Long term safety of recombinant human growth hormone (rhGH) in patients treated during childhood
Giuseppe Reimondo1, Enrico Palmas1, Silvia Vannelli2, Jaele Bellone3, Simonetta Bellone5, Patrizia Matarazzo3, Valentina Gasco4, Alberto Borraccino6, Giuseppe Migliaretti6, Franco Cavallo6, Aldo Ravaglia1, Alberto Angeli1, Gianluca Aimaretti4 & Massimo Terzolo1
The potential side effects of the rhGH therapy have been evaluated only during treatment and the accessible databases have been developed as a post-marketing surveillance only by the Companies distributing rhGH. Aim of the present study was to evaluate health consequences (metabolic diseases and/or malignancies) in adults previously treated with rhGH during childhood. We recruited 284 patients (median age at diagnosis 12 years, range 317) who underwent rhGH treatment between 1986 and 2000 at four tertiary referral centers in Piedmont and were treated for a median period of 36 months (range 12132). Follow-up for this study was closed in December 2006. When patients started with rhGH therapy, none of them had diabetes mellitus or malignant neoplasia. We submitted by regular mail a questionnaire including the following requests: a) present weight and height, b) presence of diabetes, hypertension or dyslipidemia, c) other diseases (including neoplasia). The responders to the questionnaire, by mail or phone interview, were 193 (68%). To obtain follow-up information of the 91 non-responders the individual records were linked to the registry office of Piedmont Region and the registry of the National Institute of Statistics. During follow-up: 1 patient developed type 1 diabetes mellitus, 1 had a diagnosis of melanoma and 1 a synovial sarcoma, 8 patients reported dyslipidemia. None of the patients developed hypertension and cardiovascular events or died during follow-up. In a multiple regression analysis, BMI of the male patients at the time of administration of the questionnaire was inversely correlated to the rhGH dose (P<0.0001), whereas in female patients the association was not demonstrated. In conclusion, we did not observed an increased risk for metabolic diseases or malignancies in patients who were treated with rhGH until reaching the final height. In men, rhGH doses seems to influence BMI during adulthood.