Fixed Dose Telmisartan/Indapamide SR Combination Therapy in Systemic Hypertension in Taiwanese Adults

Abstract

Background: Antihypertensive therapy has evolved considerably during the past several decades. Two drug combinations at low dosages have been found to be effective and well tolerated, as recommended by 2003 ESH/ESC and JNC VII hypertensive-guidelines. Few studies have examined the efficacy of this combination therapy in Asian patients.Ojective: The aim of this open-label, uncontrolled study was to assess the 24-h effectiveness and tolerability of once-daily fixed dose Tel/lnd-SR combination therapy by using noninvasive ambulatory BP monitoring (ABPM) in Chinese patients.Methods: A total of 34 patients with untreated essential hypertension were enrolled. Patients with prehypertension, stage I or II hypertension(as defined by the Seventh Report of Joint National Committee on pressure)were treated with Tel 40mg/plus Ind-SR 1.5mg/day combination therapy once-daily for 8 weeks. The patients were seen in the clinic every 4 weeks to have office BP and heart rate checked .However, if their supine diastolic BP was ≧95mmhg or more, the dose of telmisartan was increased to 80mg/day or a third drug was added and they were exclude from the study. Metabolic effects including serum sodium, potassium, uric acid and fasting plasma glucose determinations were carried out before and after 8 weeks of therapy. Medication compliance was carried out by counting the tablets at each visit and the tablets returned at the end of the study. Any adverse events possible related to combotherapy were asked and reported by patients.Results: A total of 29 patients (age 52±8 yrs ), 13 men and 16 women completed the study. Mean 24-h systolic /diastolic BP after Tel/lnd-SR combotherapy was significantly decreased compared with baseline values (127±21/80±11 vs. 146±19/92±11 mm Hg; p＜0.0005/0.0005). Mean daytime (6 A.M. to 6 P.M.) BP decreased from 151±19/95±11 to 129± 20/82± 11 mm Hg (p＜0.0005/0 .0005) and night time BP (6 P.M. to 6 A.M.) from 142± 21/89± 12 to 125± 22/79± 22 mm Hg (p＜0.0005/0.0005). BP reduction was more pronounced during the day. Before treatment, the circadian rhythm showed a peak BP at 11 A.M. and a nadir at 12 P.M. After treatment, significant BP reduction (P＜0.05/0.05) was observed throughout 23 of the 24 hourly mean points. The circadian rhythm of BP was preserved as indicated by similar BP standard deviations (23± 3/14± 2 vs. 23±2/14± 1 mm Hg). Mean heart rate did not change. Dizziness was reported in 4 patients, of which 2 were thought to be possible related to excessive BP reduction. Indapamide SR was premature terminated in these 2 patients. Hypokalemia was found in another 2 patients.Conclusions: A fixed low-dose combination of telmisartan/indapamide-SR therapy produced significant BP reduction through-out 23 of the 24 hourly mean points pre-serving circadian BP cycles and is generally well toterated in Taiwanese patients.