Formulary Watch |

Optimizing treatment outcomes dependent on appropriate categorization of insomnia

There is a growing interest in the study of insomnia; this is reflected in emerging trends in clinical management and increased research. One key question is being asked: Is insomnia a symptom or a disease?

Recent evidence supports safety, efficacy of nonbenzodiazepine hypnotics for long-term treatment of insomnia

Long-term insomnia is a substantial problem. Of the 50% of the population that report sleep difficulties, up to 36% report symptoms of insomnia lasting more than 1 year.

Sizable proportion of elementary schoolchildren sleep less than the recommended 9 hours

Approximately 11%-12% of elementary school children experience daytime sleepiness, and up to 21% have fatigue during the school day.

Sleep deprivation may adversely impact neuroendocrine control of appetite

Sleep plays an important role in energy homoeostasis. A study was conducted to test the hypothesis that circulating levels of leptin are influenced by sleep duration.

Short self-reported sleep duration associated with increased CHD risk in women

Researchers conducted a study to determine if self-reported sleep deprivation is associated with an increased risk of coronary events.

Focus on 2004: A year of novel pharmacologic agents in review

In each issue, the Focus On article reviews a newly approved or investigational drug of interest to pharmacy and therapeutics committee members. Because so many readers have told the editors of Formulary that they reference this column frequently when making formulary decisions for their hospitals, health-systems, or managed-care organizations, the editors have compiled this review of all the Focus On articles published in 2004, along with updates on the status of each agent.

Impact of counterfeit drugs on the formulary decision-making process

As initiatives to legalize the importation of prescription drugs draw more attention, the concern over counterfeit drugs is growing. The possibility of receiving counterfeit drugs has created an emerging dilemma for health-care professionals. FDA is relying on pharmacists to help ensure the integrity of drug products before they reach health-care consumers. Pharmacy and therapeutics committees can play a key role in achieving this goal by reviewing policies for medication acquisition and ensuring that necessary controls are in place to help prevent the acquisition of counterfeit drugs. FDA is also taking steps to help alleviate counterfeiting by mandating bar codes on all hospital drug packaging and implementing electronic pedigree papers to track distribution. FDA leaders project that by 2007, all prescription drugs will be tracked electronically to help ensure their authenticity. Formulary decision-makers, pharmacy directors, and clinicians must continue to be educated about the problem to help prevent counterfeit drugs from polluting the drug supply.

Government, industry provide pharmaceutical policy outlook for 2005 and beyond

Government, industry provide pharmaceutical policy outlook for 2005; $139 million to advance information technology, records; Rofecoxib hearings point to failures in clinical testing design, decision-making transparency; New guidance for generic drugs clarifies protocol, increases speed to market

New molecular entities: erlotinib, solifenacin, natalizumab

New molecular entities: erlotinib, solifenacin, natalizumab

Worldwide study finds that fluoroquinolones are still effective against CAP; Weekly nesiritide may have greatest benefit in highest-risk heart failure patients

Worldwide study finds that fluoroquinolones are still effective against CAP; Weekly nesiritide may have greatest benefit in highest-risk heart failure patients

Valdecoxib meta-analysis finds increased cardiovascular risk

Valdecoxib meta-analysis finds increased cardiovascular risk

Drug pricing concerns help shape policy decisions during past year

Agencies encourage development of more affordable treatments and take steps to ensure safer product use

Treatment options for the management of chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a disease state characterized by the progressive development of airflow limitation that is not fully reversible. The airflow limitation is associated with an abnormal inflammatory response of the lungs to noxious particles or gases. It affects approximately 15 million Americans and is associated with high morbidity and mortality. Previously, pharmacologic therapeutic options were limited by relatively short durations of action in the first-line medications and limited efficacy data and/or a high rate of adverse effects in the second-line medications. Today, there are several new and emerging medications to treat this disease state, and new guidelines have been published for disease management. This review examines current therapeutic options, compares efficacy data, and highlights the recommendations from international guidelines.

New indications: Aripiprazole

Atypical antipsychotic approved for acute bipolar mania This atypical antipsychotic is believed to exert its effect through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. An expanded indication for aripiprazole was approved on September 29, 2004, to include the treatment of acute manic and mixed episodes associated with Bipolar Disorder.

Nebivolol: A beta antagonist with novel pharmacologic properties

Nebivolol is a beta-blocker under FDA review for the treatment of hypertension. Nebivolol has unique pharmacologic properties, including high specificity for the beta-1 receptor and a nitric oxide-mediated vasodilatory effect. The agent provides significant blood pressure reduction from baseline values and as compared to placebo. Clinical trials have demonstrated that nebivolol reduces blood pressure similarly to atenolol, bisoprolol, amlodipine, nifedipine, lisinopril, and hydrochlorothiazide. The tolerability of nebivolol is similar to or better than that of these agents. If approved, nebivolol would likely be a viable alternative therapy for hypertension; however, additional studies are needed in patients with heart failure and coronary artery disease.

Suit alleges FDA overstepped jurisdiction in regulating compounding pharmacies

Suit alleges FDA overstepped jurisdiction in regulating compounding pharmacies; Report lists steps to improve product quality regulatory system; ASHP, AMCP recommend criteria for Medicare formulary design, formulary decision-maker responsibilities; Illinois, Wisconsin specify safeguards, provisions in state-sponsored WWW prescription drug pharmacy

New indications: Aripiprazole

Atypical antipsychotic approved for acute bipolar mania This atypical antipsychotic is believed to exert its effect through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. An expanded indication for aripiprazole was approved on September 29, 2004, to include the treatment of acute manic and mixed episodes associated with Bipolar Disorder.

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Vancomycin resistance: Means of prevention, control, and treatment revisited

There has been a nationwide increase in the incidence of vancomycin-resistant Enterococcus (VRE) reported over the last decade and a half. The heightened concern caused by VRE and the possibility of vancomycin resistance gene transfer to other gram positive organisms, especially methicillin-resistant Staphylococcus aureus (MRSA), led the Centers for Disease Control and Prevention (CDC) and the Hospital Infection Control Practices Advisory Committee (HICPAC) to publish recommendations for the prevention and control of vancomycin resistance. However, in 2002, the first documented case of vancomycin-resistant S aureus (VRSA) was reported in Michigan in an immunocompromised patient with a history of diabetes, peripheral vascular disease, and renal failure. Since then, 2 other cases have been reported: 1 in Pennsylvania in October 2002 and 1 in New York in March 2004. The limited availability of effective antimicrobial agents against vancomycin-resistant strains of Enterococcus and Staphylococcus species and the morbidity, mortality, and cost associated with resistance represent serious reasons for concern. This article presents a general overview of the current literature on the prevention and control of vancomycin resistance and a review of potential antimicrobial agents used in the treatment of VRE, vancomycin intermediate S aureus (VISA), and VRSA infections.

Rofecoxib voluntarily withdrawn from market due to cardiovascular risk

Rofecoxib voluntarily withdrawn from market due to cardiovascular risk

Cinacalcet: The first calcimimetic approved for secondary hyperparathyroidism

Secondary hyperparathyroidism is a common sequelae of chronic kidney disease. Treatment of this condition with traditional agents such as phosphate binders and vitamin D analogs is often complicated by the development of hypercalcemia and hyperphosphatemia. Cinacalcet (Sensipar, Amgen) is the first agent in a new class of drugs called calcimimetics. The agent sensitizes the calcium-sensing receptors in the parathyroid gland to extracellular calcium and directly lowers arathyroid hormone levels. Cinacalcet is FDA-approved for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. In this patient population, cinacalcet reduces plasma intact parathyroid hormone (iPTH) levels, serum calcium and phosphorus levels, and the calcium-phosphorus product without associated hypercalcemia and hyperphosphatemia. Cinacalcet appears to be well-tolerated, with nausea, vomiting, and hypocalcemia as the main adverse events. The drug is also approved for the treatment of hypercalcemia in patients with parathyroid carcinoma and holds promise for the treatment of primary hyperparathyroidism.

FDA combats illegal WWW drug sales

FDA combats illegal WWW drug sales; Electronic database allows greater public access to studies; ‘Roadmap’ developed to prepare for and respond to pandemic; Government seeks posting of clinical trial results online; Purchasing pools yield more options, savings for states; New efforts to increase antimicrobial research gain momentum

High-dose simvastatin fails to achieve primary end point in trial of ACS

Initiating high-dose simvastatin (Zocor, Merck) early after an acute coronary syndrome (ACS) event does not result in significantly superior clinical outcomes compared to delayed initiation of low-dose simvastatin.This major finding of phase Z of the A to Z Trial is in contrast to the results of 2 previous clinical trials in which aggressive therapy with atorvastatin (Lipitor, Pfizer) was found to be superior to less aggressive statin therapy in reducing the risk of adverse clinical events in ACS patients.

Study evaluates aspirin comedication rates among long-term COX-2 inhibitor users

A telephone survey investigating comedication rates of aspirin, acetaminophen, or nonaspirin NSAIDs (ibuprofen and naproxen) among long-term cyclooxygenase 2 (COX-2) inhibitor users (at least a 90-day supply of a COX-2 inhibitor) (N=325, mean age 71, 67% female) revealed that 50% used aspirin concurrently despite its apparent GI adverse effects. Aspirin use was higher for those aged ?56 years (50%) than for those aged 37 to 55 years (25%) (P=.03).

Aspirin, warfarin may lack heart failure benefits

The Warfarin/Aspirin Study in Heart Failure provided no evidence that aspirin is effective or safe in heart failure patients.

Higher-dose rofecoxib linked to 3x greater risk of acute cardiac events compared to other NSAIDs

A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.

Higher-dose rofecoxib linked to 3x greater risk of acute cardiac events compared to other NSAIDs

A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.

Liraglutide effective in treating type 2 diabetes

Once-daily injections of liraglutide, a long-acting, acylated, glucagon-like peptide 1 analog, have proven to be effective in the treatment of patients with type 2 diabetes.

Atorvastatin associated with modest but clinically apparent improvement in RA symptoms

Investigators in the Trial of Atorvastatin in Rheumatoid Arthritis (TARA) assessed whether statins would reduce inflammatory symptoms in patients with RA. Patients with RA (N=116) were randomized in the double-blind, placebo-controlled trial to receive 40 mg of atorvastatin or placebo in addition to their current disease-modifying antirheumatic drug (DMARD) therapy.

Topiramate

Epilepsy therapy approved for migraine prophylaxis