What's New | Decker

Over the past two decades, considerable progress has been made in the medical management of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Recently the field has seen the addition of several new pulmonary vasodilator agents: a soluble guanylate cyclase stimulator (riociguat), a new endothelin receptor antagonist (macitentan) and two new oral prostanoid agents (treprostinil and selexipag).
Initial combination therapy for the treatment of pulmonary arterial hypertension has heralded a new era in the treatment of PAH. Patients receiving initial combination therapy with a phosphodiesterase inhibitor, tadalafil and an endothelin receptor antagonist, ambrisentan demonstrated improved progression-free survival compared with monotherapy with either tadalafil or ambrisentan.
For patients with inoperable or persistent chronic thromboembolic pulmonary hypertension, riociguat has emerged as an attractive alternative.

Over the past two decades, considerable progress has been made in the medical management of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Recently the field has seen the addition of several new pulmonary vasodilator agents: a soluble guanylate cyclase stimulator (riociguat), a new endothelin receptor antagonist (macitentan) and two new oral prostanoid agents (treprostinil and selexipag).
Initial combination therapy for the treatment of pulmonary arterial hypertension has heralded a new era in the treatment of PAH. Patients receiving initial combination therapy with a phosphodiesterase inhibitor, tadalafil and an endothelin receptor antagonist, ambrisentan demonstrated improved progression-free survival compared with monotherapy with either tadalafil or ambrisentan.
For patients with inoperable or persistent chronic thromboembolic pulmonary hypertension, riociguat has emerged as an attractive alternative.

Because of the complex nature of clinical trial design, significant resources and infrastructure are invested in drug development. Many drugs fail to progress beyond the phase I/II stage, and many phase III trials take years to accrue and publish results, leading to a delay in Food and Drug Administration (FDA) approval for diseases that desperately need better therapeutic options. The relatively recent FDA Safety and Innovation Act has allowed for the creation of priority and expedited review for drugs and biologics in serious conditions and where there is an unmet medical need. The designation of fast-track or breakthrough therapy may be granted when there is preclinical or clinical evidence to suggest that the intervention may result in a substantial improvement over currently available therapies.
Prior to embarking on a clinical trial, data entry, editing (“cleaning”), and analysis should be anticipated. Planning for data management begins with developing rules for coding the variables for computer entry. The appropriate hardware and software programs should be selected and standardized across study sites.
A type I error (false positive) occurs if an investigator rejects a null hypothesis that is true in the population. A type II error (false negative) occurs if the investigator fails to reject a null hypothesis that is false in the population. Neither of these errors can be avoided entirely.

Immunotherapy and targeted therapy represent innovative medical therapies to improve survival in anorectal melanoma. Pembrolizumab is a PD-1 inhibitor used as immunotherapy in melanoma.
Clinical trials are under way examining medical therapy options in imatinib-resistant GISTs.
Safety and effectiveness of transanal minimally invasive surgery are being studied for rectal GISTs.

Evidence that the 9-valent HPV vaccine covers approximately 20% more high-risk infections
Enhanced understanding of the benefits of cervical cancer screening
Interim evidence suggests primary HPV testing is an option for women starting at age 25 years

Evidence that the 9-valent HPV vaccine covers approximately 20% more high-risk infections
Enhanced understanding of the benefits of cervical cancer screening
Interim evidence suggests primary HPV testing is an option for women starting at age 25 years

Immunotherapy and targeted therapy represent innovative medical therapies to improve survival in anorectal melanoma.
Clinical trials are under way examining medical therapy options in imatinib-resistant GISTs.
Safety and effectiveness of transanal minimally invasive surgery are being studied for rectal GISTs.

Evidence that the 9-valent HPV vaccine covers approximately 20% more high-risk infections
Enhanced understanding of the benefits of cervical cancer screening
Interim evidence suggests primary HPV testing is an option for women starting at age 25 years

Cardiovascular Medicine