Remodulin (Treprostinil) is a SQ drug used in the treatment of Pulmonary Hypertension. The most common side effect of the drug is site pain. The Site pain does seem to taper off at about 8 weeks but the management of the patient for the first several weeks can be a struggle. Our study compares two groups - a control group which did not utilize the pain management protocol and a new protocol group which did.
Our study was based on a historic control group that was compared to a study group using a special site management protocol and observation of current new Treprostinil “starts.” We utilized two groups for the study. The control group consisted of patients started on Remodulin form 3/15/03- 07/15/03 utilizing miscellaneous pain medications. The study group consisted of patients from 08/18/03 –12/31/03. The special pain management in the study group consisted of adding Duoderm patches with PLO GEL, adding oral drugs and being much more psychologically supportive with the patients and families. The authors have found a 90-day improvement after the start of Treprostinil therapy for site pain reduction and getting the patient to the 15ng dose seems to be the point at which most patients stay on therapy.
There were 9 patients started on Treprostinil in the control group from 3/15/03 through 7/15/03, 7 or a 77% discontinued therapy due to site pain during the 16-week period. From the period of 8/18/03 through 12/18/03, 12 patients started Remodulin therapy. ALL of the patients are still on the therapy in the study group for a 0% rate of discontinuation during the 16-week trial.
Our study demonstrates that the pain protocol used in this study can keep patients on drug with 100% compliance VS a 77% discontinution rate.
Our study demonstrates that this pain protocol can influence patient discontinuation rate, maintains patient comfort, reduces site pain and keeps the patient on therapy, which increases the long-term survival of the patient.
L.K. Ashby, None.