{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:polypill",
  "owner": "cardio",
  "kind": "intervention",
  "slug": "polypill",
  "name": "Cardiovascular polypill",
  "aliases": [
    "Polypill"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "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.",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "risk-and-prevention",
        "coronary-and-vascular-disease"
      ]
    }
  },
  "payload": {
    "subtype": "medicine",
    "mechanism": "Combines aspirin, ramipril (an ACE inhibitor) and atorvastatin (a statin) in one pill taken once a day.",
    "components": null
  },
  "content_digest": "505c53b19b652e67aa88fb2664b5af719e4add2dac534f91997bf5983f340017",
  "review": {
    "content_digest": "505c53b19b652e67aa88fb2664b5af719e4add2dac534f91997bf5983f340017",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
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      "id": "cardio:claim-secure-polypill-primary",
      "owner": "cardio",
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      "category": "effect",
      "statement": "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.",
      "context": {
        "id": "cardio:ctx-secure-older-adults-recent-mi",
        "label": "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_note": "Adults aged 65 or older (registry minimum age 65 years, no maximum)",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Median follow-up of 36 months (abstract); the registry plans follow-up of at least 2 years and at most 5 years.",
        "eligibility": {
          "inclusion": [
            "Type 1 myocardial infarction within the previous 6 months (registry)",
            "Aged 65 or older with at least one additional condition listed by the registry"
          ],
          "exclusion": [
            "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)"
          ]
        }
      },
      "evidence_stage": "interventional",
      "certainty": "not_assessed",
      "certainty_method": null,
      "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.",
      "editorial_state": "draft",
      "checked_at": "2026-10-15",
      "next_review_due": null,
      "valid_from": null,
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            "publisher": "The New England journal of medicine",
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