Somatropin Shows Long-Term Safety and Effectiveness in Pediatric Patients with growth hormone deficiency: Study

Written By : Jacinthlyn Sylvia |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-04-06T03:00:47+05:30 | Updated On 6 April 2024 4:27 PM IST

A recent study found Omnitrope® (somatropin) to be effective and safe in pediatric patients over long term. The findings from the PATRO Children study were published in the journal of Drug Design, Development and Therapy.

Amidst the ongoing concerns over the safety and effectiveness of pediatric treatments, Omnitrope® (somatropin) which is a biosimilar recombinant human growth hormone (rhGH) showed positive outcomes. The latest data from the PATRO Children study highlights its remarkable performance in real-world clinical settings.

The PATRO Children study was conducted to monitor the long-term safety and efficacy of Omnitrope® and enrolled a substantial cohort of 7359 pediatric patients, majority of whom were treatment-naïve. The results underline the well-tolerated nature of this treatment with a notable 86.0% of patients being new to therapy at the onset of the study.

Growth hormone deficiency was found to be the predominant indication for treatment, that was followed closely by patients born small for gestational age (SGA). Throughout the study duration, the patients expressed a sustained catch-up growth with the standard deviation scores (SDS) of height significantly improving over time.

Despite the concerns inherent to any therapeutic intervention, the adverse events (AEs) associated with Omnitrope® were largely mild to moderate in severity that reaffirms its favorable safety profile. A mere 8.3% of patients experienced AEs suspected to be treatment-related, with commonly reported issues including headaches and injection-site discomfort. The low incidence rates of significant complications such as type 2 diabetes mellitus and primary malignancies further consolidated the safety credentials of this treatment.

Source:

Loche, S., Kanumakala, S., Backeljauw, P., Schwab, K., Lechuga-Sancho, A., Esmael, A., Urosevic, D., Boldea, A., & Zabransky, M. (2024). Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study. In Drug Design, Development and Therapy: Vol. Volume 18 (pp. 667–684). Informa UK Limited. https://doi.org/10.2147/dddt.s440009

Drug Design Development and TherapyOmnitroperecombinant human growth hormone

Source : Drug Design, Development and Therapy

Jacinthlyn Sylvia

Neuroscience Masters graduate

Jacinthlyn Sylvia, a Neuroscience Master's graduate from Chennai has worked extensively in deciphering the neurobiology of cognition and motor control in aging. She also has spread-out exposure to Neurosurgery from her Bachelor’s. She is currently involved in active Neuro-Oncology research. She is an upcoming neuroscientist with a fiery passion for writing. Her news cover at Medical Dialogues feature recent discoveries and updates from the healthcare and biomedical research fields. She can be reached at editorial@medicaldialogues.in

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751