Effectiveness of Polypill for Primary and Secondary Prevention of Cardiovascular Diseases: A Pragmatic Cluster Randomized Controlled Trial

Roshandel, Gholamreza; Khoshnia, Masoud; Hemming, Karla; Kamangar, Farin; Gharavi, Abdolsamad; Ostovaneh, Mohammadreza; Nateghi, Alireza; Majed, Masoud; Navabakhsh, Behrooz; Merat, Shahin; Pourshams, Akram; Nalini, Mahdi; Malekzadeh, Fatemeh; Sadeghi, Masoumeh; Mohammadifard, Noushin; Sarrafzadegan, Nizal; Naemi-Tabiei, Mohammad; Fazel, Abdolreza; Brennan, Paul; Etemadi, Arash; Boffetta, Paolo; Thomas, G. Neil; Marshall, Tom; Cheng, Kar Keung

doi:10.2139/ssrn.3408063

Cited by 6 publications

(7 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…29 In further support of the HOPE 4 approach, the PolyIran RCT demonstrated that an intervention comprised of community screening with CHWs and the use of a single polypill (combination antihypertensives with a statin) resulted in significant reductions in cardiovascular events as compared to usual care. 45 Our current Canadian pilot study expands on these data to explore the feasibility of the intervention package, including task sharing, in a high-income country. Three RCTs also support components of the HOPE 4 health system interventions in high-income countries.…”

Section: Discussionmentioning

confidence: 98%

Exploring New Models for Cardiovascular Risk Reduction: The Heart Outcomes Prevention and Evaluation 4 (HOPE 4) Canada Pilot Study

et al. 2021

View full text Add to dashboard Cite

Background There is a gap between evidence and practice in the management of cardiovascular (CV) risk. Previous research indicated benefits from community-based, multi-faceted interventions to screen, diagnose, and manage CV risk in people with hypertension. Methods The Heart Outcomes Prevention and Evaluation 4 Canada pilot study (HOPE 4) was a quasi-experimental pre–post interventional study, involving one community each in Hamilton, Ontario and Surrey, British Columbia, Canada. Individuals aged ≥50 years with newly diagnosed or poorly controlled hypertension were included. The intervention was comprised of: (i) simplified diagnostic/treatment algorithms implemented by community health workers (firefighters in British Columbia and community health workers in Ontario) guided by decision support and counselling software; (ii) recommendations for evidence-based CV medications and lifestyle modifications; and (iii) support from family/friends to promote healthy behaviours. The intervention was developed as part of the international Heart Outcomes Prevention and Evaluation 4 Canada pilot study trial and adapted to the Canadian context. The primary outcome was the change in Framingham Risk Score 10-year CV disease risk estimate between baseline and 6 months. Results Between 2016 and 2017, a total of 193 participants were screened, with 37 enrolled in Surrey, and 19 in Hamilton. Mean age was 69 years (standard deviation 11), with 54% female, 27% diabetic, and 73% with a history of hypertension. An 82% follow-up level had been obtained at 6 months. Compared to baseline, there were significant improvements in the Framingham Risk Score 10-year risk estimate (30.6% vs 24.7%, P < 0.01), and systolic blood pressure (153.1 vs 136.7 mm Hg, P < 0.01). No significant changes in lipids or healthy behaviours were noted. Conclusions A comprehensive approach to health care delivery, using a community-based intervention with community health workers, supported by mobile-health technologies, has the potential to significantly reduce cardiovascular risk, but further evaluation is warranted.

show abstract

Section: Discussionmentioning

confidence: 98%

Exploring New Models for Cardiovascular Risk Reduction: The Heart Outcomes Prevention and Evaluation 4 (HOPE 4) Canada Pilot Study

et al. 2021

View full text Add to dashboard Cite

show abstract

“…5 The other long-term polypill study, The PolyIran study included 6838 participants from Iran and followed them up for 5 years. 6 The study used hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg and enalapril 5 mg or valsartan 40 mg (in those who developed cough). Akin to TIPS-3, it showed that oncedaily polypills reduced the risk of major cardiovascular events in both those with and without CVD.…”

Section: Commentmentioning

confidence: 99%

Polypill for primary prevention in individuals with intermediate risk for cardiovascular disease

Yadav

Roy

2021

NMJI

View full text Add to dashboard Cite

Polypill, comprising multiple cardioprotective medications, has been proposed to lower cardiovascular disease (CVD) among intermediateto-high risk individuals. The International Polycap Study 3 (TIPS-3) was a randomized factorial design placebo-controlled trial done to study the impact of polypill and aspirin individually and in combination. The polypill comprised 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide and 10 mg of ramipril. Aspirin was SUMMARYThe WHO Antenatal Corticosteroids for Improving Outcomes in preterm Newborns (ACTION-I) trial is a randomized study that investigated the safety and efficacy of antenatal steroid, dexamethasone, among women at risk of preterm birth in low-and middle-income countries (LMICs). A total of 2852 women between 26 weeks 0 days and 33 weeks 6 days of gestation from 29 secondaryand tertiary-level hospitals across five LMICs-Bangladesh, India, Kenya, Nigeria and Pakistan-were randomized to receive intramuscular dexamethasone at a dose of 6 mg every 12 hours for four doses or an identical placebo if preterm birth was expected in the next 48 hours. Eligible women were assessed by obstetric care providers and gestational age was confirmed using ultrasonographic examination performed in early gestation or at presentation. Women with clinical signs of severe infection, major congenital foetal anomalies and those with previous use or contraindication to systemic glucocorticoids were excluded from the study. One repeat course (identical to initial diseases (PolyIran): A pragmatic, cluster-randomised trial.

show abstract

“…In these groups, combination tablets have been shown to significantly and substantially reduce CVD risk in otherwise difficult to reach populations, specifically in low to middle income countries and groups less likely to seek primary healthcare. 99,100 Optimal medical therapy is clearly superior but perfect should not become the enemy of good in this scenario and prescribing with appreciation of patient-specific factors remains important. Currently neither ESC nor AHA/ACC recommend its use, particularly in place of optimal guideline recommended therapies, 6,39 though it appears to offer benefit in difficult-to-reach patient populations.…”

Section: Pharmacological Therapiesmentioning

confidence: 99%

Primary prevention of cardiovascular disease: Updated review of contemporary guidance and literature

Stewart

Addy

Campbell

et al. 2020

JRSM Cardiovascular Disease

View full text Add to dashboard Cite

Cardiovascular disease remains a substantial concern in terms of global mortality and morbidity, while prevalence of cardiovascular disease is increasing as treatment modalities improve survival. With an ageing population and increasing costs of chronic medical care, primary prevention of cardiovascular disease is an important target for healthcare providers. Since the previous iteration of this paper, new international guidelines have been produced regarding hypertension and lipid lowering therapies, whilst there is a growing body of evidence and new therapies emerging in other areas of lifestyle and pharmacotherapeutic intervention. This review outlines emerging evidence in the field and compares and contrasts contemporary recommendations from European and American guidelines.

show abstract

Effectiveness of Polypill for Primary and Secondary Prevention of Cardiovascular Diseases: A Pragmatic Cluster Randomized Controlled Trial

Cited by 6 publications

References 0 publications

Exploring New Models for Cardiovascular Risk Reduction: The Heart Outcomes Prevention and Evaluation 4 (HOPE 4) Canada Pilot Study

Exploring New Models for Cardiovascular Risk Reduction: The Heart Outcomes Prevention and Evaluation 4 (HOPE 4) Canada Pilot Study

Polypill for primary prevention in individuals with intermediate risk for cardiovascular disease

Primary prevention of cardiovascular disease: Updated review of contemporary guidance and literature

Contact Info

Product

Resources

About