Formulary Watch |

Alteplase demonstrated as safe, effective stroke treatment

Alteplase demonstrated to be safe and effacious for use in treatment of stroke within 3 hours of onset, according to a large multicenter, observational study.

Antihypertensive 'polypill' reduces blood pressure more than standard doses of commonly used medications

Treament of hypertension with a polypill is more effacious than single-drug treatment, according to a randomized, controlled, open-label trial.

Vildagliptin and rosiglitazone demonstrate similar efficacy, tolerability in patients with type 2 diabetes

Results of a double-blind, randomized, contolled trial of vildagliptin versus rosiglitazone demonstrate similar efficacy and tolerability in patients with type 2 diabetes.

The pharmacologic management of pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.

Med Safety actions in brief

Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)

Venlafaxine associated with increased risk of suicide and attempted suicide

A large retrospective cohort study demonstrated an increased risk of suicide with use of the antidepressant venlafaxine.

Increased risk of MI with COX-2 inhibitors among patients with history of MI

In a large, population-based, case-control study, rofecoxib and celecoxib were associated with an excess risk of acute myocardial infarction (MI) in patients with a history of MI.

First-time generic approvals

First-time generic drug approvals: Nadolol/bendroflumethiazide and ciprofloxacin

Pipeline preview

The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir

Keppra: Levetiracetam

Levetiracetam (Keppra) is now approved by FDA as an antiepileptic agent for adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy.

HepaGam B: Hepatits B immune globulin intravenous (human)

HepaGam B, a solution of hepatitis B immune globulin (human), is now approved by FDA for the prevention of hepatitis B recurrence after liver transplantation in HBsAg-positive patients.

Janumet: Sitagliptin/metformin

The combination of sitagliptin/metformin is now approved by FDA to improve glycemic control in adult patients with type 2 diabetes mellitus.

Disclosure Form (PDF)

All authors contributing manuscripts for consideration for publication in Formulary must disclose any real or apparent conflicts of interest due to affiliation with any company or manufacturer whose products are mentioned in the article they author.

Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (April 2007) (PDF)

A review of agents in late-stage development for the treatment of gastrointestinal disorders (April 2007).

Continuous erythropoiesis receptor activator (CERA): An erythropoiesis-stimulating agent for the treatment of anemia in patients with chronic kidney disease

Chronic kidney disease (CKD) affects 20 million Americans, and an additional 20 million are at increased risk for developing CKD. Anemia is a common complication in patients with CKD. Continuous erythropoiesis receptor activator (CERA) is a new erythropoiesis-stimulating agent (ESA) that is undergoing FDA review for the treatment of anemia in patients with CKD, including in those undergoing dialysis.

No shortage of recommendations for PDUFA IV as Congress and professional organizations weigh in on drug safety

The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires September 30, 2007, has set the stage for congressional action on broader legislation to improve the handling of drug safety issues. Bills under consideration aim to expand FDA oversight by establishing new requirements for postmarket risk assessment, for posting active clinical trials and resulting study data, and for completing postmarket studies.

The use of antibiotic pharmacodynamic end points in incremental cost-effectiveness analyses: A novel approach for consideration during hospital formulary reviews

We propose using the results of pharmacodynamic Monte Carlo simulation studies as a surrogate marker for potential efficacy of antibiotic dosage regimens and applying these end points to the calculation of an incremental cost-effectiveness ratio (ICER).

E-prescribing offers a neat and safe alternative to pad and pen

One of the numerous factors shaping pharmacy and therapeutics (P&T) committees' operations and decisions is the push for electronic health information systems, including electronic prescribing (e-prescribing). E-prescribing is expected to help prescribers comply with plan formularies and formulary policies.

Sunitinib demonstrates superior survival, quality-of-life benefits compared with interferon alfa

In patients with metastatic renal cell carcinoma, treatment with sunitinib yields longer progression-free survival rates and a better health-related quality of life than does the standard treatment, interferon alfa therapy, according to the results of a phase 3 trial published in the New England Journal of Medicine (NEJM). A total of 750 patients aged ≥18 years participated in this international, multicenter, randomized trial.

Imatinib demonstrates improved survival rates in patients with chronic myeloid leukemia

Maintaining treatment with imatinib as initial therapy in patients with chronic myeloid leukemia (CML) may yield positive outcomes, including increased overall survival to ≥5 years, according to a study published in the New England Journal of Medicine (NEJM). The follow-up study of the International Randomized Study of Interferon and ST1571 (IRIS), a multicenter, international, randomized, phase 3 trial, included patients aged 18 to 70 years diagnosed with Ph-positive CML in chronic phase within 6 months before the start of the study.

Salmeterol plus fluticasone fails to reduce mortality in patients with COPD

In a randomized double-blind, parallel- group trial, salmeterol plus fluticasone failed to reduce all-cause death in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) compared with each of the agents alone or placebo. The results of the Towards a Revolution in COPD Health (TORCH) trial were published in the New England Journal of Medicine (NEJM).

American College of Cardiology: 56th Annual Scientific Session focuses on emerging clinical trial data, continuing research

Healthcare professionals assembled at the 56th Annual Scientific Session of the American College of Cardiology (ACC) from March 24 to 27, 2007, in New Orleans, La, to exchange information and updates about new and continuing research in cardiovascular disease.

Safety labeling updates & new warnings

A discussion of FDA-requested boxed warnings and medication labeling changes

Rate of anticoagulant-associated intracerebral hemorrhage quintuples

The rate of anticoagulant-associated intracerebral hemorrhage has increased dramatically since 1988, according to an observational study published in the journal Neurology. Researchers identified all patients hospitalized with first-ever intracerebral hemorrhage (ICH) in the 5-county Greater Cincinnati, Ohio/Northern Kentucky area during 3 unique time periods.

FDA actions in brief

A discussion of new FDA-approved indications and formulations of drugs

First-time generic approvals

A discussion of generic drugs recently approved by FDA

Pipeline preview

A discussion of drugs under consideration/review for FDA approval

Adalimumab

Recombinant monoclonal antibody approved for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease

Eculizumab

Recombinant monoclonal antibody approved for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis

Lapatinib

4-anilinoquinazoline kinase inhibitor approved in combination with capecitabine for the treatment of advanced or metastatic breast cancer