Cardiovascular polypill

A single pill that combines several heart medicines. In the SECURE trial, adults aged 65 or older who had a type 1 heart attack in the previous 6 months and at least one further risk condition (such as diabetes, kidney impairment, an earlier heart attack, revascularization or stroke, or age 75 or older) were assigned to a polypill containing aspirin, ramipril and atorvastatin or to usual care. Over a median of 36 months, fewer people on the polypill had a major cardiovascular event (cardiovascular death, heart attack, ischemic stroke or urgent revascularization), patients reported better medication adherence, and adverse events were similar between groups. SECURE was open-label, and this record covers that trial only.

Also called Polypill

Intervention
In this atlas

Overview

Technical summary

Subtype medicine, a care strategy and not a branded product. The SECURE polypill contained aspirin 100 mg, ramipril 2.5, 5 or 10 mg and atorvastatin 20 or 40 mg, taken once a day (registry). The usual-care arm followed European secondary-prevention guidelines, with drugs and doses at the physicians' discretion (registry). The abstract describes the three medicines as aspirin, an ACE inhibitor and a statin. No polypill regulatory status was looked up. Other polypill trials are not recorded.

About this intervention

Type: Medicine
Mechanism: Combines aspirin, ramipril (an ACE inhibitor) and atorvastatin (a statin) in one pill taken once a day.

Claims and evidence

Context Adults aged 65 or older with a recent myocardial infarction (SECURE)

Recipient: Adult
Population: Patients aged 65 or older with a type 1 myocardial infarction in the previous 6 months and at least one further condition from the registry list (diabetes, mild to moderate renal dysfunction, a prior myocardial infarction, prior coronary revascularization, prior stroke, or age 75 or older).
Care setting: Trial sites in seven European countries (registry).
Geography: Spain, Italy, Germany, France, Hungary, Poland and Czechia (registry countries; the registry description names the Czech Republic).
Life stage: Adults aged 65 or older (registry minimum age 65 years, no maximum)
Follow-up: Median follow-up of 36 months (abstract); the registry plans follow-up of at least 2 years and at most 5 years.

Eligibility: 2 inclusion criteria; 3 exclusion criteria

Included: Type 1 myocardial infarction within the previous 6 months (registry)
Aged 65 or older with at least one additional condition listed by the registry
Excluded: Contraindications to any of the components of the polypill (registry)
Living in a nursing home (registry)
Severe congestive heart failure, NYHA III to IV (registry)

Effect Interventional Certainty not assessed

SECURE was a phase 3, randomized, controlled clinical trial in which patients with a myocardial infarction within the previous 6 months (the registry requires a type 1 infarction, age 65 or older and at least one further risk condition) were assigned to a polypill-based strategy or to usual care. The polypill consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg) and atorvastatin (20 or 40 mg). A total of 2499 patients underwent randomization and were followed for a median of 36 months. The primary composite outcome (cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization) occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio 0.76; 95% CI 0.60 to 0.96; P = 0.02). A key secondary outcome (cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke) occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio 0.70; 95% CI 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group, and adverse events were similar between groups.
Applies to Adult
- Patients aged 65 or older with a type 1 myocardial infarction in the previous 6 months and at least one further condition from the registry list (diabetes, mild to moderate renal dysfunction, a prior myocardial infarction, prior coronary revascularization, prior stroke, or age 75 or older).
- Trial sites in seven European countries (registry).
- Spain, Italy, Germany, France, Hungary, Poland and Czechia (registry countries; the registry description names the Czech Republic).
- Adults aged 65 or older (registry minimum age 65 years, no maximum)
Follow-up Median follow-up of 36 months (abstract); the registry plans follow-up of at least 2 years and at most 5 years.
Certainty method
Not assessed

Limitations
The registry lists masking as none, so the trial was open-label as registered. The abstract gives 2499 randomized patients and group denominators of 1237 and 1229; the source does not explain the difference and it is not reconciled here. Adherence was reported by the patients. Patients were aged 65 or older with at least one further risk condition (registry) and a recent type 1 myocardial infarction, at sites in seven European countries. The usual-care arm used drugs and doses chosen by the treating physicians (registry). Only the PubMed abstract and the registry record were read.

Last checked
2026-10-15

Next evidence check due
Not scheduled
Sources and citations (4)
1. Supports Polypill Strategy in Secondary Cardiovascular Prevention
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-09-15 · DOI: 10.1056/NEJMoa2208275 · PMID: 36018037
  
  Locator
  Abstract, RESULTS, sentences 1 to 3
  
  How it applies
  Randomized number, follow-up and primary and key secondary outcome results.
  
  Retrieved
  2026-10-15T13:48:15Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
2. Supports Polypill Strategy in Secondary Cardiovascular Prevention
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-09-15 · DOI: 10.1056/NEJMoa2208275 · PMID: 36018037
  
  Locator
  Abstract, RESULTS, sentences 4 to 6
  
  How it applies
  Subgroups, adherence and adverse events.
  
  Retrieved
  2026-10-15T13:48:15Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
3. Background Polypill Strategy in Secondary Cardiovascular Prevention
  
  Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-09-15 · DOI: 10.1056/NEJMoa2208275 · PMID: 36018037
  
  Locator
  Abstract, METHODS, sentences 1 to 4
  
  How it applies
  Design, polypill content and outcome definitions.
  
  Retrieved
  2026-10-15T13:48:15Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971
  
  Reuse basis
  PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
4. Background Secondary Prevention of Cardiovascular Disease in the Elderly Trial
  
  Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2025-05-23. · NCT: NCT02596126
  
  Locator
  protocolSection.designModule.designInfo.maskingInfo.masking
  
  How it applies
  The registry lists masking as none.
  
  Retrieved
  2026-10-15T13:48:10Z
  
  Source effective date
  2025-05-23
  
  Source state
  Current
  
  Snapshot hash
  0954459c83c092d1c5b20b857c0e3fb5fea376d7b579219ed4d16ed811cc98a9
  
  Reuse basis
  Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/cl-ctgov-NCT02596126.json.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact SECURE, adults aged 65 or older with a type 1 heart attack in the previous 6 months and at least one further risk condition: fewer major cardiovascular events than usual care: Heart attack (myocardial infarction) (Evaluated for)
Applies to Adult
- Patients aged 65 or older with a type 1 myocardial infarction in the previous 6 months and at least one further condition from the registry list (diabetes, mild to moderate renal dysfunction, a prior myocardial infarction, prior coronary revascularization, prior stroke, or age 75 or older).
- Trial sites in seven European countries (registry).
- Spain, Italy, Germany, France, Hungary, Poland and Czechia (registry countries; the registry description names the Czech Republic).
- Adults aged 65 or older (registry minimum age 65 years, no maximum)
Follow-up Median follow-up of 36 months (abstract); the registry plans follow-up of at least 2 years and at most 5 years.
SECURE was a phase 3, randomized, controlled clinical trial in which patients with a myocardial infarction within the previous 6 months (the registry requires a type 1 infarction, age 65 or older and at least one further risk condition) were assigned to a polypill-based strategy or to usual care. The polypill consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg) and atorvastatin (20 or 40 mg). A total of 2499 patients underwent randomization and were followed for a median of 36 months. The primary composite outcome (cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization) occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio 0.76; 95% CI 0.60 to 0.96; P = 0.02). A key secondary outcome (cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke) occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio 0.70; 95% CI 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group, and adverse events were similar between groups.
Limitations. The registry lists masking as none, so the trial was open-label as registered. The abstract gives 2499 randomized patients and group denominators of 1237 and 1229; the source does not explain the difference and it is not reconciled here. Adherence was reported by the patients. Patients were aged 65 or older with at least one further risk condition (registry) and a recent type 1 myocardial infarction, at sites in seven European countries. The usual-care arm used drugs and doses chosen by the treating physicians (registry). Only the PubMed abstract and the registry record were read.

Record details

Record id: cardio:polypill
Content hash: 505c53b19b652e67aa88fb2664b5af719e4add2dac534f91997bf5983f340017