Evidence map›Paper›PMID 20653798›Full record

Trial reportInternational journal of clinical practice2010

A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors.

F Malekzadeh, T Marshall, A Pourshams, M Gharravi, A Aslani, A Nateghi, M Rastegarpanah, M Khoshnia, S Semnani, R Salahi and 4 more

3 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of clinical practice, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 44 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 8 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03047538 phase4withdrawnstarted 2017, after this paper: background citation

Fixed Combination for Lipid and Blood Pressure Control. Randomized Cross-over Study

Ran2017Enrolled0Registered outcomes5Posted comparisons0ConditionsArterial Hypertension, Blood Pressure, Dyslipidemias, Lipid Metabolism DisordersArmsAtorvastatin, Amlodipine, Perindopril
PMID 21205325PMID 24002278PMID 19339045PMID 22815989PMID 24707184PMID 20479948PMID 19125855PMID 3946459PMID 21647425PMID 18456100PMID 20026768other papers from this trial
Open the trial in the graph
NCT01271985 phase3completednot on this mapstarted 2011, after this paper: background citation

Fixed-dose Combination Therapy (PolyPill) in Primary and Secondary Prevention of Cardiovascular Disease in Middle-aged and Elderly Iranians

TypeinterventionalSponsorTehran University of Medical SciencesRan2011 to 2019Enrolled8,410ConditionsCardiovascular DiseasesArmsPolyPill, Minimal care
NCT03459560 phase3unknown statusnot on this mapstarted 2015, after this paper: background citation

Effectiveness of Polypill for Primary Prevention of Cardiovascular Disease (PolyPars): Study Design and Rationale for a Pragmatic Cluster Randomized Controlled Trial

TypeinterventionalSponsorTehran University of Medical SciencesRan2015 to 2022Enrolled4,415ConditionsCardiovascular DiseasesArmsPolyPill
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Effect of atorvastatin on testosterone levels.The Cochrane database of systematic reviews · 2021
    Pooled it
  6. Pooled it
  7. Fixed-dose combination therapy for the prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2014
    Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Polypills in the Management of Cardiovascular Risk-A Perspective.Journal of clinical medicine · 2024 · on this map
    Article
  16. Article
  17. Review
  18. Article
  19. The association between diabetic complications and health-related quality of life in patients with type 2 diabetes: a cross-sectional study from Iran.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

F MalekzadehDigestive Disease Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.
T Marshall
A Pourshams
M Gharravi
A Aslani
A Nateghi
M Rastegarpanah
M Khoshnia
S Semnani
R Salahi
G N Thomas
B Larijani
K K Cheng
R Malekzadeh

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimOur objective was to investigate the effects and tolerability of fixed-dose combination therapy on blood pressure and LDL in adults without elevated blood pressure or lipid levels.

methodsThis was a double-blind randomised placebo-controlled trial in residents of Kalaleh, Golestan, Iran. Following an 8-week placebo run-in period, 475 participants, aged 50 to 79 years, without cardiovascular disease, hypertension or hyperlipidaemia were randomised to fixed-dose combination therapy with aspirin 81 mg, enalapril 2.5 mg, atorvastatin 20 mg and hydrochlorothiazide 12.5 mg (polypill) or placebo for a period of 12 months. The primary outcomes were changes in LDL-cholesterol, systolic and diastolic blood pressure and adverse reactions. Analysis was by intention-to-treat basis.

resultsAt baseline, there were differences in systolic blood pressure (6 mmHg). Taking account of baseline differences, at 12 months, polypill was associated with statistically significant reductions in blood pressure (4.5/1.6 mmHg) and LDL-cholesterol (0.46 mmol/l). The study drug was well tolerated, but resulted in the modest reductions in blood pressure and lipid levels.

conclusionThe effects of the polypill on blood pressure and lipid levels were less than anticipated, raising questions about the reliability of the reported compliance. There is a case for a fully powered trial of a polypill for the prevention of cardiovascular disease.

Indexed as

AgedAnticholesteremic AgentsAntihypertensive AgentsAspirinAtorvastatinBlood PressureCardiovascular DiseasesCholesterol, LDLChronic DiseaseDouble-Blind MethodDrug CombinationsEnalaprilFemaleHeptanoic AcidsHumansHydrochlorothiazideAnticholesteremic AgentsAntihypertensive AgentsAspirinAtorvastatinCholesterol, LDLDrug CombinationsEnalaprilHeptanoic AcidsHydrochlorothiazidePlatelet Aggregation InhibitorsPyrrolesTablets

Identifiers

PMID20653798

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.