mesalamine enteric coated tablets / Generic mfg. - LARVOL DELTA

Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack. (PubMed, AAPS PharmSciTech) - "Additionally, a novel dissolution/permeation tool (Dissoflux) was employed to compare permeability behavior of formulations. Overall, this work enabled BE prediction for complex mesalamine enteric coated tablets and helped to understand parameters that can impact in vivo performance."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Intestinal concentrations and efficacy of different mesalazine tablets in patients with ulcerative colitis. Valutazioni delle concentrazioni intestinali e dell'efficacia di diverse compresse di mesalazina in paziente con colite ulcerosa. (clinicaltrialsregister.eu) - P4; N=36; Completed; Sponsor: CONSORZIO UNIVERSITARIO UNIFARM

Clinical • New P4 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis. (PubMed, Cochrane Database Syst Rev) - "There is high-certainty evidence that 5-ASA is superior to placebo, and moderate-certainty evidence that 5-ASA is not more effective than SASP. Considering relative costs, a clinical advantage to using oral 5-ASA in place of SASP appears unlikely. High-certainty evidence suggests 5-ASA dosed once daily appears to be as efficacious as conventionally-dosed 5-ASA. There may be little or no difference in efficacy or safety among the various 5-ASA formulations."

Clinical • Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

New European guidelines for the management of dyslipidaemias: their aggressiveness is not legitimated by current evidence (PubMed, Epidemiol Prev) - "Questa, con terapie ipocolesterolemizzanti più intensive, non si è ridotta nelle metanalisi di RCT con pazienti con cLDL tra 80 e <100 mg/dl al basale; con inibitori di PCSK9, pazienti con questi valori mostrano persino tendenza all'aumento della mortalità totale...A oggi, ciò vale ancora di più per anziani nella popolazione generale, in cui una revisione sistematica di studi di coorte ha mostrato relazioni nulle o più spesso inverse tra cLDL e mortalità. Le nuove linee guida europee forzano le prove disponibili, trascurano il principio di precauzione e non possono esser base per un equo consenso informato."

Journal • Cardiovascular • Dyslipidemia

Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: A multi-center, randomized, double-blind, controlled trial. (PubMed, Medicine (Baltimore)) - "The results of this trial will provide compelling evidence of the efficacy and safety of HEC for treatment of mild active UC and preliminarily show the potential mechanism of how HEC acts. Finally, it will widen treatment options for patients with mild active UC."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis

Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations. (PubMed, Expert Rev Clin Pharmacol) - "Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs."

Journal • Biosimilar

Evaluating Risk of Incident Diabetes Between Patients Who Used Lovastatin and Red Yeast Rice Prescriptions (LipoCol Forte): A Retrospective Cohort Study Based on a Real-World Database. (PubMed, Diabetes Metab Syndr Obes) - "There was a dose-response relationship between RYR prescriptions and the reduced risk of incident diabetes. We raised the possibility that people who used RYR prescriptions may have a lower risk of incident diabetes compared with the lovastatin cohort."

Journal • Real-World Evidence • Retrospective data

Effects of Differential Food Patterns on the Pharmacokinetics of Enteric-Coated Mesalazine Tablets in the Same Cohort of Healthy Chinese Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "Food delayed the absorption of 5-ASA, especially a high-fat meal. Therefore, enteric-coated mesalazine tablets should be taken before meals to avoid causing patients slow response and any effect of food on its efficacy."

Clinical • Journal • PK/PD data