Clinical Pharmacology

Canagliflozin (Janssen Research & Development), developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, raised the level of bad cholesterol in patients during clinical trials and may post heart risks, according to FDA and reported by Reuters.

In 2012, FDA was able to achieve milestone and make groundbreaking strides through the approval of 39 innovative and cutting-edge drug therapies to populations in need.

Women who regularly took the analgesics ibuprofen or acetaminophen 2 more days per week had an increased risk of hearing loss, according to a recent study published in a recent issue of the American Journal of Epidemiology.

Antimicrobial stewardship programs are being implemented in a variety of settings to assist with the challenges associated with the management of infectious diseases. Here's a review of ASPs from the perspective of a formulary decision-maker.

With limited treatments available, the discovery of mutations in Janus kinase 2 (JAK 2) in 2005 was a major step forward for scientists in search of new therapies for myeloproliferative neoplasms (MPNs).

The American Academy of Pediatrics has announced its endorsement of the World Health Organization's (WHO) recommendation that thimerosal not be banned from vaccines.

Benzodiazepines, which have been associated with an increased incidence of infections in the critically ill, also may increase the risk of community-acquired pneumonia, according to a recent report published in Thorax.

Adverse drug events in the elderly can be prevented with appropriate monitoring, according to CDC.

A study of 1.7 million patients with diabetes indicates that reducing inflammation of the mouth can produce improvement in other health measures.

A look at the statin prescription trends in the Advocate Physician Partners organization.

Perampanel is a selective, non-competitive AMPA receptor antagonist that is used as adjunctive therapy for refractory partial-onset seizures and was approved by the FDA on October 22, 2012.

Gastric bypass surgery can improve glycemic control in adults with type 2 diabetes, but doesn't cure diabetes, according to the largest community-based study of long-term diabetes outcomes after bariatric surgery, published online ahead of print in Obesity Surgery.

New molecular entity: FDA approved linaclotide (Linzess, Ironwood Pharmaceuticals and Forest Pharmaceuticals) for the treatment of chronic idiopathic constipation and irritable bowel syndrome (IBS) with constipation in adults.

Recent FDA action (through December 2012) related to, Rabeprazole sodium delayed-release sprinkle capsules, CXA-201, CB-215, Buprenorphine subdermal implant, LX1033, ISIS-TTR Rx, Digoxin Immune Fab, Glucagon, AAV1-FS344, Trans sodium crocetinate, Betamethasone valerate foam 0.12%

African-American men and women continue to have higher risks of dying at the first presentation of heart disease compared with their white counterparts, according to a study published in the Journal of the American Medical Association.

Self-management has small effects on pain and disability in people with low back pain, according to a study published online in Arthritis Care & Research.

Recent FDA Approvals (through December 2012) related to (Bedaquiline, Janssen, Oseltamivir, Genetech, Apixaban, Bristol-Myers Squibb, Lomitapide, Aegerion, Varicella zoster immune globulin preparation, Cangene, Teduglutide, NPS Pharmaceuticals, Pasireotide diaspartate, Novartis, Ponatinib, ARIAD Pharmaceuticals, Influenza virus vaccine, GlaxoSmithKline, Raxibacumab, Crofelemer, Salix, Cabozantinib, Exelixis)

There is evidence of risk with the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy and to neonatal health and beyond, according to a study published in Human Reproduction.

Recent FDA action (through November 2012) related to, H5N1 adjuvanted influenza vaccine, Pasireotide, Digoxin immune fab, Etirinotecan pegol, OBI-1, beclomethasone 17, 21-dipropionate, Regorafenib, Trastuzumab emtansine, A4250, Sildenafil

Adverse drug events in the elderly can be prevented with appropriate monitoring, according to CDC.

Multiple sclerosis (MS) specialty drug costs now account for more than two-thirds of MS patients' total cost of care, according to a new study presented at the Academy of Managed Care Pharmacy 2012 Educational Conference in Cincinnati, Ohio, in October.

Individuals with high cholesterol who stay on their statin medications over a 2-year period are healthier than comparable nonadherent individuals, but the overall cost of their care is slightly higher, according to a new study presented at the Academy of Managed Care Pharmacy 2012 Education Conference, in Cincinnati, Ohio, in October.

Pre-emptive therapy with the selective serotonin reuptake inhibitor escitalopram in patients initiating interferon therapy for hepatitis C virus (HCV) without psychiatric risk factors reduced the risk of depression, according to a recent study published in the Annals of Internal Medicine.

Recent FDA Approvals (through November 2012) related to (Tofacitinib, Pfizer, Omacetaxine mepesuccinate, Teva, rivaroxaban, Janssen, darunavir)

Topical ivermectin provided a good degree of cure in patients with head lice infection with 1 simple and easy-to-use application, according to a study published in the November 1 issue of the New England Journal of Medicine.

New molecular entity: FDA approved teriflunomide (Aubagio, Genzyme, a Sanofi-Aventis company), a pyrimidine synthesis inhibitor, for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Women who regularly took the analgesics ibuprofen or acetaminophen 2 more days per week had an increased risk of hearing loss, according to a recent study published in a recent issue of the American Journal of Epidemiology.

New combination: FDA approved aclidinium bromide (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with COPD.

A look at the pharmacologic agents reviewed by Formulary in 2012.

Early initiation of basal insulin did not impact cardiovascular outcomes compared to standard management of glucose in patients with type 2 diabetes or elevated fasting glucose with cardiovascular risk factors.