In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.
P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight; Focus on golimumab; Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders
Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.
New indication: Bevacizumab (Avastin), a monoclonal antibody, was approved on July 31, 2009, for the treatment of metastatic renal cell carcinoma in combination with interferon alfa
Generic drug approved by FDA (through September 2009): tacrolimus capsules
The P&T committee is positioned to provide knowledge, strategies to improve treatment of patients with cardiometabolic disorders.
Recent FDA approvals (through September 2009) related to Saphris, Tracleer, Livalo, Tyvaso, Tekturna HCT, Onsolis, Forteo, Invega Sustenna, Colcrys, Acuvail, Lipsovir, and Kogenate FS
New molecular entity: Saxagliptin (Onglyza), a DPP-4 inhibitor, was approved on July 31, 2009, for the treatment of type 2 diabetes mellitus
New formulation: Sumatriptan (Sumavel DosePro) formulated as a needle-free injection was approved on July 15, 2009, for the acute treatment of migraine and cluster headaches
Recent FDA action (through September 2009) related to cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, and beclomethasone 17,21-dipropionate
Golimumab is a human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that was recently approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Agents in late-stage development for the treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, and short bowel syndrome
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has prematurely terminated a trial of sildenafil for the treatment of pulmonary arterial hypertension (PAH) in adult patients with sickle cell disease because of safety concerns.
After completing an analysis of safety data for tumor necrosis factor (TNF)-blockers, FDA has stated that there is an increased risk of lymphoma and other cancers in pediatric patients who are treated with these agents.
Lundbeck and Solvay have announced that they are discontinuing development of bifeprunox for the maintenance treatment of schizophrenia.
Lilly and BioMS Medical reported that their investigational agent dirucotide did not meet the primary end point of delaying disease progression in patients with secondary progressive multiple sclerosis (SPMS) in the phase 3 MAESTRO-01 trial.
A study published in Urology demonstrated that alpha-blocker use is associated with a lower risk of sexual dysfunction in men aged >40 years.
Initiation of antipsychotic therapy associated with hyperglycemia in older diabetic patients
With healthcare-reform legislation moving forward, insurers, providers, and pharmaceutical companies are keeping a sharp eye on policy proposals likely to affect coverage, costs, and benefits. Various constituencies in the healthcare community are supporting initiatives that will increase access to healthcare and make the nation's costly healthcare system more efficient and effective.
Emerging risk factors and risk markers for CV disease; Focus on rivaroxaban; Drug Watch: Agents in late-stage development for the treatment of osteoarthritis and acute/chronic pain
In a retrospective analysis published in the journal Neurology, investigators demonstrated that previous treatment with intravenous immunoglobulin (IVIg) was associated with a reduced risk of the development of Alzheimer's disease and related disorders (ADRD) in patients aged at least 65 years.
This review discusses emerging risk factors for CVD, including hs-CRP, lipoprotein(a), homocysteine, fibrinogen, homocysteine, and coronary artery calcification.
Recent FDA approvals (through August 2009) related to Ozurdex, Cambia, Ilaris, Feraheme, Plan B One-Step, Alimta, and Isentress
Rivaroxaban is a highly potent direct factor Xa inhibitor that is pending FDA approval for the indication of venous thromboembolism (VTE) prophylaxis in patients undergoing total knee replacement or total hip replacement surgery.
Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa
Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets
