Formulary Watch |

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.

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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).

ADEs responsible for more than 700,000 visits to US emergency departments in 2004 and 2005

Adverse drug events (ADEs) led to the treatment of an estimated 701,547 patients in US emergency departments (EDs) in 2004 and 2005, according to a recent study in the Journal of the American Medical Association (JAMA). Significantly, those patients ?65 years of age were 2 times more likely to have ED treatment for an ADE and approximately 7 times more likely to need hospitalization than their younger counterparts.

Pipeline Preview (December 2006)

Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations

Infliximab

Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

Pramipexole

Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

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.

Drug Watch: Agents in late-stage development for the treatment of ankylosing spondylitis, osteoarthritis, and related pain (December 2006) (PDF)

Review of agents in late-stage development for the treatment of ankylosing spondylitis, osteoarthritis, and related pain (December 2006).

Low testosterone levels associated with increased CHD risk in postmenopausal women

Low levels of testosterone are associated with an increased risk of mortality from coronary heart disease (CHD) in postmenopausal women, reported Gail A. Laughlin, PhD.

Study finds that men who suffer from migraines are at increased risk for cardiovascular events

Men who suffer from migraines are at increased risk for cardiovascular events, according to researchers. The new findings follow similar reports that women with migraines are at higher risk for cardiovascular disease.

Changes in heart rate predict risk of mortality in healthy middle-aged men

A change in resting heart rate in healthy middle-aged men is tied to mortality risk, with those who experience a long-term rise in resting heart rate having an increased risk of mortality and those with a long-term decrease in resting heart rate having a reduced risk of mortality.

Stem cell research could have long-term implications for cardiology

After years of minimal results, stem cell research is forging ahead. "This is a new appetizer for what may be an excellent meal in years to come," said former AHA president Valentin Fuster, MD, PhD, at a press briefing Tuesday morning. "Reports the past couple of years have been equivocal at best."

Anemia and heart failure: Improvement in outcomes tied to increase in hemoglobin level

A rise in hemoglobin of at least 1 g/dL appears necessary to affect the course of heart failure in patients with symptomatic heart failure and anemia, according to a post hoc analysis of STAMINA-HeFT (Studies of Anemia in Heart Failure-Heart Failure Trial).

No benefit to late reperfusion in stable MI patients

The practice of late reperfusion-percutaneous coronary intervention (PCI) performed 2 to 28 days after myocardial infarction (MI)-in patients who are stable does not lead to improved clinical outcomes compared with medical therapy, said Judith S. Hochman, MD, lead investigator of the Occluded Artery Trial (OAT).

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