Onderzoek naar de kosten-effectiviteit van het stoppen van bloeddrukverlagers en/of cholesterolverlagers bij patiënten met een laag risico op hart- en vaatziekten in de huisartsenpraktijk.

Cost-effectiveness of an active withdrawal of medication policy versus usual care in patients currently treated for hypertension and hypercholesterolemia: A cluster-randomised controlled non-inferiority trial in general practice ECSTATIC 'Evaluating Cessation of STatins and Antihypertensive Treatment In primary Care'.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29344

Enrollment

464

Registered

2012-06-20

Start date

2012-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hypertensie, hypercholesterolemie, hart- en vaatziekten. Hypertension, hypercholesterolemia, cardiovascular disease.

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 2011.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women aged 40 to 70 years; 2. 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: 1. Cardiovascular disease (ICPC codes: K74, K75, K76, K89, K90.03, K91, K92.01 and K99.01); 2. Use of platelet aggregation inhibitors (heparin excluded) (ATC code: B01AC); 3. Use of antihypertensive medication for another reason than prevention of CVD; 4. Familial hypercholesterolemia/lipidemia (ICPC code: T93.04); 5. Patients with a current SBP >180 mmHg, or a SBP >180 mmHg before the start of medication; 6. Patients with a current TC/HDL ratio >8, or a TC/HDL ratio >8 before the start of medication; 7. Patients with a 10-year CVD risk >16%; 8. 10-year CVD risk of 10-16% who need pharmacological treatment according to the guideline CVRM 2011.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Secondary outcome measures are quality of life (EQ-5D + VAS), health care costs, (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.	—

Measure

Time frame

Secondary outcome measures are quality of life (EQ-5D + VAS), health care costs, (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.

—

Contacts

Public ContactClare H. Luymes

Leids Universitair Medisch Centrum Afdeling Public Health en Eerstelijnsgeneeskunde (V6-74) Postbus 9600

c.h.luymes@lumc.nl+31 (0)71 5268420

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)