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EVALUATION OF THERAPEUTIC RESPONSE OF METFORMIN HCl AND ITS RATIONALE COMBINATIONS ON

GLYCEMIC VALUE IN DIABETICS

C SUJANIB UMA MAHESH

B SUNIL GAVASKARD SIVA SANKAR

K V HIMA BINDUK V GOPINATH & B PUSHPA KUMARI

DEPARTMENT OF PHARMACOLOGY SRI PADMAVATHI SCHOOL OF PHARMACY

TIRUPATI - 517 503 (A.P.)INDIA

Aim

To evaluate the therapeutic response of Metformin HCl & it’s rationale combinations

Objectives

    • To assess the therapeutic response

• To appropriately counsel patients & evaluate the outcome of the same

• Adverse drug reactions

• Diabetic complications

• BMI & Demographic data

Plan of Work

Design of Study

Retrospective and prospective

Study Site

T.T.D Central hospital, SVIMS

Study Period

October, 06 to March, 2007

Inclusive Criteria

Type 1 diabetic and Type 2 diabetics

Age group 12 to 60 and above

Glucometer tests

Sign written informed consent

Exclusive Criteria

• Patients with chronic diseases

• Less than 90%compliant in drug usage

• Voluntary withdrawal

• Pregnant women and children

Plan of Work

Phase I

Provide basic diabetic facts

Written and verbal instructions

Advise on use of ER

Medications

Plan of Work

Phase II

Patients having clinical symptoms of diabetic

Diabetic diagnosis on basis of glucometer test

Prescribing diabetic drugs

Signing consent form by the patient

Designing of a standard data collection

Patient Counseling

Plan of Work

Phase III

Establish therapeutic goals

Provide instructions for monitoring and reporting

Practice use of glucometer test

Plan of Work

Follow-up

See patients every 30 days interval

Assess attainment of goals Make necessary adjustments to

treatment Updated written Diabetic (self)

Action Plan Check patient’s Glucometer test Assessment of outcome variables

by Standard statistical analysis

Data on diseases

5 14

14

7

17

5 23

7

11

32

32

0

23

4

0

200

400

600

800

1000

1200

DM

HT

TB

Ep

ilep

sy

Ast

hm

a

DM

& H

T

Mis

cella

ne

ou

s

To

tal

Name of the Disease

Nu

mb

er

of P

atie

nts

Demographic data based on sex(n=320)

155165

320

0

50

100

150

200

250

300

350

Male Female Total

Sex

Pe

rce

nta

ge

of P

atie

nts

Demographic data based on age(n=320)

217

71

101

129

0

20

40

60

80

100

120

140

20-29 30-39 40-49 50-59 >60

Age in Years

% o

f P

atie

nts

Demographic data based on education (n=320)

103

7377

57

19

0

20

40

60

80

100

120

Illeterates Middle School High School College Higher

Education

% o

f P

atients

Demographic data based on Occupation

Employee50%House w ife

44%

Unemployee5%Cultivation

1%

Demographic data based on Smoking (n=320)

35

285

0

50

100

150

200

250

300

Yes No

Smoking

% o

f P

atients

Demographic data based on Alcohol social habit (n=320)

37

283

0

50

100

150

200

250

300

Yes No

Alcohol

% o

f P

atie

nts

Demographic data based on Mean + SD (n=206)

020406080

100120140160180

Age Height Weight BMI

Demographic Data Parameters

Mea

n Va

lue

+ SD

Causes of diabetes (n=320)

89

67

48

10

20

40

60

80

100

Genetic Sedentory Obesity DrugInduced

Causes of Diabetes

% o

f Pat

ient

s

Risk factor - BMI

Normal, 89( 43%)

Overweight 85 (40%)

Obesity, 36 (17%)

Demographic data based on treatment profile (n=210)

41

130

36

30

20

40

60

80

100

120

140

One Two Three Four

Number of Drugs

% o

f P

atie

nts

Effect of anti-diabetic drug(s) 0n glycemic value (%change)

Met + Pioz + Acar25%

Met + Pioz + glim19%

Met + Insu7%

Met 5%

Met + Glib 15%

Met + Glip19%

Met + Pioz10%

Percentage change in glycemic value of Metformin HCl

13.5

07

33.2

4.8

01

24.4

81

0

5

10

15

20

25

30

35

% C

hange in

Gly

cem

ic V

alu

e

baseline Follow up

Glycemic Value

Fasting

PP

Percentage change in glycemic value of Metformin + Glibenclamide treatment

23.8

968

53.0

437

20.8

095

48.6

5

0

10

20

30

40

50

60

% C

hang

e

Base line Follow up

Glycemic Value (mg/dl)

Fasting

PP

Percentage change in glycemic value of Metformin + Glipizide treatment

30.7

698

26.0

952

55.3

811

52.2

8

0

10

20

30

40

50

60

Base line Follow up

Glycemic Value (mg/dl)

% C

hange

Fasting

PP

Percentage change in glycemic value of Met + Pioz + Acarbose treatment

-12.6

9

-25.4

9

7.5

0

-30

-25

-20

-15

-10

-5

0

5

10

Base line Follow up

Glycemic Value (mg/dl)

% C

hange in G

lycem

ic V

alu

e

Fast

PP

Therapeutic response of anti-diabetic drug(s) on glycemic value

200

239

192

166

116

282

126

132

102

14215

9

152

138

120

160

200

0

50

100

150

200

250

300

Normal Met Met +Glib

Met +Glip

Met +Pioz

Met +Pioz +Acar

Met +Pioz +glimer

Met +Insu

Drug(s)

Gly

cem

ic V

alue

(m

g/dl

)

Fast

PP

Adverse Drug Reactions of Anti-Diabetic Drugs (n=320)

47

93

111

4

44

54

120

0

20

40

60

80

100

120

140

Hypo/h

yper

Sw

eating

Appetite

Asth

neia

Dia

rrhoea

Tre

mors

Mala

ise

Adverse Drug Reaction

% o

f P

atients

Data on diabetic complications

6

13

20

4

11

00

5

10

15

20

25

Hypo/Hyper Risk of Infections Diabetic Retinopathy

Complications

Num

ber

of P

atie

nts

Total Diabetics

Diabetics using Metformin

Conclusion

Glimepride, pioglitazone and metformin or Acarbose, pioglitazone and metformin have a complementary mechanisms of action combination therapy with these agents result in improved glycemic control and improved tolerability at lower doses of individual agents.

Diabetes is more common in overweight or obese persons.

The impact of patient counseling on management of Diabetes was studied and it is very significant.

Conclusion

Improves confidence, and patient compliance

Cuts cost of therapy

Minimize the usage of medication per day

Reduces side effects, and diabetic complications

Faculty members, SPSP

The Principal, SPSP

The Chairman, SPSP, Tirupati

Medical &Para Medical Staff, TTD Hospitals

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