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

Completed

Conditions: high blood pressure
high cholesterol
hypercholesterolemia
Hypertension
10007963
10082206
10057166

Registration Number: NL-OMON39214

Lead Sponsor: Zorgonderzoek Nederland (ZON)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 464

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the change in 10-year CVD risk according to the<br /><br>risk table from the guideline CVRM 2011.</p><br>

Secondary Outcome Measures

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