Formulary Watch |

The role of pharmacoeconomics in formulary decision-making

The role of cost- and pharmacoeconomic-related criteria in formulary decision-making was assessed in a literature review of 31 studies of hospital (n=18) and managed care (n=13) pharmacy and therapeutics (P&T) committees. In both settings, cost was important, although the elements of cost considered varied. Acquisition cost was mentioned more frequently than pharmacoeconomic or cost-effectiveness information. Other factors, including drug characteristics, quality of life, supply-related issues, and physician demand, also influenced decisions.

COX-2 inhibitor demonstrates lower incidence of adverse cardiorenal events compared with nonselective NSAIDs

A meta-analysis of data from randomized, parallel-designed, placebo-controlled studies involving >44,000 patients demonstrated that those who had taken the cycloxygenase-2 (COX-2) inhibitor celecoxib (50–800 mg TDD) had a lower incidence of adverse cardiorenal events including hypertension, edema, or congestive heart failure than those taking nonselective non-steroidal anti-inflammatory drugs (NSAIDs), according to an oral and poster presentation at the 21st annual scientific meeting of the American Society of Hypertension (ASH) in New York, NY.

High-dose non-COX-2 NSAIDs associated with increased vascular risk

While the increased risk of vascular events associated with cyclooxygenase-2 (COX-2) inhibitors has been well established, new data are emerging that demonstrate similar risk increases associated with non-steroidal anti-inflammatory drugs (NSAIDs) that are not selective for COX-2. The data, published in the British Medical Journal (BMJ), were from a meta-analysis of published and unpublished randomized trials. The study comes more than a year after the withdrawals of the COX-2-selective NSAIDs rofecoxib and valdecoxib from the US market.

COX-2 inhibitors, nonselective NSAID use increases risk of death, reinfarction in acute MI patients

A meta-analysis of data from national hospital records in Denmark and from the country's national prescription registry showed that the use of selective cyclooxygenase-2 (COX-2) inhibitors in all doses and nonselective non-steroidal anti-inflammatory drugs (NSAIDs) in high doses raised the risk of death in patients who experienced first-time acute myocardial infarction (MI).

First-time generic approvals (August 2006)

Metronidazole topical gel, 0.75% (equiv to Metrogel topical gel)

Pipeline Preview (August 2006)

Hepatitis B immune globulin (human) (Nabi-HB, Nabi Bio-pharmaceuticals) for the treatment of hepatitis B infection

FDA actions in brief

FDA approved the etonogestrel 68-mg implant (Implanon, Organon), a single-rod implantable device that prevents pregnancy for up to 3 years.

Atripla

This fixed-dose combination tablet contains: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a synthetic nucleoside analog of cytidine; and tenofovir disoproxil, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Sprycel

Dasatinib is an inhibitor of multiple tyrosine kinases and is active in vitro against leukemic cell lines representing variants of imatinib-sensitive and -resistant disease.

Prezista

This inhibitor of human immunodeficiency virus type 1 (HIV-1) protease selectively inhibits the cleavage of HIV-encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.

Lucentis

This recombinant humanized IgG1 monoclonal antibody fragment binds to the receptor-binding site of active forms of human vascular endothelial growth factor A (VEGF-A).

Drug Watch: Agents in late-stage development for the treatment of generalized anxiety disorder and sleep disorders (August 2006) (PDF)

A review of agents in late-stage development for the treatment of generalized anxiety disorder and sleep disorders (August 2006).

Salmeterol/fluticasone combination lowers asthma exacerbations

A salmeterol/fluticasone combination (SFC) surpassed a formoterol/budesonide combination (FBC) in reducing the rate of moderate-to-severe exacerbations in patients with persistent asthma, according to a study published by the journal Respiratory Medicine.

Antihypertensives demonstrate benefit in reducing Alzheimer's disease risk

Potassium-sparing diuretics reduced the risk of Alzheimer's disease (AD) by >70% in patients aged >64 years while other antihypertensive (AH) medications, including all diuretics, beta blockers, and dihydropyridine calcium channel blockers, were linked with somewhat smaller decreases in Alzheimer's risk.

Statins, beta blockers may reduce vulnerability of coronary disease patients to acute ischemic events

An observational case-control study of 1,384 adults presenting with coronary disease for the first time found that patients who presented with acute myocardial infarction (MI) received statins and beta blockers less often than patients who presented with stable exertional angina.

Use of ACE inhibitors in first trimester raises risk of fetal cardiovascular, CNS malformation

An observational cohort study found that the risk of major congenital malformations for infants who were exposed to angiotensin-converting enzyme (ACE) inhibitors during their first trimester increased by a factor of more than 2, while exposure to other antihypertensive medications did not demonstrate an increased risk.

NSAID use among elderly increases risk of first-time hospitalization for heart failure

A cohort study with a nested case-control analysis of first hospitalizations for heart failure (HF) associated the use of non-steroidal anti-inflammatory drugs (NSAIDs) with a 30% increase in the target end point among patients aged 60 to 84 years.

Asthma patient hospitalization risk more than doubles with long-acting beta-agonist use of 3 months

A meta-analysis of 19 randomized, controlled clinical studies that lasted at least 3 months indicates that long-acting beta-agonists (LABAs) more than double the rates at which asthma patients may become hospitalized.

Wellbutrin XL

Bupropion extended-release tablets

Formulary June 2008 BPA Statement

Formulary June 2008 BPA Statement

Ambrisentan improves exercise capacity in phase 3 trial

Ambrisentan, a propanoic acid type-A selective endothelin receptor antagonist, improved exercise capacity and delayed clinical worsening in patients with pulmonary arterial hypertension (PAH) in phase 3 clinical trial results presented at the annual international conference of the American Thoracic Society in San Diego, Calif.

Anticonvulsant lacosamide exhibits pain reduction in phase 3 diabetic neuropathy trial

The anticonvulsant lacosamide is effective in relieving diabetic neuropathy and produces increased pain reduction with continued treatment for 22 months, according to phase 3 study results presented during the 25th Annual Scientific Meeting of APS in San Antonio, Texas. "This is a promising treatment that maintains a long-term effect," said Tibor Hidvegi, MD, Medical Department, Petz Hospital, Gyor, Hungary.

Once-daily morphine shows greater improvement than oxycodone BID for chronic back pain

Morphine extended-release once daily significantly reduced pain among patients with chronic, moderate-to-severe low back pain compared with oxycodone controlled-release twice daily, according to results of a study presented at the 25th Annual Scientific Meeting of the American Pain Society (APS) in San Antonio, Texas. The once-daily opioid also demonstrated significant improvement in sleep scores, said Richard L. Rauck, MD, Carolinas Pain Institute, Winston-Salem, NC.

Valsartan monotherapy reduces hs-CRP levels

Valsartan is associated with a reduction in the levels of high-sensitivity C-reactive protein (hs-CRP), the inflammatory marker that is highly predictive of adverse cardiovascular outcomes, independent of its blood pressure-lowering effect, said Paul M. Ridker, MD, MPH, lead investigator of a trial presented at the 21st annual meeting of ASH.

Once-daily plasma renin inhibitor aliskiren effective antihypertensive alone or with a thiazide diuretic

The investigative agent aliskiren, the first orally active renin inhibitor, is an effective antihypertensive agent as monotherapy and in combination with hydrochlorothiazide, reported investigators at the 21st annual scientific meeting of ASH.

Nebivolol demonstrates efficacy and favorable safety profile in treatment of hypertension

Phase 3 clinical trials demonstrated that the once-daily, highly selective beta blocker nebivolol lowers blood pressure in a dose-dependent manner and is well tolerated at all doses, according to presenters at the 21st annual scientific meeting of the American Society of Hypertension (ASH), in New York, NY.

FDA safety efforts target counterfeiting, unapproved products, and confusing abbreviations; enrollment in Medicare Part D rises above 38 million

FDA has announced further steps it plans to take to target the sales of counterfeit medications. The agency also rolled out a joint campaign with the Institute of Safe Medication Practices (ISMP) to discourage the use of confusing abbreviations that can potentially cause medication errors.

New ALLHAT findings: Diuretic most effective antihypertensive for preventing heart failure

Diuretics are superior to both calcium channel blockers (CCBs) and, at least in the short term, angiotensin-converting enzyme (ACE) inhibitors in preventing heart failure (HF) in hypertensive patients, according to a follow-up analysis of the largest clinical trial on hypertension to date.

SSRIs demonstrate risk reduction for colorectal tumors dependent on dose level in case-control study

Investigators conducting a population-based, nested case-control study observed an association between the daily dose level of selective serotonin reuptake inhibitors (SSRIs) and a decreased risk of colorectal cancer among patients aged 5 to 85 years old. No consistent association was found between colorectal cancer risk and the use of tricyclic antidepressants (TCAs).

TELICAST trial of telithromycin produces split results in asthma treatment

A double-blind, randomized, placebo-controlled study of the ketolide telithromycin administered orally over a 10-day period to 278 asthma patients demonstrated a reduction in asthma symptoms, but did not show a significant treatment effect on patients' morning peak expiratory flow.