Individual reevaluation therapy Primairy Cardiovascular Prevention

According to the new guideline for cardiovascular risk management of the Dutch
College of General Practice, risk factors (NHG-standaard M84 Cardiovasculair
risicomanagement), such as hypertension and hypercholesterolemia, are treated
in association with each other, through the calculation of one risk score. The
guideline defines two categories: patients with previous cardiovascular disease
or diabetes and patients without this.

Within the Zorgcoöperatie Katwijk langs de Rijn U.A., general practitioners and
practice assistants use a protocol for patients with diabetes. In the near
future, in collaboration with the hospitals in the area a protocol will be
developed for the prevention of cardiovascular disease for patients with
previous cardiovascular disease (secondary prevention). Additionally, the
Zorgcoöperatie wrote a protocol in May 2007 for the primary prevention of
cardiovascular disease (for patients without previous cardiovascular disease or
diabetes mellitus) using the guideline for cardiovascular risk management.

One problem encountered during the development of the protocol for primary
prevention are the patients using medication for hypertension or
hypercholesterolemia since a long time, who would not need this medication
according to the new guidelines. With these patients the general practitioner
can discuss the necessity of discontinuation of the medication. Not every
patient will agree to discontinuation. To find an efficient way to deal with
this problem, knowledge about which patients will be prepared to reevaluate the
medication, which patient receive unnecessary medication and what the
determinants for a successful attempt to stop the medication, will be of
enormous value.

The aim of this project is to evaluate how many patients use medication for
primary prevention of cardiovascular disease, how many patients are willing to
be reevaluated and how many patients receive unnecessary treatment according to
the new guidelines for cardiovascular risk management. Furthermore, we want to
know how many of these patients are willing to discontinue their medication and
what the determinants play a role in this decision. The costs and benefits of
the reevaluation and discontinuation of medication will be evaluated. Adverse
events will be carefully monitored.

Phase 1:
With literature research and the help of the Department of Public Health and
Primary Care we identified possible determinants for a successful
discontinuation of preventive cardiovascular medication.(appendix A). With this
we developed a registration form per patient. In this phase we will identify
the patients, aged 25-75 years without previous cardiovascular disease and
without diabetes who receive preventive cardiovascular medication. (appendix B).

Fase 2:
During 18 months the selected patients without previous cardiovascular disease
and without diabetes who receive preventive cardiovascular medication will be
invited for a consultation with the practice nurse. The practice nurse explains
the aims of the study and hands out an information letter. If the patient
agrees to a reevaluation, an informed consent will be signed and a new risk
profile will be made with a new risk score (see below). With this new risk
score the practice nurse will reevaluate the necessity of preventive
cardiovascular medication. If there is no increased risk for cardiovascular
disease (<10%), the practice nurse will make an appointment for a consultation
with the general practitioner. The practice nurse will fill in the registration
form (two copies). One copy will be handed over to the general practitioner.
During a subsequent consultation the general practitioner will discuss the
result of the reevaluation with the patient and will propose to discontinue the
medication according to a personalized protocol, developed in cooperation with
the local pharmacist. The general practitioner fills in the rest of the
registration form and returns this form to the practice nurse. An appointment
for follow up will be made.

Adverse events:
Adverse events will be notified every two weeks to the monitoring commission.
Members of the monitoring commission are: E.P. Walma MD PhD, general
practitioner in Schoonhoven, and department of general practice in Rotterdam,
H.G.L.M. Grundmeijer MD PhD, general practitioner in Diemen, and department of
general practice in, Amsterdam Medical Center. The forms with adverse events
will be sent to the members of the commission every two weeks. The information
about the adverse event will be separated from the personal identifying data.
Personal data will remain in the practice. A serious adverse event will be
notified the same day. In case no serious adverse events occur in the first
three months of the project, the forms will be sent once a month to the
commission. Still, in case of a serious adverse event, this will be done the
same day.

The monitoring commission evaluates which adverse events can be related to the
discontinuation of the medication. When needed, the commission will advise to
stop the project, guided by the incidence of adverse events and guided by the
seriousness of the adverse events.

Estimation of the size of the research population.
Approximately 1200 patients use primary preventive cardiovascular medication.
We estimate that approximately 300 patients will be offered to discontinue the
medication after reevaluation of the cardiovascular risk.

Phase 3:
After the second phase, in cooperation with the department of Public Health and
Primary care, the results will be analyzed and an end evaluation of the project
will be presented in a scientific article.


New risk estimation

During the second phase, all patients will be seen by the practice nurse.
He/she will make a new risk estimation based on the new guidelines for
cardiovascular risk management. She will follow the next criteria:
• In case of no anti-hypertensive treatment, the blood pressure will be
measured and the systolic blood pressure value will be used for the risk
estimation.
• In case of anti-hypertensive treatment, a systolic blood pressure of 180 mmHg
will be used for the new risk estimation, unless the value of the systolic
blood pressure at the start of the hypertensive treatment can be retrieved.
• In case of no cholesterol lowering medication, the total
cholesterol/HDL-cholesterol ratio will be calculated and used in the new risk
estimation.
• In case of cholesterol lowering medication, a total
cholesterol/HDL-cholesterol ratio of 8 mmol/l will be used, unless the ratio
at the start of the cholesterol lowering medication can be retrieved.

The estimated values can be somewhat arbitrary. The choice for these values is
made in this way in order to prevent a false positive low risk. In addition, in
case of a systolic blood pressure or a ratio higher than the chosen values,
more diagnostic evaluation would have taken place, even according to previous
guidelines.

See study design

Patients will come to the practice once for a reevaluation. After this, a
number of patients will come to the general practitioner for consultation to
discuss discontinuation of medication. In case the patient decides to
discontinue medication, a few more consultations will follow during the follow
up (see protocol).