FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3211302807> ?p ?o ?g. }

• W3211302807 endingPage "5736" @default.
• W3211302807 startingPage "5721" @default.
• W3211302807 abstract "Hyponatremia is a common condition of varying etiology among hospitalized patients and is associated with adverse outcomes. Treatment to normalize serum sodium is advisable. Tolvaptan received European Union marketing authorization for hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Post-marketing pharmacovigilance activities were required to characterize the safety profile of tolvaptan more fully in this population, which is often elderly with a high burden of comorbid illness.This was a prospective, observational, multinational, post-authorization pharmacovigilance study (NCT01228682) in seven European countries. Hospitalized patients were enrolled who received tolvaptan for hyponatremia associated with SIADH and consented to data collection. Tolvaptan was initiated and assessments performed at physician discretion per local standards of care. To reflect actual clinical practice, no assessments or procedures were required outside the standard of care. Patients who continued to receive long-term tolvaptan following hospital discharge and provided consent received follow-up from their community physicians.A total of 252 patients (mean age 70.6 years) enrolled. Mean tolvaptan treatment duration was 139.4 days, median 18.5 (range 1-1130) days; most frequent dose was 15 mg/day (used in 75% of patients). Serum sodium increased from baseline (mean 123.2 mmol/l) during treatment week 1 and remained stable during follow-up, with little difference across doses of 7.5, 15, and 30 mg/day. Hyponatremia symptoms (e.g., confusion, unsteady gait, lethargy) were present in 122/252 (48.4%) patients at pre-treatment baseline, decreasing to 46/252 (18.3%) during treatment. Sixty-two patients (24.6%; mean baseline serum sodium 120 mmol/l) experienced rapid correction of hyponatremia within 72 h. No osmotic demyelination syndrome occurred.In clinical practice, tolvaptan improved serum sodium and decreased hyponatremia symptoms in hyponatremia secondary to SIADH. Serum sodium should be monitored during treatment to minimize risk of rapid correction.Clinicaltrials.gov identifier NCT01228682.Hospitalized patients often experience abnormally low blood sodium levels (hyponatremia), which can cause significant symptoms and poses a serious health risk (Wald et al. in Arch Intern Med 170:294–302, 2010). Yet, increasing sodium levels too rapidly in these patients can unintentionally cause osmotic demyelination syndrome, resulting in long-term neurologic damage or death. Tolvaptan was approved in the European Union to treat one type of hyponatremia caused by a hormonal imbalance known as the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Tolvaptan effectively increased patient sodium levels in clinical trials, but real-world data are needed to understand tolvaptan treatment more fully in everyday clinical practice. We evaluated patterns of use, efficacy, and safety of tolvaptan in patients treated in hospitals and after discharge for hyponatremia due to SIADH. Tolvaptan was correctly used to treat only hyponatremia caused by SIADH in nearly all of the 252 patients studied. Patient sodium levels increased in the first week of tolvaptan treatment and then stabilized. Hyponatremia symptoms, such as confusion, nausea, tiredness, and dizziness, were present in 48.4% of patients before treatment and in 18.3% after starting tolvaptan. Consistent with earlier studies, some patients (24.6%) experienced excessively rapid correction of hyponatremia. However, no subsequent neurologic problems or deaths were attributed to the rapid correction, which suggests that medical providers were carefully monitoring and managing sodium levels to prevent serious consequences. Our study indicates that tolvaptan is being used safely and effectively to treat hyponatremia due to SIADH in a patient population with complex medical needs." @default.
• W3211302807 created "2021-11-08" @default.
• W3211302807 creator A5040115357 @default.
• W3211302807 creator A5060235599 @default.
• W3211302807 creator A5065470987 @default.
• W3211302807 date "2021-10-25" @default.
• W3211302807 modified "2023-10-04" @default.
• W3211302807 title "Using Tolvaptan to Treat Hyponatremia: Results from a Post-authorization Pharmacovigilance Study" @default.
• W3211302807 cites W1971488039 @default.
• W3211302807 cites W2022217182 @default.
• W3211302807 cites W2023270528 @default.
• W3211302807 cites W2031896985 @default.
• W3211302807 cites W2037211180 @default.
• W3211302807 cites W2040609083 @default.
• W3211302807 cites W2051685107 @default.
• W3211302807 cites W2083761954 @default.
• W3211302807 cites W2084309775 @default.
• W3211302807 cites W2097908284 @default.
• W3211302807 cites W2102262217 @default.
• W3211302807 cites W2112224267 @default.
• W3211302807 cites W2116296294 @default.
• W3211302807 cites W2118916148 @default.
• W3211302807 cites W2120040647 @default.
• W3211302807 cites W2122242217 @default.
• W3211302807 cites W2132470127 @default.
• W3211302807 cites W2138086580 @default.
• W3211302807 cites W2139140962 @default.
• W3211302807 cites W2158121233 @default.
• W3211302807 cites W2214942826 @default.
• W3211302807 cites W2743249113 @default.
• W3211302807 cites W2788363286 @default.
• W3211302807 cites W2791812103 @default.
• W3211302807 cites W3081932636 @default.
• W3211302807 cites W3113246114 @default.
• W3211302807 doi "https://doi.org/10.1007/s12325-021-01947-9" @default.
• W3211302807 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/8572184" @default.
• W3211302807 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/34693505" @default.
• W3211302807 hasPublicationYear "2021" @default.
• W3211302807 type Work @default.
• W3211302807 sameAs 3211302807 @default.
• W3211302807 citedByCount "4" @default.
• W3211302807 countsByYear W32113028072022 @default.
• W3211302807 countsByYear W32113028072023 @default.
• W3211302807 crossrefType "journal-article" @default.
• W3211302807 hasAuthorship W3211302807A5040115357 @default.
• W3211302807 hasAuthorship W3211302807A5060235599 @default.
• W3211302807 hasAuthorship W3211302807A5065470987 @default.
• W3211302807 hasBestOaLocation W32113028071 @default.
• W3211302807 hasConcept C126322002 @default.
• W3211302807 hasConcept C177713679 @default.
• W3211302807 hasConcept C187212893 @default.
• W3211302807 hasConcept C194828623 @default.
• W3211302807 hasConcept C197934379 @default.
• W3211302807 hasConcept C23131810 @default.
• W3211302807 hasConcept C2776703092 @default.
• W3211302807 hasConcept C2778983183 @default.
• W3211302807 hasConcept C2779420931 @default.
• W3211302807 hasConcept C2780615674 @default.
• W3211302807 hasConcept C2908647359 @default.
• W3211302807 hasConcept C57658597 @default.
• W3211302807 hasConcept C71315377 @default.
• W3211302807 hasConcept C71924100 @default.
• W3211302807 hasConcept C99454951 @default.
• W3211302807 hasConceptScore W3211302807C126322002 @default.
• W3211302807 hasConceptScore W3211302807C177713679 @default.
• W3211302807 hasConceptScore W3211302807C187212893 @default.
• W3211302807 hasConceptScore W3211302807C194828623 @default.
• W3211302807 hasConceptScore W3211302807C197934379 @default.
• W3211302807 hasConceptScore W3211302807C23131810 @default.
• W3211302807 hasConceptScore W3211302807C2776703092 @default.
• W3211302807 hasConceptScore W3211302807C2778983183 @default.
• W3211302807 hasConceptScore W3211302807C2779420931 @default.
• W3211302807 hasConceptScore W3211302807C2780615674 @default.
• W3211302807 hasConceptScore W3211302807C2908647359 @default.
• W3211302807 hasConceptScore W3211302807C57658597 @default.
• W3211302807 hasConceptScore W3211302807C71315377 @default.
• W3211302807 hasConceptScore W3211302807C71924100 @default.
• W3211302807 hasConceptScore W3211302807C99454951 @default.
• W3211302807 hasIssue "12" @default.
• W3211302807 hasLocation W32113028071 @default.
• W3211302807 hasLocation W32113028072 @default.
• W3211302807 hasLocation W32113028073 @default.
• W3211302807 hasOpenAccess W3211302807 @default.
• W3211302807 hasPrimaryLocation W32113028071 @default.
• W3211302807 hasRelatedWork W1748520764 @default.
• W3211302807 hasRelatedWork W2157240517 @default.
• W3211302807 hasRelatedWork W2217279932 @default.
• W3211302807 hasRelatedWork W2571092226 @default.
• W3211302807 hasRelatedWork W2801524779 @default.
• W3211302807 hasRelatedWork W2803602945 @default.
• W3211302807 hasRelatedWork W2990295600 @default.
• W3211302807 hasRelatedWork W3030702859 @default.
• W3211302807 hasRelatedWork W3211302807 @default.
• W3211302807 hasRelatedWork W4385419774 @default.
• W3211302807 hasVolume "38" @default.
• W3211302807 isParatext "false" @default.
• W3211302807 isRetracted "false" @default.
• W3211302807 magId "3211302807" @default.

• next