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Improved cortisol e...
Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency : a prospective randomised trial of a novel hydrocortisone dual-release formulation
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- Johannsson, Gudmundur, 1960 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Sahlgrenska Academy, University of Gothenburg
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- Nilsson, Anna G, 1968 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Sahlgrenska Academy, University of Gothenburg
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- Bergthorsdottir, Ragnhildur, 1971 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Sahlgrenska Academy, University of Gothenburg
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- Burman, Pia (author)
- Lund University,Lunds universitet,Genomik, diabetes och endokrinologi,Forskargrupper vid Lunds universitet,Genomics, Diabetes and Endocrinology,Lund University Research Groups,Skånes University Hospital, Malmö
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- Dahlqvist, Per (author)
- Umeå universitet,Medicin,Umeå University
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- Ekman, Bertil (author)
- Östergötlands Läns Landsting,Linköpings universitet,Endokrinologi,Hälsouniversitetet,Endokrinmedicinska kliniken,Linköpings universitet, Endokrinologi,Uppsala University, Uppsala, Sweden
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- Edén Engström, Britt (author)
- Uppsala universitet,Institutionen för medicinska vetenskaper
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- Olsson, Tommy (author)
- Umeå universitet,Medicin,Umeå University
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- Ragnarsson, Oskar, 1971 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Sahlgrenska Academy, University of Gothenburg
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- Ryberg, Mats (author)
- Umeå universitet,Medicin,Umeå University
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- Wahlberg, Jeanette (author)
- Östergötlands Läns Landsting,Linköpings universitet,Endokrinologi,Hälsouniversitetet,Endokrinmedicinska kliniken,Linköpings University, Linköping, Sweden
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- Biller, B. M. K. (author)
- Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
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- Monson, J. P. (author)
- St. Bartholomew's Hospital, Queen Mary University of London, London, United Kingdom
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- Stewart, P. M. (author)
- University of Birmingham, Birmingham United Kingdom
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- Lennernäs, Hans (author)
- Uppsala universitet,Institutionen för farmaci,Uppsala University
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- Skrtic, Stanko, 1970 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för klinisk prövning och entreprenörskap,Institute of Medicine, Department of Clinical Trials and Entrepreneurship,Sahlgrenska Academy, University of Gothenburg
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(creator_code:org_t)
- The Endocrine Society, 2012
- 2012
- English.
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In: Journal of Clinical Endocrinology and Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 97:2, s. 473-481
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Abstract
Subject headings
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- Context: Patients with treated adrenal insufficiency (AI) have increased morbidity and mortality rate. Our goal was to improve outcome by developing a once-daily (OD) oral hydrocortisone dual-release tablet with a more physiological exposure-time cortisol profile.Objective: The aim was to compare pharmacokinetics and metabolic outcome between OD and the same daily dose of thrice-daily (TID) dose of conventional hydrocortisone tablets.Design and Setting: We conducted an open, randomized, two-period, 12-wk crossover multicenter trial with a 24-wk extension at five university hospital centers.Patients: The trial enrolled 64 adults with primary AI; 11 had concomitant diabetes mellitus (DM).Intervention: The same daily dose of hydrocortisone was administered as OD dual-release or TID.Main Outcome Measure: We evaluated cortisol pharmacokinetics.Results: Compared with conventional TID, OD provided a sustained serum cortisol profile 0-4 h after the morning intake and reduced the late afternoon and the 24-h cortisol exposure. The mean weight (difference = -0.7 kg, P = 0.005), systolic blood pressure (difference = -5.5 mm Hg, P = 0.0001) and diastolic blood pressure (difference: -2.3 mm Hg; P = 0.03), and glycated hemoglobin (absolute difference = -0.1%, P = 0.0006) were all reduced after OD compared with TID at 12 wk. Compared with TID, a reduction in glycated hemoglobin by 0.6% was observed in patients with concomitant DM during OD (P = 0.004).Conclusion: The OD dual-release tablet provided a more circadian-based serum cortisol profile. Reduced body weight, reduced blood pressure, and improved glucose metabolism were observed during OD treatment. In particular, glucose metabolism improved in patients with concomitant DM.
Subject headings
- 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 (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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Johannsson, Gudm ...
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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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Edén Engström, B ...
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Olsson, Tommy
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Ragnarsson, Oska ...
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Ryberg, Mats
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Wahlberg, Jeanet ...
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Biller, B. M. K.
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Monson, J. P.
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Stewart, P. M.
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Lennernäs, Hans
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Skrtic, Stanko, ...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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Linköping University
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Örebro University
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Umeå University
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Lund University
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Uppsala University
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University of Gothenburg