Merck & Co., Inc. announced that it has received an approvable letter from the US Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Emend (fosaprepitant dimeglumine) for Injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting. More »
A 45-year-old man with chronic ulcerative colitis for more than 10 years presents with diarrhea for 4 days. The diarrhea is nonbloody, watery, and associated with abdominal pain, nausea, vomiting, low-grade fevers, and chills for 2 days. The abdominal pain was diffuse, but worse in the right upper quadrant. More »
The National Comprehensive Cancer Network (NCCN) recently announced updates to the NCCN Antiemesis Guidelines. The NCCN Clinical Practice Guidelines in Oncology are used extensively by managed care companies and by Medicare as the basis for coverage policies. The guidelines have a new recommendation for breakthrough treatment—Nabilone (Cesamet, Valeant)—for chemotherapy-induced nausea/vomiting. More »
Merck & Co.'s antiemetic Emend (aprepitant) has been granted expanded approval by the FDA to prevent postoperative nausea and vomiting (PONV). Emend, a substance P/neurokinin 1 (NK-1) receptor antagonist, works through a mechanism distinct from that of the 5-HT3 receptor antagonists. Approval was based on two randomized double-blind studies of 1,658 patients undergoing open abdominal surgery. Emend was previously approved for the prevention of chemotherapy-induced nausea and vomiting. More »
Bioavailability studies show that oral spray delivery of the antiemetic 5-HT3 antagonist ondansetron is equivalent to oral delivery with ondansetron tablets (Zofran), Wayne Yates, MBA, and Greg Berk, MD, of Hana Biosciences, said at the American Society of Clinical Oncology 42nd Annual Meeting (abstract 8622). Hana Biosciences has submitted a New Drug Application to the FDA for the oral spray (brand name Zensana) for the prevention of nausea and vomiting associated with chemotherapy or... More »
Chemotherapy regimens differ according to the tumor type being treated and are associated with varying degrees of emetogenic potential. Since the distribution of risk factors for chemotherapy-induced nausea and vomiting differs across tumor types, it is important to understand the efficacy of antiemetic regimens in multiple patient populations. To characterize treatment response in patients with various malignancies (e.g., breast, gastrointestinal, genitourinary, and lung) treated with either highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) regimens, a pooled analysis of patient-level data from 4 large randomized trials was performed (N=2813). Patients receiving an antiemetic regimen containing aprepitant, ondansetron, and dexamethasone were compared with patients receiving an active-control antiemetic regimen containing ondansetron plus dexamethasone. In all tumor types analyzed, complete responses were observed in a higher proportion of HEC-treated
There is a need for interferon-free treatment regimens for hepatitis C virus (HCV) infection. The goal of this study was to evaluate ABT-450, a potent HCV NS3 protease inhibitor, combined with low-dose ritonavir (ABT-450/r), in addition to ABT-333, a nonnucleoside NS5B polymerase inhibitor, and ribavirin, for the treatment of HCV infection.|We conducted a 12-week, phase 2a, open-label study involving patients who had HCV genotype 1 infection without cirrhosis. All patients received ABT-333 (400 mg twice daily) and ribavirin (1000 to 1200 mg per day) and one of two daily doses of ABT-450/r. Groups 1 and 2 included previously untreated patients; group 1 received 250 mg of ABT-450 and 100 mg of ritonavir, and group 2 received 150 mg and 100 mg, respectively. Group 3, which included patients who had had a null or partial response to previous therapy with peginterferon and ribavirin, received daily doses of 150 mg of ABT-450 and 100 mg of ritonavir. The primary end point was an
Dexamethasone has an established role in decreasing postoperative nausea and vomiting (PONV); however, the optimal dexamethasone dose for reducing PONV when it is used as a single or combination prophylactic strategy has not been clearly defined. In this study, we evaluated the use of 4 mg to 5 mg and 8 mg to 10 mg IV doses of dexamethasone to prevent PONV when used as a single drug or as part of a combination preventive therapy.|A wide search was performed to identify randomized clinical trials that evaluated systemic dexamethasone as a prophylactic drug to reduce postoperative nausea and/or vomiting. The effects of dexamethasone dose were evaluated by pooling studies into 2 groups: 4 mg to 5 mg and 8 mg to 10 mg. The first group represents the suggested dexamethasone dose to prevent PONV by the Society for Ambulatory Anesthesia (SAMBA) guidelines, and the second group represents twice the dose range recommended by the guidelines. The SAMBA guidelines were developed in response to
Little is known about basilar artery stroke (BAS) in children. The objective of this study was to calculate the incidence of BAS in children and to analyse the clinical presentation, risk factors, radiological findings, therapeutic approaches, and outcome of BAS in childhood.|A prospective, population-based study including children with arterial ischaemic stroke and a systematic review of the literature was undertaken.|Seven children with BAS were registered at the Swiss Neuropaediatric Stroke Registry between January 2000 and June 2011 (incidence 0.037 per 100,000 children per year, 95% confidence interval [CI] 0.013-0.080). A further 90 cases were identified through the literature search. The majority of patients were male (73 males, 24 females) and the median age was 9 years (interquartile range [IQR]=6-13y). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score was 15 (IQR=4-27). Presenting signs and symptoms comprised impaired consciousness (n=64),
Clonidine may be used along with intrathecal morphine for single-dose postoperative analgesia in adults. The efficacy of this is not clear.|A meta-analysis was performed for two endpoints of efficacy: the time to first postoperative analgesia request and the amount of systemic morphine used during the first 24 h after operation. A Bayesian inference supporting direct statements about the probability of the magnitude of an effect was also used. The frequency of the five adverse events (postoperative nausea or vomiting, sedation, respiratory depression, pruritus, and hypotension) was analysed.|Clonidine increased the duration of analgesia by 1.63 h [95% confidence interval (CI): 0.93-2.33]. There is a 90% probability that clonidine increases the duration of postoperative analgesia by more than 75 min compared with morphine alone. Clonidine reduced the amount of postoperative morphine by a mean of 4.45 mg (95% CI: 1.40-7.49 mg). There is a probability of 90% to obtain a decrease >2.3 mg
Primary Care Can't Thrive Without Nurse Practitioners Courtney H. Lyder, ND, May 17, 2013 With a projected shortfall of primary-care physicians, it's time for alternate solutions to patient care. Nurse practitioners are one logical remedy.
