January 1, 2008Vascular Health and Risk ManagementOpen Access

Application in the STRATHE trial of a score system to compare the efficacy and the tolerability of different therapeutic strategies in the management of hypertension

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=329). Intervention: Fixed-dose combination strategy (perindopril/indapamide) vs. Sequential monotherapy (atenolol, losartan, amlodipine) or stepped-care strategy (valsartan, hydrochlorothiazide). Primary outcome: Total score integrating efficacy and tolerability over 9 months.

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Key result

A fixed-dose combination of perindopril and indapamide resulted in a higher mean efficacy-tolerability score (13.1) compared to sequential monotherapy (-7.2) and stepped-care (-17.5) in hypertensive patients.

Why the study?

Does a fixed-dose combination of perindopril/indapamide improve a combined efficacy and tolerability score compared to sequential monotherapy or stepped-care in patients with hypertension?

Study Design

Type

RCT (n=329)

Blinding

Double-blind

Randomization

random allocation

Multicenter

Yes

Structured PICO

Does a fixed-dose combination of perindopril/indapamide improve a combined efficacy and tolerability score compared to sequential monotherapy or stepped-care in patients with hypertension?

Population

329 hypertensive patients with baseline blood pressure ≥160/95 mmHg whose treatment was strictly adjusted according to protocol, followed for 9 months.

Intervention

Fixed-dose combination strategy (perindopril/indapamide 2 mg/0.625 mg, with the possibility to increase the dose to 3 mg/0.935 mg, and 4 mg/1.250 mg if needed) for 9 months.

Comparator

Sequential monotherapy (atenolol 50 mg, followed by losartan 50 mg and amlodipine 5 mg if needed) or stepped-care strategy (valsartan 40 mg, followed by valsartan 80 mg and valsartan 80 mg + hydrochlorothiazide 12.5 mg if needed).

Outcome

Total score integrating the evolution of efficacy (blood pressure <140/90 mmHg) and tolerability (side effects) over a 9-month period.composite

Main Result

Absolute Event Rate: 13.1% vs -7.2%

A novel scoring system integrating efficacy and tolerability demonstrated that a fixed-dose combination of perindopril and indapamide yielded better overall outcomes than sequential monotherapy or stepped-care in hypertension management.

Limitations

The scores were not predefined endpoints and were not subjected to statistical analysis.
The analysis only included a subset of patients in whom the study protocol was strictly applied.
Further prospective studies are needed to test whether this type of analysis is more informative than analyzing efficacy and tolerability separately.
Scores were not subjected to statistical analysis since they were not predefined endpoints.
Includes only the subset of patients who underwent changes in therapy strictly according to protocol.

Discussion

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Implication

Supports upfront fixed-dose perindopril/indapamide in hypertension; extends evidence for combinations over sequential strategies.

Cite This Study

Bernard Waeber (2008) conducted an RCT in Hypertension (n=329). Fixed-dose combination strategy (perindopril/indapamide) vs. Sequential monotherapy (atenolol, losartan, amlodipine) or stepped-care strategy (valsartan, hydrochlorothiazide) was evaluated on Total score integrating efficacy and tolerability over 9 months. A fixed-dose combination of perindopril and indapamide resulted in a higher mean efficacy-tolerability score (13.1) compared to sequential monotherapy (-7.2) and stepped-care (-17.5) in hypertensive patients.

synapsesocial.com/papers/6a9167a8f4a38da3d533f162 https://doi.org/10.2147/vhrm.2008.04.01.249

Topics

Hypertension management

View Full Paper

Ask AI

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Application in the STRATHE trial of a score system to compare the efficacy and the tolerability of different therapeutic strategies in the management of hypertension

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

Application in the STRATHE trial of a score system to compare the efficacy and the tolerability of different therapeutic strategies in the management of hypertension

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider