 |
 |
|
|
|  PubMed
|
| |||||||||||||||||||||||||||||||||||||||||||||||
Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
Pulmonary hypertension is a rare and very serious disease. It causes disabling shortness of breath and is often fatal. Various treatments may help reduce symptoms, but there is no cure for the disease. Treatment include a drug (epoprostenol) that is given intravenously through a small tube and a pill whose active ingredient is more commonly used for erectile dysfunction. Despite such therapy, many patients with pulmonary hypertension do poorly. Whether treating patients with 2 drugs rather than a single drug would improve their outcomes is unclear.
SUMMARIES FOR PATIENTS
A Combination Treatment for Pulmonary Hypertension
21 October 2008 | Volume 149 Issue 8 | Page I-38
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician. The summaries may be reproduced for not-for-profit educational purposes only. Any other uses must be approved by the American College of Physicians.
The summary below is from the full report titled "Addition of Sildenafil to Long-Term Intravenous Epoprostenol Therapy in Patients with Pulmonary Arterial Hypertension. A Randomized Trial." It is in the 21 October 2008 issue of Annals of Internal Medicine (volume 149, pages 521-530). The authors are G. Simonneau, L.J. Rubin, N. Galiè, R.J. Barst, T.R. Fleming, A.E. Frost, P.J. Engel, M.R. Kramer, G. Burgess, L. Collings, N. Cossons, O. Sitbon, and D.B. Badesch, for the PACES Study Group.
What is the problem and what is known about it so far?
Pulmonary hypertension is high blood pressure in the arteries that deliver blood to the lungs. It is usually caused by scar tissue that narrows or destroys small arteries. The damaged arteries make it harder for blood to flow through the lungs. As pressure builds, the right side of the heart must contract more vigorously than normal to maintain blood flow. This weakens the heart muscle and leads to heart failure. As the disease worsens, the lungs and heart have difficulty providing oxygen to the body.
Why did the researchers do this particular study?
To see whether a combination of sildenafil and epoprostenol improves outcomes more than epoprostenol alone in patients with pulmonary hypertension.
Who was studied?
267 patients with pulmonary hypertension. All had received intravenous epoprostenol for at least 3 months.
How was the study done?
The researchers recruited patients already receiving epoprostenol therapy from 41 centers in 11 countries. They randomly assigned these patients to receive either a dummy pill or sildenafil (20 mg) 3 times daily. They followed the patients monthly for 16 weeks and increased pill dosages to 4 pills 3 times daily, if tolerated. Neither the researchers nor the patients knew which pills the patients received. At baseline and follow-up visits, the researchers measured patients' exercise capacity (distance walked in 6 minutes) and pulmonary artery pressure and asked about symptoms of breathlessness and adverse events.
What did the researchers find?
At follow-up, patients given sildenafil could walk longer distances in 6 minutes and had greater decreases in pulmonary arterial pressures than did those given the dummy pills. Neither sildenafil nor the dummy pills affected breathlessness symptoms. None of the 134 patients given sildenafil died; however, 7 of the 131 patients given dummy pills died. More patients given dummy pills required changes in epoprostenol doses because of clinical deterioration. More patients given sildenafil reported side effects, such as headaches and abdominal discomfort (dyspepsia).
What were the limitations of the study?
The study duration was short. The improvements in walking distances with sildenafil were seen mostly in a subgroup of patients who had walked further than 324 meters in 6 minutes at their baseline visits.
What are the implications of the study?
Adding sildenafil to epoprostenol therapy may improve outcomes for some patients with pulmonary hypertension.
CiteULike 
Complore 
Connotea 
Del.icio.us 
Digg 
Facebook 
Reddit 
Technorati 
Twitter What's this?
Related articles in Annals:
This article has been cited by other articles:
|
|
 |
|
  A. J. Peacock, R. Naeije, N. Galie, and L. Rubin End-points and clinical trial design in pulmonary arterial hypertension: have we made progress? Eur. Respir. J., July 1, 2009; 34(1): 231 - 242. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. M. Hoeper, H. Gall, H. J. Seyfarth, M. Halank, H. A. Ghofrani, J. Winkler, H. Golpon, K. M. Olsson, N. Nickel, C. Opitz, et al. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension Eur. Respir. J., July 1, 2009; 34(1): 132 - 137. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. J. Barst, J. S. R. Gibbs, H. A. Ghofrani, M. M. Hoeper, V. V. McLaughlin, L. J. Rubin, O. Sitbon, V. F. Tapson, and N. Galie Updated evidence-based treatment algorithm in pulmonary arterial hypertension. J. Am. Coll. Cardiol., June 30, 2009; 54(1 Suppl): S78 - S84. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
V. V. McLaughlin, D. B. Badesch, M. Delcroix, T. R. Fleming, S. P. Gaine, N. Galie, J. S. R. Gibbs, N. H. Kim, R. J. Oudiz, A. Peacock, et al. End Points and Clinical Trial Design in pulmonary arterial hypertension. J. Am. Coll. Cardiol., June 30, 2009; 54(1 Suppl): S97 - 107. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 N. Galie, B. H. Brundage, H. A. Ghofrani, R. J. Oudiz, G. Simonneau, Z. Safdar, S. Shapiro, R. J. White, M. Chan, A. Beardsworth, et al. Tadalafil Therapy for Pulmonary Arterial Hypertension Circulation, June 9, 2009; 119(22): 2894 - 2903. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
V. V. McLaughlin, S. L. Archer, D. B. Badesch, R. J. Barst, H. W. Farber, J. R. Lindner, M. A. Mathier, M. D. McGoon, M. H. Park, R. S. Rosenson, et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association Developed in Collaboration With the American College of Chest Physicians; American Thoracic Society, Inc.; and the Pulmonary Hypertension Association J. Am. Coll. Cardiol., April 28, 2009; 53(17): 1573 - 1619. [Full Text] [PDF]
|
|
|
|
|
|
Writing Committee Members, V. V. McLaughlin, S. L. Archer, D. B. Badesch, R. J. Barst, H. W. Farber, J. R. Lindner, M. A. Mathier, M. D. McGoon, M. H. Park, et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: Developed in Collaboration With the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association Circulation, April 28, 2009; 119(16): 2250 - 2294. [Full Text] [PDF]
|
|
|
|
 |
|
 M. Humbert Update in Pulmonary Hypertension 2008 Am. J. Respir. Crit. Care Med., April 15, 2009; 179(8): 650 - 656. [Full Text] [PDF]
|
|
|
|
 |
|
 R. Souza and C. Jardim Trends in pulmonary arterial hypertension Eur. Respir. Rev., March 1, 2009; 18(111): 7 - 12. [Full Text] [PDF]
|
|
|
|
 |
|
 N. Galie, A. Manes, L. Negro, M. Palazzini, M. L. Bacchi-Reggiani, and A. Branzi A meta-analysis of randomized controlled trials in pulmonary arterial hypertension Eur. Heart J., February 2, 2009; 30(4): 394 - 403. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. D. McGoon and G. C. Kane Pulmonary Hypertension: Diagnosis and Management Mayo Clin. Proc., February 1, 2009; 84(2): 191 - 207. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 Correction: Addition of Sildenafil to Long-Term Intravenous Epoprostenol Therapy in Patients with Pulmonary Arterial Hypertension Ann Intern Med, January 6, 2009; 150(1): 63 - 63. [Full Text] [PDF]
|
|
|
|
 |
|
 Epoprostenol Plus Sildenafil for Pulmonary Arterial Hypertension? Journal Watch (General), November 6, 2008; 2008(1106): 1 - 1. [Full Text]
|
|
|
|
 |
|
 All you need to read in the other general journals BMJ, October 28, 2008; 337(oct27_2): a2294 - a2294. [Full Text]
|
|
|
|
|
|
D. B. Taichman Therapy for Pulmonary Arterial Hypertension: The More, the Merrier? Ann Intern Med, October 21, 2008; 149(8): 583 - 585. [Full Text] [PDF]
|
|
