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Sildenafil citrate for the prevention of high altitude hypoxic pulmonary hypertension: double blind, randomized, placebo-controlled trial.
High Alt Med Biol. 2011 Fall; 12(3):207-14.HA

Abstract

Exaggerated hypoxic pulmonary vasoconstriction is a key factor in the development of high altitude pulmonary edema (HAPE). Due to its effectiveness as a pulmonary vasodilator, sildenafil has been proposed as a prophylactic agent against HAPE. By conducting a parallel-group double blind, randomized, placebo-controlled trial, we investigated the effect of chronic sildenafil administration on pulmonary artery systolic pressure (PASP) and symptoms of acute mountain sickness (AMS) during acclimatization to high altitude. Sixty-two healthy lowland volunteers (36 male; median age 21 years, range 18 to 31) on the Apex 2 research expedition were flown to La Paz, Bolivia (3650 m), and after 4-5 days acclimatization ascended over 90 min to 5200 m. The treatment group (n=20) received 50 mg sildenafil citrate three times daily. PASP was recorded by echocardiography at sea level and within 6 h, 3 days, and 1 week at 5200 m. AMS was assessed daily using the Lake Louise Consensus symptom score. On intention-to-treat analysis, there was no significant difference in PASP at 5200 m between sildenafil and placebo groups. Median AMS score on Day 2 at 5200 m was significantly higher in the sildenafil group (placebo 4.0, sildenafil 6.5; p=0.004) but there was no difference in prevalence of AMS between groups. Sildenafil administration did not affect PASP in healthy lowland subjects at 5200 m but AMS was significantly more severe on Day 2 at 5200 m with sildenafil. Our data do not support routine prophylactic use of sildenafil to reduce PASP at high altitude in healthy subjects with no history of HAPE. TRIALS REGISTRATION NUMBER: NCT00627965.

Authors+Show Affiliations

Mitochondrial Research Group, Medical School, Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, United Kingdom. matthew.bates@ncl.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21962063

Citation

Bates, Matthew G D., et al. "Sildenafil Citrate for the Prevention of High Altitude Hypoxic Pulmonary Hypertension: Double Blind, Randomized, Placebo-controlled Trial." High Altitude Medicine & Biology, vol. 12, no. 3, 2011, pp. 207-14.
Bates MG, Thompson AA, Baillie JK, et al. Sildenafil citrate for the prevention of high altitude hypoxic pulmonary hypertension: double blind, randomized, placebo-controlled trial. High Alt Med Biol. 2011;12(3):207-14.
Bates, M. G., Thompson, A. A., Baillie, J. K., Sutherland, A. I., Irving, J. B., Hirani, N., & Webb, D. J. (2011). Sildenafil citrate for the prevention of high altitude hypoxic pulmonary hypertension: double blind, randomized, placebo-controlled trial. High Altitude Medicine & Biology, 12(3), 207-14. https://doi.org/10.1089/ham.2011.0007
Bates MG, et al. Sildenafil Citrate for the Prevention of High Altitude Hypoxic Pulmonary Hypertension: Double Blind, Randomized, Placebo-controlled Trial. High Alt Med Biol. 2011;12(3):207-14. PubMed PMID: 21962063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sildenafil citrate for the prevention of high altitude hypoxic pulmonary hypertension: double blind, randomized, placebo-controlled trial. AU - Bates,Matthew G D, AU - Thompson,A A Roger, AU - Baillie,J Kenneth, AU - Sutherland,Andrew I, AU - Irving,John B, AU - Hirani,Nikhil, AU - Webb,David J, PY - 2011/10/4/entrez PY - 2011/10/4/pubmed PY - 2012/2/18/medline SP - 207 EP - 14 JF - High altitude medicine & biology JO - High Alt. Med. Biol. VL - 12 IS - 3 N2 - Exaggerated hypoxic pulmonary vasoconstriction is a key factor in the development of high altitude pulmonary edema (HAPE). Due to its effectiveness as a pulmonary vasodilator, sildenafil has been proposed as a prophylactic agent against HAPE. By conducting a parallel-group double blind, randomized, placebo-controlled trial, we investigated the effect of chronic sildenafil administration on pulmonary artery systolic pressure (PASP) and symptoms of acute mountain sickness (AMS) during acclimatization to high altitude. Sixty-two healthy lowland volunteers (36 male; median age 21 years, range 18 to 31) on the Apex 2 research expedition were flown to La Paz, Bolivia (3650 m), and after 4-5 days acclimatization ascended over 90 min to 5200 m. The treatment group (n=20) received 50 mg sildenafil citrate three times daily. PASP was recorded by echocardiography at sea level and within 6 h, 3 days, and 1 week at 5200 m. AMS was assessed daily using the Lake Louise Consensus symptom score. On intention-to-treat analysis, there was no significant difference in PASP at 5200 m between sildenafil and placebo groups. Median AMS score on Day 2 at 5200 m was significantly higher in the sildenafil group (placebo 4.0, sildenafil 6.5; p=0.004) but there was no difference in prevalence of AMS between groups. Sildenafil administration did not affect PASP in healthy lowland subjects at 5200 m but AMS was significantly more severe on Day 2 at 5200 m with sildenafil. Our data do not support routine prophylactic use of sildenafil to reduce PASP at high altitude in healthy subjects with no history of HAPE. TRIALS REGISTRATION NUMBER: NCT00627965. SN - 1557-8682 UR - https://www.unboundmedicine.com/medline/citation/21962063/Sildenafil_citrate_for_the_prevention_of_high_altitude_hypoxic_pulmonary_hypertension:_double_blind_randomized_placebo_controlled_trial_ L2 - https://www.liebertpub.com/doi/full/10.1089/ham.2011.0007?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -