News
Article Outline
- New Boxed Warning on Severe Liver Injury with Propylthiouracil
- ACS Updates Prostate Cancer Screening Guidelines
- Federal Screening Recommendations for Obesity in Kids and Teens
- FDA OKs Therapy to Treat Gaucher Disease
- New Formulation for OxyContin Gets Green Light
- Heartburn Drug Kapidex Gets New Name
Artificial Pancreas Trials Show Benefits for Kids
In a landmark study of children and teenagers with type 1 diabetes, University of Cambridge researchers showed that using a first-generation artificial pancreas system overnight can lower the risk of low blood glucose emergencies while the subjects are sleeping and, at the same time, improve diabetes control.
The trials tested the safety and effectiveness of the pancreas system used overnight in a hospital setting with 17 participants between the ages of 5 and 18 years old with type 1 diabetes. The system combined commercially available blood glucose sensors and insulin pumps controlled by a sophisticated computer program that determined insulin dosage based on blood glucose levels while the participants slept. Notably, the Cambridge study showed that the children and teenagers spent twice as much time during the night within targeted blood glucose levels when their diabetes was regulated with the artificial pancreas system than when they followed conventional “manual” therapy, and low blood sugars were minimized.
Roman Hovorka, from the Institute of Metabolic Science at the University of Cambridge, the principal investigator of the study, said, “These results suggest that closed-loop devices may be able to significantly lower the patient's risk of developing complications later in life by reducing or even overcoming the burden of hypoglycemia.…Based on these results, this study is a significant step towards an artificial pancreas.”
Results from the studies, funded by the Juvenile Diabetes Research Foundation, were published in the February 5, 2010, issue of The Lancet. Read more at http://www.jdrf.org/index.cfm?fuseaction5home.viewPage&page_id59E97A677-1279-CFD5-A76167CC41B0EF94&page_version_id59EA74F02-1279-CFD5-A75E23F19B0D3B3B.
Xifaxan Approved for Use in Patients with Liver Disease
In March, the FDA approved the use of Xifaxan (rifaximin) for reducing the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for rifaximin, a drug that has been approved for the treatment of traveler's diarrhea.
The efficacy of Xifaxan was established in a randomized placebo-controlled clinical trial of adult patients in the United States, Canada, and Russia. Patients with liver disease who entered the trial had no or mild symptoms of HE. Patients treated with the drug were less likely to develop HE during the trial than placebo-treated patients.
Xifaxan was not studied in patients with the most severe forms of liver disease. Since most patients were also taking lactulose (a synthetic sugar that helps prevent absorption of ammonia from the intestine) during the trial, the efficacy of Xifaxan as a stand-alone treatment for HE could not be assessed. The most common adverse reactions included swelling of the arms and legs (peripheral edema), nausea, gas, and headache.
FDA Continues Safety Review of Stalevo for Prostate Cancer Risk
The FDA is evaluating clinical trial data that may suggest that patients taking Stalevo, a Parkinson's disease (PD) medication, may be at increased risk for developing prostate cancer. In this trial, patients taking Stalevo were compared to those taking carbidopa and levodopa (Sinemet), a combination medication also used to treat PD. As of March 31, 2010, the review was ongoing, and no new conclusions or recommendations about the use of this drug had been made.
Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan; both Stalevo and Comtan are used to treat PD symptoms.
The data being reviewed are from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation–Parkinson Disease (STRIDE-PD). STRIDE-PD evaluated the time to onset of dyskinesia (difficulty controlling voluntary movement) in patients with PD taking Stalevo compared to those taking only carbidopa/levodopa. An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer than those taking carbidopa/levodopa.
The agency is exploring additional ways to better understand whether Stalevo actually increases the risk of prostate cancer. Previous controlled clinical trials of shorter duration evaluating Stalevo in the treatment of PD have not found an increased risk of prostate cancer, and prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial.
New Boxed Warning on Severe Liver Injury with Propylthiouracil
The US Food and Drug Administration (FDA) has required the addition of a boxed warning on the label for propylthiouracil, a drug used to treat hyperthyroidism (overactive thyroid), to include information about reports of severe liver injury and acute liver failure, some of which have been fatal in adult and pediatric patients using this medication.
The new warning also states that for patients who are starting on treatment for hyperthyroidism, it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine, or surgery. In addition, given the occurrence of birth defects that have been observed with methimazole during the first trimester, propylthiouracil may be the treatment of choice during and just before the first trimester.
Propylthiouracil has been shown to be effective in reducing thyroid hormone levels and decreasing symptoms associated with hyperthyroidism. However, to help patients understand the known benefits and potential risks of this medication, as part of a Risk Evaluation and Mitigation Strategy (REMS), FDA is requiring that a Medication Guide be given to every patient who fills a prescription.
ACS Updates Prostate Cancer Screening Guidelines
Updated prostate cancer screening guidelines from the American Cancer Society reaffirm the recommendation that men should discuss the uncertainties, risks, and potential benefits of screening for prostate cancer before deciding whether to be tested. The first update since 2001, the guidelines include these recommendations:
The guidelines also includes updated clinical recommendations regarding screening tests, intervals, and follow-up of abnormal results for those men who choose to be screened after considering the possible benefits and risks. The guidelines acknowledge the limited contribution of digital rectal exam (DRE) to early detection of prostate cancer and state that screening can be performed using a prostate antigen-specific (PSA) test with or without the DRE. The guidelines recommend annual screening for men whose PSA level is 2.5 ng/ml or higher but state that screening intervals can be safely extended to every 2 years for men whose PSA level is less than 2.5 ng/ml. The guidelines affirm that a PSA level of 4.0 ng/ml or higher remains a reasonable threshold at which to recommend referral for further evaluation or biopsy for men at average risk of developing prostate cancer; for PSA levels between 2.5 and 4.0 ng/ml, health care providers should consider an individualized risk assessment that incorporates other risk factors for prostate cancer in the referral decision.
The authors conclude by noting the urgent need for better ways to detect and treat early-stage prostate cancer, particularly the need to distinguish between cancers that do not require treatment and those that are aggressive, to help “tip the balance clearly in favor of screening. Until that time, however, it will remain incumbent on health care providers and the health care system as a whole to provide men with the opportunity to decide whether they wish to pursue early detection of prostate cancer.”
Read the full ACS release at pressroom.cancer.org/index.php?s543&item5224.
Federal Screening Recommendations for Obesity in Kids and Teens
The US Preventive Services Task Force recommends that clinicians screen children ages 6 and older for obesity and offer or refer them to intensive counseling and behavioral interventions to promote improvements in weight. The recommendation and the accompanying summary of evidence appeared in the February issue of Pediatrics. The Task Force found new and existing evidence that comprehensive, moderate- to high-intensity programs that include dietary, physical activity, and behavioral counseling components for obese children and teens between the ages of 6 and 18 can yield short-term—up to 12 months—improvements in weight. Behavioral management techniques were also used in these programs. Parent involvement was a part of interventions aimed at younger children. However, the Task Force did not find sufficient evidence for screening children younger than 6 years old. The evidence for the effectiveness of low-intensity interventions—those with 25 or less contact hours over 6 months—was inadequate, according to the Task Force. For more information, go to www.ahrq.gov/clinic/uspstf/uspschobes.htm.
FDA OKs Therapy to Treat Gaucher Disease
The FDA has approved velaglucerase alfa (VPRIV) for injection to treat children and adults with a form of the rare genetic disorder, Gaucher disease. This disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. Without it, harmful amounts of a certain fatty substance (lipid) can build up in the liver, spleen, bones, bone marrow, and nervous system and prevent cells and organs from working properly. About 1 case in 50,000 to 1 case in 100,000 people in the general population have Gaucher disease.
VPRIV provides long-term enzyme replacement therapy for type 1 Gaucher disease, the most common form of the genetic disorder. It is an alternative to Cerezyme (imiglucerase), another enzyme-replacement therapy, which is in short supply. The safety and effectiveness of VPRIV were assessed in three clinical studies involving 82 patients, ages 4 years and older, with type 1 Gaucher disease. The studies included patients who switched to VPRIV after being treated with Cerezyme. The most common adverse reactions are allergic reactions; other reactions are headache, dizziness, abdominal pain, back pain, joint pain, nausea, fatigue/weakness, fever, and prolongation of activated partial thromboplastin time, a measure of clotting time.
New Formulation for OxyContin Gets Green Light
The FDA gave its approval of a new formulation of the controlled-release drug OxyContin (oxycodone) that has been designed to help discourage misuse and abuse. OxyContin is made to slowly release the potent opioid oxycodone to treat patients who require a continuous, around-the-clock opioid analgesic for management of their moderate to severe pain for an extended period.
Because of controlled-release properties, each tablet contains a large quantity of oxycodone, which allows patients to take the drug less often. However, people intent on abusing the previous formulation were able to release high levels of oxycodone all at once, which can result in a fatal overdose and contributes to high rates of abuse.
The reformulated drug is intended to prevent the opioid medication from being cut, broken, chewed, crushed, or dissolved to release more medication. The new formulation may result in less risk of overdose from tampering and will likely result in less abuse by snorting or injection, but it still can be abused or misused by simply ingesting larger doses than recommended.
Heartburn Drug Kapidex Gets New Name
The FDA has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications, Casodex (bicalutamide) and Kadian (morphine sulfate). Effective in late April 2010, Takeda Pharmaceuticals North America Inc. began marketing Kapidex under the new name Dexilant.
Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex and Kadian, which have uses that are very different from Kapidex and from each other.
Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain.
PII: S1555-4155(10)00293-X
doi:10.1016/j.nurpra.2010.05.012
