The value of approved therapies for pulmonary arterial hypertension.


In this issue of the Journal, Macchia et al present the first meta-analysis of trials for pulmonary arterial hypertension (PAH). Their findings are startling, yet not surprising at the same time. Meta-analyses can be very helpful in strengthening the power of small intervention effects and in providing guidance for future clinical trials with respect to the population enrolled, appropriate end points, and length of follow-up. One should also remember that metaanalyses taken from studies published in the literature potentially suffer from a negative publication bias because negative trials are often not published, and thus the meta-analyses oftentimes represent bthe best of the best.Q In addition, if the clinical trials are widely heterogeneous with respect to the patient population under study, or by design, the conclusions may need to be tempered. This article is particularly timely, given the recent approval of several medications for PAH, which is widely considered as a seriously disabling and fatal disease. Currently, there are 7 medications approved for PAH worldwide, which are estimated to generate N1600 million dollars in revenue in 2007 (personal communication). Because PAH has now become among the most expensive diseases to treat in the world, it is certainly fair to ask if we are getting a fair bbang for our buck.Q This meta-analysis included data from 16 randomized clinical trials extracted from the published literature, representing 3 different classes of approved therapies (prostacyclins, endothelin receptor blockers, and phosphodiesterase 5 inhibitors). One of the observations was the remarkable homogeneity among the studies. All but 1 of the trials included patients who had World Health Organization Category 1 PAH, and 70% of the patients


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@article{Rich2007TheVO, title={The value of approved therapies for pulmonary arterial hypertension.}, author={Stuart Rich}, journal={American heart journal}, year={2007}, volume={153 6}, pages={889-90} }