peripheral arterial disease

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.

MERLIN: Ranolazine associated with antiarrhythmic effect

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.

GRACE and SCAAR add to the debate about stents

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.

Statins associated with reduction in 10-year risk of cataracts

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.