Efficacy and Acceptability of the Indapamide SR 1,5 mg (Tertensif ® SR) in Patients above 55 Years of Age with Isolated Systolic Hypertension - the STIP Study

Abstract

Background Isolated systolic hypertension is a significant health problem for Polish society.Modified release forms of available drugs are becoming the treatments of choice. The aim of the presented work was to evaluate the efficacy and tolerance of a sustained release form of indapamide at a dose of 1,5 mg (Tertensif ® SR)in the treatment of patients above 55 years of age,with mild to moderate isolated systolic hypertension.
Materials and methods The study was a multi-centre study in Polish health centres.Patients were recruited into the study from those taking part in the WISHE-Poland programme,where isolated systolic hypertension was diagnosed i.e:the average SBP pressure was in the range of 140 –179 mm Hg and DBP <90 mm Hg.Treatment was carried out for 12 weeks,during which time the patient attended 2 assessment visits,after 6 and 12 weeks.During the first 6 weeks patients received indapamide SR at a dose of 1,5 mg as a monotherapy.Patients who recorded a systolic pressure of 160 –179 mm Hg at week 6,were also given perindopril at a daily dose of 4 mg.After 12 weeks the investigator assessed the efficacy and tolerance of the treat- ment,in addition the patient was also asked to give their opinion on the tolerance.
Results The study was carried out in 570 patients between 56 –94 years of age (average age 67,5),61%of the patients were female.The mean baseline SBP/DBP value was 160/82 mm Hg.After 12 weeks of treatment,the mean value was 137/77 mm Hg.The mean decrease in SBP was over 20 mm Hg and that of DBP — nearly 5 mm Hg.The reduction in SBP pressure of the studied group was 14% and that of DBP — 6%.Analysis of the efficacy of the study treatment in the whole group of patients who completed the study (525 patients)shows that a good response (decrease in SBP >20 mm Hg and DBP <90 mm Hg) together with a normalization of the arterial pressure was seen in 70%of patients.The mean value of the partnership coefficient at week six was 98%and that at week twelve 99%.Less than 5%of patients (26 patients) experienced adverse events.A relationship between adverse events and treatment with indapamide was observed in 21 patients (<4%).99%of the patients assessed tolerance as good or very good,the investigator assessed such tolerance in 99%of the pateints.
Conclusions 1,5 mg indapamide SR (Tertensif ® SR)when administered to patients aged over 55,with mild to moderate isolated systolic hypertension,successfully decreased systolic pressure and was very well tolerated.