Search

Adult growth hormone deficiency (AGHD) is a rare endocrine disorder characterized by an abnormal body composition, metabolic abnormalities associated with increased cardiovascular diseases, bone loss, and impaired quality of life. Daily subcutaneous injections with recombinant growth hormone (GH) can alleviate the abnormalities associated with AGHD. Several long-acting GH (LAGH) preparations are currently in development that aim to reduce treatment burden for patients receiving daily GH injections. Somapacitan (Sogroya ® ; Novo Nordisk, Denmark) is the first LAGH preparation that has been approved for treatment of AGHD in the United States, Europe, and Japan. The recent approval of somapacitan and anticipated approval of other LAGH molecules presents new questions for physicians planning to treat AGHD with LAGH in the future. Differences in the technologies used to prolong the half-life of recombinant GH are expected to result in variations in pharmacokinetic and pharmacodynamic profiles between preparations. Therefore, it is essential that physicians understand and consider such variations when treating patients with these novel GH replacement therapies. Here, we present a set of treatment recommendations that have been created to guide physicians initiating therapy with somapacitan in patients with AGHD who are eligible for GH replacement. Furthermore, we will review the published data that underlie these recommendations to explain the rationale for the treatment and monitoring advice provided., Competing Interests: MB has received research support, lecture fees and/or consulting honoraria from Antisense, Chiasma, Diasorin, Genexine, Genescience, IDS, Ionis, IPSEN, Midatech, Novartis, Novo Nordisk, ONO, OPKO, Pfizer, Roche, Sandoz and StrongBridge; Beverly MK Biller has received occasional consulting honoraria from Aeterna Zentaris, Ascendis, Merck Serono and Novo Nordisk, and has served as the PI of a research grant to Massachusetts General Hospital from Ascendis; DC has served as a consultant for Novo Nordisk and on advisory boards. He has also served as a consultant for Crinetics and Pfizer; JJ has received lecture fees and serves on advisory boards for Novo Nordisk and has also served on advisory boards for Ascendis, in addition to having received unrestricted research grants from Pfizer; Hiroshi Nishioka has received honoraria from Teijin Pharma and Novo Nordisk, and has received grant support from Teijin Pharma; YT has received honoraria from Novo Nordisk, Novartis, Eli Lilly, Recordati Rare Disease, Otsuka Pharma and Ascendis Pharma, and has received grant support from Ono Pharma, Teijin Pharma, Novo Nordisk, Kowa Pharma, Taisho Pharma, Daiichi Sankyo Pharma and Tanabe Mitsubishi Pharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Bidlingmaier, Biller, Clemmons, Jørgensen, Nishioka and Takahashi.)

The Endocrine Society guidelines suggest to screen patients with primary aldosteronism (PA) free of hypertensive medications or alternatively to switch to drugs known to have minimal influence on the aldosterone to renin ratio (ARR). We retrospectively investigated the impact of such strategy on clinical outcome. 25 patients with PA and 25 with essential hypertension (EH) were studied. Initially all subjects were evaluated biochemically and received if possible an adjustment of their medication following the guidlines. Mineralocorticoid antagonists were discontinued in all subjects. Only 26 of 50 patients could be studied under optimal conditions (drug free or on medication with minimal influence on ARR) whereas the remaining 24 subjects had to receive additional drugs (such as ACE inhibitor, angiotensin-2 receptor blocker, or betablockers) because of initial blood pressure or comorbidities. Every fifth patient with a switch of the medication experienced a significant increase in blood pressure. 13 of 25 of PA patients needed potassium supplementation (105+/-25 mEq per day; range 8-320 mEq). Nine of these patients remained hypokalemic despite substitution (serum K 2.82+/-0.07 mmol/l), with 7 classified severely hypokalemic (<.3.0). We observed 6 serious adverse events requiring hospitalization including hypertensive crisis (n = 3), atrial fibrillation (n = 1), heart failure (n = 1) and ICD triggered electric shock (n = 1). In conclusion, in our experience the adjustment of the antihypertensive treatment during screening for PA is only possible in approximately half of patients and can cause severe side effect. Such recommendation, therefore, must include a note of caution because of possibly deleterious side effects.