Formulary Watch |

Budesonide plus formoterol associated with better control of persistent asthma control than gold standard therapy

In a 6-month, randomized, double-blind study, use of budesonide/formoterol as both maintenance and reliever therapy was demonstrated to provide better asthma control than either salmeterol/fluticasone plus terbutaline as needed or a fixed maintenance dose of budesonide/formoterol plus terbutaline as needed.

ADAPT: Naproxen and celecoxib demonstrated to be ineffective in primary prevention of AD

Use of naproxen or celecoxib does not prevent Alzheimer's disease (AD), at least within the early years after treatment initiation, according to a randomized, placebo-controlled, multicenter study.

HORIZON: Yearly infusion of zoledronic acid reduces risk of fracture in postmenopausal women with osteoporosis

Three-year results of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial show that a single, annual intravenous infusion of zoledronic acid can decrease risk of vertebral fracture by 70% and the risk of hip fracture by 41% among women with osteoporosis.

Vernakalant: A novel antiarrhythmic agent for the treatment of atrial fibrillation

Atrial fibrillation (AF) is a disorder that affects >2 million people in the United States. Firstline antiarrhythmic agents (per American College of Cardiology/American Heart Association/European Society of Cardiology guidelines) that are currently used to treat recent-onset AF work by indiscriminately blocking various ionic channels, thereby inducing a prolonged ventricular action potential duration or possibly inducing ventricular arrhythmias in the presence of myocardial ischemia because of excessive conduction slowing in diseased cardiac tissue. Vernakalant is an atrial-selective, potassium and sodium-channel-blocking agent awaiting FDA approval for the indication of conversion of recent-onset AF to normal sinus rhythm.

Dr von Eschenbach's vision: FDA's newest commissioner faces multiple challenges

Andrew von Eschenbach, MD, has faced a number of tough issues since he was sworn in as FDA's commissioner in December 2006, not the least of which is drug safety. Fewer new drugs have been coming to market, and pressure continues to mount for FDA to do more with limited resources. Legislation to reauthorize user fees for pharmaceutical and medical device manufacturers has to be approved by Congress by September 30, 2007, or FDA will have to lay off hundreds of staff members. The need for speedy legislative action has focused public attention on agency operations and policies, a trend likely to continue as the nation's healthcare system and prescription drug costs become a central issue in next year's presidential elections.

FDA action related to medication safety labeing and warnings, August 2007

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

DAD study: Use of protease inhibitors increases risk of myocardial infarction

In a prospective, observational study, exposure to protease inhibitors (PIs) was associated with an increased risk of myocardial infarction (MI). The authors stated that this association is partly explained by dyslipidemia.

Interim analysis of RECORD trial provides inconclusive data regarding cardiovascular safety of rosiglitazone

In this multicenter, randomized, open-label trial, it was demonstrated that among patients whose diabetes was not well controlled with either a sulfonylurea or metformin alone, the addition of rosiglitazone (n=2,220) did not increase the risk of cardiac-related hospitalization or death compared with patients who received metformin plus a sulfonylurea (n=2,227).

FDA actions in brief, August 2007

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals, August 2007

First-time generic approvals, August 2007

FDA pipeline preview, August 2007

The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135

Exforge: New combination recently approved by FDA for amlodipine/valsartan

Amlodipine/valsartan, a combination of calcium-channel blocker and angiotensin II receptor antagonist is now approved by FDA for the treatment of hypertension

Lyrica: FDA approves new indication for pregabalin

Pregabalin, an anticonvulsant agent, is now approved by FDA for the management of fibromyalgia.

Letairis: New molecular entity recently approved by FDA for ambrisenten

Ambrisentan, an endothelin-receptor antagonist is now approved by FDA for the treatment of PAH

W-9 for Authors (PDF)

W-9 form for Authors

Optimizing The Use Of Carbapenems In The Face Of Increasing Gram-Negative Resistance

As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.

Optimizing The Use Of Carbapenems In The Face Of Increasing Gram-Negative Resistance

As a result of the broad spectrum and enhanced potency of the carbapenems, this class of agents has long been held in reserve in an attempt to avoid the development of pathogen resistance to this important group of antimicrobials.

First-time generic approvals, July 2007

First-time generic drug approval: amlodipine/benazepril capsules

Drug Watch: Agents in late-stage development for the treatment of asthma (July 2007) (PDF)

A review of agents in late-stage development for the treatment of asthma (July 2007).

Aspirin as primary prevention reduces all-cause mortality in women

In a nested case-control study, the use of low-to-moderate doses of aspirin (ASA) in women was associated with a significant reduction in all-cause mortality.

From Digestive Disease Week 2007: Statins demonstrated to have benefit in treatment of hepatitis C virus

New research presented at the Digestive Disease Week 2007 regarding the effect of statins on hepatitis C infection.

From the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition: ACCOMPLISH: Investigators note 'unprecedented' levels of blood pressure control with benazepril plus either amlodipine or hydrochlorothiazide at 18 months

In the Avoiding Cardiovascular Events Through Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) study, initial treatment of hypertension with a fixed-dose, dual-drug combination demonstrated "unprecedented" levels of control at 18 months.

From the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition: Nebivolol demonstrates long-term efficacy in treatment of hypertension; benefit extends to patients who are obese

Nebivolol is associated with long-term control of blood pressure and is as effective in obese patients as in nonobese patients with hypertension, according to the results of a 9-month extension study and a post-hoc analysis that were presented at the American Society of Hypertension 22nd Annual Scientific Meeting and Exposition.

AMADEO: Telmisartan demonstrates greater reductions in urinary protein levels than losartan

In a randomized, controlled trial, telmisartan demonstrated a greater antiproteinuric effect than losartan in hypertensive patients with type 2 diabetes and chronic kidney disease.

From the American Academy of Neurology 59th Annual Meeting: BENEFIT: Rituximab offers early promise in the treatment of RRMS

Rituximab, which is currently FDA-approved for the treatment of certain B-cell lymphomas and moderate-to-severe rheumatoid arthritis, demonstrated benefit in the treatment of relapsing-remitting multiple sclerosis (RRMS) in 2 early-phase experimental trials.

From the American Academy of Neurology 59th Annual Meeting: BENEFIT: FAST: rFVIIa has no effect on death or disability after ICH

Hemostatic treatment with recombinant activated factor vIIa (rFVIIa) failed to reduce death or disability in a phase 3 trial of patients with intracerebral hemorrhage (ICH), according to results presented during the AAN 59th annual meeting.

From the American Academy of Neurology 59th Annual Meeting: BENEFIT: Better outcomes demonstrated with early versus late initiation of interferon beta-1b for MS

Immediate initiation of interferon beta-1b in patients with a first event suggestive of multiple sclerosis (MS) significantly reduces the risk of permanent neurologic impairment compared with delayed initiation, according to findings from the BENEFIT study presented during the AAN's 59th annual meeting.

Aprotinin associated with increased renal dysfunction, but not with increased cerebrovascular or cardiovascular events

In a large cohort study, aprotinin was not associated with an increased risk of cerebrovascular events or myocardial infarction (MI) in patients undergoing cardiothoracic surgery.

Pharmacologic management of chronic hepatitis B

Chronic hepatitis B is a common disease worldwide with significant morbidity and mortality. Early diagnosis is essential but difficult, as most patients with chronic hepatitis B do not have specific symptoms until the symptoms of advanced disease occur. The main goal of therapy is to prevent cirrhosis and hepatocellular carcinoma by suppressing hepatitis B virus (HBV) DNA levels. The decision to treat and the choice of therapy require careful consideration of both patient and drug characteristics, as stated in both an expert panel consensus recommendation and the American Association for the Study of Liver Diseases (AASLD) treatment guidelines. Lamivudine, once the mainstay of oral antiviral treatment, has been supplanted by newer agents such as adefovir, entecavir, and telbivudine, which produce less drug resistance overall; these oral agents often require long-term treatment. Pegylated interferon alfa-2a, which has a predefined treatment course but is often poorly tolerated, is now the main option in..

Rosiglitazone associated with increased risk of MI and cardiovascular-related death

Rosiglitazone is associated with an increased risk of myocardial infarction [MI] and death from cardiovascular causes, according to findings of a meta analysis.