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Cost-effectiveness of an active withdrawal of medication policy versus usual care in patients currently treated for hypertension and/or hypercholesterolemia: a cluster-randomised controlled non-inferiority trial in general practice

Cost-effectiveness of an active withdrawal of medication policy versus usual care in patients currently treated for hypertension and/or hypercholesterolemia: a cluster-randomised controlled non-inferiority trial in general practice - ECSTATIC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39214
Enrollment
464
Registered
2012-06-11
Start date
2012-11-07
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high blood pressure high cholesterol hypercholesterolemia Hypertension

Interventions

The general practitioners (GPs) of the practices in the intervention group will actively withdraw medication in patients who do not need pharmacological treatment according to the guideline CVRM 201

Sponsors

Zorgonderzoek Nederland (ZON)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age 40 to 70 years; • Prescription of antihypertensive medication and/or lipid-lowering drugs for hypertension and/or hypercholesterolemia during the last 12 months (using ATC codes: C02, C03, C07, C08, C09, C10).

Exclusion criteria

Exclusion criteria: • Cardiovascular disease (ICPC codes: K74, K75, K76, K89, K90.03, K91, K92.01 and K99.01); • Use of platelet aggregation inhibitors (heparin excluded) (ATC code: B01AC); • Use of antihypertensive medication for another reason than prevention of CVD; • Familial hypercholesterolemia/lipidemia (ICPC code: T93.04); • Patients with a current SBP >180 mmHg, or a SBP >180 mmHg before the start of medication; • Patients with a current TC/HDL ratio >8, or a TC/HDL ratio >8 before the start of medication; • Patients with a 10-year CVD risk >16% • 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with at least one additional major risk-increasing factor; • 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with two or more additional minor risk-increasing factors; • 10-year CVD risk of 10-16%, based on the 2011 risk table, in combination with one additional minor risk-increasing factor and an SBP >140 mmHg and/or LDL >2.5 mmol/L.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the change in 10-year CVD risk according to the risk table from the guideline CVRM 2011.

Secondary

MeasureTime frame
Secondary outcome measures are quality of life (EQ-5D + VAS), (CVD related) mortality, cardiovascular events and side effects related to withdrawal of medication or use of medication. Other outcome measures are related to modifiable risk factors, such as smoking behaviour (smoking behaviour questionnaire), physical activity (SQUASH), alcohol consumption, eating habits (Standard nutrition questionnaire of Dutch common health services), systolic blood pressure (SBP), ratio of total cholesterol/HDL-cholesterol (TC/HDL ratio) in blood, Body Mass Index (body weight and height), and waist circumference.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)