Formulary Watch |

IV esomeprazole: A new proton pump inhibitor formulation

The intravenous (IV) formulation of esomeprazole, the S-isomer of the proton pump inhibitor (PPI) omeprazole, is currently under FDA review for the short-term treatment of gastroesophageal reflux disease (GERD) as an alternative in patients unable to continue taking oral esomeprazole. Clinical studies have shown esomeprazole to be equivalent to the other currently available PPIs with respect to safety. The intravenous formulation, given either as a 30-minute infusion or 3-minute injection, has been found to be comparable to the oral dosage form based on pharmacokinetic and pharmacodynamic studies in healthy subjects. Limited studies suggest that IV esomeprazole 40 mg/d may provide a more effective antisecretory profile than either IV lansoprazole 30 mg/d or IV pantoprazole 40 mg/d. Data on clinical efficacy is limited to 1 abstract that reported no significant differences in healing rates in subjects with erosive esophagitis administered esomeprazole either 40 mg orally or IV daily. More clinical studies are needed to define its limited role as an alternative in those patients with acid-related disorders unable to tolerate the oral formulations.

States jump on drug import bandwagon

More state governments and public health agencies that are facing funding cutbacks are looking for ways to obtain less expensive pharmaceuticals from Canada in order to reduce spending on pharmaceuticals. So far this year, 21 states have considered drug reimportation bills or resolutions, according to the National Conference of State Legislatures.

CEE alone increases stroke risk in post-menopausal women

Findings from a newly released Women's Health Initiative (WHI) study suggest that conjugated equine estrogen (CEE) alone should not be used for chronic disease prevention, specifically coronary heart disease (CHD), in postmenopausal women. The study, published in the Journal of the American Medical Association, found that CEE increased the risk of stroke by 39% and offered no protection against heart disease.

Acetaminophen linked to increased rate of newly diagnosed adult-onset asthma

Acetaminophen use is associated with an increased rate of newly diagnosed adult-onset asthma, according to a study published in the American Journal of Respiratory and Critical Care Medicine. The study findings, from the Nurses Health Study, confirmed and extended the results of similar cross-sectional studies, although the authors stated that it would be premature to recommend the avoidance of acetaminophen for all adults with asthma.

Early-stage breast cancer patients not receiving full benefits of chemotherapy

More than half the women suffering from early-stage breast cancer (ESBC) are at increased risk of recurrence or death because of substantial reductions-planned or unplanned-in relative dose-intensity (RDI) when treated with adjuvant chemotherapy, according to a study published in the Journal of Clinical Oncology.

Clopidogrel combined with aspirin lowers risk of CEA-induced cerebral emboli

Combination use of clopidogrel and aspirin the night before undergoing carotid endarterectomy (CEA) may significantly reduce the risk of cerebral emboli, according to a study published in the journal Circulation.

ACE inhibitor delays prevalence of WML in stroke victims

Perindopril, an angiotensin-converting enzyme (ACE) inhibitor, can help stop or delay the progress of white matter lesions (WML) in patients with prior cerebrovascular disease, according to research presented at the annual meeting of the American Academy of Neurology.

Adjusted-dose warfarin lowers stroke risk in AF patients vs aspirin

Adjusted-dose warfarin compared to aspirin more effectively reduces the high risk of secondary stroke in atrial fibrillation (AF) patients who have a history of transient ischemic attack (TIA), according to a study published in the journal Stroke.

Campaign to permit drug imports challenges drug prices

It remains to be seen how these importation proposals could affect R&D and drug development over the long run.

Switching from tamoxifen to exemestane could reduce breast cancer recurrence

Disease-free survival in postmenopausal women with primary breast cancer significantly improved when tamoxifen monotherapy treatment was switched to exemestane therapy after 2-3 years, according to a study published in the New England Journal of Medicine. The existing treatment paradigm calls for tamoxifen, an estrogen-receptor modulator, to be taken alone for all 5 years, but some patients have experienced relapse.

New molecular entity: Apomorphine injection

First therapy approved for “off” episodes in advanced Parkinson’s disease

New molecular entity: Apomorphine injection

First therapy approved for “off” episodes in advanced Parkinson’s disease

Etanercept for plaque psoriasis

Biologic approved for plaque psoriasis

The appropriateness of hospital antimicrobial use between medical and surgical specialties

Two published studies from the 1970s describe a higher inappropriate use of antimicrobials among surgeons compared to internal medicine physicians. If this assertation is indeed true, institutions with limited resources should focus interventions on surgical services to improve antimicrobial use. The appropriateness of antimicrobial use in internal medicine and general surgical patients over a 10-month period was evaluated at the University of Louisville Hospital (Louisville, Ky) based upon established institutional antimicrobial guidelines. Antimicrobial selection and dose were evaluated for 1,300 antimicrobial courses. Compliance to institutional guidelines for antimicrobial selection and dose were found in 448 (93%) of 480 courses prescribed by internal medicine services and 728 (88%) of 820 courses prescribed by surgical services (P=.009). Although we were able to identify a 5% difference among specialties, we did not consider this to be a clinically significant difference. We concluded that focused interventions to improve antimicrobial use at the University of Louisville should be applied equally to medical and surgical specialties.

Darifenacin: An M3-selective muscarinic antagonist for the treatment of overactive bladder

Darifenacin (Enablex, Novartis) is a muscarinic antagonist in phase 3 clinical trials for the treatment of overactive bladder (OAB). Darifenacin demonstrates relative selectivity for the M3 muscarinic receptor subtype over the M1 and M2 subtypes. In clinical trials, darifenacin has been compared to placebo for the treatment of symptoms of OAB in adult men and women. Patients treated with darifenacin experienced significantly greater reductions in the number of incontinence episodes per week, nocturnal awakenings, and warning time before micturitions. It appears to have similar efficacy to available anticholinergic agents for the treatment of OAB. Commonly reported adverse events include dry mouth and constipation, and preliminary data suggest that darifenacin may be associated with decreased impairment of salivary flow versus oxybutynin. Darifenacin has not been found to have an effect on the cardiovascular system or cognition in clinical trials. Further research is needed to determine the efficacy of darifenacin compared to other available anticholinergic agents such as oxybutynin and tolterodine, as well as emerging therapies. In addition, further investigation of the adverse effect profile in elderly patients is warranted.

New class may help smokers quit, curb post-cessation weight gain

In phase 3 trials, the first agent in a novel class known as the selective cannabinoid type 1 receptor blockers doubled the odds of quitting smoking while reducing post-cessation weight gain compared with placebo. The agent, rimonabant, also improved several features of the metabolic syndrome in patients with abdominal obesity, reported researchers at the 53rd Annual Scientific Session of the American College of Cardiology (ACC).

Enoxaparin clinically equivalent to UFH in the treatment of high-risk ACS

>Enoxaparin is an effective and safe alternative to unfractionated heparin (UFH) in the early and invasive management of high-risk patients with non-ST-elevation acute coronary syndromes (ACS), said Robert Califf, MD, at the 53rd Annual Scientific Session of the American College of Cardiology (ACC).

Medicare coverage boosts interest in drug value, prices

Mark McClellan, MD, PhD, now administrator of the Centers for Medicare and Medicaid Services (CMS), is seeking more evidence-based information about how medical treatments affect patients in the real world. Dr McClellan says his first priority is to use the new Medicare pharmacy program, starting with the drug discount card, to lower drug costs. One prime strategy for doing so is to evaluate which therapies are most efficacious as well as cost-effective for specific patient subgroups in order to curb unnecessary spending on prescription drugs.

Perfusion scanning following AMI can identify low-risk group

Adenosine Tc99m-sestamibi stress myocardial perfusion scintigraphy canidentify a low-risk population of patients with acute myocardial infarction(AMI) who can be discharged safely from the hospital without coronary angiography,said John J. Mahmarian, MD, at the 53rd Annual Scientific Session of theAmerican College of Cardiology (ACC).

Ezetimibe added to statin results in greater achievement of LDL goals

Ezetimibe added to a stable dose of statin therapy reduces low-densitylipoprotein (LDL) cholesterol by an additional 23% and results in significantlymore patients achieving their LDL cholesterol goals, said Thomas Pearson,MD, MPH, at the 53rd Annual Scientific Session of the American College ofCardiology (ACC) in New Orleans.

Erectile dysfunction: A review and update

Erectile dysfunction (ED) is now recognized as a common problem in men. Several medical problems, including diabetes mellitus, coronary artery disease, hypertension, and hyperlipidemia are known to increase the likelihood of developing ED. Diagnosis depends on an adequate history and physical examination. Several therapies are now available for the treatment of ED. With the advent of the phosphodiesterase type 5 (PDE5) inhibitors, therapy for ED has become more acceptable for many men. Oral therapy is usually the first-line treatment due to the ease of use and the effectiveness of this therapy. For men who do not respond to or have a contraindication to PDE5 therapy, intrapenile injection therapy, intraurethral therapy, and vacuum devices are effective alternatives.

Rasagiline: An oral irreversible MAO-B inhibitor for the treatment of Parkinson’s disease

Rasagiline (Teva/Eisai), a second-generation irreversible MAO inhibitor highly selective for type B of the enzyme, is expected to gain FDA approval in late 2004/early 2005 for the treatment of Parkinson’s disease in monotherapy or as adjunct therapy to levodopa. Rasagiline is more potent than selegiline, the only FDA-approved drug within the same class, and may be devoid of the undesirable effects (blood pressure increases, euphoria, and sleep disturbances) often reported with selegiline. Rasagiline has been studied and proven effective versus placebo in patients with moderate and advanced Parkinson’s disease in both phase 2 and 3 clinical trials. The drug is administered orally once daily and does not require titration. Furthermore, rasagiline has demonstrated neuroprotective activity in various in vitro models and may show promise in the treatment of other neurologic diseases; however, these properties have yet to be studied in humans.

High-dose atorvastatin following ACS reduces risk of long-term adversecardiovascular outcomes

Aggressive lipid-lowering with high-dose atorvastatin initiated immediatelyafter hospitalization for an acute coronary syndrome (ACS) significantlyreduces the risk of long-term adverse cardiovascular outcomes compared withlipid-lowering with standard-dose pravastatin. As such, target levels oflow-density lipoprotein cholesterol (LDL-C) may need to be lower than theones currently recommended in patients at risk of cardiovascular events,said Christopher Cannon, MD, at the 53rd annual scientific session of theAmerican College of Cardiology in New Orleans.

Tiotropium: A novel anticholinergic for the once-daily treatment of COPD (PDF)

Chronic obstructive pulmonary disease (COPD) is a major public health problem, with inhaled anticholinergic agents being the treatment of choice. The disadvantage of currently approved therapies for the treatment of COPD is that agents such as ipratropium (Atrovent, Boehringer Ingelheim) must be administered numerous times daily. Tiotropium (Spiriva, Pfizer/Boehringer Ingelheim) is a new, recently FDA-approved, long-acting anticholinergic drug that requires only once-daily dosing. Tiotropium displays selective receptor kinetics by dissociating more slowly from M1 and M3 receptors than M2 receptors. In patients with COPD, tiotropium 18 mcg inhaled once daily results in significant improvement in lung function. Furthermore, improvements appear sustained for up to 3 weeks after discontinuing tiotropium. Tiotropium is well tolerated with minimal systemic absorption resulting in a favorable adverse effect profile. The most common adverse effect associated with tiotropium is dry mouth. Given the longer duration of action, once-daily dosing, minimal adverse effects, and documented improvements in lung function, tiotropium is poised to replace ipratropium as the inhaled anticholinergic of choice.

The ocular allergic response: A pharmacotherapeutic review (PDF)

One of the most common ophthalmic conditions that directs a patient to a primary-care physician or eye-care practitioner is the red, itchy eye. The highest percentage of conjunctivitis is noninfectious or inflammatory, and frequently these cases are allergic in nature. The ophthalmic armamentarium is now filled with a number of pharmaceutical compounds that act specifically at different points along the inflammatory cascade. Formulary decision-making should be based on sound knowledge of the ocular inflammatory cascade and the pathways through which the various ophthalmic antiallergic preparations exert their anti-inflammatory effects.

FDA commissioner moves to Medicare as drug import battle escalates

FDA rolls out new policies on DTC advertising,counterfeit drugs, and bar codes before McClellan departs

Caduet (Amlodipine and atorvastatin) PFIZER

Calcium channel blocker/statin combination receives approval

Avastin (Bevacizumab) GENENTECH

First angiogenesis-inhibiting cancer therapy approved

Spiriva HandiHaler (Tiotropium)

Anticholinergic approved for COPD

Erbitux (Cetuximab)

Chimeric monoclonal antibody targets EGFR for the treatment of colon cancer