It is time to carpe diem with porcine ACTH – A comparison of porcine sequence corticotropin to tetracosactide hexaacetate in testing the hypothalamic pituitary adrenal axis in healthy individuals

Abstract

Context:Our literature search revealed that the use of porcine sequence corticotropin has not been validated against tetracosactide hexaacetate in a healthy population.Aims:To study the efficacy of using porcine sequence corticotropin in comparison with tetracosactide hexaacetate in the evaluation of hypothalamo pituitary adrenal (HPA) axis.Materials and Methods:Fifteen healthy volunteers were enrolled. Serum cortisol was measured at 0 minute in all subjects and at 30 and 60 minutes after tetracosactide hexaacetate 250 μg intravenously. Four weeks later, serum cortisol level was measured at 0 minute and at 30 and 60 minutes following 24 units of porcine sequence corticotropin given intramuscularly.Results:Mean serum cortisol values with tetracosactide were 30.3 (±7.83) μg/dl and 31.27 (±7.36) μg/dl at 30 and 60 minutes, respectively. The mean cortisol values with porcine sequence corticotropin were 26.33 (±5.47) μg/dl and 31.59 (±6.40) μg/dl at 30 and 60 minutes, respectively. All subjects had a response qualified as normal or adequate at 30 minutes itself. Mean peak serum cortisol response was 32.65 (±7.76) μg/dl in tetracosactide group and 31.59 (±6.4) μg/dl in porcine sequence corticotropin group, and the responses in two groups were comparable (P = 0.686). There were no immediate side effects in both groups, with a lower cost of procedure in the porcine corticotropin group.Conclusion:Our study established the efficacy of porcine sequence corticotropin in testing the adequacy of HPA axis in healthy individuals. Our study also revealed that, the intactness of the HPA axis could be confirmed as early as 30 minutes in healthy individuals.

Long acting porcine sequence ACTH in the diagnosis of adrenal insufficiency

“…The average cortisol level achieved in patients with normal adrenal reserve in our study on APST was 26.1 ± 5.6 μg/dL, whereas that in the control group of the aforementioned study was 29.6 ± 5.9 μg/dL. Another study by Wagmode et al documented the response of both tests but, the study included healthy volunteers only (12). Sharma et al have compared the long acting ACTH (Acton Prolongatum ® ) test against ITT for the diagnosis of secondary AI in children in which the peak values of cortisol obtained on the ACTH test were much higher than those on the ITT (13).…”

“…Limitations of our study include absence of dose titration of porcine ACTH and lack of an assay specific cut-off for Synacthen-stimulated serum cortisol in our laboratory. As opposed to previous studies using 25 units of Acton Prolongatum ® for the APST, this study used 30 units considering the ease of dispensing from a 5 mL vial containing 300 units (6,12,13). No adverse events were observed with Synacthen or Acton Prolongatum in the present study.…”

Long‐acting porcine ACTH stimulated salivary cortisol in the diagnosis of adrenal insufficiency

“…Synthetic porcine sequence corticotrophin in carboxy methyl cellulose (CMC) is marketed in India as Acton Prolongatum (Ferring Pharmaceuticals Pvt Ltd, Thane, India) in a multidose vial (300 units in 5 ml) for intramuscular (IM) injection. This repository porcine ACTH in CMC preparation has recently been compared to human ACTH, and the cortisol stimulatory capacity of ACTH was confirmed to be comparable(p=0.68) 19 . Reversible binding of ACTH to CMC protects the peptide against enzymatic breakdown and prolongs its stimulatory action to a duration of about 15 hours 20 .…”

“…22,23 Other investigators from India have also assessed the performance of Acton prolongatum stimulated serum cortisol measurements in healthy children and adults against SST and ITT. 19,35,36 To the best of our knowledge, this is the first study to assess the diagnostic accuracy of salivary cortisol response to long-acting porcine sequence ACTH for diagnosing AI. 24 The reported crossreactivity with cortisone was only 6.58%.…”

“…This repository porcine ACTH in CMC preparation has recently been compared to human ACTH, and the cortisol stimulatory capacity of ACTH was confirmed to be comparable(p=0.68). 19 Reversible binding of ACTH to CMC protects the peptide against enzymatic breakdown and prolongs its stimulatory action to a duration of about 15 hours. 20 It needs to be stored at 2°-10°C and protected from light during storage.…”