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When it comes to GH, there are a few things to keep in mind. For instance, if you’re going to be taking it on a regular basis, you need to know how to get the best results and how to be safe in the process.<\/p>\n
Adherence to daily growth hormone<\/a> (GH) therapy is critical for improving clinical outcomes. Patients who are non-adherent may miss more than one injection per week, which may significantly impact their growth trajectories. In addition, poor adherence can be a result of inadequate understanding of the disorder or treatment.<\/p>\n Poor adherence to GH has been associated with decreased annual height velocity and reduced linear growth. Although adherence to GH can impact growth and quality of life, few studies have investigated the association between adherence and growth outcomes. This study aimed to better characterize adherence patterns and their impact on clinical outcomes.<\/p>\n Patients with pGHD were evaluated for adherence at initiation and at six months. They were classified as good if they missed less than 5 percent of their doses. Those with good adherence had higher IGF-I levels and better growth velocity scores.<\/p>\n The GH compliance survey included 177 children in New Zealand. GH patients were categorized into four adherence segments based on the percentage of doses missed. Non-adherent patients had more days missed than adherent ones. However, the proportion of days covered did not show a significant correlation.<\/p>\n For children ages 10 years and older, the risk of discontinuing r-hGH was significantly higher. The risk was also higher for black and Hispanic children. Compared with children with good adherence, those with poor adherence had lower predicted height velocities.<\/p>\n These findings suggest that a better understanding of adherence to GH may lead to improved growth and quality of life. Increasing awareness of adherence can help clinicians confirm that patients are adhering to therapy. Several initiatives may be tailored to specific patient subgroups to improve adherence and clinical outcomes.<\/p>\n The majority of patients with pGHD exhibit poor adherence. It is estimated that up to 66% of children miss more than a single dose of GH per week. Among adolescents, up to 33% discontinue therapy.<\/p>\n Long-acting GH preparations have been reported to increase adherence, although the underlying mechanisms of this change remain unclear. A transition from daily to weekly GH injections could result in improved adherence and may also promote patient satisfaction.<\/p>\n Using a growth hormone<\/a> a day to increase height in kids with a growth hormone<\/a> deficiency is nothing new, but long-acting versions of the drug are now on the scene. A recent study in GlobalData found that by 2030, long-acting recombinant human growth hormones are expected to outnumber all other forms of GH in terms of total revenue. One of the most prominent players in this space is Novo Nordisk, which has a slew of FDA approved GH products on its roster.<\/p>\n The long-acting growth hormone<\/a> market is a niche and highly competitive one, largely due to the lack of any single-dose therapy for children with growth hormone<\/a> deficiencies. It’s no surprise then that the company is making its presence known with the aforementioned Sogroya, the first FDA approved long-acting recombinant growth hormone<\/a>. While the long-acting form of rhGH is a welcome addition to the treatment options for pediatric patients, it’s no secret that the adherence rate amongst patients with the condition is low. As a result, a strategy to improve somatropin adherence may be the key to unlocking the doors to success for pGHD patients.<\/p>\n In addition to the most popular rhGH modalities, the industry is seeing a slew of novel, more cost effective preparations in the pipeline. Some of these products are actually designed to be administered once a week, thus avoiding the dreaded injection site visits. Compared to the daily modalities of the past, long-acting rhGHs are also expected to have a smaller risk of injectable site associated adverse events such as lipohypertrophy and pruritus. Furthermore, a number of studies have shown that long-acting rhGHs may even offer some of the benefits of a daily dose, namely improved patient compliance and a better quality of life. Having said that, the industry is likely to see a decline in market share over the next decade, which is where the long-acting rhGHs of the future will come in.<\/p>\n TransCon hGH is a long-acting human growth hormone<\/a> prodrug, which is designed to maintain the same distribution in the body as daily hGH. The product is an unmodified recombinant growth hormone<\/a>, which is transiently bound to a carrier molecule by a linker. It is expected to become the leading long-acting GH on the market.<\/p>\n During the Phase 3 heiGHt Trial, 161 treatment-naive children with GHD were randomized to receive either a weekly dose of TransCon hGH or Genotropin, an annualized height velocity (AHV) therapy. Results showed that the two therapies are comparable in safety and adherence, as well as clinical efficacy.<\/p>\n In addition, there was no significant difference in growth or lipoatrophy between the two treatments. Plasma IGF1 levels were similar for both groups at all doses. However, the mean annualized height velocity was higher for TransCon GH than for Genotropin. Compared to the daily hGH group, hGH administered weekly was associated with fewer adverse events, although one subject experienced injection site pain.<\/p>\n A 70-year-old female who had a history of several adrenal crises developed moderate pleuritic chest pain, which was likely caused by pulmonary infiltrate. This was reported to be the first serious adverse event in the trial, and was not attributed to the trial treatment.<\/p>\n TransCon GH was not found to cause nodule formation or lipoatrophy. However, there was one incident of a serious adrenal crisis, which was attributed to the treatment. Nevertheless, the investigator stated that the study cannot be definitively ruled out as a contributing factor to the crisis.<\/p>\n The study was designed to be a PK and PD trial, and it compared the safety of weekly TransCon GH with the pharmacokinetics of daily Omnitrope, a commercially available daily GH product. Blood samples were collected pre-dose on Days 1, 8, 15 and 22. Additional samples were also collected post-dose on Days 29, 31, 35 and 42. PK and PD assessments were repeated for up to 20 days following Day 22.<\/p>\n Statistical significance for superiority was achieved with a p-value of 0.0088. Although this was not a numerical superiority claim, the study showed that weekly TransCon GH has better tolerability, a more consistent and comparable safety profile, and a better IGF1 response than daily Omnitrope.<\/p>\n There is no cure for Prader-Willi syndrome, but growth hormone<\/a> (GH) therapy is effective in increasing height and improving body composition. In addition, GH treatment can improve physical strength and cognition.<\/p>\n Many people with Prader-Willi syndrome have problems controlling their appetite and eating. This can result in obesity. While weight loss surgery is not recommended for those with PWS, a dietitian can give advice.<\/p>\n Children with PWS can also have behavioral challenges. Those with PWS often become overly anxious or stressed out. The disease affects the endocrine system, which can lead to hypogoninism. Other symptoms include hypotonia and learning disabilities.<\/p>\n Several studies have shown that growth hormone<\/a> therapy is effective in children with Prader-Willi syndrome. During treatment, children’s height, body fat, and muscle tone are normalized. After four years of treatment, the weight of children with Prader-Willi syndrome is at a similar level to those of their peers.<\/p>\n A study from the Netherlands showed that early GH therapy for children with Prader-Willi syndrome was associated with improved cognitive function. However, other questions still remain about the appropriate care for these patients.<\/p>\n One study found that families with children with PWS tended to report higher levels of caregiver burden. They also reported that a disruption to their routines caused significant stress. Another study of parents of older children with Prader-Willi syndrome found that the increase in age had a significant impact on their family relationships.<\/p>\n Adults with PWS have some of the same behavioural challenges as children, but they can also live active social lives. Behavioral problems can be treated with antidepressants, cognitive behavioural therapy, or psychosis therapy.<\/p>\n Families of children with Prader-Willi Syndrome have support groups and organizations. These groups can help parents cope. Parents can also talk with a mental health professional.<\/p>\n Prader-Willi syndrome is a complex disease that needs specialized medical care. Patients with the condition can benefit from growth hormone<\/a> therapy and should work with their doctor to identify and address any issues. If you think that your child might have the disorder, get a diagnosis as soon as possible. Identifying problems in advance can improve the quality of life for both you and your child.<\/p>\n Long-acting growth hormones<\/h2>\n
TransCon GH<\/h2>\n
Prader-Willi syndrome<\/h2>\n