PK/Statistical model in depression hypertension.

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PK/Statistical model in depression hypertension.

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Title: PK/Statistical model in depression hypertension.
Author: Loan, G. M (Scholar); Wafai, Z. A (Guide)
Abstract: Background: Depression hypertension is a co-morbid disease and needs treatment with more than one drug. Material & Methods: 25 patients each from depression hypertension and hypertension were included in the study. In order to evaluate the PK/PD statistical model, single dose 100mg Amitriptyline was administered to the depression hypertension and hypertension subjects. PK parameters of Amitriptyline and its metabolite, nortriptyline was determined. The concentration of Amitriptyline and Nortriptyline was estimated by HPLC, which is the versatile, accurate and sensitive method. Plasma samples at 0, 1, 2, 4, 8, 12, 24 hours were drawn from each subject along with the Pharmacodynamic changes like blood pressure, heart rate and respiratory rate. After a wash-out period of 7 days, Amlodipine 10mg was administered to each group when 10-15mmHg diastolic blood pressure was decreased and then the Amitriptyline 100mg wad again administered. PK and PD parameters were again estimated. The groups were as follows: T1 and C1 of 23 patients each. These 2 groups were sub-divided into four groups i. E. (1) T1a (Depressive hypertension before Amlodipine), (2) T1b (Depressive hypertensive after Amlodipine), C1a (Hypertensive before amlodipine) and C1b (Hypertensive after Amlodipine). Results: Pharmacokinetic parameters of Amitriptyline like T½, Cmax, Tmax, AUC, Vd, clearance of these two groups were compared. T½ (hours) of C12, C1b were 20.213±4.51 and 23.78±3.99 having P value <.05, T ½ of T1a, T1b were 19.805±5.66 and 20.327±4.27 having p. Value of 0.752. Cmax (ng/ml) of C1a, C1b were 31.88±13.54 and 32.45±13.14 having p. Value of 0.649, Cmax of T1a and T1b were 30.90±11.8 and 31.08±12.0 having p. value of 0.584. AUC (ng/ml into hour) of C1a and C1b were 186.09±44.18 and 203.88±43.39 having p. value <0.05, AUC of T1a and T1b¬ were 182.80±39.6 and 210.57±48.86 having p. value <0.05. Volume of distribution (Vd l/kg) of C1a and C1b were 15.18±2.43 and 18.78±2.50, Vd of T1a and T1b were 14.61±3.43 and 16.56±2.54 having p. value <0.05. Clearance (l/hr) of C1a and C1b were 9.55±2.6 and 8.59±2.32 having p. value of 0.129, clearance of T1a and T1b were 9.59±2.32 and 8.59±2.32 having p. value <0.05. Conclusions: There is a significant change of PK parameters in the group C1a and C1b in T½, AUC and Vd. In the group T1a and T1b, there is also a significant change in AUC, Vd and Clearance as well. So by changing the blood flow, there is a significant change of PK parameters in the object drug Amitriptyline.
URI: http://dspaces.uok.edu.in/handle/1/752
Date: 2009


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