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Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study.

Nilsson, Anna G, 1968 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine
Bergthorsdottir, Ragnhildur, 1971 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden,University of Gothenburg, Sweden
Burman, Pia (författare)
Lund University,Lunds universitet,Genomik, diabetes och endokrinologi,Forskargrupper vid Lunds universitet,Genomics, Diabetes and Endocrinology,Lund University Research Groups,Skåne University Hospital
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Dahlqvist, Per (författare)
Umeå universitet,Medicin,Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden,Umeå University, Sweden
Ekman, Bertil (författare)
Linköping University,Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
Engström, Britt Edén (författare)
Uppsala University Hospital
Ragnarsson, Oskar, 1971 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden,University of Gothenburg, Sweden
Skrtic, Stanko, 1970 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;AstraZeneca R&D, Molndal, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden,University of Gothenburg, Sweden; AstraZeneca RandD, Sweden
Wahlberg, Jeanette (författare)
Linköping University
Achenbach, Heinrich (författare)
Shire Int GmbH, Zug, Switzerland,Shire Int GmbH, Switzerland,Shire International GmbH
Uddin, Sharif (författare)
Shire, Lexington, MA USA,Shire, MA USA
Marelli, Claudio (författare)
Shire Int GmbH, Zug, Switzerland,Shire Int GmbH, Switzerland,Shire International GmbH
Johannsson, Gudmundur, 1960 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden,University of Gothenburg, Sweden
Engstrom, Britt Eden (författare)
Nilsson, Anna G. (författare)
University of Gothenburg,Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden,University of Gothenburg, Sweden
Engström, Britt E (författare)
Uppsala universitet,Endokrinologi och mineralmetabolism
Eden Engstrom, Britt (författare)
University Hospital, Sweden
Wahlberg Topp, Jeanette (författare)
Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
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BIOSCIENTIFICA LTD, 2017
2017
Engelska.
Ingår i: European journal of endocrinology. - : BIOSCIENTIFICA LTD. - 1479-683X .- 0804-4643. ; 176:6, s. 715-725
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • To investigate the long-term safety and tolerability of a once-daily, dual-release hydrocortisone (DR-HC) tablet as oral glucocorticoid replacement therapy in patients with primary adrenal insufficiency (AI).Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden.Seventy-one adult patients diagnosed with primary AI who were receiving stable glucocorticoid replacement therapy were recruited. Safety and tolerability outcomes included adverse events (AEs), intercurrent illness episodes, laboratory parameters and vital signs. Quality of life (QoL) was evaluated using generic questionnaires.Total DR-HC exposure was 328 patient-treatment years. Seventy patients reported 1060 AEs (323 per 100 patient-years); 85% were considered unrelated to DR-HC by the investigator. The most common AEs were nasopharyngitis (70%), fatigue (52%) and gastroenteritis (48%). Of 65 serious AEs reported by 32 patients (20 per 100 patient-years), four were considered to be possibly related to DR-HC: acute AI (n = 2), gastritis (n = 1) and syncope (n = 1). Two deaths were reported (fall from height and subarachnoid hemorrhage), both considered to be unrelated to DR-HC. From baseline to 5 years, intercurrent illness episodes remained relatively stable (mean 2.6-5.4 episodes per patient per year), fasting plasma glucose (0.7 mmol/L; P < 0.0001) and HDL cholesterol (0.2 mmol/L; P < 0.0001) increased and patient-/investigator-assessed tolerability improved. QoL total scores were unchanged but worsening physical functioning was recorded (P = 0.008).In the first prospective study evaluating the long-term safety of glucocorticoid replacement therapy in patients with primary AI, DR-HC was well tolerated with no safety concerns observed during 5-year treatment.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- General Practice (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Allmänmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Surgery (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kirurgi (hsv//swe)

Nyckelord

Addison Disease
drug therapy
Adult
Aged
Delayed-Action Preparations
Fatigue
chemically induced
Female
Gastroenteritis
chemically induced
Glucocorticoids
therapeutic use
Hormone Replacement Therapy
adverse effects
methods
Humans
Hydrocortisone
therapeutic use
Longitudinal Studies
Male
Middle Aged
Nasopharyngitis
chemically induced
Quality of Life
Sweden
Treatment Outcome

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