Efficacy and tolerability of fixed dose combination of metoprolol and amlodipine in Indian patients with essential hypertension
N Srinivasa Rao1, Abraham Oomman2, PL Bindumathi3, Vikram Sharma4, Satish Rao5, Latha Subramanya Moodahadu6, Ashis Patnaik6, B. R. Naveen Kumar6
1 Department of General Medicine, Osmania General Hospital and Medical College, Hyderabad, Andhra Pradesh, India
2 Department of Cardiology, Apollo Hospital, Chennai, Tamil Nadu, India
3 Department of General Medicine, Dr. BR Ambedkar Medical College, Bengaluru, Karnataka, India
4 Department of Neurology, St. Theresa's General Hospital, Hyderabad, Andhra Pradesh, India
5 Department of General Medicine, Kasturba Medical College, Mangalore, Karnataka, India
6 Global Medical Affairs, Dr. Reddy's Laboratories, Hyderabad, Andhra Pradesh, India
Latha Subramanya Moodahadu
G 5, Mount Meru Apartment, Road # 5, Avenue 7, Banjara Hills, Hyderabad - 500 034, Andhra Pradesh
Source of Support: Study was sponsored by Dr. Reddy’s Laboratories
Ltd. Hyderabad, India, Conflict of Interest: Nil for authors 1 to 5.
These authors are the investigators who conducted the study. Dr. Latha
Subramanya Moodahadu and Dr. Ashis Patnaik are the employees of
the sponsor company and are stakeholders having financial stakes in
Dr. Reddy’s Laboratories Ltd. by means of salary, company stocks or
both. Dr. Naveen Kumar B R was a former employee of Dr. Reddy’s
Laboratories Ltd. and is presently not having any stakes in Dr. Reddy’s
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.
Materials and Methods: Of 101 enrolled patients, 64 drug naοve 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.
Conclusion: This combination was safe, efficacious, and well-tolerated in study population.