title: Safety and effectiveness of candesartan and candesartan/HCT fixed dose combination in patients with hypertension.
abstract: OBJECTIVE
  to assess the safety and effectiveness of candesartan and candesartan/HCT fixed-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-naive 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-naive 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-naive patients than in previously treated patients, although not statistically significant. However, in terms of patients achieving a BP of <140/90 mm Hg between groups were significantly superior in treatment-naive 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).
  
  
  CONCLUSIONS
  results of this open observational study showed that candesartan and candesartan/HCT were well tolerated and effective in both treatment-naive patients and uncontrolled hypertensive patients with previous antihypertensive treatment.
authors.affiliation: Clinical Study Unit, Faculty of Medicine Universitas Indonesia, Jakarta, Indonesia.
authors.forename: Arini
authors.initials: A
authors.lastname: Setiawati
authors.forename: Taufik
authors.initials: T
authors.lastname: Pohan
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D001713:Biphenyl Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D002637:Chest Pain / Q000139:chemically induced; D004232:Diuretics / Q000009:adverse effects* / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010292:Paresthesia / Q000139:chemically induced; D011446:Prospective Studies; D013777:Tetrazoles / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D004232:Diuretics; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C077793:candesartan cilexetil