Plain English Summary
Background and study aims
Hypertension and hypercholesterolemia are two of the most commonly co-occurring cardiovascular risk factors. Hypertension is the leading cardiovascular risk factor contributing to global mortality and nearly half of the hypertensive patients are also diagnosed with hypercholesterolemia. Co-existence of hypertension and hypercholesterolemia has more than an additive adverse impact on the vascular endothelium, resulting in increased atherosclerosis and a subsequent increase in coronary events. Unfortunately, concomitant hypertension and hypercholesterolemia are very difficult to control. This is in part due to poor adherence to medication in individuals at high cardiovascular risk and in patients with coronary artery disease, resulting in worse outcomes and higher healthcare costs. Evidence shows that single-pill combination therapy decreases the risk of medication non-adherence compared with free combination therapy and improved adherence in turn has been shown to significantly improve CV outcomes. In Belgium, there are few epidemiological data on current treatment of hypertensive patients with concomitant hypercholesterolemia or stable coronary artery disease and the way in which general practitioners apply the treatment recommendations in current clinical practice. With this study we try to bridge this gap of knowledge by evaluating in daily clinical practice at the general practitioner level the control of risk factors to develop atherosclerosis in patients treated with at least one antihypertensive agent and a statin.
Who can participate?
Adults treated with at least one antihypertensive agent and one statin and seen by a general practitioner in Belgium.
What does the study involve?
General practitioners records information of patient on a routine consultation about their background, current medical treatment, blood pressure and LDL-c levels.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those taking part in the study.
Where is the study run from?
Servier BeNeLux (Belgium)
When is the study starting and how long is it expected to run for?
November 2017 to January 2019
Who is funding the study?
Servier BeNeLux (Belgium)
Who is the main contact?
Mr. Bregt Van Nieuwenhuyse
Trial website
Contact information
Type
Scientific
Primary contact
Mr Bregt Van Nieuwenhuyse
ORCID ID
Contact details
Servier Benelux
Internationalelaan 57
Anderlecht
1070
Belgium
+32 252 94311
bregt.vannieuwenhuyse@servier.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ATHERO IC4-05153-024-BEL
Study information
Scientific title
Cross-sectional study evaluating the control of risk factors to develop ATHEROsclerosis in the general population of Belgium and Luxembourg treated with at least one antihypertensive agent and a statin.
Acronym
ATHERO
Study hypothesis
The aim of this study is to evaluate in daily clinical practice at the general practitioner level in Belgium and Luxembourg the control of risk factors that develop atherosclerosis in patients treated with at least one antihypertensive agent and a statin.
Ethics approval
Due to the observational nature of this study, it does not require ethics approval according to the European directive and Belgian law.
Study design
Cross-sectional observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Condition
Hypertension
Intervention
All participants attend an appointment to see their general practitioner, who is asked to record the following information:
1. Number of the patient in the study (1 to 15)
2. Age, sex, weight and height of the patient
3. Presence of concomitant cardiovascular risk factors/co-morbidities (diabetes, prior CV events, renal disease, heart failure, peripheral vascular disease, smoking, at risk age, familial predisposition)
4. Systolic/diastolic blood pressure (mmHg)
5. LDL-c and total cholesterol values (mg/dl) (measured within previous 12 months)
6. Physician-reported attainment of LDL target and BP control according to international guidelines
7. Antihypertensive treatment before consultation (name, therapeutic class and daily dose)
8. Cholesterol lowering treatment before consultation (name, therapeutic class and daily dose)
9. Motivation to use single pill combinations before treatment of hypertension and dyslipidemia
Due to the transversal nature of the study, no follow-up of the patients is performed.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Systolic and diastolic blood pressure values is measured using according to the general practitioners’ standard operating procedure during consultation
2. LDL-c and total cholesterol is noted based on medical records at time of consultation
Secondary outcome measures
1. Number of antihypertensive and cholesterol lowering drugs taken before consultation is measured using medical records
2. Cardiovascular risk of on-treatment patients in Belgium and Luxembourg is measured using medical records and patient anamnesis during consultation
3. Judged BP control and cholesterol control is measured by asking the general practitioners’ clinical evaluation during consultation
4. Judgement of the suitability of the patient for single pill combinations & motivation is measured using by asking the general practitioners’ clinical evaluation during consultation
5. Types of antihypertensive and lipid lowering treatment used in Belgium and Luxembourg is measured using medical records
Overall trial start date
15/11/2017
Overall trial end date
31/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age ≥ 18 years
2. Confirmed (in medical records) diagnosis of hypertension
3. Confirmed (in medical records) diagnosis of hypercholesterolemia or stable coronary artery disease
4. Prescription of ≥ 1 antihypertensive drug
5. Prescription of a statin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4725
Total final enrolment
2337
Participant exclusion criteria
Patients hospitalised for cardiovascular diseases in the last 3 months (including revascularization).
Recruitment start date
01/02/2018
Recruitment end date
19/01/2019
Locations
Countries of recruitment
Belgium, Luxembourg
Trial participating centre
Servier Benelux
Internationalelaan 57
Anderlecht
1070
Belgium
Sponsor information
Organisation
Servier Benelux
Sponsor details
Internationalelaan 57
Anderlecht
1070
Belgium
+32 252 94311
bregt.vannieuwenhuyse@servier.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Servier Benelux
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
After completion of the study a scientific report will be written and data will be send out for publication.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from bregt.vannieuwenuyse@servier.com.
Intention to publish date
01/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list