Drug Pipeline

FDA approved sapropterin on December 13, 2007, to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due ro BH4-responsive phenylketonuria (PKU).

Until 2005, irbesartan was the only ARB available on the Veterans Affairs (VA) healthcare system's national formulary. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. For those patients who were to continue ARB therapy via a switch to either losartan or valsartan, dosing guidelines were created by the Veterans Integrated System Network 7 to facilitate the change. These guidelines suggested that patients taking irbesartan 150 mg once daily be treated with either valsartan 80 mg or losartan 50 mg once daily and that patients taking irbesartan 300 mg once daily be treated with either valsartan 160 mg or losartan 100 mg once daily. To determine if the dosing guidelines resulted in equal antihypertensive effectiveness, we carried out a retrospective chart review, examining the cases of 86 patients at the William Jennings Bryan Dorn VA Medical Center in Columbia, South Carolina, who had switched from irbesartan to either losartan or valsartan.

Bar coding drugs has been demonstrated to improve patient safety by reducing medication errors.

Two tumor necrosis factor-alpha (TNF-alpha) inhibitors, infliximab and adalimumab, are approved by FDA for the treatment of moderate-to-severe Crohn's disease (CD) in patients who have an inadequate response to conventional therapies. Certolizumab is a pegylated TNF-alpha inhibitor being investigated for the treatment of moderate-to-severe CD.

Labeling updates and warnings through January 2008 for mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin

The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.

FDA-related information through January 2008 for sorafenib (Nexavar), aripiprazole (Abilify), rosuvastatin (Crestor), irbesartan/hydrochlorothiazide (Avalide), extended-release quetiapine (Seroquel XL), delayed-release oral suspension of pantoprazole (Protonix), lopinavir/ritonavir (Kaletra), and dasatinib (Sprycel)

First-time generic approvals: oxycodone/ibuprofen

FDA-related information through January 2008 on Extended-release ropinirole (Requip XL); Indiplon; Xience V Everolimus Eluting Coronary Stent System; tetrabenazine; vernakalant (Kynapid); gepirone extended-release; lovastatin (Mevacor); bevacizumab (Avastin); tedisamil; rabies monoclonal antibody cocktail; AVI-4658; alfimeprase; Prochymal; aripiprazole (Abilify); bendamustine (Treanda); ATIR; CDX-110; and ISIS 333611

FDA approved methoxy polyethylene glycol-epoetin beta on November 14, 2007, for the treatment of anemia associated with chronic renal failure in adults, including those undergoing dialysis and those not undergoing dialysis.

FDA approved sapropterin on December 13, 2007, to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due ro BH4-responsive phenylketonuria (PKU).

According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.

First-time generic approvals: rivastigmine capsules

The 2007 American Heart Association (AHA) Scientific Sessions took place November 3 to 7, 2007, in Orlando, Florida. Among the new data presented were the much anticipated results of a phase 3 trial of prasugrel versus clopidogrel in patients scheduled for percutaneous coronary intervention (PCI). Other clinical trials of note were the first prospective study of a statin in patients with ischemic heart disease and heart failure and a comparison of eptifibatide with abciximab on ST-segment resolution in patients with myocardial infarction (MI) who are undergoing primary PCI. This AHA Special Report details these and other trials.

Anecdotal reports of hospital readmissions secondary to adverse drug events (ADEs) prompted the pharmacy & therapeutics (P&T) committee at University Hospital, SUNY Upstate Medical University, to authorize a pharmacy-led retrospective review of patient records.

Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..

Labeling updates and warnings related to rosiglitazone, erythropoiesis-stimulating agents, and aprotinin (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)

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 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.

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.

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.

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.

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.

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..

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.