[Cost effectiveness of GnRH antagonists in patients with prostate cancer and cardiovascular risk : Comparative analysis against Leuprorelin by the Number Needed to Treat]. / Kosteneffektivität von GnRH-Antagonisten bei Patienten mit Prostatakarzinom und kardiovaskulärem Risiko : Vergleichende Analyse gegenüber Leuprorelin anhand der Number Needed to Treat.

BACKGROUND: Recent studies suggest that androgen deprivation therapy (ADT) is associated with increased cardiovascular (CV) risk for patients with hormone-sensitive prostate cancer (PCa) and pre-existing CV disease. This risk seems to be different for the gonadotropin-releasing hormone (GnRH) agonists leuprolide and goserelin and GnRH antagonists, whereas the slightly more expensive GnRH antagonist shows a beneficial risk profile. The present study assesses the cost effectiveness of degarelix compared to leuprolide for PCa patients with increased CV risk. METHODS: This analysis is based on a pooled analysis of six phase III, randomized, controlled trials comparing the GnRH agonists leuprolide and goserelin with the GnRH antagonist degarelix. For the combined endpoint of CV events or death a superiority of degarelix was determined with a Number-Needed-to-Treat of 12. From the perspective of German statutory health insurance, this evaluation estimates and compares the additional drug costs of degarelix treatment to the cost of one (avoided) CV event. The CV event costs were estimated via emergency treatment and transportation, inpatient treatment, and rehabilitation. The difference of these two cost pools divided by 12 yields the average saving per patient and year. RESULTS: For every 12 PCa patients with CV history that are treated with GnRH antagonists to prevent one CV event, there will be additional drug costs in comparison with leuprolide treatment of € 3111 per year. Costs of € 8447 per year are prevented. Therefore, each patient with a history of CV who is treated with degarelix instead of a leuprolide generates savings of € 445 per patient and year. CONCLUSIONS: Compared to leuprolide, degarelix is cost effective for patients with increased CV risk.

[Genetically engineered drugs and their application with the example of erythropoietin]. / Gentechnische Herstellung von Arzneimitteln und ihre Anwendung am Beispiel des Erythropoetins.

Over the past two decades, many genetically engineered drugs have been developed and approved for the treatment of patients. Typically, these drugs are characterized by a high and specific activity in the presence of optimal safety. They include hormones, enzymes, growth and coagulation factors, antibodies as well as vaccines. All these proteins are generated using recombinant DNA technology. An expression vector with the gene encoding for the protein of interest is introduced into an appropriate microorganism or cell line. The biochemical machinery of the host cell then translates the genetic information into the corresponding protein. Large scale production of the recombinant drugs uses biotechnological processes. The genetically modified organisms are grown in bioreactors from which the desired protein is finally isolated and purified. This review focuses on the production and clinical application of recombinant erythropoietin in the areas of nephrology, hemato-oncology and elective surgery.