← Antihypertensives × adverse events & safety

TrialLancet (London, England)2009

Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial.

Indian Polycap Study (TIPS) et al.PubMed ↗Publisher ↗

  • Polycapno clear effectLower systolic blood pressure, lower diastolic blood pressure, lower LDL cholesterol.Nothing cleared the noise.
  • Simvastatin aloneno clear effectLower LDL cholesterol.Nothing cleared the noise.
  • Three blood-pressure-lowering drugs plus aspirinno clear effectLower 11-dehydrothromboxane B2.Nothing cleared the noise.
  • Aspirin aloneno clear effectLower 11-dehydrothromboxane B2.Nothing cleared the noise.

What the trial testedas reported · 2,053 people · 2009

Not counted

Lowered systolic blood pressure

−7.40mm Hg−8.10 to −6.10

Polycap vs groups not receiving blood-pressure-lowering drugs

As reported

difference −7.40 mm Hg, 95% CI −8.10 to −6.10

Not counted

Lowered diastolic blood pressure

−5.60mm Hg−6.40 to −4.70

Polycap vs groups not receiving blood-pressure-lowering drugs

As reported

difference −5.60 mm Hg, 95% CI −6.40 to −4.70

Not counted

Lowered LDL cholesterol

−0.70mmol/L−0.78 to −0.62

Polycap vs groups without simvastatin

As reported

difference −0.70 mmol/L, 95% CI −0.78 to −0.62

Not counted

Lowered LDL cholesterol

−0.83mmol/L−0.93 to −0.72

simvastatin alone vs groups without simvastatin

As reported

difference −0.83 mmol/L, 95% CI −0.93 to −0.72

+4 more in the walkthrough ↓

Who was studied, and how

2,053people with hypertension, in this paper

The trial randomly assignedassigned by chance

Polycap
groups not receiving blood-pressure-lowering drugs

Lowered systolic blood pressure−7.40

Lowered diastolic blood pressure−5.60

randomised

The trial randomly assignedassigned by chance

Polycap
groups without simvastatin

Lowered LDL cholesterol−0.70

randomised

the abstract, start to end

… reduced systolic blood pressure by 7.4 mm Hg (95% CI 6.1-8.1) and diastolic blood pressure by 5.6 mm Hg (4.7-6.4), which was …

Polycap reduced LDL cholesterol by 0.70 mmol/L (95% CI 0.62-0.78), which was less than that with simvastatin alone (0.83 mmol/L, 0.72-0.93; p=0.04); …

… groups using atenolol were similar (7.0 beats per min), and both were …

… B2 were similar with the Polycap (283.1 ng/mmol creatinine, 95% CI 229.1-337.0) compared with the three blood-pressure-lowering drugs plus aspirin (350.0 ng/mmol creatinine, 294.6-404.0), and aspirin alone (348.8 ng/mmol creatinine, …

← favours treatmentfavours comparator →
could be chance
No interval given · direction only, strength unknown
Systolic blood pressurePolycap vs groups not receiving blood-pressure-lowering drugs
−7.40−8.10 to −6.10
Diastolic blood pressurePolycap vs groups not receiving blood-pressure-lowering drugs
−5.60−6.40 to −4.70
LDL cholesterolPolycap vs groups without simvastatin
−0.70−0.78 to −0.62
LDL cholesterolsimvastatin alone vs groups without simvastatin
−0.83−0.93 to −0.72
Heart ratePolycap vs groups without atenolol
−7.00
11-dehydrothromboxane B2Polycap vs groups without aspirin
−283−337 to −229
11-dehydrothromboxane B2three blood-pressure-lowering drugs plus aspirin vs groups without aspirin
−350−404 to −295
11-dehydrothromboxane B2aspirin alone vs groups without aspirin
−349−420 to −278
StatinsAntihypertensivesAntiplatelet & anticoagulantLipidsBlood pressureCardiovascular eventsAdverse events & safety
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120 papers cite itlatest 60 shown

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this paperpooled ittrialcites it

5 trials

NCT004437942,050 enrolled2007NCT03047538phase 40 enrolled2017NCT01271985phase 38,410 enrolled2011NCT03459560phase 34,415 enrolled2015NCT05514938phase 2140 enrolled2022
Full record →Abstract, authors, funding and every citing paper · PMID 19339045