Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial
Abstract Background Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill...
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | BMC Cardiovascular Disorders |
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| Online Access: | https://doi.org/10.1186/s12872-022-03013-w |
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| author | José M. Mostaza Carmen Suárez-Fernández Juan Cosín-Sales Ricardo Gómez-Huelgas Carlos Brotons Francisco Pestana Araujo Gabriela Borrayo Emilio Ruiz VULCANO investigators |
| author_facet | José M. Mostaza Carmen Suárez-Fernández Juan Cosín-Sales Ricardo Gómez-Huelgas Carlos Brotons Francisco Pestana Araujo Gabriela Borrayo Emilio Ruiz VULCANO investigators |
| author_sort | José M. Mostaza |
| collection | DOAJ |
| description | Abstract Background Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. Methods The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. Results The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. Conclusion The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ). |
| first_indexed | 2024-04-11T05:09:16Z |
| format | Article |
| id | doaj.art-06629dab1ef049818d948fc48e5f4e59 |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-04-11T05:09:16Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-06629dab1ef049818d948fc48e5f4e592022-12-25T12:04:48ZengBMCBMC Cardiovascular Disorders1471-22612022-12-0122111510.1186/s12872-022-03013-wSafety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trialJosé M. Mostaza0Carmen Suárez-Fernández1Juan Cosín-Sales2Ricardo Gómez-Huelgas3Carlos Brotons4Francisco Pestana Araujo5Gabriela Borrayo6Emilio Ruiz7VULCANO investigatorsInternal Medicine Service, Hospital Carlos IIIInternal Medicine Department Hospital de la PrincesaCardiology Service, Hospital Arnau de VilanovaInternal Medicine Department, Regional University Hospital of MálagaSardenya Primary Health Care CenterHospital dos LusíadasInstituto Mexicano del Seguro Social (IMSS)Corporate Medical Affairs Department, Ferrer InternacionalAbstract Background Cardiovascular (CV) polypills are a useful baseline treatment to prevent CV diseases by combining different drug classes in a single pill to simultaneously target more than one risk factor. The aim of the present trial was to determine whether the treatment with the CNIC-polypill was at least non-inferior to usual care in terms of low-density lipoprotein cholesterol (LDL-c) and systolic BP (SBP) values in subjects at high or very high risk without a previous CV event. Methods The VULCANO was an international, multicentre open-label trial involving 492 participants recruited from hospital clinics or primary care centres. Patients were randomised to the CNIC-polypill -containing aspirin, atorvastatin, and ramipril- or usual care. The primary outcome was the comparison of the mean change in LDL-c and SBP values after 16 weeks of treatment between treatment groups. Results The upper confidence limit of the mean change in LDL-c between treatments was below the prespecified margin (10 mg/dL) and above zero, and non-inferiority and superiority of the CNIC-polypill (p = 0.0001) was reached. There were no significant differences in SBP between groups. However, the upper confidence limit crossed the prespecified non-inferiority margin of 3 mm Hg. Significant differences favoured the CNIC-polypill in reducing total cholesterol (p = 0.0004) and non-high-density lipoprotein cholesterol levels (p = 0.0017). There were no reports of major bleeding episodes. The frequency of non-serious gastrointestinal disorders was more frequent in the CNIC-polypill arm. Conclusion The switch from conventional treatment to the CNIC-polypill approach was safe and appears a reasonable strategy to control risk factors and prevent CVD. Trial registration This trial was registered in the EU Clinical Trials Register (EudraCT) the 20th February 2017 (register number 2016-004015-13; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-004015-13 ).https://doi.org/10.1186/s12872-022-03013-wCardiovascular diseasePrimary preventionFixed-dose combinationPolypillNon-inferiority trialCardiovascular risk factors |
| spellingShingle | José M. Mostaza Carmen Suárez-Fernández Juan Cosín-Sales Ricardo Gómez-Huelgas Carlos Brotons Francisco Pestana Araujo Gabriela Borrayo Emilio Ruiz VULCANO investigators Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial BMC Cardiovascular Disorders Cardiovascular disease Primary prevention Fixed-dose combination Polypill Non-inferiority trial Cardiovascular risk factors |
| title | Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial |
| title_full | Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial |
| title_fullStr | Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial |
| title_full_unstemmed | Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial |
| title_short | Safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event: the international VULCANO randomised clinical trial |
| title_sort | safety and efficacy of a cardiovascular polypill in people at high and very high risk without a previous cardiovascular event the international vulcano randomised clinical trial |
| topic | Cardiovascular disease Primary prevention Fixed-dose combination Polypill Non-inferiority trial Cardiovascular risk factors |
| url | https://doi.org/10.1186/s12872-022-03013-w |
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