A common problem that I encounter in the office is when a patient with PAH needs to have a procedure such as colonoscopy, upper endoscopy or orthopedic surgery. For the average healthy person, these procedures represent minimal risk and can be done in outpatient endoscopy centers or at orthopedic hospitals. However, for patients with PAH or other advanced lung diseases these … [Read more...]
Recent Clinical Trial Results with Orenitram
After six years, the FREEDOM-EV clinical trial has finished and preliminary results have been released. This study included patients with PAH who were already on a single oral therapy (either a PDE 5 inhibitor or an ERA). They were then randomized to have either a placebo or Orenitram added to their regimen. Although we don’t have all of the final results, United Therapeutics … [Read more...]
Generic Adcirca is Coming!
After many years under patent protection, the generic medication Tadalafil will soon be available. What does this mean for patients? Hopefully generic Tadalafil will be much less expensive than Adcirca. We can look back at what happened with a similar medicine, Revatio, when it went generic as sildenafil. Pricing We don’t know precise pricing but we expect deep discounts … [Read more...]
Inhaled Nitric Oxide and PAH: Update
Bellerophon announced that their phase 3 clinical trial using portable nitric oxide in patients with PAH has been stopped. The trial was stopped early after an analysis of data gathered so far showed no evidence of efficacy (the inhaled medication was not effective). There did not appear to be a safety problem. This clinical trial was exciting as very low nitric oxide … [Read more...]
Entire Implantable System for Remodulin Approved by the FDA
It is finally here! The Food and Drug Administration approved Remodulin in its implantable delivery system for treatment of Pulmonary Arterial Hypertension. We have been providing updates on the 8-year study that investigated the use of an implanted pump to deliver Remodulin removing the need for external pumps and are excited to announce it is finally approved. The pump … [Read more...]
