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.
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.
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 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.
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.
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.
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.
17 alpha-hydroxyprogesterone (Gestiva, Adeza) for the prevention of preterm labor
Paroxetine oral suspension 10 mg/5 mL equiv base (equiv to Paxil oral suspension 10 mg/5 mL equiv base)
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).
Angiogenesis inhibitor approved as part of combination therapy for first-line treatment of nonsquamous NSCLC
Proteasome inhibitor approved for treatment of relapsed mantle cell lymphoma
Botanical agent approved for topical treatment of external genital and perianal warts
Oxybutynin extended-release tablets, 15 mg (equiv to Ditropan XL extended-release tablets, 15 mg)
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 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.
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.
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..
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.
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.
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.
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).
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.
Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations
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 was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).
