# Cardiovascular polypill

Intervention · id `cardio:polypill` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: Polypill

Browse, organ or system: Heart  
Browse, condition area: Risk and prevention; Coronary and vascular disease  

## In plain language

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.

## 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.

## Claims, with the population each applies to

## 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.

### 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.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: 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.
- 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
- Sources:
  1. Supports: Polypill Strategy in Secondary Cardiovascular Prevention (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa2208275>
     Locator: Abstract, RESULTS, sentences 1 to 3. Retrieved 2026-10-15T13:48:15Z. Source state: Current. Snapshot hash: d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971.
     How it applies: Randomized number, follow-up and primary and key secondary outcome results.
  2. Supports: Polypill Strategy in Secondary Cardiovascular Prevention (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa2208275>
     Locator: Abstract, RESULTS, sentences 4 to 6. Retrieved 2026-10-15T13:48:15Z. Source state: Current. Snapshot hash: d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971.
     How it applies: Subgroups, adherence and adverse events.
  3. Background: Polypill Strategy in Secondary Cardiovascular Prevention (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1056/NEJMoa2208275>
     Locator: Abstract, METHODS, sentences 1 to 4. Retrieved 2026-10-15T13:48:15Z. Source state: Current. Snapshot hash: d6f7cf983f37eeed8e8528b1733bc1226b3f7ccb794d7af7e0c15d8a5e763971.
     How it applies: Design, polypill content and outcome definitions.
  4. Background: Secondary Prevention of Cardiovascular Disease in the Elderly Trial (Registry, edition ClinicalTrials.gov API v2 record, last update posted 2025-05-23.) <https://clinicaltrials.gov/study/NCT02596126>
     Locator: protocolSection.designModule.designInfo.maskingInfo.masking. Retrieved 2026-10-15T13:48:10Z. Source state: Current. Snapshot hash: 0954459c83c092d1c5b20b857c0e3fb5fea376d7b579219ed4d16ed811cc98a9.
     How it applies: The registry lists masking as none.

## Connected pages

- 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) (`cardio:myocardial-infarction`) [a claim, not a settled fact; see claim `cardio:claim-secure-polypill-primary` and its context]
- Filed under this front: Medicines (`cardio:front-medicines`)
- A statin, atorvastatin, is one of its three medicines in the SECURE trial: Statins (`cardio:statins`)
- Aspirin is one of its three medicines in the SECURE trial: Aspirin (`core:aspirin`)
- A combined medicine tested in people after a heart attack: Preventing heart attack, stroke and heart failure (`cardio:cardiovascular-prevention`)
- Investigated in: SECURE (`cardio:secure-trial`)

## Provenance

Content hash: 505c53b19b652e67aa88fb2664b5af719e4add2dac534f91997bf5983f340017
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15