S.M Abdullah1*, M Tandon1, N Saha2, K K Pillai3
1M.Pharm, Department of Clinical Pharmacology Unit, Ranbaxy Laboratories Ltd, India.
2Department of Medical Affairs & Clinical Research, Ranbaxy Laboratories Ltd, India.
3Ph.D, Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard, India.
The principle for the treatment of hypertension as per JNC-7 guideline is ‘treat to blood pressure (BP) <140/90 mmHg’ but in common clinical practice it is often difficult to lower the BP below 140/90 mmHg with monotherapy. While majority of patients requires two or more drugs to achieve target BP, this finally calls for comparative clinical evaluation of antihypertensive drugs as co-administration verses monotherapy.
METHOD: This study was randomized, single-blind, double-dummy, three-treatment, crossover study includednewly diagnosed treatment naive essential hypertensive patients; aged 20-45 years with sitting office BP ranged 140-159/94-104 mmHg. After 4 weeks of regular measurements of BP, all subjects received each treatment in randomized order for 1 week: imidapril 5 mg and placebo (I/P), lercanidipine 10 mg and placebo (L/P) or imidapril 5 mg and lercanidipine 10 mg (I/L). Prior to dosing and at the end of each treatment period, 24-hours ambulatory blood pressure monitoring (ABPM) was performed. Recorded data was analyzed for the evaluation of pharmacodynamic potential of each treatment.Beside this time-effect profile was also evaluated in terms of trough-to-peak (T/P) ratio.