ASH Clinical News November 2015 | Page 31

CLINICAL NEWS panel outlined the following six best practices based on the literature review: • Use validated clinical prediction rules to estimate pretest probability in patients in whom acute PE is being considered. • Do not obtain D-dimer measurements or imaging studies in patients with a low pretest probability of PE and who meet all PE Rule-Out Criteria (PERC). • Obtain a high-sensitivity D-dimer measurement as the initial diagnostic test in patients who have an intermediate pretest probability of PE or in patients with low pretest probability of PE who do not meet al PERC. • Use age-adjusted D-dimer thresholds in patients older than 50 years to determine whether imaging is necessary. • Do not obtain any imaging studies in patients with a D-dimer level below the age-adjusted cutoff. • Obtain imaging with CT pulmonary angiography in patients with high pretest probability of PE. Source: Raja AS, Greenberg JO, Qaseem A, et al. Evaluation of patients with suspected acute pulmonary embolism: Best practice advice from the clinical guidelines committee of the American College of Physicians. Ann Intern Med. 2015 September 28. [Epub ahead of print] ASH is in the process of developing its own evidence-based guidelines for venous thromboembolism (VTE), as was mentioned in the feature article “How Guidelines Happen” in the August issue. Wendy Lim, MD, chair of the ASH guideline panel on diagnosis of VTE, said, “The ASH guidelines will cover both pulmonary embolism (PE) and deep-vein thrombosis (DVT), but they will differ from the ACP guideline in that the ASH guidelines are evaluating the evidence supporting the use of various diagnostic tests in determining VTE, as opposed to looking at best practice recommendations. It is likely that some ‘best practice’ recommendations will be apparent in our final recommendations as there is increasing awareness that unnecessary diagnostic tests are costly and can expose patients to unnecessary risk (e.g., radiation exposure with CT scans). As we are seeking to improve the quality of practice, selection of appropriate diagnostic tests is an important consideration in the assessment and management of these patients. FDA Approves New Treatment for Chemotherapy-Induced Nausea and Vomiting The U.S. FDA has approved rolapitant to prevent chemotherapy-induced nausea and vomiting that occurs from 24 hours up to 120 hours after the start of chemotherapy (also known as delayed-phase nausea and vomiting). The approval was based on the results from three randomized, double-blind, controlled trials that examined the safety and efficacy of rolapitant (an NK-1 receptor agonist) in combination with granisetron and dexamethasone. A total of 2,800 patients were randomized to receive either rolapitant or placebo with granisetron and dexamethasone. Patients had received chemotherapy that included highly emetogenic drugs, including cisplatin and the combination anthracycline and cyclophosphamide, and other moderately emetogenic chemotherapy drugs. In these studies, patients treated with the placebo were more likely to experience vomiting and to need rescue medication for nausea and vomiting during the delayed phase compared with the rolapitant group (pooled studies: 71% vs. 60%; p=0·0001). The most common adverse events associated with rolapitant include neutropenia, hiccups, decreased appetite, and dizziness. Rolapitant was previously approved in combination with antiemetic agents for the prevention of nausea and vomiting associated with initial and repeat courses of vomit-inducing cancer chemotherapy. ● Source: U.S. FDA press release, September 2, 2015. Raspberry-Flavored Oral Solution Now Available Exclusively from Akorn Need-based patient assistance is available; visit our website at amicar.org for more information NDC 49411-052-08 NDC 49411-050-30 Learn more at amicar.org Available through your authorized wholesaler or distributor 1925 West Field Court, Suite 300 • Lake Forest, IL 60045 • 800-932-5676 • www.akorn.com P539 Rev 09/15