News

Greater dietary fiber intake is significantly associated with lower risk of first stroke, according to a recent study published in Stroke.

For critically ill adults with multiorgan failure, early supplementation with glutamine or antioxidants does not improve clinical outcomes, and glutamine may increase the mortality rate of this patient population, according to a study published in the April 18 issue of the New England Journal of Medicine.

Eighteen years of follow-up of the Prostate Cancer Prevention Trial (PCPT) suggests that 7 years of treatment with the 5-alpha-reductase inhibitor finasteride (Proscar) for prostate cancer prevention does not appear to affect mortality but does reduce the risk of a prostate cancer diagnosis.

Older men with metastatic castration-resistant prostate cancer (mCRPC) derive a similar if not superior survival benefit from treatment with enzalutamide as do younger men, according to a post-hoc analysis of the phase III AFFIRM trial.

Autism spectrum disorders (ASD) are complex neurodevelopmental disorders that involve significant social functional impairment and behavioral inflexibility. Autism is the most severe form of ASD and includes significant impairment in communication skills. Treatment of ASD is complex and involves a comprehensive educational interventional plan. Medications are used only as adjuncts, and only in cases in which maladaptive behaviors are severe or life-threatening, or to enable a patient to participate in their behavioral therapies. The most commonly used medications include second-generation antipsychotics (SGAs), selective serotonin reuptake inhibitors (SSRIs), and psychostimulants. Risperidone and aripiprazole are the only medications to carry an FDA indication to treat ASD-related symptoms. There is interest in using newer agents, such as atomoxetine, galantamine, rivastigmine, and memantine, to treat ASD-associated symptoms, but data are lacking to support their use.

Use of tivozanib, an experimental tyrosine kinase inhibitor (TKI) with increased specificity and potency for the vascular endothelial growth factor (VEGF) receptor, as initial targeted therapy for patients with advanced renal cell carcinoma did not translate into improved overall survival compared with sorafenib (Nexavar) in a phase 3 clinical trial.

The standard of care for hepatitis C (HCV) was uprooted in 2011. Prevailing treatment involved a combination of 2 drugs-pegylated-interferon and anti-viral ribavirin-taken for 1 year. Two new protease inhibitors, boceprevir and telaprevir, joined the regimen.

Medication Reconciliation, “Med Rec” as it has come to be known, is recognized as an important part of the growing practice of medication management and a critical step in improving the care of patients in all settings. Despite the many challenges associated with implementation of a successful Med Rec program, the potential for significant value drives the ongoing effort to find scalable, cost-effective solutions.

Anticoagulation while on docetaxel (Taxotere) chemotherapy is an independent predictor of survival in men with metastatic castration-resistant prostate cancer (mCRPC).

Pipeline preview, FDA actions in brief

Ponatinib (Iclusig; Ariad Pharmaceuticals) is an oral tyrosine kinase inhibitor (TKI) that was approved by FDA on December 14, 2012, for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myelogenous leukemia (CML) that is resistant or intolerant to previous TKI therapy, and for Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (Ph+ALL).

They might not recognize the early symptoms, such as depression, anxiety, sleep disturbance, and paranoia, of serious mental illness

Payers, providers must design compliant policies and ensure access

CMS has overlooked the importance of identifying not for profit status for consumers in the exchanges

While it may be impossible to prevent a data breach, anticipate vulnerabilities and implement fixes

Significant variation across states and therapeutic areas continue to exist after shifting to managed-care Medicaid

CMS revises rates for 2014 following heated protests from Congress, beneficiaries

Medicare Advantage could set a precedent for plan switching

The provider and payer will develop a suite of health plans and an accountable care model with fully insured, self-insured and Medicare products

The 21 to 27 age group will see net costs increase $470, and that's the worst of it

Providers are understandably anxious about mechanisms that reduce their income

The comprehensive context of PPACA continues to change as more information comes to light

Some plans must increase benefits and premiums to meet requirements

The marketing tools include bilingual websites and printed materials that partners can co-brand

The 32 Pioneers asked CMS to delay the move to pay for performance in 2013

Payers and providers are working together to control treatment costs

A new multinational study confirms the impact of the recently-approved lung cancer medication, crizotinib, on testosterone. The study was published online first in the April 12, 2013, issue of Cancer.

Prenatal exposure to valproate significantly increased the risk of autism spectrum disorder and childhood autism in the offspring of mothers who took the anti-epileptic agent, according to a study published in the April 24 issue of the Journal of the American Medical Association.

A draft bill that hopes to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.