Formulary Watch |

ADA 2010: New diagnostic guidelines spur debate

The new standards using glycated hemoglobin for the diagnosis of diabetes issued in January 2010 have not come without controversy.

Formulary Digital Edition, July 2010

Hemophilia: Etiology, complications, and current options in management; Rifaximin: A nonabsorbable, broad-spectrum antibiotic for reduction in the risk for recurrence of overt hepatic encephalopathy; Agents in late-stage development for the treatment of female and male cancers

Drug Watch: Agents in late-stage development for the treatment of female and male cancers (PDF) (July 2010)

Agents in late-stage development for the treatment of female and male cancers.

Denosumab (Prolia): A human IgG2 monoclonal antibody that binds to RANKL (or receptor activator of nuclear factor kappa-B ligand), preventing RANKL from activating its receptor (RANK) on the surface of osteoclasts

New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.

Progressive multifocal leukoencephalopathy risk increases with longer natalizumab exposure

Forty-two cases of progressive multifocal leukoencephalopathy (PML) in patients receiving the humanized monoclonal antibody natalizumab have been documented since 2006 from MedWatch reports.

Aztreonam for inhalation (Cayston): An inhaled antibiotic to improve lung symptoms in cystic fibrosis patients with pseudomonal infections

New Formulation: Aztreonam for inhalation (Cayston) was approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas Aeruginosa.

FDA Actions in Brief July 2010 (Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna)

Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna

First-time generic approvals July 2010

Generic drugs approved by FDA (through June 2010): Venlafaxine hydrochloride extended-release capsules, Meropenem for injection, Adapalene 0.1% gel, Aztreonam for injection, Oxaliplatin for injection

FDA alerts to ongoing olmesartan cardiovascular review

On June 11, 2010, FDA announced in a drug safety communication that the agency was currently evaluating whether the use of the angiotensin II receptor blocker olmesartan (Benicar, Daiichi Sankyo) (also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.

Transparency Initiative to provide more information on FDA regulation and drug development

Transparency has become the lead philosophy governing biomedical research and regulation. FDA and the National Institutes of Health are requiring more disclosure of financial relationships between industry and scientists and physicians.

Glitazones for diabetes prevention found superior to other oral antidiabetic drug classes

A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.

Oral cladribine phase 3 results show relapse reductions, lower total cost for patients with RRMS

New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

Rifaximin: A nonabsorbable, broad-spectrum antibiotic for reduction in the risk for recurrence of overt hepatic encephalopathy

A recent landmark phase 3 trial in patients in remission from recurrent hepatic encephalopathy demonstrated that rifaximin at a dose of 550 mg twice daily is significantly more effective than placebo in maintaining remission and reducing the risk of hospitalization. Rifaximin's approval by FDA in March 2010, offers clinicians the first pharmacologic treatment for hepatic encephalopathy in more than 30 years.

Increased cataracts risk in elderly associated with SSRIs, SNRIs

In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.

Rosiglitazone use increases odds of myocardial infarction, confirmed

A systematic review and meta-analysis evaluating the effects of rosiglitazone on cardiovascular morbidity and mortality confirmed the finding of increased odds of myocardial infarction with rosiglitazone.

Hemophilia: Etiology, complications, and current options in management

Hemophilia is a rare congenital bleeding disorder, resulting from a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B). Deficiency of either of these factors interrupts normal hemostasis resulting in an inability to form a stable fibrin clot to halt bleeding. This article reviews the etiology of hemophilia, available pharmacologic approaches to bleeding episodes, and treatment options in the presence of complications.

ADA 2010: Promising pilot study of resveratrol

A pilot study of resveratrol in 10 older adults suggests that the compound may be beneficial for patients with impaired glucose tolerance.

ADA 2010: One-year data on exenatide show that improvements in glycated hemoglobin and CV risk markers are maintained

In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials.

ADA 2010: Liraglutide clinical trial program suggests higher rates of achievement of glycated hemoglobin targets without weight gain or hypoglycemia versus active comparators

A post hoc analysis of 5 clinical trials of liraglutide suggests that it was significantly better than active comparators on a composite end point of glycated hemoglobin less than 7% without hypoglycemia or weight gain, reported French investigators.

ADA 2010: Liraglutide more successful than sitagliptin in achieving glycemic target

Liraglutide is more successful in reducing glycated hemoglobin levels to 7% or less regardless of baseline glycated hemoglobin level compared with sitagliptin in adults with type 2 diabetes, said Melanie Davies, MD, MB ChB, professor of diabetes medicine, University of Leicester, United Kingdom.

ADA 2010: Exenatide beats insulin glargine in glycated hemoglobin , weight control

Patients who are not well controlled on metformin may get better control of glycated hemoglobin levels and weight using once-weekly exenatide than by titrating insulin glargine.

ADA 2010: Investigational GLP-1 analog produces glycemic control similar to available agents but with equal or better weight loss

Data from phase 3 trials of an investigational once-weekly injectable human GLP-1 analog?taspoglutide?show that it compares favorably with currently available agents in terms of glycemic control while offering favorable gastrointestinal tolerability and equal or superior weight loss.

Hepatitis C drug raises cure rate in late trial

An experimental drug for hepatitis C from Vertex Pharmaceuticals, telaprevir, sharply increased the cure rate in a clinical trial, while reducing the time needed for treatment. Experts said the results could herald a new era in treating the sometimes-fatal disease that is often overlooked, as reported by The New York Times.

Drug for RSV linked to shorter hospital stays

Most patients with resistant rheumatoid arthritis (RA) who failed to respond to an initial cycle of rituximab (Rituxan) showed clinical improvement following a second treatment cycle, a British study found, as reported by MedPage.

Repeat rituximab therapy helps in resistant RA

Most patients with resistant rheumatoid arthritis (RA) who failed to respond to an initial cycle of rituximab (Rituxan) showed clinical improvement following a second treatment cycle, a British study found, as reported by MedPage.

One-a-day heart polypill to be tested in new international trial

Researchers will explore whether a new, very low-cost, one-a-day combined ?polypill? could reduce the risk of heart attacks, strokes, and other cardiovascular problems across the world, in a major new international trial that has just launched, as reported by ScienceDaily.

Children's consumption of chronic medications on the rise, new research shows

In 2009, the drug trend for children, a measure of prescription spending growth, increased 10.8%, driven by a 5% increase in drug utilization and higher medication costs, according to the Medco 2010 Drug Trend Report.

Study explores effects of oral SCE-B on postmenopausal nocturnal vasomotor symptoms

Low-dose hormone therapy significantly reduced ?sleep time? awakenings caused by hot flashes in postmenopausal women, according to the results of a recent multicenter study conducted at 19 US sites.

Triple antihypertensive combination therapy offers greater blood pressure reductions compared with dual treatments

Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ), demonstrated significantly greater mean reductions at week 12 in blood pressure.

Reports of severe liver injury prompt black box warning and new recommendations for propylthiouracil use

As early as April 2009, FDA and the American Thyroid Association began recommending that propylthiouracil not be prescribed as first-line therapy in most adults or children based on reports of propylthiouracil-related serious liver injury from both the FDA Adverse Event Reporting System and liver transplantation monitoring programs.