What question did this study set out to answer?

To evaluate the efficacy and tolerability of a four-component combination pill in individuals with elevated cardiovascular disease risk without individual indications for its components.

May 25, 2011PLoS ONEOpen Access

An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Raised cardiovascular risk (n=378). Intervention: Polypill (aspirin, lisinopril, hydrochlorothiazide, simvastatin) vs. Placebo. Primary outcome: Change in systolic blood pressure (SBP) at 12 weeks (MD 9.9 mmHg reduction, 95% CI 7.7 to 12.1, p=<0.0001).

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Key result

The four-component polypill reduced systolic blood pressure by 9.9 mmHg and LDL-cholesterol by 0.8 mmol/L compared to placebo over 12 weeks, though it caused side effects in about 1 in 6 people.

Why the study?

Does a four-component polypill (aspirin, lisinopril, hydrochlorothiazide, simvastatin) reduce systolic blood pressure and LDL-cholesterol in individuals with an estimated 5-year cardiovascular disease risk over 7.5%?

Population

378 individuals without an indication for any component of the polypill, but who had an estimated 5-year…

Comparison

Polypill containing aspirin 75 mg, lisinopril 10… vs Placebo

Design

RCT, randomised, double-blind

Follow-up

12 weeks

Discussion

Member takes

Implication

Supports polypill initiation in moderate-risk patients; extends RCT evidence to those without component-specific indications.

Key Points

To evaluate the efficacy and tolerability of a four-component combination pill in individuals with elevated cardiovascular disease risk without individual indications for its components.
Conducted a randomised, double-blind, placebo-controlled trial across international sites involving 378 individuals with an estimated 5-year cardiovascular disease risk exceeding 7.5% (ACTRN12607000099426).
Participants received either placebo or a daily polypill containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg, and simvastatin 20 mg for 12 weeks.
Polypill treatment reduced systolic blood pressure by 9.9 mmHg (95% CI: 7.7 to 12.1) and LDL-cholesterol by 0.8 mmol/L (95% CI: 0.6 to 0.9) compared to placebo over 12 weeks.
Treatment discontinuation occurred in 23% of the polypill group versus 18% of the placebo group (RR 1.33, 95% CI: 0.89 to 2.00, p = 0.2).
Adverse effects known to the component medicines were more frequent with the polypill than placebo (58% vs 42%, p = 0.001), but typically did not require treatment cessation.

Study Design

Type

RCT (n=378)

Blinding

Double-blind

Randomization

Computer-based minimization algorithm

Multicenter

Yes

Structured PICO

Population

378 adults with raised cardiovascular risk and no indication for component medicines, followed for 12 weeks.

Intervention

Polypill containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg, and simvastatin 20 mg

Comparator

Placebo

Outcome

Systolic blood pressure (SBP), LDL-cholesterol, and tolerability (proportion discontinued randomised therapy) at 12 weeks follow-upsurrogate

Main Result

Mean Difference: 9.9 (95% CI 7.7–12.1)

p-value: p=<0.0001

A four-component polypill achieved sizeable reductions in systolic blood pressure and LDL-cholesterol in individuals with raised cardiovascular risk, though it caused side effects in about 1 in 6 people.

Limitations

Short follow-up of 12 weeks precluded assessment of long-term drop-out rates.
Study design precluded definitive attribution of which component caused which side effects.
Patient population represented a relatively narrow group.
Predicted reductions in cardiovascular risk are based on indirect estimates from risk factor reductions rather than hard clinical endpoints.

Cite This Study

A 2011 study conducted an RCT in Raised cardiovascular risk (n=378). Polypill (aspirin, lisinopril, hydrochlorothiazide, simvastatin) vs. Placebo was evaluated on Change in systolic blood pressure (SBP) at 12 weeks (MD 9.9 mmHg reduction, 95% CI 7.7 to 12.1, p=<0.0001). The four-component polypill reduced systolic blood pressure by 9.9 mmHg and LDL-cholesterol by 0.8 mmol/L compared to placebo over 12 weeks, though it caused side effects in about 1 in 6 people.

synapsesocial.com/papers/6a86fd2c740e6cf4b5cf8ce6 https://doi.org/10.1371/journal.pone.0019857

Topics

Women and heart disease

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May 25, 2011PLoS ONEOpen Access

An International Randomised Placebo-Controlled Trial of a Four-Component Combination Pill (“Polypill”) in People with Raised Cardiovascular Risk

View Full Paper

Ask AI

Bookmark

Key result

The four-component polypill reduced systolic blood pressure by 9.9 mmHg and LDL-cholesterol by 0.8 mmol/L compared to placebo over 12 weeks, though it caused side effects in about 1 in 6 people.

Why the study?

Population

378 individuals without an indication for any component of the polypill, but who had an estimated 5-year…

Comparison

Polypill containing aspirin 75 mg, lisinopril 10… vs Placebo

Design

RCT, randomised, double-blind

Follow-up

12 weeks

Discussion

Member takes

Implication

Supports polypill initiation in moderate-risk patients; extends RCT evidence to those without component-specific indications.

Key Points

To evaluate the efficacy and tolerability of a four-component combination pill in individuals with elevated cardiovascular disease risk without individual indications for its components.
Conducted a randomised, double-blind, placebo-controlled trial across international sites involving 378 individuals with an estimated 5-year cardiovascular disease risk exceeding 7.5% (ACTRN12607000099426).
Participants received either placebo or a daily polypill containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg, and simvastatin 20 mg for 12 weeks.
Polypill treatment reduced systolic blood pressure by 9.9 mmHg (95% CI: 7.7 to 12.1) and LDL-cholesterol by 0.8 mmol/L (95% CI: 0.6 to 0.9) compared to placebo over 12 weeks.
Treatment discontinuation occurred in 23% of the polypill group versus 18% of the placebo group (RR 1.33, 95% CI: 0.89 to 2.00, p = 0.2).
Adverse effects known to the component medicines were more frequent with the polypill than placebo (58% vs 42%, p = 0.001), but typically did not require treatment cessation.

Study Design

Type

RCT (n=378)

Blinding

Double-blind

Randomization

Computer-based minimization algorithm

Multicenter

Yes

Structured PICO

Population

378 adults with raised cardiovascular risk and no indication for component medicines, followed for 12 weeks.

Intervention

Polypill containing aspirin 75 mg, lisinopril 10 mg, hydrochlorothiazide 12.5 mg, and simvastatin 20 mg

Comparator

Placebo

Outcome

Systolic blood pressure (SBP), LDL-cholesterol, and tolerability (proportion discontinued randomised therapy) at 12 weeks follow-upsurrogate

Main Result

Mean Difference: 9.9 (95% CI 7.7–12.1)

p-value: p=<0.0001

Limitations

Short follow-up of 12 weeks precluded assessment of long-term drop-out rates.
Study design precluded definitive attribution of which component caused which side effects.
Patient population represented a relatively narrow group.
Predicted reductions in cardiovascular risk are based on indirect estimates from risk factor reductions rather than hard clinical endpoints.

Cite This Study

synapsesocial.com/papers/6a86fd2c740e6cf4b5cf8ce6 https://doi.org/10.1371/journal.pone.0019857

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

Topics

Women and heart disease

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