title: Efficacy and tolerability of fixed dose combination of metoprolol and amlodipine in Indian patients with essential hypertension.
abstract: BACKGROUND
  This open-labeled, post-marketing study was conducted to assess the efficacy and tolerability of fixed dose combination of amlodipine and metoprolol extended release capsules in mild to moderate hypertension in adult Indian patients.
  
  
  METHODS
  Of 101 enrolled patients, 64 drug naïve patients were treated with regimen A (amlodipine 5 mg + metoprolol 25 mg) and those with prior history of hypertension (n = 37) were treated with regimen B (amlodipine 5 mg + metoprolol 50 mg) for 8 weeks. Treatment response was assessed at week 4 and 8. Dose up titration to regimen B was carried out for those who failed to achieve the target blood pressure (BP) at week 4 in regimen A and additional antihypertensives were added to those in regimen B. Safety laboratory tests were performed at baseline and end of study.
  
  
  RESULTS
  Mean age (±SD) of patients was 53.36 (±11.26) years and body weight (±SD) 63.40 (10.03) kg. Ninety five patients (94.06%) were only hypertensive and 6 (5.94%) had hypertension with history of coronary artery disease; mean duration (±SD) of hypertension was 42.50 (48.07) months. At baseline, patients had a mean (±SD) systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 154.98 (±7.76) mmHg and 95.55 (±5.70) mmHg respectively. There was a statistically significant (P < 0.001) reduction of 12.16% and 14.69% in SBP, 11.49% and 14.65% in DBP at week 4 and week 8 respectively, compared to baseline. Normalization of overall BP was achieved in 49.49% and 70.71% patients at week 4 and 8, respectively. Peripheral edema was reported in 2.97% (3/101) patients.
  
  
  CONCLUSIONS
  This combination was safe, efficacious, and well-tolerated in study population.
authors.affiliation: Department of General Medicine, Osmania General Hospital and Medical College, Hyderabad, Andhra Pradesh, India.
authors.forename: N Srinivasa
authors.initials: NS
authors.lastname: Rao
authors.affiliation: Department of Cardiology, Apollo Hospital, Chennai, Tamil Nadu, India.
authors.forename: Abraham
authors.initials: A
authors.lastname: Oomman
authors.affiliation: Department of General Medicine, Dr. BR Ambedkar Medical College, Bengaluru, Karnataka, India.
authors.forename: P L
authors.initials: PL
authors.lastname: Bindumathi
authors.affiliation: Department of Neurology, St. Theresa's General Hospital, Hyderabad, Andhra Pradesh, India.
authors.forename: Vikram
authors.initials: V
authors.lastname: Sharma
authors.affiliation: Department of General Medicine, Kasturba Medical College, Mangalore, Karnataka, India.
authors.forename: Satish
authors.initials: S
authors.lastname: Rao
authors.affiliation: Global Medical Affairs, Dr. Reddy's Laboratories, Hyderabad, Andhra Pradesh, India.
authors.forename: Latha Subramanya
authors.initials: LS
authors.lastname: Moodahadu
authors.affiliation: Global Medical Affairs, Dr. Reddy's Laboratories, Hyderabad, Andhra Pradesh, India.
authors.forename: Ashis
authors.initials: A
authors.lastname: Patnaik
authors.affiliation: Global Medical Affairs, Dr. Reddy's Laboratories, Hyderabad, Andhra Pradesh, India.
authors.forename: B R Naveen
authors.initials: BR
authors.lastname: Kumar
keywords: Amlodipine and metoprolol; essential hypertension; fixed dose combination; peripheral edema