Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial

G. Mancia; G. Cha; B. Gil-Extremera; P. Harvey; A. J. Lewin; G. Villa; S. E. Kjeldsen; J. Agaiby; N. Aggarwal; P. Ainsworth; R. Akhras; V. Amaluan; A. Ballarin; L. Bardauskiene; F. C. Berra; M. Blagden; B. Bodalia; C. Borghi; C. Bundy; L. Burgess; R. Buynak; A. Cafferata; T. Cahill; L. Capiau; V. Capuano; R. Casanova; J. Cecil; G. Cha; J. Chapman; M. Chilvers; S. Christensen; Y. H. Cho; W. B. Chung; F. Cipollone; A. Coca; H. Colombo; E. M. Contreras; D. Crowley; B. Cusco-Prieto; F. Decarlini; J. H. Doh; P. Dzongowski; G. Dzyak; A. Ellery; B. G. Extremera; E. Farias; C. Farrington; J. Fidelholtz; L. Fouche; A. Gabito; M. Gainza; M. Gani; R. Gaunt; E. Gelersztein; M. Giuliano; A. Glazunov; N. Glorioso; B. Goloschekin; M. Gumbley; A. Gupta; L. Guzman; J. W. Ha; R. Hart; P. Harvey; D. Haworth; S. Henein; D. Henry; S. H. Her; F. Heyvaert; G. Hollanders; M. Hominal; B. K. Hong; T. J. Hong; K. K. Hwang; A. Jacovides; J. Jacqmein; H. K. Jeon; N. Jones; S. Kanani; H. Kang; O. Karpenko; D. Kenton; N. Kimzey; S. E. Kjeldsen; V. Kovalenko; M. Kushnir; B. Lasko; K. J. Lee; N. Lee; A. Lewin; M. Litvak; D. Luksiene; C. Majul; E. Mannarino; O. Manuale; A. Marcadis; D. Miller; R. Mills; K. Misik; J. Mortelmans; M. O'Mahony; W. O'Mahony; C. Park; R. Pedrinelli; Z. Petrulioniene; F. Pettyjohn; D. Piskorz; G. Poss; K. Pudi; W. B. Pyun; G. Raad; G. Raila; M. F. Ramirez Espinosa; P. Ramlachan; M. Rhee; L. Rudenko; T. S. Ruiz; J. Ryan; G. Schacter; J. H. Shin; D. Short; D. Sica; Y. Sirenko; R. Slapikas; R. Somani; M. Stanislavchuk; R. Stewart; Y. Svishchenko; O. Sychov; I. Teitelbaum; V. Tseluyko; D. J. Van Rensburg; J. V. Vaquer Perez; L. M. Via; M. Vico; G. Villa; V. Vizir; D. Vogel; H. Wellmann; B. S. Yoo

doi:10.1038/jhh.2016.54

Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial

G. Mancia
, G. Cha
, B. Gil-Extremera
, P. Harvey
, A. J. Lewin
, G. Villa
, S. E. Kjeldsen
, J. Agaiby
, N. Aggarwal
, P. Ainsworth
, R. Akhras
, V. Amaluan
, A. Ballarin
, L. Bardauskiene
, F. C. Berra
, M. Blagden
, B. Bodalia
, C. Borghi
, C. Bundy
, L. Burgess

R. Buynak, A. Cafferata, T. Cahill, L. Capiau, V. Capuano, R. Casanova, J. Cecil, G. Cha, J. Chapman, M. Chilvers, S. Christensen, Y. H. Cho, W. B. Chung, F. Cipollone, A. Coca, H. Colombo, E. M. Contreras, D. Crowley, B. Cusco-Prieto, F. Decarlini, J. H. Doh, P. Dzongowski, G. Dzyak, A. Ellery, B. G. Extremera, E. Farias, C. Farrington, J. Fidelholtz, L. Fouche, A. Gabito, M. Gainza, M. Gani, R. Gaunt, E. Gelersztein, M. Giuliano, A. Glazunov, N. Glorioso, B. Goloschekin, M. Gumbley, A. Gupta, L. Guzman, J. W. Ha, R. Hart, P. Harvey, D. Haworth, S. Henein, D. Henry, S. H. Her, F. Heyvaert, G. Hollanders, M. Hominal, B. K. Hong, T. J. Hong, K. K. Hwang, A. Jacovides, J. Jacqmein, H. K. Jeon, N. Jones, S. Kanani, H. Kang, O. Karpenko, D. Kenton, N. Kimzey, S. E. Kjeldsen, V. Kovalenko, M. Kushnir, B. Lasko, K. J. Lee, N. Lee, A. Lewin, M. Litvak, D. Luksiene, C. Majul, E. Mannarino, O. Manuale, A. Marcadis, D. Miller, R. Mills, K. Misik, J. Mortelmans, M. O'Mahony, W. O'Mahony, C. Park, R. Pedrinelli, Z. Petrulioniene, F. Pettyjohn, D. Piskorz, G. Poss, K. Pudi, W. B. Pyun, G. Raad, G. Raila, M. F. Ramirez Espinosa, P. Ramlachan, M. Rhee, L. Rudenko, T. S. Ruiz, J. Ryan, G. Schacter, J. H. Shin, D. Short, D. Sica, Y. Sirenko, R. Slapikas, R. Somani, M. Stanislavchuk, R. Stewart, Y. Svishchenko, O. Sychov, I. Teitelbaum, V. Tseluyko, D. J. Van Rensburg, J. V. Vaquer Perez, L. M. Via, M. Vico, G. Villa, V. Vizir, D. Vogel, H. Wellmann, B. S. Yoo

Department of Internal Medicine

University of Milan - Bicocca
KRK Medical Research Institute
Hospital Universitario San Cecilio
Crouch Oak Family Practice
National Research Institute
IRCCS Istituti Clinici Scientifici Maugeri S.p.A. SB - Pavia
University of Oslo

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate<90 ml min^-1, n=422), type 2 diabetes mellitus (n=202), hypercholesterolaemia (n=206) and cardiovascular (CV) risk factors (n=971), as well as the impact of gender, age and body mass index (BMI). Participants with grade I/II hypertension were randomised to treatment with nifedipine GITS (N) 20, 30, 60 mg and/or candesartan cilexetil (C) 4, 8, 16, 32 mg or placebo for 8 weeks. Mean systolic BP and diastolic BP reductions after treatment in high-risk participants were greater, overall, with N/C combinations vs respective monotherapies or placebo, with indicators of a dose-response effect. Highest rates of BP control (ESH/ESC 2013 guideline criteria) were also achieved with highest doses of N/C combinations in each high-risk subgroup. The benefits of combination therapy vs monotherapy were additionally observed in patient subgroups categorised by gender, age or BMI. All high-risk participants reported fewer vasodilatory adverse events in the pooled N/C combination therapy than the N monotherapy group. In conclusion, consistent with the DISTINCT main study outcomes, high-risk participants showed greater reductions in BP and higher control rates with N/C combinations compared with respective monotherapies and lesser vasodilatory side-effects compared with N monotherapy.

Original language	English
Pages (from-to)	178-188
Number of pages	11
Journal	Journal of Human Hypertension
Volume	31
Issue number	3
DOIs	https://doi.org/10.1038/jhh.2016.54
State	Published - 1 Mar 2017

Bibliographical note

Publisher Copyright:
© The Author(s) 2017.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1038/jhh.2016.54

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Mancia, G., Cha, G., Gil-Extremera, B., Harvey, P., Lewin, A. J., Villa, G., Kjeldsen, S. E., Agaiby, J., Aggarwal, N., Ainsworth, P., Akhras, R., Amaluan, V., Ballarin, A., Bardauskiene, L., Berra, F. C., Blagden, M., Bodalia, B., Borghi, C., Bundy, C., ... Yoo, B. S. (2017). Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial. Journal of Human Hypertension, 31(3), 178-188. https://doi.org/10.1038/jhh.2016.54

@article{b3745254d68f4adeab8da9f0fb933dcb,

title = "Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial",

abstract = "The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate<90 ml min-1, n=422), type 2 diabetes mellitus (n=202), hypercholesterolaemia (n=206) and cardiovascular (CV) risk factors (n=971), as well as the impact of gender, age and body mass index (BMI). Participants with grade I/II hypertension were randomised to treatment with nifedipine GITS (N) 20, 30, 60 mg and/or candesartan cilexetil (C) 4, 8, 16, 32 mg or placebo for 8 weeks. Mean systolic BP and diastolic BP reductions after treatment in high-risk participants were greater, overall, with N/C combinations vs respective monotherapies or placebo, with indicators of a dose-response effect. Highest rates of BP control (ESH/ESC 2013 guideline criteria) were also achieved with highest doses of N/C combinations in each high-risk subgroup. The benefits of combination therapy vs monotherapy were additionally observed in patient subgroups categorised by gender, age or BMI. All high-risk participants reported fewer vasodilatory adverse events in the pooled N/C combination therapy than the N monotherapy group. In conclusion, consistent with the DISTINCT main study outcomes, high-risk participants showed greater reductions in BP and higher control rates with N/C combinations compared with respective monotherapies and lesser vasodilatory side-effects compared with N monotherapy.",

author = "G. Mancia and G. Cha and B. Gil-Extremera and P. Harvey and Lewin, \{A. J.\} and G. Villa and Kjeldsen, \{S. E.\} and J. Agaiby and N. Aggarwal and P. Ainsworth and R. Akhras and V. Amaluan and A. Ballarin and L. Bardauskiene and Berra, \{F. C.\} and M. Blagden and B. Bodalia and C. Borghi and C. Bundy and L. Burgess and R. Buynak and A. Cafferata and T. Cahill and L. Capiau and V. Capuano and R. Casanova and J. Cecil and G. Cha and J. Chapman and M. Chilvers and S. Christensen and Cho, \{Y. H.\} and Chung, \{W. B.\} and F. Cipollone and A. Coca and H. Colombo and Contreras, \{E. M.\} and D. Crowley and B. Cusco-Prieto and F. Decarlini and Doh, \{J. H.\} and P. Dzongowski and G. Dzyak and A. Ellery and Extremera, \{B. G.\} and E. Farias and C. Farrington and J. Fidelholtz and L. Fouche and A. Gabito and M. Gainza and M. Gani and R. Gaunt and E. Gelersztein and M. Giuliano and A. Glazunov and N. Glorioso and B. Goloschekin and M. Gumbley and A. Gupta and L. Guzman and Ha, \{J. W.\} and R. Hart and P. Harvey and D. Haworth and S. Henein and D. Henry and Her, \{S. H.\} and F. Heyvaert and G. Hollanders and M. Hominal and Hong, \{B. K.\} and Hong, \{T. J.\} and Hwang, \{K. K.\} and A. Jacovides and J. Jacqmein and Jeon, \{H. K.\} and N. Jones and S. Kanani and H. Kang and O. Karpenko and D. Kenton and N. Kimzey and Kjeldsen, \{S. E.\} and V. Kovalenko and M. Kushnir and B. Lasko and Lee, \{K. J.\} and N. Lee and A. Lewin and M. Litvak and D. Luksiene and C. Majul and E. Mannarino and O. Manuale and A. Marcadis and D. Miller and R. Mills and K. Misik and J. Mortelmans and M. O'Mahony and W. O'Mahony and C. Park and R. Pedrinelli and Z. Petrulioniene and F. Pettyjohn and D. Piskorz and G. Poss and K. Pudi and Pyun, \{W. B.\} and G. Raad and G. Raila and \{Ramirez Espinosa\}, \{M. F.\} and P. Ramlachan and M. Rhee and L. Rudenko and Ruiz, \{T. S.\} and J. Ryan and G. Schacter and Shin, \{J. H.\} and D. Short and D. Sica and Y. Sirenko and R. Slapikas and R. Somani and M. Stanislavchuk and R. Stewart and Y. Svishchenko and O. Sychov and I. Teitelbaum and V. Tseluyko and \{Van Rensburg\}, \{D. J.\} and \{Vaquer Perez\}, \{J. V.\} and Via, \{L. M.\} and M. Vico and G. Villa and V. Vizir and D. Vogel and H. Wellmann and Yoo, \{B. S.\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2017.",

year = "2017",

month = mar,

day = "1",

doi = "10.1038/jhh.2016.54",

language = "English",

volume = "31",

pages = "178--188",

journal = "Journal of Human Hypertension",

issn = "0950-9240",

publisher = "Springer Nature",

number = "3",

}

Mancia, G, Cha, G, Gil-Extremera, B, Harvey, P, Lewin, AJ, Villa, G, Kjeldsen, SE, Agaiby, J, Aggarwal, N, Ainsworth, P, Akhras, R, Amaluan, V, Ballarin, A, Bardauskiene, L, Berra, FC, Blagden, M, Bodalia, B, Borghi, C, Bundy, C, Burgess, L, Buynak, R, Cafferata, A, Cahill, T, Capiau, L, Capuano, V, Casanova, R, Cecil, J, Cha, G, Chapman, J, Chilvers, M, Christensen, S, Cho, YH, Chung, WB, Cipollone, F, Coca, A, Colombo, H, Contreras, EM, Crowley, D, Cusco-Prieto, B, Decarlini, F, Doh, JH, Dzongowski, P, Dzyak, G, Ellery, A, Extremera, BG, Farias, E, Farrington, C, Fidelholtz, J, Fouche, L, Gabito, A, Gainza, M, Gani, M, Gaunt, R, Gelersztein, E, Giuliano, M, Glazunov, A, Glorioso, N, Goloschekin, B, Gumbley, M, Gupta, A, Guzman, L, Ha, JW, Hart, R, Harvey, P, Haworth, D, Henein, S, Henry, D, Her, SH, Heyvaert, F, Hollanders, G, Hominal, M, Hong, BK, Hong, TJ, Hwang, KK, Jacovides, A, Jacqmein, J, Jeon, HK, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, Kjeldsen, SE, Kovalenko, V, Kushnir, M, Lasko, B, Lee, KJ, Lee, N, Lewin, A, Litvak, M, Luksiene, D, Majul, C, Mannarino, E, Manuale, O, Marcadis, A, Miller, D, Mills, R, Misik, K, Mortelmans, J, O'Mahony, M, O'Mahony, W, Park, C, Pedrinelli, R, Petrulioniene, Z, Pettyjohn, F, Piskorz, D, Poss, G, Pudi, K, Pyun, WB, Raad, G, Raila, G, Ramirez Espinosa, MF, Ramlachan, P, Rhee, M, Rudenko, L, Ruiz, TS, Ryan, J, Schacter, G, Shin, JH, Short, D, Sica, D, Sirenko, Y, Slapikas, R, Somani, R, Stanislavchuk, M, Stewart, R, Svishchenko, Y, Sychov, O, Teitelbaum, I, Tseluyko, V, Van Rensburg, DJ, Vaquer Perez, JV, Via, LM, Vico, M, Villa, G, Vizir, V, Vogel, D, Wellmann, H & Yoo, BS 2017, 'Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial', Journal of Human Hypertension, vol. 31, no. 3, pp. 178-188. https://doi.org/10.1038/jhh.2016.54

TY - JOUR

T1 - Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals

T2 - Subgroup analysis of the DISTINCT randomised trial

AU - Mancia, G.

AU - Cha, G.

AU - Gil-Extremera, B.

AU - Harvey, P.

AU - Lewin, A. J.

AU - Villa, G.

AU - Kjeldsen, S. E.

AU - Agaiby, J.

AU - Aggarwal, N.

AU - Ainsworth, P.

AU - Akhras, R.

AU - Amaluan, V.

AU - Ballarin, A.

AU - Bardauskiene, L.

AU - Berra, F. C.

AU - Blagden, M.

AU - Bodalia, B.

AU - Borghi, C.

AU - Bundy, C.

AU - Burgess, L.

AU - Buynak, R.

AU - Cafferata, A.

AU - Cahill, T.

AU - Capiau, L.

AU - Capuano, V.

AU - Casanova, R.

AU - Cecil, J.

AU - Cha, G.

AU - Chapman, J.

AU - Chilvers, M.

AU - Christensen, S.

AU - Cho, Y. H.

AU - Chung, W. B.

AU - Cipollone, F.

AU - Coca, A.

AU - Colombo, H.

AU - Contreras, E. M.

AU - Crowley, D.

AU - Cusco-Prieto, B.

AU - Decarlini, F.

AU - Doh, J. H.

AU - Dzongowski, P.

AU - Dzyak, G.

AU - Ellery, A.

AU - Extremera, B. G.

AU - Farias, E.

AU - Farrington, C.

AU - Fidelholtz, J.

AU - Fouche, L.

AU - Gabito, A.

AU - Gainza, M.

AU - Gani, M.

AU - Gaunt, R.

AU - Gelersztein, E.

AU - Giuliano, M.

AU - Glazunov, A.

AU - Glorioso, N.

AU - Goloschekin, B.

AU - Gumbley, M.

AU - Gupta, A.

AU - Guzman, L.

AU - Ha, J. W.

AU - Hart, R.

AU - Harvey, P.

AU - Haworth, D.

AU - Henein, S.

AU - Henry, D.

AU - Her, S. H.

AU - Heyvaert, F.

AU - Hollanders, G.

AU - Hominal, M.

AU - Hong, B. K.

AU - Hong, T. J.

AU - Hwang, K. K.

AU - Jacovides, A.

AU - Jacqmein, J.

AU - Jeon, H. K.

AU - Jones, N.

AU - Kanani, S.

AU - Kang, H.

AU - Karpenko, O.

AU - Kenton, D.

AU - Kimzey, N.

AU - Kjeldsen, S. E.

AU - Kovalenko, V.

AU - Kushnir, M.

AU - Lasko, B.

AU - Lee, K. J.

AU - Lee, N.

AU - Lewin, A.

AU - Litvak, M.

AU - Luksiene, D.

AU - Majul, C.

AU - Mannarino, E.

AU - Manuale, O.

AU - Marcadis, A.

AU - Miller, D.

AU - Mills, R.

AU - Misik, K.

AU - Mortelmans, J.

AU - O'Mahony, M.

AU - O'Mahony, W.

AU - Park, C.

AU - Pedrinelli, R.

AU - Petrulioniene, Z.

AU - Pettyjohn, F.

AU - Piskorz, D.

AU - Poss, G.

AU - Pudi, K.

AU - Pyun, W. B.

AU - Raad, G.

AU - Raila, G.

AU - Ramirez Espinosa, M. F.

AU - Ramlachan, P.

AU - Rhee, M.

AU - Rudenko, L.

AU - Ruiz, T. S.

AU - Ryan, J.

AU - Schacter, G.

AU - Shin, J. H.

AU - Short, D.

AU - Sica, D.

AU - Sirenko, Y.

AU - Slapikas, R.

AU - Somani, R.

AU - Stanislavchuk, M.

AU - Stewart, R.

AU - Svishchenko, Y.

AU - Sychov, O.

AU - Teitelbaum, I.

AU - Tseluyko, V.

AU - Van Rensburg, D. J.

AU - Vaquer Perez, J. V.

AU - Via, L. M.

AU - Vico, M.

AU - Villa, G.

AU - Vizir, V.

AU - Vogel, D.

AU - Wellmann, H.

AU - Yoo, B. S.

PY - 2017/3/1

Y1 - 2017/3/1

N2 - The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate<90 ml min-1, n=422), type 2 diabetes mellitus (n=202), hypercholesterolaemia (n=206) and cardiovascular (CV) risk factors (n=971), as well as the impact of gender, age and body mass index (BMI). Participants with grade I/II hypertension were randomised to treatment with nifedipine GITS (N) 20, 30, 60 mg and/or candesartan cilexetil (C) 4, 8, 16, 32 mg or placebo for 8 weeks. Mean systolic BP and diastolic BP reductions after treatment in high-risk participants were greater, overall, with N/C combinations vs respective monotherapies or placebo, with indicators of a dose-response effect. Highest rates of BP control (ESH/ESC 2013 guideline criteria) were also achieved with highest doses of N/C combinations in each high-risk subgroup. The benefits of combination therapy vs monotherapy were additionally observed in patient subgroups categorised by gender, age or BMI. All high-risk participants reported fewer vasodilatory adverse events in the pooled N/C combination therapy than the N monotherapy group. In conclusion, consistent with the DISTINCT main study outcomes, high-risk participants showed greater reductions in BP and higher control rates with N/C combinations compared with respective monotherapies and lesser vasodilatory side-effects compared with N monotherapy.

AB - The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate<90 ml min-1, n=422), type 2 diabetes mellitus (n=202), hypercholesterolaemia (n=206) and cardiovascular (CV) risk factors (n=971), as well as the impact of gender, age and body mass index (BMI). Participants with grade I/II hypertension were randomised to treatment with nifedipine GITS (N) 20, 30, 60 mg and/or candesartan cilexetil (C) 4, 8, 16, 32 mg or placebo for 8 weeks. Mean systolic BP and diastolic BP reductions after treatment in high-risk participants were greater, overall, with N/C combinations vs respective monotherapies or placebo, with indicators of a dose-response effect. Highest rates of BP control (ESH/ESC 2013 guideline criteria) were also achieved with highest doses of N/C combinations in each high-risk subgroup. The benefits of combination therapy vs monotherapy were additionally observed in patient subgroups categorised by gender, age or BMI. All high-risk participants reported fewer vasodilatory adverse events in the pooled N/C combination therapy than the N monotherapy group. In conclusion, consistent with the DISTINCT main study outcomes, high-risk participants showed greater reductions in BP and higher control rates with N/C combinations compared with respective monotherapies and lesser vasodilatory side-effects compared with N monotherapy.

UR - https://www.scopus.com/pages/publications/84981164341

U2 - 10.1038/jhh.2016.54

DO - 10.1038/jhh.2016.54

M3 - Article

C2 - 27511476

AN - SCOPUS:84981164341

SN - 0950-9240

VL - 31

SP - 178

EP - 188

JO - Journal of Human Hypertension

JF - Journal of Human Hypertension

IS - 3

ER -

Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial

Abstract

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