A randomised control trial on sequential drug monotherapy versus conventional step care therapy in the treatment of mild to moderate hypertension.

ABSTRACT

OBJECTIVES: There are many studies in the literature on single drug therapy (monotherapy) for mild to moderate hypertension. These studies show comparable efficacy, side effect profile and compliance. It has not been shown yet, whether the number of patients controlled on monotherapy can be improved by systematically stopping a drug which does not adequately control blood pressure and starting another drug in a sequential manner until blood pressure is well controlled. The aim is to show that sequential drug monotherapy (SDM) is as good as step care therapy (SCT) in controlling mild to moderate hypertension. METHODS: Patients attending three medical outpatient departments of Christian Medical College and Hospital, with mild to moderate hypertension uncontrolled on single drug therapy formed the patient population. They were then randomised to the sequential drug monotherapy or step care therapy. The choice of one of the five antihypertensive drugs was left to the attending physician. RESULTS: Thirty two and 42 patients entered the study and 28 and 35 completed the study in SCT and SDM group, respectively. Follow up was for a period of three months. BP was controlled 100% each in SCT and SDM groups. Efficacy with intention to treat was 85.2% in SCT and 81.8% in SDM group. Percent controlled with second drug was 82 and 71, controlled with third drug was 18 and 14 in SCT and SDM, respectively. Mean duration of treatment for control for BP was 1.7 and 2.3 months in SCT and SDM groups respectively. Average cost in SCT was Rs 66.28 and in SDM was Rs 45.53 per month (p = 0.005). Incidence of ADR was 28.6% and 10.5% in SCT and SDM groups, respectively (p = 0.06). CONCLUSIONS: SDM is as effective as SCT, SDM offers the following advantages less expensive, better compliance, fewer complications, drug interaction and thus improved quality of life.