Safety and Effectiveness of Candesartan and Candesartan/HCT Fixed Dose Combination in Patients with Hypertension
ABSTRACT: to assess the safety and effectiveness of candesartan and candesartan/HCT fxed-dose combination (FDC) in patients with hypertension in daily clinical practice. Methods: an open observational study with a 12-week period of treatment. Candesartan tablets of 4 mg, 8 mg, or 16 mg, or candesartan/HCT FDC tablets (16/12.5 mg) were prescribed to adult hypertensive subjects, both treatment-naïve patients and previously treated but uncontrolled patients, depending on the physicians’ discretion based on his/her judgment on the clinical condition. Results: from a total of 112 treatment-naïve patients and 381 previously treated patients eligible for safety analysis, there were only 3 patients with adverse events, and 2 of which were considered possibly related to candesartan (0.41%) and there were no serious adverse events. Both patients were previously treated patients, one patient experienced nausea and the other patient experienced paresthesia. Candesartan and candesartan/HCT were effective in lowering systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline at weeks 4, 8, and 12, in both groups, with 26-27 mm Hg decreases in SBP at week 12 and a trend toward a larger reduction in treatment-naïve patients than in previously treated patients, although not statistically signifcant. However, in terms of patients achieving a BP of <140/90 mm Hg between groups were signifcantly superior in treatment-naïve patients than in previously treated patients at week 8 (56% vs 40%; p = 0.003) and week 12 (69% vs 53%; p=0.004). Candesartan and candesartan/HCT were also effective for patients with long-standing (>4 years) uncontrolled hypertension with previous antihypertensive therapy, which was most commonly calcium channel blockers (became controlled in >50% of all uncontrolled patients). Conclusion: results of this open observational study showed that candesartan and candesartan/HCT were well tolerated and effective in both treatment-naïve patients and uncontrolled hypertensive patients with previous antihypertensive treatment.
Author: Arini Setiawati, Taufk Pohan
Journal Code: jpkedokterangg130265