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Antonio J Vidal-Puig, Manuel Muñoz-Torres, Esteban Jódar-Gimeno, Carlos J García-Calvente, P Lardelli, María E Ruiz-Requena, and Fernando Escobar-Jiménez

Vidal-Puig AJ, Muñoz-Torres M, Jódar-Gimeno E, García-Calvente CJ, Lardelli P, Ruiz-Requena ME, Escobar-Jiménez F. Ketoconazole therapy: hormonal and clinical effects in non-tumoral hyperandrogenism. Eur J Endocrinol 1994;130:333–8. ISSN 0804–4643.

The aim of this study was to assess the usefulness of ketoconazole as a therapeutic alternative to polycystic ovary syndrome. The study group comprised 37 women with signs of hyperandrogenism (hirsutism, acne) and oligomenorrhea. A low dose (400 mg/day) of ketoconazole was tested in a 9-month prospective clinical study. Clinical response (Ferriman & Gallway score, acne) and modifications in hormone pattern (luteinizing hormone, follicle-stimulating hormone, estradiol, testosterone, prolactin, 17-hydroxy-progesterone, androstenedione, steroid hormone-binding globulin, dehydroepiandrosterone sulfate, cortisol, adrenocorticotropin (ACTH) and free testosterone index) were measured, and ACTH stimulation tests were performed. Tolerance and side-effects also were assessed. After 9 months of ketoconazole treatment, the patients' Ferriman & Gallway scores (18.26 ± 4.6 vs 12.4 ± 4.1; p < 0.001) and acne had improved markedly. Hormone patterns also became more favorable, with decreases in androgenic steroids (testosterone, androstenedione, free testosterone index and dehydroepiandrosterone sulfate; p < 0.01) and increases in estradiol (p < 0.01). Basal cortisol levels and cortisol after ACTH stimulation were not changed significantly, remaining within the reference range. Increases in ACTH were observed only in the 3rd month (p < 0.01). Initial levels of androgenic steroids were correlated inversely with their percentage decrease in successive samplings. Decreases in adrenal androgenic steroids were associated with an increase in steroid hormone-binding globulin. The side-effects of treatment, although not severe, caused some discomfort and led to a high drop-out rate (30%). Our results suggest that low doses of ketoconazole (400 mg/day) are an alternative therapy for non-tumoral hyperandrogenism, although the bothersome side-effects, which require close monitoring and maximal patient compliance, make this treatment advisable only in selected patients.

Manuel Muñoz-Torres, Plaza Isabel la Católica no. 2, E-18009, Granada, Spain

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Leo Niskanen, Lawrence A Leiter, Edward Franek, Jianping Weng, Taner Damci, Manuel Muñoz-Torres, Jean-Paul Donnet, Lars Endahl, Trine Vang Skjøth, and Allan Vaag

The journal and the authors apologise for errors in of this article that was published in the August issue (vol 167, pp 287–294). The n values were incorrectly published. The correct values are presented below and the table is published in full below.

Table 2

Observed mean changes from baseline HbA1c, FPG and body weight. Data are observed as mean (s.d.) for all randomised subjects (full analysis set).

nBaselineWeek 16Change from baseline
HbA1c (%)
 IDegAsp618.5 (1.2)6.7 (1.0)−1.8 (1.1)
 AF598.5 (0.9)6.6 (0.6)−1.9 (1.1)
 BIAsp 30628.6 (1.0)6.7 (0.7)−1.8 (0.9)
FPG (mmol/l)
 IDegAsp6111.5 (2.6)6.4 (2.2)−5.1 (2.9)
 AF5911.8 (2.9)6.5 (1.9)−5.3 (3.0)
 BIAsp 306211.7 (3.1)7.5 (2.1)−4.3 (3.0)
Body Weight (kg)
 IDegAsp6187.5 (16.3)88.6 (16.9)1.1 (2.8)
 AF5984.9 (14.3)85.6 (14.9)0.7 (2.5)
 BIAsp 306291.8 (13.5)93.2 (13.1)1.4 (3.2)

Values at randomisation.

Last observation carried forward.

% points.

Open access

Leo Niskanen, Lawrence A Leiter, Edward Franek, Jianping Weng, Taner Damci, Manuel Muñoz-Torres, Jean-Paul Donnet, Lars Endahl, Trine Vang Skjøth, and Allan Vaag

Objective

Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of insulin degludec (70%) and insulin aspart (IAsp: 30%). Here, we compare the efficacy and safety of IDegAsp, an alternative IDegAsp formulation (AF: containing 45% IAsp), and biphasic IAsp 30 (BIAsp 30).

Design

Sixteen-week, open-label, randomised, treat-to-target trial.

Methods

Insulin-naive subjects with type 2 diabetes (18–75 years) and a HbA1c of 7–11% were randomised to twice-daily IDegAsp (n=61), AF (n=59) or BIAsp 30 (n=62), all in combination with metformin. Insulin was administered pre-breakfast and dinner (main evening meal) and titrated to pre-breakfast and pre-dinner plasma glucose (PG) targets of 4.0–6.0 mmol/l.

Results

Mean HbA1c after 16 weeks was comparable for IDegAsp, AF and BIAsp 30 (6.7, 6.6 and 6.7% respectively). With IDegAsp, 67% of subjects achieved HbA1c <7.0% without confirmed hypoglycaemia in the last 4 weeks of treatment compared with 53% (AF) and 40% (BIAsp 30). Mean fasting PG was significantly lower for IDegAsp vs BIAsp 30 (treatment difference (TD): −0.99 mmol/l (95% confidence interval: −1.68; 0.29)) and AF vs BIAsp 30 (TD: −0.88 mmol/l (−1.58; −0.18)). A significant, 58% lower rate of confirmed hypoglycaemia was found for IDegAsp vs BIAsp 30 (rate ratio (RR): 0.42 (0.23; 0.75)); rates were similar for AF vs BIAsp 30 (RR: 0.92 (0.54; 1.57)). IDegAsp and AF had numerically lower rates of nocturnal confirmed hypoglycaemia vs BIAsp 30 (RR: 0.33 (0.09; 1.14) and 0.66 (0.22; 1.93) respectively).

Conclusions

IDegAsp provided comparable overall glycaemic control to BIAsp 30 with a significantly lower rate of hypoglycaemia.

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Elisa Merchán Ramírez, Guillermo Sanchez-Delgado, Cristina Arrizabalaga-Arriazu, Borja Martinez-Tellez, Andrea Mendez-Gutierrez, Manuel Muñoz-Torres, Jose M. Llamas-Elvira, and Jonatan R Ruiz

Purpose: Thyroid hormones (THs) are important mediators of brown adipose tissue (BAT) differentiation. However, the association of TH concentrations with human BAT is unclear. The present work examines the associations between circulating thyroid-stimulating hormone (TSH) and THs concentrations (i.e. free tri-iodothyronine, FT3, and free thyroxine, FT4), under thermoneutral [22-23ºC] and cold-induced conditions, and BAT volume, 18F-fluorodeoxyglucose (18F-FDG) uptake and mean radiodensity.

Methods: A total of 106 young healthy, euthyroid adults (34 men/72 women; 22.0 ± 2.1 years old; 24.9 ± 4.6 kg/m2) participated in this cross-sectional study. BAT volume, 18F-FDG uptake and mean radiodensity were assessed after 2 h of personalized (i.e., contemplating each individual's shivering threshold) cold exposure via positron emission tomography/computerized tomography (PET/CT) static scanning. TSH and THs levels were determined before (thermoneutral) and 1 h after the cold exposure.

Results: Cold exposure increased circulating FT4 (P=0.038) and reduced of TSH levels (P≤0.001). Conversely, the FT3 serum concentration was not modified by cold exposure (P=0.435). No associations were found between the TSH and THs thermoneutral (all P>0.289) or cold-induced levels (all P>0.067) and BAT volume,18F-FDG uptake and mean radiodensity. These findings were independent of sex and body mass index.

Conclusions: Thyroid function is modulated by cold exposure, yet it is not associated with BAT volume or glucose metabolism assessed after 2h of cold exposure in young healthy, euthyroid adults.