Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination

The ALL-IN-ONE trial

Giuseppe Marazzi, Francesco Pelliccia, Giuseppe Campolongo, Luca Cacciotti, Rosalba Massaro, Sara Poggi, Alessandra Tanzilli, Martina Di Iorio, Maurizio Volterrani, Mitja Lainscak, Giuseppe M. Rosano

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. Methods The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The “fixed group” was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg. The “free group” was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. Results At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p = 0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. Conclusion This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539

Original languageEnglish
Pages (from-to)885-887
Number of pages3
JournalInternational Journal of Cardiology
Volume222
DOIs
Publication statusPublished - Nov 1 2016

Fingerprint

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Drug Combinations
Risk Reduction Behavior
Indapamide
Antihypertensive Agents
Compliance
Amlodipine
Cholesterol
Safety
Multicenter Studies
Therapeutics
Serum
Atorvastatin Calcium

Keywords

  • Cardiovascular risk
  • Combination therapy
  • Hypercholesterolemia
  • Hypertension

ASJC Scopus subject areas

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine

Cite this

Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination : The ALL-IN-ONE trial. / Marazzi, Giuseppe; Pelliccia, Francesco; Campolongo, Giuseppe; Cacciotti, Luca; Massaro, Rosalba; Poggi, Sara; Tanzilli, Alessandra; Di Iorio, Martina; Volterrani, Maurizio; Lainscak, Mitja; Rosano, Giuseppe M.

In: International Journal of Cardiology, Vol. 222, 01.11.2016, p. 885-887.

Research output: Contribution to journalArticle

@article{cf27130dd36e4e27ab56678792fa2775,
title = "Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial",
abstract = "Background The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. Methods The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The “fixed group” was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg. The “free group” was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. Results At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89{\%} and 80{\%} respectively, p = 0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. Conclusion This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539",
keywords = "Cardiovascular risk, Combination therapy, Hypercholesterolemia, Hypertension",
author = "Giuseppe Marazzi and Francesco Pelliccia and Giuseppe Campolongo and Luca Cacciotti and Rosalba Massaro and Sara Poggi and Alessandra Tanzilli and {Di Iorio}, Martina and Maurizio Volterrani and Mitja Lainscak and Rosano, {Giuseppe M.}",
year = "2016",
month = "11",
day = "1",
doi = "10.1016/j.ijcard.2016.07.163",
language = "English",
volume = "222",
pages = "885--887",
journal = "International Journal of Cardiology",
issn = "0167-5273",
publisher = "Elsevier Ireland Ltd",

}

TY - JOUR

T1 - Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination

T2 - The ALL-IN-ONE trial

AU - Marazzi, Giuseppe

AU - Pelliccia, Francesco

AU - Campolongo, Giuseppe

AU - Cacciotti, Luca

AU - Massaro, Rosalba

AU - Poggi, Sara

AU - Tanzilli, Alessandra

AU - Di Iorio, Martina

AU - Volterrani, Maurizio

AU - Lainscak, Mitja

AU - Rosano, Giuseppe M.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Background The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. Methods The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The “fixed group” was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg. The “free group” was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. Results At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p = 0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. Conclusion This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539

AB - Background The ultimate goal of antihypertensive therapy is cardiovascular risk (CVR) reduction. The aim of this study was to compare the efficacy and safety of once-daily fixed combination (ODFC) versus free-drug combination (FDC) of 3antihypertensive agents and statin. Methods The ALL-IN-ONE trial was a 12-week randomized, prospective, multicenter trial. A total of 305 hypertensive patients were randomized 1:1. The “fixed group” was given an ODFC of perindropil 10 mg plus indapamide 2.5 mg plus amlodipine 5 or 10 mg plus atorvastatin 20 mg. The “free group” was given a FDC of the 3antihypertensive agents plus atorvastatin 20 mg. Primary end-points were the differences in clinic BP, cholesterol levels and CVR risk between the 2 groups after treatments. Secondary end-points included intragroup differences in clinic BP. Safety and compliance were also assessed. Results At 12-weeks, the fixed group had lower systolic BP and similar diastolic BP compared to the free group. BP targets at week 12 were more commonly reached with fixed than free combination (89% and 80% respectively, p = 0.048). For cholesterol serum in both groups there was a significant reduction of values. Also CVR reduction was greater in those taking ODF. Safety was not significantly different between the 2 groups. Conversely, compliance was significantly greater in the fixed-group vs. the free-group. Conclusion This randomized trial shows that ODF combination of perindropil, indapamide and amlodipine is as safe as free combination of the 3 drugs, but is associated with a greater efficacy in BP control, compliance and, associated with statin, in cholesterol reduction. A better cardiovascular risk control is achieved with ODF combination than with a free administration. ClinicalTrials.gov ID: NCT02710539

KW - Cardiovascular risk

KW - Combination therapy

KW - Hypercholesterolemia

KW - Hypertension

UR - http://www.scopus.com/inward/record.url?scp=84981173503&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84981173503&partnerID=8YFLogxK

U2 - 10.1016/j.ijcard.2016.07.163

DO - 10.1016/j.ijcard.2016.07.163

M3 - Article

VL - 222

SP - 885

EP - 887

JO - International Journal of Cardiology

JF - International Journal of Cardiology

SN - 0167-5273

ER -