Efficacy and safety of two different testosterone undecanoate formulations in
hypogonadal men with metabolic syndrome.
Author(s): Aversa A, Bruzziches R, Francomano D, Spera G, Lenzi A.
Affiliation(s): Department of Experimental Medicine, Sapienza University of Rome, Viale
Policlinico 155, Rome, Italy. antonio.aversa@uniroma1.it
Publication date & source: 2010, J Endocrinol Invest. , 33(11):776-83
AIM: To investigate efficacy and safety of two different preparations of
testosterone undecanoate (TU) in 52 hypogonadal men [mean age 57 yr and mean
testosterone (T) < 320 ng/dl] with metabolic syndrome (MS).
SUBJECTS AND METHODS: Randomized, double-blind, double-dummy study with three
parallel treatment arms [oral TU; transdermal placebo gel (P); im TU]
administration for 12 months (mo). Each subject was randomized (1:1:3) to receive
either oral TU (2 capsules of 40 mg/twice per day at breakfast and dinner,
equalling a total dose of 160 mg/day; no.=10) for 6 mo and continued with im TU
for further 6 mo, or P (3-4 g/day; no.=10) and im TU (1000 mg/12 weeks from week
6; no.=32) for 12 mo.
RESULTS: After 6 mo, im TU increased T and free- T levels (p<0.0001), and
improved metabolic parameters [reduction in Homeostasis Model Assessment (HOMA)
index, p<0.0001; waist circumference and fat mass, p<0.001, respectively], in
International Index of Erectile Function-5 and Aging Males' Symptoms scores
(p<0.01, respectively). After 12 months, im TU produced further increases in T
and free- T levels (p<0.0001) and metabolic parameters (reduction in HOMA-index,
p<0.0001; waist circumference p<0.0001; fat mass, p<0.001). No major adverse
event due to T treatment occurred.
CONCLUSIONS: Clinical efficacy of T replacement therapy in hypogonadal men with
MS is reached when its plasmatic levels approach into the medium-high range of
normality (>5 ng/ml), although subjective threshold values may be different.
Administration of im TU was more effective than oral TU to reach the target for T
levels and to improve MS parameters. TU was safe over 12 months and
discontinuation rates were similar to placebo.
|
