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Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial.
Ann Intern Med. 2006 Oct 03; 145(7):497-506.AIM

Abstract

BACKGROUND

High-altitude pulmonary edema (HAPE) is caused by exaggerated hypoxic pulmonary vasoconstriction associated with decreased bioavailability of nitric oxide in the lungs and by impaired reabsorption of alveolar fluid.

OBJECTIVE

To investigate whether dexamethasone or tadalafil reduces the incidence of HAPE and acute mountain sickness (AMS) in adults with a history of HAPE.

DESIGN

Randomized, double-blind, placebo-controlled study performed in summer 2003.

SETTING

Ascent from 490 m within 24 hours and stay for 2 nights at 4559 m.

PATIENTS

29 adults with previous HAPE.

INTERVENTION

Prophylactic tadalafil (10 mg), dexamethasone (8 mg), or placebo twice daily during ascent and stay at 4559 m.

MEASUREMENTS

Chest radiography was used to diagnose HAPE. A Lake Louise score greater than 4 defined AMS. Systolic pulmonary artery pressure was measured by using Doppler echocardiography, and nasal potentials were measured as a surrogate marker of alveolar sodium transport.

RESULTS

Two participants who received tadalafil developed severe AMS on arrival at 4559 m and withdrew from the study; they did not have HAPE at that time. High-altitude pulmonary edema developed in 7 of 9 participants receiving placebo and 1 of the remaining 8 participants receiving tadalafil but in none of the 10 participants receiving dexamethasone (P = 0.007 for tadalafil vs. placebo; P < 0.001 for dexamethasone vs. placebo). Eight of 9 participants receiving placebo, 7 of 10 receiving tadalafil, and 3 of 10 receiving dexamethasone had AMS (P = 1.0 for tadalafil vs. placebo; P = 0.020 for dexamethasone vs. placebo). At high altitude, systolic pulmonary artery pressure increased less in participants receiving dexamethasone (16 mm Hg [95% CI, 9 to 23 mm Hg]) and tadalafil (13 mm Hg [CI, 6 to 20 mm Hg]) than in those receiving placebo (28 mm Hg [CI, 20 to 36 mm Hg]) (P = 0.005 for tadalafil vs. placebo; P = 0.012 for dexamethasone vs. placebo). No statistically significant difference between groups was found in change in nasal potentials and expression of leukocyte sodium transport protein messenger RNA.

LIMITATIONS

The study involved a small sample of adults with a history of HAPE.

CONCLUSIONS

Both dexamethasone and tadalafil decrease systolic pulmonary artery pressure and may reduce the incidence of HAPE in adults with a history of HAPE. Dexamethasone prophylaxis may also reduce the incidence of AMS in these adults. ClinicalTrials.gov identifier: NCT00274430.

Authors+Show Affiliations

University Hospital Zürich, Zürich, Switzerland; Université de Bruxelles, Brussels, Belgium. klinmax@usz.unizh.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17015867

Citation

Maggiorini, Marco, et al. "Both Tadalafil and Dexamethasone May Reduce the Incidence of High-altitude Pulmonary Edema: a Randomized Trial." Annals of Internal Medicine, vol. 145, no. 7, 2006, pp. 497-506.
Maggiorini M, Brunner-La Rocca HP, Peth S, et al. Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial. Ann Intern Med. 2006;145(7):497-506.
Maggiorini, M., Brunner-La Rocca, H. P., Peth, S., Fischler, M., Böhm, T., Bernheim, A., Kiencke, S., Bloch, K. E., Dehnert, C., Naeije, R., Lehmann, T., Bärtsch, P., & Mairbäurl, H. (2006). Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial. Annals of Internal Medicine, 145(7), 497-506.
Maggiorini M, et al. Both Tadalafil and Dexamethasone May Reduce the Incidence of High-altitude Pulmonary Edema: a Randomized Trial. Ann Intern Med. 2006 Oct 3;145(7):497-506. PubMed PMID: 17015867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomized trial. AU - Maggiorini,Marco, AU - Brunner-La Rocca,Hans-Peter, AU - Peth,Simon, AU - Fischler,Manuel, AU - Böhm,Thomas, AU - Bernheim,Alain, AU - Kiencke,Stefanie, AU - Bloch,Konrad E, AU - Dehnert,Christoph, AU - Naeije,Robert, AU - Lehmann,Thomas, AU - Bärtsch,Peter, AU - Mairbäurl,Heimo, PY - 2006/10/4/pubmed PY - 2006/10/19/medline PY - 2006/10/4/entrez SP - 497 EP - 506 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 145 IS - 7 N2 - BACKGROUND: High-altitude pulmonary edema (HAPE) is caused by exaggerated hypoxic pulmonary vasoconstriction associated with decreased bioavailability of nitric oxide in the lungs and by impaired reabsorption of alveolar fluid. OBJECTIVE: To investigate whether dexamethasone or tadalafil reduces the incidence of HAPE and acute mountain sickness (AMS) in adults with a history of HAPE. DESIGN: Randomized, double-blind, placebo-controlled study performed in summer 2003. SETTING: Ascent from 490 m within 24 hours and stay for 2 nights at 4559 m. PATIENTS: 29 adults with previous HAPE. INTERVENTION: Prophylactic tadalafil (10 mg), dexamethasone (8 mg), or placebo twice daily during ascent and stay at 4559 m. MEASUREMENTS: Chest radiography was used to diagnose HAPE. A Lake Louise score greater than 4 defined AMS. Systolic pulmonary artery pressure was measured by using Doppler echocardiography, and nasal potentials were measured as a surrogate marker of alveolar sodium transport. RESULTS: Two participants who received tadalafil developed severe AMS on arrival at 4559 m and withdrew from the study; they did not have HAPE at that time. High-altitude pulmonary edema developed in 7 of 9 participants receiving placebo and 1 of the remaining 8 participants receiving tadalafil but in none of the 10 participants receiving dexamethasone (P = 0.007 for tadalafil vs. placebo; P < 0.001 for dexamethasone vs. placebo). Eight of 9 participants receiving placebo, 7 of 10 receiving tadalafil, and 3 of 10 receiving dexamethasone had AMS (P = 1.0 for tadalafil vs. placebo; P = 0.020 for dexamethasone vs. placebo). At high altitude, systolic pulmonary artery pressure increased less in participants receiving dexamethasone (16 mm Hg [95% CI, 9 to 23 mm Hg]) and tadalafil (13 mm Hg [CI, 6 to 20 mm Hg]) than in those receiving placebo (28 mm Hg [CI, 20 to 36 mm Hg]) (P = 0.005 for tadalafil vs. placebo; P = 0.012 for dexamethasone vs. placebo). No statistically significant difference between groups was found in change in nasal potentials and expression of leukocyte sodium transport protein messenger RNA. LIMITATIONS: The study involved a small sample of adults with a history of HAPE. CONCLUSIONS: Both dexamethasone and tadalafil decrease systolic pulmonary artery pressure and may reduce the incidence of HAPE in adults with a history of HAPE. Dexamethasone prophylaxis may also reduce the incidence of AMS in these adults. ClinicalTrials.gov identifier: NCT00274430. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/17015867/full_citation L2 - https://www.annals.org/aim/fullarticle/doi/10.7326/0003-4819-145-7-200610030-00007 DB - PRIME DP - Unbound Medicine ER -