Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

Anthony Rodgers; Abdul Salam; William Cushman; Asita de Silva; Gian Luca Di Tanna; Sonali R. Gnanenthiran; Diederick Grobbee; Krzysztof Narkiewicz; Dike Ojji; Suzanne Oparil; Neil Poulter; Markus P. Schlaich; Aletta E. Schutte; Wilko Spiering; Bryan Williams; Jackson T. Wright; Paul Whelton

doi:10.5334/gh.1283

Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

Anthony Rodgers^*, Abdul Salam, William Cushman, Asita de Silva, Gian Luca Di Tanna, Sonali R. Gnanenthiran, Diederick Grobbee, Krzysztof Narkiewicz, Dike Ojji, Suzanne Oparil, Neil Poulter, Markus P. Schlaich, Aletta E. Schutte, Wilko Spiering, Bryan Williams, Jackson T. Wright, Paul Whelton

^*Corresponding author for this work

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

Abstract

Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these ‘hypertension polypills’ were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/ indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.

Original language	English
Article number	18
Journal	Global Heart
Volume	19
Issue number	1
DOIs	https://doi.org/10.5334/gh.1283
Publication status	Published - 14 Feb 2024

Keywords

blood pressure
fixed dose
hypertension
polypill
single pill combination

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10.5334/gh.1283Licence: CC BY

65cc968cf354eFinal published version, 2.27 MBLicence: CC BY

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Rodgers, A., Salam, A., Cushman, W., de Silva, A., Di Tanna, G. L., Gnanenthiran, S. R., Grobbee, D., Narkiewicz, K., Ojji, D., Oparil, S., Poulter, N., Schlaich, M. P., Schutte, A. E., Spiering, W., Williams, B., Wright, J. T., & Whelton, P. (2024). Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension. Global Heart, 19(1), Article 18. https://doi.org/10.5334/gh.1283

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title = "Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension",

abstract = "Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these {\textquoteleft}hypertension polypills{\textquoteright} were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/ indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.",

keywords = "blood pressure, fixed dose, hypertension, polypill, single pill combination",

author = "Anthony Rodgers and Abdul Salam and William Cushman and {de Silva}, Asita and {Di Tanna}, {Gian Luca} and Gnanenthiran, {Sonali R.} and Diederick Grobbee and Krzysztof Narkiewicz and Dike Ojji and Suzanne Oparil and Neil Poulter and Schlaich, {Markus P.} and Schutte, {Aletta E.} and Wilko Spiering and Bryan Williams and Wright, {Jackson T.} and Paul Whelton",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.",

year = "2024",

month = feb,

day = "14",

doi = "10.5334/gh.1283",

language = "English",

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Rodgers, A, Salam, A, Cushman, W, de Silva, A, Di Tanna, GL, Gnanenthiran, SR, Grobbee, D, Narkiewicz, K, Ojji, D, Oparil, S, Poulter, N, Schlaich, MP, Schutte, AE, Spiering, W, Williams, B, Wright, JT & Whelton, P 2024, 'Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension', Global Heart, vol. 19, no. 1, 18. https://doi.org/10.5334/gh.1283

TY - JOUR

T1 - Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

AU - Rodgers, Anthony

AU - Salam, Abdul

AU - Cushman, William

AU - de Silva, Asita

AU - Di Tanna, Gian Luca

AU - Gnanenthiran, Sonali R.

AU - Grobbee, Diederick

AU - Narkiewicz, Krzysztof

AU - Ojji, Dike

AU - Oparil, Suzanne

AU - Poulter, Neil

AU - Schlaich, Markus P.

AU - Schutte, Aletta E.

AU - Spiering, Wilko

AU - Williams, Bryan

AU - Wright, Jackson T.

AU - Whelton, Paul

N1 - Publisher Copyright: © 2024 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/.

PY - 2024/2/14

Y1 - 2024/2/14

N2 - Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these ‘hypertension polypills’ were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/ indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.

AB - Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these ‘hypertension polypills’ were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/ indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.

KW - blood pressure

KW - fixed dose

KW - hypertension

KW - polypill

KW - single pill combination

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U2 - 10.5334/gh.1283

DO - 10.5334/gh.1283

M3 - Article

C2 - 38371656

AN - SCOPUS:85185614754

SN - 2211-8160

VL - 19

JO - Global Heart

JF - Global Heart

IS - 1

M1 - 18

ER -

Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

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