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  • 1.
    Nilsson, Anna G.
    et al.
    Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden.
    Bergthorsdottir, Ragnhildur
    Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden.
    Burman, Pia
    Lund Univ, Skane Univ Hosp Malmo, Dept Endocrinol, Lund, Sweden.
    Dahlqvist, Per
    Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden.
    Ekman, Bertil
    Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden;Linkoping Univ, Dept Endocrinol, Linkoping, Sweden.
    Engström, Britt E
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrinology and mineral metabolism.
    Ragnarsson, Oskar
    Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden.
    Skrtic, Stanko
    Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;AstraZeneca R&D, Molndal, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden.
    Wahlberg, Jeanette
    Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden;Linkoping Univ, Dept Endocrinol, Linkoping, Sweden.
    Achenbach, Heinrich
    Shire Int GmbH, Zug, Switzerland.
    Uddin, Sharif
    Shire, Lexington, MA USA.
    Marelli, Claudio
    Shire Int GmbH, Zug, Switzerland.
    Johannsson, Gudmundur
    Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Endocrinol, Gothenburg, Sweden;Univ Gothenburg, Inst Med, Sahlgrenska Acad, Gothenburg, Sweden.
    Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study2017In: European Journal of Endocrinology, ISSN 0804-4643, E-ISSN 1479-683X, Vol. 176, no 6, p. 715-725Article in journal (Refereed)
    Abstract [en]

    Objective: 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). Design: Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden. Methods: 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. Results: 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). Conclusions: 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.

  • 2.
    Ragnarsson, Oskar
    et al.
    Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Internal Med & Clin Nutr, SE-41345 Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden.
    Olsson, Daniel S.
    Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Internal Med & Clin Nutr, SE-41345 Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden.
    Papakokkinou, Eleni
    Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Internal Med & Clin Nutr, SE-41345 Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden.
    Chantzichristos, Dimitrios
    Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Internal Med & Clin Nutr, SE-41345 Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden.
    Dahlqvist, Per
    Umea Univ, Dept Publ Hlth & Clin Med, SE-90187 Umea, Sweden.
    Segerstedt, Elin
    Umea Univ, Dept Publ Hlth & Clin Med, SE-90187 Umea, Sweden.
    Olsson, Tommy
    Umea Univ, Dept Publ Hlth & Clin Med, SE-90187 Umea, Sweden.
    Petersson, Maria
    Karolinska Inst, Dept Mol Med & Surg, SE-17176 Stockholm, Sweden;Karolinska Univ Hosp, Dept Endocrinol Metab & Diabetol, SE-17177 Stockholm, Sweden.
    Berinder, Katarina
    Karolinska Inst, Dept Mol Med & Surg, SE-17176 Stockholm, Sweden;Karolinska Univ Hosp, Dept Endocrinol Metab & Diabetol, SE-17177 Stockholm, Sweden.
    Bensing, Sophie
    Karolinska Inst, Dept Mol Med & Surg, SE-17176 Stockholm, Sweden;Karolinska Univ Hosp, Dept Endocrinol Metab & Diabetol, SE-17177 Stockholm, Sweden.
    Höybye, Charlotte
    Karolinska Inst, Dept Mol Med & Surg, SE-17176 Stockholm, Sweden;Karolinska Univ Hosp, Dept Endocrinol Metab & Diabetol, SE-17177 Stockholm, Sweden.
    Edén Engström, Britt
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrinology and mineral metabolism.
    Burman, Pia
    Lund Univ, Skane Univ Hosp, Dept Endocrinol, SE-21428 Malmo, Sweden.
    Bonelli, Lorenza
    Lund Univ, Skane Univ Hosp, Dept Endocrinol, SE-21428 Malmo, Sweden.
    Follin, Cecilia
    Skane Univ Hosp, Dept Endocrinol, SE-22242 Lund, Sweden.
    Petranek, David
    Skane Univ Hosp, Dept Endocrinol, SE-22242 Lund, Sweden.
    Erfurth, Eva Marie
    Skane Univ Hosp, Dept Endocrinol, SE-22242 Lund, Sweden.
    Wahlberg, Jeanette
    Linkoping Univ, Dept Endocrinol, SE-58183 Linkoping, Sweden;Linkoping Univ, Dept Med & Hlth Sci, SE-58183 Linkoping, Sweden.
    Ekman, Bertil
    Linkoping Univ, Dept Endocrinol, SE-58183 Linkoping, Sweden;Linkoping Univ, Dept Med & Hlth Sci, SE-58183 Linkoping, Sweden.
    Åkerman, Anna-Karin
    Orebro Univ, Sch Hlth & Med Sci, Dept Internal Med, SE-70281 Orebro, Sweden.
    Schwarcz, Erik
    Orebro Univ, Sch Hlth & Med Sci, Dept Internal Med, SE-70281 Orebro, Sweden.
    Bryngelsson, Ing-Liss
    Orebro Univ Hosp, Dept Occupat & Environm Med, SE-70281 Orebro, Sweden.
    Johannsson, Gudmundur
    Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Internal Med & Clin Nutr, SE-41345 Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Endocrinol, SE-41345 Gothenburg, Sweden.
    Overall and Disease-Specific Mortality in Patients With Cushing Disease: A Swedish Nationwide Study2019In: Journal of Clinical Endocrinology and Metabolism, ISSN 0021-972X, E-ISSN 1945-7197, Vol. 104, no 6, p. 2375-2384Article in journal (Refereed)
    Abstract [en]

    Context: Whether patients with Cushing disease (CD) in remission have increased mortality is still debatable. Objective: To study overall and disease-specific mortality and predictive factors in an unselected nationwide cohort of patients with CD. Design, Patients, and Methods: A retrospective study of patients diagnosed with CD, identified in the Swedish National Patient Registry between 1987 and 2013. Medical records were systematically reviewed to verify the diagnosis. Standardized mortality ratios (SMRs) with 95% CIs were calculated and Cox regression models were used to identify predictors of mortality. Results: Of 502 identified patients with CD (n = 387 women; 77%), 419 (83%) were confirmed to be in remission. Mean age at diagnosis was 43 (SD, 16) years and median follow-up was 13 (interquartile range, 6 to 23) years. The observed number of deaths was 133 vs 54 expected, resulting in an overall SMR of 2.5 (95% CI, 2.1 to 2.9). The commonest cause of death was cardiovascular diseases (SMR, 3.3; 95% CI, 2.6 to 4.3). Excess mortality was also found associated with infections and suicide. For patients in remission, the SMR was 1.9 (95% CI, 1.5 to 2.3); bilateral adrenalectomy and glucocorticoid replacement therapy were independently associated with increased mortality, whereas GH replacement was associated with improved outcome. Conclusion: Findings from this large nationwide study indicate that patients with CD have excess mortality. The findings illustrate the importance of achieving remission and continued active surveillance, along with adequate hormone replacement and evaluation of cardiovascular risk and mental health.

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