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Long-term safety of...
Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study.
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- Nilsson, Anna G, 1968 (författare)
- University of Gothenburg,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
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- Bergthorsdottir, Ragnhildur, 1971 (författare)
- University of Gothenburg,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
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- Burman, Pia (författare)
- Lund University,Lunds universitet,Translationell muskelforskning,Forskargrupper vid Lunds universitet,Translational Muscle Research,Lund University Research Groups,Skåne University Hospital,Lund Univ, Skane Univ Hosp Malmo, Dept Endocrinol, Lund, Sweden,Lund University, Sweden
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- Dahlqvist, Per (författare)
- Umeå universitet,Umeå University,Medicin,Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden,Umeå University, Sweden
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- Ekman, Bertil (författare)
- Linköpings universitet,Linköping University,Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden;Linkoping Univ, Dept Endocrinol, Linkoping, Sweden,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
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- Engström, Britt E (författare)
- Uppsala universitet,Endokrinologi och mineralmetabolism,University Hospital, Sweden
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- Ragnarsson, Oskar, 1971 (författare)
- University of Gothenburg,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
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- Skrtic, Stanko, 1970 (författare)
- University of Gothenburg,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
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- Wahlberg Topp, Jeanette (författare)
- Linköpings universitet,Linköping University,Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden;Linkoping Univ, Dept Endocrinol, Linkoping, Sweden,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
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- Achenbach, Heinrich (författare)
- Shire International GmbH,Shire Int GmbH, Zug, Switzerland
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- Uddin, Sharif (författare)
- Shire, Lexington, MA USA
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- Marelli, Claudio (författare)
- Shire International GmbH,Shire Int GmbH, Zug, Switzerland
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- Johannsson, Gudmundur, 1960 (författare)
- University of Gothenburg,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
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(creator_code:org_t)
- BIOSCIENTIFICA LTD, 2017
- 2017
- Engelska.
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Ingår i: European journal of endocrinology. - : BIOSCIENTIFICA LTD. - 1479-683X .- 0804-4643. ; 176:6, s. 715-725
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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 (0.7mmol/L; P<0.0001) and HDL cholesterol (0.2mmol/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 -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
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
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Nilsson, Anna G, ...
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Bergthorsdottir, ...
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Burman, Pia
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Dahlqvist, Per
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Ekman, Bertil
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Engström, Britt ...
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Ragnarsson, Oska ...
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Skrtic, Stanko, ...
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Wahlberg Topp, J ...
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Achenbach, Heinr ...
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Uddin, Sharif
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Marelli, Claudio
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Johannsson, Gudm ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Endokrinologi oc ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Allmänmedicin
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kirurgi
- Artiklar i publikationen
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European journal ...
- Av lärosätet
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Göteborgs universitet
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Lunds universitet
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Umeå universitet
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Uppsala universitet
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Linköpings universitet