Publications by authors named "S Edlavitch"

Purpose: The first paper to specify the core content of pharmacoepidemiology as a profession was published by an ISPE (International Society for Pharmacoepidemiology) workgroup in 2012 (Jones JK et al. PDS 2012; 21[7]:677-689). Due to the broader and evolving scope of pharmacoepidemiology, ISPE considers it important to proactively identify, update and expand the list of core competencies to inform curricula of education programs; thus, better positioning pharmacoepidemiologists across academic, government (including regulatory), and industry positions.

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It is important that negative, as well as positive, studies be published to complete the available picture in areas of scientific inquiry. At the same time, it is critical that the implications of a negative study not be overstated and generalized when major issues of study design and data accuracy may be the reason that no relationship was discovered. The challenge of avoiding type II errors in interpreting negative findings has major public health implications, especially when the relationship of an exposure to birth defects is the concern.

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Background: Therapy for functional dyspepsia remains a challenge. This study aimed to evaluate esomeprazole (E) versus placebo (P) regarding (1) the effectiveness in providing relief of abdominal pain or discomfort during 16 weeks of therapy in patients with functional dyspepsia having moderate or severe symptoms; (2) the effects on gastric acid suppression and (3) the relationship between symptom relief and gastric pH.

Methods: Enrolled patients were randomized to E (n = 38) or P (n = 35) in a double-blind, placebo-controlled trial.

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Article Synopsis
  • The clinical trial aimed to determine if lubiprostone enhances mucus and mucin secretion, as well as the viscosity, in patients with chronic constipation (CC).
  • Lubiprostone is a chloride channel stimulator that is already approved for CC treatment, but its effects on mucus production were previously unclear.
  • The study involved 20 patients and used a double-blind, crossover design to compare the effects of lubiprostone and a placebo over a 3-week period, measuring various parameters including mucus content and viscosity of gastric secretions.
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