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Kansartan cycle meeting, q1-2017
1. QUICK Revision on
Kansartan®
LINE 2A
Management: Dr Bassem Saeed.
Line Manager: Dr Emad William
Product Manager: Dr Joseph Saied
Prepared by Marco Makram
2.
3. Content:
1. Position of ARBs among other
antihypertensive classes.
1.1. JNC 8, 2014 (Joint National Committee)
1.2. ASH-2013 (American Society of Hypertension)
2. Position of Irbesartan among other ARBs.
2.1. Pharmacokinetic considerations.
2.2 B.P. Control & Efficacy.
Vs. Losartan
Vs. Valsartan
Vs. Enalapril (ACEI)
2.3 Renoprotection.
4. Position of ARBs in
recent Guidelines:
• JNC 8-2014
(Eighth Joint National
Committee-2014)
• ASH-2013
(American Society of
Hypertension-2013)
5.
6.
7.
8. • Clinical Practice Guidelines for the
Management of Hypertension in the
Community A Statement by the American
Society of Hypertension and the International
Society of Hypertension-2013.
16. Benefits of high Bioavailability:
• A high oral bioavailability reduces the amount of
an administered drug necessary to achieve a
desired pharmacological effect and therefore
could reduce the risk of side-effects and
toxicity. A poor oral bioavailability can result in
low efficacy and higher inter-individual
variability and therefore can lead to
unpredictable response to a drug.
– Ref:http://www.pharmainformatic.com/html/oral_bio
availability__f__.html
19. • No need for Dose Adjustment in
Renal Patients.
20. • No need for Dose Adjustment in
Hepatic and Elderly Patients.
21. II. Efficacy of Irbesartan as
control of SBP & DPB.
– Comparative trials with other
ARBs:
• Vs. Losartan.
• Vs. Valsartan.
– Comparative trials with ACEI:
• Vs. Enalapril.
22. Irbesartan Vs. Losartan
Kassler_Taub et al, 1998 (1)
DBP is lower from baseline by 4.9, 8.7, 9.7 and 11.7 for
Placebo, Losartan100, Kansartan150 & Kansartan300
respectively at the 8th week.
23. Irbesartan Vs. Losartan
Kassler_Taub et al, 1998 (2)
SBP is lower from baseline by 3.7, 11.3, 12.1 & 16.4 respectively
for Placebo, Losartan100, Kansartan150 & Kansartan300 at the
8th week.
24. Irbesartan Vs. Valsartan
Mancia et al, 2002
Change in SBP 11.6 Vs. 7.5 mmHg
Change in DBP 6.4 Vs. 4.8 mmHg respectively.
30. Method & End Point of IDNT trial:
• We randomly assigned 1715 hypertensive patients with
nephropathy (Serum creatinine level 1.0 - 3.0 mg/dl in
women; 1.2 - 3.0 mg/dl in men)due to type 2 diabetes
to treatment with Irbesartan (300 mg daily),
amlodipine (10 mg daily), or placebo.
• We compared the groups with regard to the time to
the primary composite end point of:
– Doubling of the base-line serum creatinine concentration,
– Development of end stage renal disease (defined as renal
transplantation, need for dialysis, or serum creatinine ≥ 6.0
mg/dl), or
– Death from any cause (all cause mortality).
31. Results of IDNT Trial:
• The mean duration of follow-up was 2.6 years.
• Treatment with Irbesartan was associated with a risk of
the primary composite end point that was:
– 20 percent lower than that in the placebo group (P=0.02)
– 23 percent lower than that in the amlodipine group
(P=0.006).
• The risk of a doubling of the serum creatinine
concentration was
– 33 percent lower in the Irbesartan group than in the
placebo group (P=0.003)
– 37 percent lower in the Irbesartan group than in the
amlodipine group (P<0.001).
