Abstract | BACKGROUND: METHODS: RESULTS: A primary end-point event occurred in 397 patients--41.6% of those in the placebo group and 27.0% of those in the selexipag group (hazard ratio in the selexipag group as compared with the placebo group, 0.60; 99% confidence interval, 0.46 to 0.78; P<0.001). Disease progression and hospitalization accounted for 81.9% of the events. The effect of selexipag with respect to the primary end point was similar in the subgroup of patients who were not receiving treatment for the disease at baseline and in the subgroup of patients who were already receiving treatment at baseline (including those who were receiving a combination of two therapies). By the end of the study, 105 patients in the placebo group and 100 patients in the selexipag group had died from any cause. Overall, 7.1% of patients in the placebo group and 14.3% of patients in the selexipag group discontinued their assigned regimen prematurely because of adverse events. The most common adverse events in the selexipag group were consistent with the known side effects of prostacyclin, including headache, diarrhea, nausea, and jaw pain. CONCLUSIONS:
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Authors | Olivier Sitbon, Richard Channick, Kelly M Chin, Aline Frey, Sean Gaine, Nazzareno Galiè, Hossein-Ardeschir Ghofrani, Marius M Hoeper, Irene M Lang, Ralph Preiss, Lewis J Rubin, Lilla Di Scala, Victor Tapson, Igor Adzerikho, Jinming Liu, Olga Moiseeva, Xiaofeng Zeng, Gérald Simonneau, Vallerie V McLaughlin, GRIPHON Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 373
Issue 26
Pg. 2522-33
(Dec 24 2015)
ISSN: 1533-4406 [Electronic] United States |
PMID | 26699168
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Acetamides
- Prodrugs
- Pyrazines
- selexipag
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Topics |
- Acetamides
(adverse effects, therapeutic use)
- Aged
- Disease Progression
- Double-Blind Method
- Drug Administration Schedule
- Female
- Hospitalization
(statistics & numerical data)
- Humans
- Hypertension, Pulmonary
(complications, drug therapy, mortality)
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Prodrugs
(adverse effects, therapeutic use)
- Pyrazines
(adverse effects, therapeutic use)
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