title: Short Term Safety and Tolerability of a Fixed Dose Combination of Olmesartan, Amlodipine and Hydrochlorothiazide.
abstract: OBJECTIVE
  To assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India.
  
  
  METHODS
  Physicians were requested to provide eight weeks observational clinical event data of the patients prescribed with FDC of Olmesartan (20/40mg), Amlodipine (5mg) and hydrochlorothiazide (12.5mg) in the prescription event monitoring (PEM) forms. Data on patients' demographics, indication for FDC, concomitant medication and other relevant history was also collected and was analysed with descriptive statistics.
  
  
  RESULTS
  Two hundred thirty eight physicians provided data of 4763 patients. Mean age of the population was 55±7 years and males were 59.3%. The commonest indication for the FDC was uncontrolled hypertension (60.7%). Diabetes and dyslipidemia were present in 37.9% and 35.1% respectively. Concomitant medications included statins (42.3%), oral anti-diabetic (33.7%) and antiplatelet agents (24.7%). Pedal oedema (0.29%) was the most common adverse event (AE) reported followed by headache (0.16%), giddiness (0.15%), light headedness (0.15) and stroke (0.15%). Other less common (0.04%) reported AEs were tiredness, dizziness, gastritis, hypersomnia, hypoglycaemia, lower respiratory tract infection (LRTI), weakness, diarrhea, labyrinthitis, urinary tract infection, hyponatremia and hypotension. Occurrence of AEs was more common in patients with uncontrolled hypertension (60.74%).
  
  
  CONCLUSIONS
  The FDC of olmesartan, amlodipine and hydrochlorothiazide prescribed most frequently for patients with uncontrolled hypertension and co-morbidities was found to be safe and well tolerated over a short period of observation.
authors.affiliation: Director, Department of Cardiology, Fortis Hospital , New Delhi, India .
authors.forename: J C
authors.initials: JC
authors.lastname: Mohan
authors.affiliation: Deputy General Manager, Department of Medical Services, Glenmark Pharmaceuticals , Mumbai, India .
authors.forename: Rishi
authors.initials: R
authors.lastname: Jain
authors.affiliation: Assistant Manager, Department of Medical Services, Glenmark Pharmaceuticals , Mumbai, India .
authors.forename: Vijay
authors.initials: V
authors.lastname: Chamle
authors.affiliation: Head, Department of Medical Services, Glenmark Pharmaceuticals , Mumbai, India .
authors.forename: Amit
authors.initials: A
authors.lastname: Bhargava
keywords: Adverse event; Hypertension; Observational; Prescription event monitoring