Formulary Watch |

The impact of antipsychotic agent choice on the risk of coronary heart disease mortality due to cholesterol effects

Schizophrenia is a chronic disease usually diagnosed when patients are in their mid- to late 20s; therefore, patients may receive decades of exposure to antipsychotic agents over their lifetime. Whenever long-term pharmacotherapy is required for a disease, the cardiovascular implications of that therapy need to be considered. This fact was recently highlighted by the removal of the cyclo-oxygenase-2 inhibitors rofecoxib and valdecoxib from the US market because of marked elevations in cardiovascular risk.

Von Eschenbach sworn in as FDA commissioner; 2007 may be year of reform at agency

In an 80-to-11 vote in December 2006, the US Senate confirmed Andrew von Eschenbach, MD, as commissioner of FDA. The nomination process included multiple holds by members of both political parties, which delayed his confirmation.

Personal health records go portable; hospitals tap into translation services by video

Five of the nation's largest employers plan to offer employees access to their own portable electronically based medical records that they can use when they travel, see a new doctor, or change jobs to retain information about their healthcare, including medications.

FDA advisory panel weighs safety of drug-eluting stents

When used for their approved indications, drug-eluting stents (DES) probably do not increase the risk of death or myocardial infarction (MI) compared with bare metal stents (BMS), an FDA advisory panel concluded at a meeting in Gaithersburg, Md, last month.

A review of the pharmacologic options for the treatment of alcohol dependence

The chronic and excessive use of alcohol adversely affects the healthcare system, work productivity, and familial and social relationships. Alcohol misuse accounts for 85,000 deaths per year in the United States, and the overall financial costs related to alcohol dependence are more than $100 billion annually. The reduction of alcohol misuse can be measured as an increase in the frequency of abstinence or a reduction in the frequency of relapses. The recommendation for alcohol dependence treatment is a combination of psychosocial support therapy and pharmacologic treatment. Currently, there are only 3 FDA-approved agents for the treatment of alcohol dependence: naltrexone, acamprosate, and disulfiram.

Study observes increased risk for CV events in men with migraines

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.

Rifaximin may prevent multiple recurrences of CDAD

Data indicate that oral rifaximin can prevent recurrences of Clostridium difficile-associated diarrhea (CDAD) in patients treated previously with vancomycin, said presenters at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Las Vegas, Nev.

Once-daily formulation of mesalamine induces, maintains remission in patients with ulcerative colitis

A once-daily formulation of mesalamine that relies on multimatrix (MMX) technology is effective at inducing and maintaining remission in patients with ulcerative colitis (UC), with no significant gender difference in the response rate, according to studies presented at Digestive Disease Week (DDW) 2006 in Los Angeles, Calif, and at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

Crohn's disease: certolizumab, adalimumab demonstrate efficacy in prior users of infliximab

Certolizumab and adalimumab demonstrated efficacy in inducing and maintaining response in patients with Crohn's disease who have lost response or are intolerant to infliximab, reported researchers at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

Fewer side effects observed with 9.5-mg transdermal rivastigmine when compared with oral capsules in Alzheimer's disease treatment

A transdermal rivastigmine patch is as effective as twice-daily oral treatment and is associated with 3 times fewer reports of nausea and vomiting, according to results of the Investigation of Transdermal Exelon in Alzheimer's Disease (IDEAL) trial reported at the 131st Annual Meeting of the American Neurological Association in Chicago, Ill.

Oral fingolimod demonstrates reduced MS activity at end of 1- and 2-year treatment periods

Fingolimid, an investigational oral agent, significantly reduces disease activity and the number of relapses among patients with relapsing multiple sclerosis (MS), according to phase 2 results presented at the 131st Annual Meeting of the American Neurological Association in Chicago, Ill.

Combination ezetimibe and simvastatin lowers LDL cholesterol to a greater extent than rosuvastatin at various doses

Combination therapy with ezetimibe and simvastatin for 6 weeks provides greater reductions in low-density lipoprotein cholesterol (LDL-C) compared with rosuvastatin at the usual starting, next highest, and maximum doses of each drug, according to a randomized, double-blind, parallel-group, multicenter trial published in the journal Current Medical Research and Opinion.

Amlodipine plus atorvastatin demonstrates potentially synergistic cardioprotective effects in ASCOT–LLA

A new substudy of the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm (ASCOT–LLA) published recently in the European Heart Journal found a potentially synergistic cardioprotective interaction between amlodipine and atorvastatin.

Graded relationship demonstrated between statins' effects on mortality and patients' coronary heart disease risk

According to an observational study recently published in the American Journal of Cardiology, use of a statin was associated with a 46% decrease in patients' odds of death compared with the risk of death in those not receiving a statin, despite the fact that statin users were in general at a higher risk for death. Furthermore, the magnitude of the observed mortality benefit associated with statin use appeared to increase as a patient's number of coronary heart disease risk factors increased.

Statins associated with lower morbidity, mortality in patients with CHF with or without CHD

A large, propensity score-adjusted cohort study recently published in the Journal of the American Medical Association (JAMA) demonstrated that statins were associated with a statistically significant reduction in the risks of death and hospitalization for heart failure when administered to patients with chronic heart failure (CHF). Although the ability of statins to lower cholesterol and prevent coronary heart disease in the general population is well known, the current finding that statins can reduce both morbidity and mortality in this broad CHF population is novel.

Pipeline Preview

17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm labor

First-time generic approvals

Paroxetine oral suspension 10 mg/5 mL equiv base (equiv to Paxil oral suspension 10 mg/5 mL equiv base)

FDA Actions in Brief

FDA granted tentative approval to a combination of valsartan and amlodipine (Exforge, Novartis) for the treatment of hypertension (approval pending the expiration of market exclusivity and patent protection for amlodipine).

Bevacizumab

Angiogenesis inhibitor approved as part of combination therapy for first-line treatment of nonsquamous NSCLC

Bortezomib for injection

Proteasome inhibitor approved for treatment of relapsed mantle cell lymphoma

Kunecatechins

Botanical agent approved for topical treatment of external genital and perianal warts

First-time generic approvals (December 2006)

Oxybutynin extended-release tablets, 15 mg (equiv to Ditropan XL extended-release tablets, 15 mg)

FDA Actions in Brief (December 2006)

Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.

Telbivudine

Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Medco reaches settlement with Department of Justice; legal paper seeks change in FDA warning letter process

The US Department of Justice (DOJ) and Medco Health Solutions, a large pharmacy benefit manager (PBM) based in Franklin Lakes, NJ, reached a settlement over allegations that the PBM had submitted false claims to the federal government, had paid kickbacks to health plans to obtain business, and had both solicited and accepted kickbacks from pharmaceutical companies.

Effects of evidence-based formulary restrictions at a Veterans Affairs medical center

The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..

Study confirms high prevalence of Methicillin-resistant Staphylococcus aureus with reduced susceptibility to vancomycin

Methicillin-resistant Staphylococcus aureus (MRSA) strains showing reduced susceptibility to vancomycin (minimum inhibitory concentration [MIC] of 2 mcg/mL) and requiring aggressive empiric vancomycin dosing are highly prevalent among those that cause invasive infections, according to a prospective cohort study.

Clinical news updates from the 2006 AHA Scientific Sessions

The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.

Aliskiren: A novel oral renin inhibitor for the treatment of hypertension

Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.

NSAID use in first trimester may increase risk of congenital anomalies

Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).