Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial

Autor: Giuseppe Marazzi, Maurizio Volterrani, Rosalba Massaro, Mitja Lainscak, Francesco Pelliccia, Luca Cacciotti, Alessandra Tanzilli, Martina Di Iorio, Sara Poggi, Giuseppe M.C. Rosano, Giuseppe Campolongo
Rok vydání: 2016
Předmět:
Adult
Male
medicine.medical_specialty
Statin
Time Factors
Combination therapy
medicine.drug_class
Atorvastatin
030204 cardiovascular system & hematology
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Risk Factors
Internal medicine
Multicenter trial
medicine
Humans
030212 general & internal medicine
Amlodipine
Prospective Studies
Antihypertensive Agents
Aged
Dose-Response Relationship
Drug
Cholesterol
business.industry
Indapamide
Middle Aged
Surgery
Treatment Outcome
chemistry
Cardiovascular Diseases
cardiovascular risk
combination therapy
hypercholesterolemia
hypertension
medicine (all)
cardiology and cardiovascular medicine
Drug Therapy
Combination
Female
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiology and Cardiovascular Medicine
business
medicine.drug
Follow-Up Studies
Zdroj: International journal of cardiology. 222
ISSN: 1874-1754
Popis: 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 10mg plus indapamide 2.5mg plus amlodipine 5 or 10mg plus atorvastatin 20mg. The "free group" was given a FDC of the 3antihypertensive agents plus atorvastatin 20mg. 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
Databáze: OpenAIRE
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