Clinical Trial News

Four U.S. trials on post-treatment Lyme syndrome showed mixed results on antibiotic therapy's efficacy. Two trials found IV ceftriaxone effective for fatigue, but its use is limited by adverse effects. Guidelines should acknowledge these findings, emphasizing the need for safer treatments and clearer criteria for patient selection.

A comprehensive study across multiple clinics in the U.S. and Europe has confirmed the efficacy of ulipristal acetate as an emergency contraceptive, showing a significant reduction in pregnancy rates when administered within 48 to 120 hours after unprotected intercourse. The study also compared its effectiveness and safety profile with levonorgestrel, another emergency contraceptive, finding ulipristal acetate to be non-inferior and well-tolerated.

GIP reduces free fatty acid (FFA) release from adipose tissue by inhibiting 11β-HSD1 activity, affecting lipid metabolism. A clinical trial showed GIP lowers circulating FFAs and reduces 11β-HSD1 and ATGL expression in human adipose tissue, indicating GIP's direct, insulin-independent effects on adipose tissue metabolism.

The FDA approved Xarelto, a next-gen blood thinner, for atrial fibrillation treatment, offering an alternative to warfarin. Xarelto, effective once daily, blocks clotting protein factor Xa, similar in stroke prevention to warfarin but with a boxed warning against abrupt discontinuation due to stroke risk.

A comprehensive analysis of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) reveals that lifestyle changes and metformin significantly reduce the risk of developing diabetes. Adherent participants to these interventions experienced a lower incidence of diabetes and accrued more quality-adjusted life-years (QALYs) compared to those on placebo. The study also highlights the cost-effectiveness of these interventions from a health system perspective, with lifestyle and metformin interventions being cost-saving relative to placebo.

The U.S. Food and Drug Administration (FDA) has approved Shire plc's Lialda (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis, following a six-month study demonstrating its safety and effectiveness. This approval adds to Lialda's previous indication for inducing remission in patients with active, mild to moderate ulcerative colitis.

Adding cetuximab to the FOLFIRI regimen significantly improves outcomes for metastatic colorectal cancer patients with KRAS wild-type, including overall survival, progression-free survival, and response rates.

Urovant Sciences announced FDA approval of GEMTESA® (vibegron) 75 mg tablets for overactive bladder (OAB) treatment, offering a new option for adults with symptoms like urge urinary incontinence, urgency, and frequency. GEMTESA, a beta-3 agonist, relaxes the bladder muscle, improving symptoms without known cognitive decline risks.

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

The FDA has released final guidance for assessing cardiovascular risks in new type 2 diabetes treatments, emphasizing the importance of clinical trials to ensure these therapies do not increase cardiovascular event risks. The guidance mandates detailed safety information from Phase II and III trials, including the establishment of a cardiovascular end-point committee and the inclusion of high-risk individuals. A meta-analysis of trial data is required post-trial to evaluate drug safety comprehensively.