PMID- 12151469
OWN - NLM
STAT- MEDLINE
DCOM- 20020807
LR  - 20231024
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 347
IP  - 5
DP  - 2002 Aug 1
TI  - Inhaled iloprost for severe pulmonary hypertension.
PG  - 322-9
AB  - BACKGROUND: Uncontrolled studies suggested that aerosolized iloprost, a stable 
      analogue of prostacyclin, causes selective pulmonary vasodilatation and improves 
      hemodynamics and exercise capacity in patients with pulmonary hypertension. 
      METHODS: We compared repeated daily inhalations of 2.5 or 5.0 microg of iloprost 
      (six or nine times per day; median inhaled dose, 30 microg per day) with 
      inhalation of placebo. A total of 203 patients with selected forms of severe 
      pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension 
      (New York Heart Association [NYHA] functional class III or IV) were included. The 
      primary end point was met if, after week 12, the NYHA class and distance walked 
      in six minutes were improved by at least one class and at least 10 percent, 
      respectively, in the absence of clinical deterioration according to predefined 
      criteria and death. RESULTS: The combined clinical end point was met by 16.8 
      percent of the patients receiving iloprost, as compared with 4.9 percent of the 
      patients receiving placebo (P=0.007). There were increases in the distance walked 
      in six minutes of 36.4 m in the iloprost group as a whole (P=0.004) and of 58.8 m 
      in the subgroup of patients with primary pulmonary hypertension. Overall, 4.0 
      percent of patients in the iloprost group (including one who died) and 13.7 
      percent of those in the placebo group (including four who died) did not complete 
      the study (P=0.024); the most common reason for withdrawal was clinical 
      deterioration. As compared with base-line values, hemodynamic values were 
      significantly improved at 12 weeks when measured after iloprost inhalation 
      (P<0.001), were largely unchanged when measured before iloprost inhalation, and 
      were significantly worse in the placebo group. Further significant beneficial 
      effects of iloprost treatment included an improvement in the NYHA class (P=0.03), 
      dyspnea (P=0.015), and quality of life (P=0.026). Syncope occurred with similar 
      frequency in the two groups but was more frequently rated as serious in the 
      iloprost group, although this adverse effect was not associated with clinical 
      deterioration. CONCLUSIONS: Inhaled iloprost is an effective therapy for patients 
      with severe pulmonary hypertension.
CI  - Copyright 2002 Massachusetts Medical Society
FAU - Olschewski, Horst
AU  - Olschewski H
AD  - Department of Internal Medicine II, University Clinic, Giessen, Germany.
FAU - Simonneau, Gerald
AU  - Simonneau G
FAU - Galie, Nazzareno
AU  - Galie N
FAU - Higenbottam, Timothy
AU  - Higenbottam T
FAU - Naeije, Robert
AU  - Naeije R
FAU - Rubin, Lewis J
AU  - Rubin LJ
FAU - Nikkho, Sylvia
AU  - Nikkho S
FAU - Speich, Rudolf
AU  - Speich R
FAU - Hoeper, Marius M
AU  - Hoeper MM
FAU - Behr, Jurgen
AU  - Behr J
FAU - Winkler, Jorg
AU  - Winkler J
FAU - Sitbon, Olivier
AU  - Sitbon O
FAU - Popov, Wladimir
AU  - Popov W
FAU - Ghofrani, H Ardeschir
AU  - Ghofrani HA
FAU - Manes, Alessandra
AU  - Manes A
FAU - Kiely, David G
AU  - Kiely DG
FAU - Ewert, Ralph
AU  - Ewert R
FAU - Meyer, Andreas
AU  - Meyer A
FAU - Corris, Paul A
AU  - Corris PA
FAU - Delcroix, Marion
AU  - Delcroix M
FAU - Gomez-Sanchez, Miguel
AU  - Gomez-Sanchez M
FAU - Siedentop, Harald
AU  - Siedentop H
FAU - Seeger, Werner
AU  - Seeger W
CN  - Aerosolized Iloprost Randomized Study Group
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Vasodilator Agents)
RN  - JED5K35YGL (Iloprost)
SB  - IM
MH  - Administration, Inhalation
MH  - Dyspnea/drug therapy/etiology
MH  - Exercise Tolerance/drug effects
MH  - Female
MH  - Hemodynamics/drug effects
MH  - Humans
MH  - Hypertension, Pulmonary/classification/*drug therapy/physiopathology
MH  - Iloprost/*administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Vasodilator Agents/*administration & dosage/adverse effects
MH  - Walking
EDAT- 2002/08/02 10:00
MHDA- 2002/08/08 10:01
CRDT- 2002/08/02 10:00
PHST- 2002/08/02 10:00 [pubmed]
PHST- 2002/08/08 10:01 [medline]
PHST- 2002/08/02 10:00 [entrez]
AID - 347/5/322 [pii]
AID - 10.1056/NEJMoa020204 [doi]
PST - ppublish
SO  - N Engl J Med. 2002 Aug 1;347(5):322-9. doi: 10.1056/NEJMoa020204.