DRUG INFORMATION HIGHLIGHTS

• In the FLOW trial, 3,533 patients with T2DM and chronic kidney disease were randomized to either semaglutide (Ozempic) 1 mg SC weekly or placebo and were followed for a median of 3.4 years, after early trial cessation based on a prespecified interim analysis. The risk of a primary outcome event (composite of onset of kidney failure, ≥ 50% reduction in eGFR from baseline, or death from kidney-related or cardiovascular [CV] causes) was reduced by 24% with semaglutide versus placebo (331 versus 410 first events; HR, 0.76, 95% CI, 0.66 to 0.88, p=0.0003). Confirmatory secondary outcomes also showed a benefit of semaglutide, and serious adverse reactions occurred in fewer patients in the semaglutide arm than placebo (49.6% versus 53.8%).
• The CDC has recommended influenza surveillance systems continue to operate at heightened levels during the summer to aid in detection of rare cases of human H5N1 virus infection. Furthermore, the agency recommends an increase in the number of positive influenza A virus samples subtyped. The intent of the increased monitoring through the summer is due to the ongoing outbreak of H5N1 among poultry and U.S. dairy cattle.
• The CDC has published an MMWR outlining recommendations for use of doxycycline postexposure prophylaxis (PEP) for bacterial sexually transmitted infection prevention in select populations. The recommended dose for doxycycline PEP is 200 mg taken within 72 hours of sexual contact.
• Sanofi-Aventis has announced discontinuation of insulin glargine 100 IU/mL injection, an unbranded biologic for Lantus, due to a business decision. Lantus remains on the market.
• Actelion/Philips Respironics has announced discontinuation of the I-neb® AAD® system as well as associated supplies (e.g., medication discs used for administering the solution). Iloprost (Ventavis) solution in the strengths of 10 ug/mL and 20 ug/mL is also being discontinued.
• Par has announced discontinuation of the 40 mg/1 mL strength of brand-name Delestrogen (estradiol valerate) injection. Generics from other manufacturers remain available.

DRUG INFORMATION HAPPENINGS

• The AHA and American College of Cardiology (ACC) published updated recommendations for management of lower extremity peripheral artery disease (PAD). The guideline defines four clinical subsets of PAD (asymptomatic PAD, chronic symptomatic PAD, chronic limb-threatening ischemia, acute limb ischemia) and details effective treatment to prevent major adverse CV events and major adverse limb events.
• The American Academy of Neurology (AAN), American Epilepsy Society, and Society for Maternal-Fetal Medicine has issued a guideline for use of antiseizure medications (ASMs) in people with epilepsy of childbearing potential (PWECP). According to the guideline, HCPs should recommend ASMs and doses that optimize seizure control and fetal outcomes at the earliest possible opportunity prior to conception. To reduce the risk for major congenital malformations, lamotrigine, levetiracetam, or oxcarbazepine should be considered when appropriate, and valproic acid should be avoided when possible.
• The European Society of Endocrinology and the Endocrine Society have released a clinical guideline for diagnosis and management of glucocorticoid-induced adrenal insufficiency. The guideline includes recommendations for tapering of systemic glucocorticoid therapy for non-endocrine conditions, diagnosis and approach to glucocorticoid-induced adrenal insufficiency and glucocorticoid withdrawal syndrome, and diagnosis and treatment of adrenal crisis.
• The ACC and the AHA published updated clinical practice guidelines for the management of hypertrophic cardiomyopathy (HCM). New recommendations include: (1) for younger patients (e.g., age ≤ 45 years of age) with a mild phenotype of nonobstructive HCM due to a pathogenic or likely pathogenic cardiac sarcomere genetic variant, valsartan may be useful to slow unfavorable cardiac remodeling; (2) in patients with HCM who develop persistent systolic dysfunction with LVEF < 50%, discontinue cardiac myosin inhibitors; and (3) mavacamten is contraindicated in pregnant women due to potential teratogenic effects.
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