TY - JOUR
T1 - Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men
T2 - Findings From the Systolic Blood Pressure Intervention Trial
AU - SPRINT Study Research Group
AU - Foy, Capri G.
AU - Newman, Jill C.
AU - Russell, Greg B.
AU - Berlowitz, Dan R.
AU - Bates, Jeffrey T.
AU - Burgner, Anna M.
AU - Carson, Thaddeus Y.
AU - Chertow, Glenn M.
AU - Doumas, Michael N.
AU - Hughes, Robin Y.
AU - Kostis, John B.
AU - Buren, Peter van
AU - Wadley, Virginia G.
N1 - Funding Information:
Funding: National Institutes of Health. The manuscript has not been published and is not being considered for publication elsewhere, in whole or in part, in any language. The Systolic Blood Pressure Intervention Trial is funded with Federal funds from the National Institutes of Health (NIH), including the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS), under Contract Numbers HHSN268200900040C, HHSN268200900046C, HHSN268200900047C, HHSN-268200900048C, HHSN268200900049C, and Inter-Agency Agreement Number A-HL-13-002-001. It was also supported in part with resources and use of facilities through the Department of Veterans Affairs.The SPRINT investigators acknowledge the contribution of study medications (azilsartan and azilsartan combined with chlorthalidone) from Takeda Pharmaceuticals International, Inc. All components of the SPRINT study protocol were designed and implemented by the investigators. The investigative team collected, analyzed, and interpreted the data. All aspects of manuscript writing and revision were carried out by the co-authors. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, the U.S. Department of Veterans Affairs, or the United States Government. For a full list of contributors to SPRINT, please see the Supplementary acknowledgement list, http://links.lww.com/HJH/A879. ClinicalTrials. gov Identifier: NCT01206062. We also acknowledge the support from the following CTSAs funded by NCATS: CWRU: UL1TR000439; OSU: UL1RR025755; U Penn: UL1RR024134 and UL1TR000003; Boston: UL1RR025771; Stanford: UL1TR000093; Tufts: UL1RR025752; UL1TR000073 and UL1TR001064; University of Illinois: UL1TR000050; University of Pittsburgh: UL1TR000005; UT Southwestern: 9U54TR000017-06; University of Utah: UL1TR000105-05; Vanderbilt University: UL1TR000445; George Washington University: UL1TR000075; University of California, Davis: UL1TR000002; University of Florida: UL1TR000064; University of Michigan: UL1TR000433; Tulane University: P30GM103337 COBRE Award NIGMS. Sources of funding support: The sources of support information for this analysis are listed above. For a full list of contributors to SPRINT, please see the Supplementary acknowledgement list: ClinicalTrials.gov Identifier: NCT01206062.
Funding Information:
The SPRINT investigators acknowledge the contribution of study medications (azilsartan and azilsartan combined with chlorthalidone) from Takeda Pharmaceuticals International, Inc. All components of the SPRINT study protocol were designed and implemented by the investigators. The investigative team collected, analyzed, and interpreted the data. All aspects of manuscript writing and revision were carried out by the co-authors. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, the U.S. Department of Veterans Affairs, or the United States Government. For a full list of contributors to SPRINT, please see the Supplementary acknowledgement list, http://links.lww.com/HJH/A879 . ClinicalTrials. gov Identifier: NCT01206062 . We also acknowledge the support from the following CTSAs funded by NCATS : CWRU : UL1TR000439 ; OSU : UL1RR025755 ; U Penn : UL1RR024134 and UL1TR000003 ; Boston : UL1RR025771 ; Stanford : UL1TR000093 ; Tufts : UL1RR025752 ; UL1TR000073 and UL1TR001064 ; University of Illinois : UL1TR000050 ; University of Pittsburgh : UL1TR000005 ; UT Southwestern : 9U54TR000017-06 ; University of Utah : UL1TR000105-05 ; Vanderbilt University : UL1TR000445 ; George Washington University : UL1TR000075 ; University of California, Davis : UL1TR000002 ; University of Florida : UL1TR000064 ; University of Michigan : UL1TR000433 ; Tulane University : P30GM103337 COBRE Award NIGMS. Sources of funding support: The sources of support information for this analysis are listed above. For a full list of contributors to SPRINT, please see the Supplementary acknowledgement list: ClinicalTrials.gov Identifier: NCT01206062 .
Publisher Copyright:
© 2019 International Society for Sexual Medicine
PY - 2020/2
Y1 - 2020/2
N2 - Introduction: The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. Aim: To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. Methods: We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). Main Outcome Measure: The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. Results: At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = −1.17; 95% CI = −1.92, −0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. Clinical Implications: The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. Strength & Limitations: Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. Conclusion: In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238–248.
AB - Introduction: The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. Aim: To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. Methods: We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). Main Outcome Measure: The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. Results: At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = −1.17; 95% CI = −1.92, −0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. Clinical Implications: The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. Strength & Limitations: Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. Conclusion: In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238–248.
KW - Erectile Function
KW - Hypertension
KW - Intensive Treatment for Blood Pressure
KW - Older Men
KW - Race and Ethnicity
KW - Sexual Function
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U2 - 10.1016/j.jsxm.2019.11.256
DO - 10.1016/j.jsxm.2019.11.256
M3 - Article
C2 - 31862174
AN - SCOPUS:85077151112
SN - 1743-6095
VL - 17
SP - 238
EP - 248
JO - Journal of Sexual Medicine
JF - Journal of Sexual Medicine
IS - 2
ER -