Bismuth preparations are commonly used to treat a variety of gastrointestinal disorders, including peptic ulcers and dyspepsia. The safety profile of currently approved bismuth preparations, such as tripotassium dicitrato bismuthate (De-Nol), bismuth subsalicylate (Pepto-Bismol) and ranitidine bismuth citrate (Pylorid, Tritec), is excellent. Adverse reactions to these agents are mild, transient and infrequent, and reports of serious adverse reactions are rare. This, in part, reflects the low systemic bioavailability of bismuth from these medicines: less than 1% of the bismuth dose administered is absorbed. During repeated dosing with ranitidine bismuth citrate 200, 400 or 800 mg b.d. trough plasma bismuth concentrations remain well below 50 micrograms/L. After 4 weeks of treatment median concentrations of 3.4 micrograms/L or less were reported amongst 1210 duodenal ulcer patients receiving this new chemical entity, while mean concentrations of 5.1 micrograms/L (plasma) and 12.3 micrograms/L (blood) have been reported in two studies of patients receiving tripotassium dicitrato bismuthate 120 mg q.d.s. for 4 weeks. Transient peak plasma bismuth concentrations greater than 50 micrograms/L are observed 30-60 min after dosing with tripotassium dicitrato bismuthate in some patients, but are not associated with any toxic effects. After discontinuation of treatment with bismuth preparations its excretion in urine may continue for up to 3 months, by which time blood bismuth concentrations have declined to pretreatment values.
BackgroundElexacaftor/tezacaftor/ivacaftor (ETI) has been associated with unprecedented clinical improvements, transforming the management of cystic fibrosis (CF). However, side effects with implications for safety and well‐being have been reported, including neuropsychiatric changes. This study aimed to better characterize the emerging positive and negative impacts of ETI.MethodsThe Cystic Fibrosis Foundation's Mental Health Advisory Committee distributed a 26‐item survey to US CF care teams to assess clinician observations of patient‐reported experiences with ETI. Survey responses measured the prevalence of these effects in five domains: (1) positive physical and psychological effects, (2) sleep difficulties, (3) cognitive difficulties, (4) worsening mental health, and (5) concerns about the future and finances.ResultsSeventy‐five healthcare providers responded from a pediatric, adult, and combined centers. Positive physical effects of ETI and increased optimism were reported in the upper quartiles (50%–100%) and rated as having a significant impact on daily functioning. Sleep and cognitive difficulties were reported in 1%–24%, with slight impacts on functioning, and psychological symptoms (e.g., increased stress, depression, anxiety) and new psychiatric medications were reported in 1%–24%, with moderate impacts. Concerns about the future were reported in 1%–24%, with minimal impacts.ConclusionAcross US centers, providers most often observed positive physical effects of ETI. However, a variety of negative side effects were also reported, including sleep disruptions and worsening psychological functioning, which should be systematically monitored by CF teams. These national‐level data are a first step in evaluating the prevalence and consequences of these side effects and can directly inform future studies.
The author presents a brief synopsis of an interview with a research participant, highlighting the individual's insights and recommendations both for participants and for researchers.
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