Effects of lisinopril or lisinopril/hydrochlorothiazide compared with adjusting of previous medication and intensifying non-pharmacological treatment in patients with mild to moderate hypertension.

The objective of this study was to compare the effectiveness of three treatment methods available for treatment of previously medicated patients with mild to moderate hypertension. The comparison was made between adjusting or increasing previous medication and switching the previous drug treatment to lisinopril (CAS 76547-98-3) or lisinopril hydrochlorothiazide (CAS 58-93-5) therapy and in both of these treatment groups the effect of additional intensified health education was tested. An open, randomised, controlled multi-centre study lasting 36 weeks involving 189 doctors and 69 nurses was carried out in 155 centres of primary health care and occupational health care system in Finland. The study population consisted of 1156 patients, age 30-70 years, (mean DBP 95-115 mmHg in the last three to five measurements during follow-up). The number of patients achieving target pressure (DBP < 90 mmHg) at the end of the study, defined daily doses (DDD) of antihypertensive drugs and side-effects in different treatment groups were regarded as the main outcome measures of the study. After exclusions and drop-outs the final analysis was carried out with 900 patients, 419 women (46.6%) and 481 men (53.4%). Patients receiving lisinopril treatment achieved target pressure significantly more often (p < 0.001) than those continuing their previous or adjusted medication at 36 weeks (59.2 and 55.5% vs 40.3 and 42.7%). Only a small additional but statistically non-significant blood pressure lowering effect was achieved with intensified non-pharmacological treatment at weeks 12 and 24, but this difference had disappeared at week 36. The mean DDDs of different antihypertensive drugs did not differ between groups except for female patients on previous or adjusted medication not receiving health education, the mean DDD being significantly (p < 0.05) higher at weeks 24 and 36 in this group. The profile of adverse effects at the end of the study clearly favoured patients on lisinopril treatment except for cough which was reported in 18% of patients vs 10% in the control groups. 81 patients on lisinopril treatment were withdrawn from the study because of cough. The results showed that hypertensive patients with poor treatment control benefit from all three approaches. A greater proportion of patients on lisinopril treatment achieved target pressure and also experienced fewer side effects than those continuing on adjusted previous medication. Intensified personal health education given once a month during six months had only a small additional beneficial effect on reaching the target pressure and this effect was lost in three months after the health education period.