Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial

Abstract Normoferritinemic women with functional hyperandrogenism show a mild iron overload. Iron excess, hyperandrogenism, and cardioautonomic dysfunction contribute to blood pressure (BP) abnormalities in these patients. Furthermore, combined oral contraceptives (COC) prescribed for hyperandrogeni...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Manuel Luque-Ramírez, Andrés E. Ortiz-Flores, Lía Nattero-Chávez, M.Ángeles Martínez-García, María Insenser, Francisco Álvarez-Blasco, Elena Fernández-Durán, Alejandra Quintero-Tobar, Sara de Lope Quiñones, Héctor F. Escobar-Morreale
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/fbf94c7821594b41a9017221ebead0ac
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:fbf94c7821594b41a9017221ebead0ac
record_format	dspace
spelling	oai:doaj.org-article:fbf94c7821594b41a9017221ebead0ac2021-11-14T12:20:53ZBloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial10.1038/s41598-021-01606-72045-2322https://doaj.org/article/fbf94c7821594b41a9017221ebead0ac2021-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-01606-7https://doaj.org/toc/2045-2322Abstract Normoferritinemic women with functional hyperandrogenism show a mild iron overload. Iron excess, hyperandrogenism, and cardioautonomic dysfunction contribute to blood pressure (BP) abnormalities in these patients. Furthermore, combined oral contraceptives (COC) prescribed for hyperandrogenic symptoms may worse BP recordings. Iron depletion by phlebotomy appears to lower BP in other acquired iron overload conditions. We aimed to determine the effect of iron depletion on the office BP, ambulatory BP monitoring, and frequency of hypertension in patients with functional hyperandrogenism submitted to standard therapy with COC. We conducted a phase 2 randomized, controlled, parallel, open-label clinical trial (NCT02460445) in adult women with functional hyperandrogenism including hyperandrogenic polycystic ovary syndrome and idiopathic hyperandrogenism. After a 3-month run-in period of treatment with 35 µg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to three scheduled bloodlettings or observation for another 9 months. Main outcome measures were the changes in office BP, 24-h-ambulatory BP, and frequency of hypertension in both study arms. From June 2015 to June 2019, 33 women were included in the intention-to-treat analyses. We observed an increase in mean office systolic BP [mean of the differences (MD): 2.5 (0.3–4.8) mmHg] and night-time ambulatory systolic BP [MD 4.1 (1.4–6.8) mmHg] after 3 months on COC. The percentage of nocturnal BP non-dippers also increased, from 28.1 to 92.3% (P < 0.001). Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm. The frequency of the non-dipping pattern in BP decreased during the experimental period [OR 0.694 (0.577–0.835), P < 0.001], regardless of the study arm. Decreasing iron stores by scheduled bloodletting does not override the BP abnormalities caused by COC in women with functional hyperandrogenism.Manuel Luque-RamírezAndrés E. Ortiz-FloresLía Nattero-ChávezM.Ángeles Martínez-GarcíaMaría InsenserFrancisco Álvarez-BlascoElena Fernández-DuránAlejandra Quintero-TobarSara de Lope QuiñonesHéctor F. Escobar-MorrealeNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Manuel Luque-Ramírez Andrés E. Ortiz-Flores Lía Nattero-Chávez M.Ángeles Martínez-García María Insenser Francisco Álvarez-Blasco Elena Fernández-Durán Alejandra Quintero-Tobar Sara de Lope Quiñones Héctor F. Escobar-Morreale Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
description	Abstract Normoferritinemic women with functional hyperandrogenism show a mild iron overload. Iron excess, hyperandrogenism, and cardioautonomic dysfunction contribute to blood pressure (BP) abnormalities in these patients. Furthermore, combined oral contraceptives (COC) prescribed for hyperandrogenic symptoms may worse BP recordings. Iron depletion by phlebotomy appears to lower BP in other acquired iron overload conditions. We aimed to determine the effect of iron depletion on the office BP, ambulatory BP monitoring, and frequency of hypertension in patients with functional hyperandrogenism submitted to standard therapy with COC. We conducted a phase 2 randomized, controlled, parallel, open-label clinical trial (NCT02460445) in adult women with functional hyperandrogenism including hyperandrogenic polycystic ovary syndrome and idiopathic hyperandrogenism. After a 3-month run-in period of treatment with 35 µg ethinylestradiol plus 2 mg cyproterone acetate, participants were randomized (1:1) to three scheduled bloodlettings or observation for another 9 months. Main outcome measures were the changes in office BP, 24-h-ambulatory BP, and frequency of hypertension in both study arms. From June 2015 to June 2019, 33 women were included in the intention-to-treat analyses. We observed an increase in mean office systolic BP [mean of the differences (MD): 2.5 (0.3–4.8) mmHg] and night-time ambulatory systolic BP [MD 4.1 (1.4–6.8) mmHg] after 3 months on COC. The percentage of nocturnal BP non-dippers also increased, from 28.1 to 92.3% (P < 0.001). Office and ambulatory BP did not change throughout the experimental period of the trial, both when considering all women as a whole or as a function of the study arm. The frequency of the non-dipping pattern in BP decreased during the experimental period [OR 0.694 (0.577–0.835), P < 0.001], regardless of the study arm. Decreasing iron stores by scheduled bloodletting does not override the BP abnormalities caused by COC in women with functional hyperandrogenism.
format	article
author	Manuel Luque-Ramírez Andrés E. Ortiz-Flores Lía Nattero-Chávez M.Ángeles Martínez-García María Insenser Francisco Álvarez-Blasco Elena Fernández-Durán Alejandra Quintero-Tobar Sara de Lope Quiñones Héctor F. Escobar-Morreale
author_facet	Manuel Luque-Ramírez Andrés E. Ortiz-Flores Lía Nattero-Chávez M.Ángeles Martínez-García María Insenser Francisco Álvarez-Blasco Elena Fernández-Durán Alejandra Quintero-Tobar Sara de Lope Quiñones Héctor F. Escobar-Morreale
author_sort	Manuel Luque-Ramírez
title	Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
title_short	Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
title_full	Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
title_fullStr	Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
title_full_unstemmed	Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
title_sort	bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/fbf94c7821594b41a9017221ebead0ac
work_keys_str_mv	AT manuelluqueramirez bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT andreseortizflores bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT lianatterochavez bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT mangelesmartinezgarcia bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT mariainsenser bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT franciscoalvarezblasco bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT elenafernandezduran bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT alejandraquinterotobar bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT saradelopequinones bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial AT hectorfescobarmorreale bloodlettinghasnoeffectonthebloodpressureabnormalitiesofhyperandrogenicwomentakingoralcontraceptivesinarandomizedclinicaltrial
_version_	1718429266904875008

Bloodletting has no effect on the blood pressure abnormalities of hyperandrogenic women taking oral contraceptives in a randomized clinical trial

Ejemplares similares