A prospective, randomized, open-label, blinded
end-point trial was conducted in Spain, by Ramon Hermida et al, on 448
hypertensive patients with type- 2 diabetes.
The patients comprised of 255 men and 193 women
whose mean age was about 62 years.
A great number of studies have reported that
hypertension during the night is highly prevalent in diabetic patients and that
blood pressure regulation during the night might be of clinical importance.
Growing evidences indicate that there is an
association between increase in sleep- time blood pressure and increased
incidence of cardiovascular disease (CVD) events in individuals, with or
(Monitorización Ambulatoria para Predicción de Eventos Cardiovasculares
[Ambulatory Blood Pressure Monitoring for Prediction of Cardiovascular Events])
study was specifically designed to find out if treatment of cardiovascular risk
reduction with ≥1 hypertension medications at bedtime exerts better blood
pressure control in hypertensive and type 2 diabetic patients than conventional
therapy (where the BP medications are taken in the morning).
Exclusion criteria included pregnancy,
history of drug/alcohol abuse, night/shift work employment, diagnosis of AIDS,
type 1 diabetes, secondary hypertension, CVD disorders, intolerance to ABPM,
and inability in the subject to communicate and follow study requirements.
Diagnosis of hypertension was carried
out as follows --an awake blood pressure mean of ≥135/85 mmHg for systolic
(SBP)/diastolic blood pressure (DBP), or, alternatively, a sleeping blood
pressure mean of ≥120/70 mmH.
period of follow-up of the patients
was 6 months while the maximum was 5 years.
After a follow-up of a little more than 5
years, patients taking one or more hypertension medications during bedtime
demonstrated a significantly lower cardiovascular morbidity and mortality,
greater blood pressure control and improved ambulatory BP than those taking
medications on waking up.
The study concludes that greater event-free
survival is associated with bedtime chronotherapy in type-2 diabetics taking
more than one BP-lowering medications in comparison to those treated with
Influence of Time of
Day of Blood Pressure-Lowering Treatment on Cardiovascular Risk in Hypertensive
Patients With Type 2 Diabetes; Ramon Hermida et al; Diabetes Care 2011.