MDNN: Opioid Failures, ACP Diabetes Guidelines, and Daclizumab Withdrawal

Hi, I’m Jenna Payesko, I’m Matt Hoffman, and this is MD Magazine News Network - it’s clinical news for connected physicians.

A study comparing the benefits of opioid versus nonopioid therapy in primary care patients with chronic or osteoarthritic pain has brought more evidence that opioids, even as a therapy for pain patients who have tried other measures, may not be worth the addictive risk. Over a 12-month period, there was no significant difference in mean pain-related function between the 2 treatment groups. Treatment for pain intensity was significantly better for the nonopioid group, and the opioid group also fared worse in medication-related symptoms rates among patients.

The American College of Physicians has released new guidelines recommending less intensive blood sugar control targets for patients with type 2 diabetes. According to the new guidelines, patients should be treated to achieve A1C levels between 7% and 8% — a lenient change from the previous 6.5% to 7% standard of the former guidelines. Though the A1C test indicates diabetes in a patient at 6.5% blood sugar level, evidence for a reduction in microvascular complications due to tighter treatment target levels is lacking. The college maintains that the only proven reductions to come from earlier treatment due to stricter guideline levels are in surrogate microvascular complications, such as excess proteins in patients’ urine.

Biogen and AbbVie announced last week that they would voluntarily withdraw daclizumab for relapsing multiple sclerosis, after the European Medicines Agency’s decision to start an urgent review following reports of 8 cases of inflammation of the brain. The companies stated that that due to the complexity of effects being reported, and the limited number of patients treated, it is not possible to characterize the evolving benefit and risk profile of the drug marketed as Zinbryta going forward. Hope you didn’t have stock in daclizumab, Matt.

I did not, because that is journalistically unethical, and also I don’t know how investing works. And now, for our weekly segment FDA Roundup, let’s go to Kevin Kunzmann, reporting live from the FDA headquarters in Silver Springs, Maryland. Kevin, didn’t they get snow down there?

Cut the banter, Matt, this is very clearly a green screen. Now, here’s your FDA headlines from this past week.

Antiretroviral therapy ibalizumab was greenlit by the FDA this week. The therapy from TaiMed Biologics is indicated for adult patients with HIV who had no success with other available therapies, including multidrug-resistant HIV. The drug’s application was previously given fast track, priority review, and breakthrough designations from the FDA.

The FDA also granted approval to 2 tests designated to detect antibodies to Babesia microti in human plasma samples and Babesia microti DNA in human whole blood samples. The tests, a fluorescent immunoassay and a nucleic acid test, are intended for donor screening for babesia parasites in whole blood samples.

Lastly, the Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff has been expanded to include a 15-millimeter valve size. With that expansion, the device becomes the smallest mechanical heart valve approved in the world, with a size indication small enough for newborn pediatric patients with heart defects.

From the other side of the room, I’m Kevin Kunzmann with FDA Roundup. Back to you guys.

For these stories and more, visit us at mdmag.com. I’m Jenna Payesko, and I’m Matt Hoffman. Thank for you watching MDNN.