José M. Castellano|Ginés Sanz|José L. Peñalvo|Sameer Bansilal|Antonio Fernández?Ortíz|Luz Álvarez|Luis A. Guzmán|Juan Carlos Linares|Fernando Flores García|Fabiana D’Aniello|Joan Albert Arnáiz|Sara Varea|Felipe Martínez|Alberto Lorenzatti|Iñaki Arratibel Imaz|Luis María Sánchez-Gómez|Maria Carla Roncaglioni|Marta Baviera|Sidney C. Smith|Kathryn A. Taubert|Stuart Pocock|Carlos Brotons|Michael E. Farkouh|Valentín Fuster
A Polypill Strategy to Improve Adherence
Spanish National Centre for Cardiovascular Research|Icahn School of Medicine at Mount Sinai|Spanish National Centre for Cardiovascular Research|Spanish National Centre for Cardiovascular Research|Icahn School of Medicine at Mount Sinai|Spanish National Centre for Cardiovascular Research|Hospital Clínico San Carlos|Spanish National Centre for Cardiovascular Research|Ferrer Grupo (Spain)|Ferrer Grupo (Spain)|Fundació Clínic per a la Recerca Biomèdica|Fundació Clínic per a la Recerca Biomèdica|Instituto Médico DAMIC|Instituto Médico DAMIC|Instituto de Salud Carlos III|Instituto de Salud Carlos III|Mario Negri Institute for Pharmacological Research|Mario Negri Institute for Pharmacological Research|World Heart Federation|World Heart Federation
adherence evidencebased cardiovascular cv medications acute myocardial infarction mi low first 6 months use fixeddose combinations fdc shown improve treatment adherence risk factor control however previous randomized trial analyzed impact polypill strategy adherence postmi patientsthe crosssectional focus fixeddose combination drug secondary cardiovascular prevention study phase 1 aimed elucidate factors interfere appropriate adherence cv medications secondary prevention acute mi additionally 695 patients phase 1 randomized controlled trial phase 2 test effect polypill containing aspirin 100 mg simvastatin 40 mg ramipril 25 5 10 mg compared 3 drugs given separately adherence blood pressure lowdensity lipoprotein cholesterol well safety tolerability period 9 months followupin phase 1 5country cohort 2118 patients analyzed patients randomized either polypill 3 drugs separately phase 2 primary endpoint adherence treatment measured final visit selfreported moriskygreen questionnaire maq pill count patients meet criteria adherence inperson visit considered adherentin phase 1 overall cv medication adherence defined maq score 20 455 multivariable regression model risk nonadherent maq 20 associated younger age depression complex medication regimen poorer health insurance coverage lower level social support consistent findings across countries phase 2 polypill group showed improved adherence compared group receiving separate medications 9 months followup 508 versus 41 p 0019 intentiontotreat population 657 versus 557 p 0012 per protocol population using primary endpoint attending final visit maq 20 high pill count 80 110 combined assess adherence adherence also higher fdc group measured maq alone 68 vs 59 p 0049 treatment difference found followup mean systolic blood pressure 1296 mm hg vs 1286 mm hg mean lowdensity lipoprotein cholesterol levels 899 mgdl vs 917 mgdl serious adverse events 23 vs 21 death 1 03 groupfor secondary prevention following acute mi younger age depression complex drug treatment plan associated lower medication adherence meanwhile adherence increased patients higher insurance coverage levels social support compared 3 drugs given separately use polypill strategy met primary endpoint adherence secondary prevention following acute mi fixed dose combination drug polypill secondary cardiovascular prevention focus nct01321255