title: IMProving Adherence using Combination Therapy (IMPACT): design and protocol of a randomised controlled trial in primary care.
abstract: BACKGROUND
  Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high.
  
  
  OBJECTIVE
  To assess whether a medication strategy using a fixed dose combination pill ('polypill') could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months.
  
  
  METHODS
  IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).
authors.affiliation: Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142, New Zealand. v.selak@ctru.auckland.ac.nz
authors.forename: Vanessa
authors.initials: V
authors.lastname: Selak
authors.forename: C Raina
authors.initials: CR
authors.lastname: Elley
authors.forename: Sue
authors.initials: S
authors.lastname: Crengle
authors.forename: Matire
authors.initials: M
authors.lastname: Harwood
authors.forename: Rob
authors.initials: R
authors.lastname: Doughty
authors.forename: Bruce
authors.initials: B
authors.lastname: Arroll
authors.forename: Linda
authors.initials: L
authors.lastname: Bryant
authors.forename: Natasha
authors.initials: N
authors.lastname: Rafter
authors.forename: Stephen Vander
authors.initials: SV
authors.lastname: Hoorn
authors.forename: Angela
authors.initials: A
authors.lastname: Wadham
authors.forename: Sue
authors.initials: S
authors.lastname: Wells
authors.forename: Richard
authors.initials: R
authors.lastname: Milne
authors.forename: Rod
authors.initials: R
authors.lastname: Jackson
authors.forename: Dale
authors.initials: D
authors.lastname: Bramley
authors.forename: Anthony
authors.initials: A
authors.lastname: Rodgers
mesh_terms: D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D010349:Patient Compliance; D015995:Prevalence; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D008055:Lipids