The potential therapeutic benefit of paracetamol, diclofenac sodium or their combination in treatment of patients with type-2 diabetes mellitus

Other Title(s)

الفائدة العلاجية المحتملة للباراسيتامول أو الدايكلوفيناك صوديوم و كليهما في معالجة مرضى السكري من النوع الثاني

Dissertant

Makki, Maha Jalil Abbud

Thesis advisor

Umran, Husam Jihad
Jawad, Abd Allah Muhammad

University

University of Basrah

Faculty

Medicine College

Department

Department of Pharmacology

University Country

Iraq

Degree

Master

Degree Date

2013

English Abstract

Background Type-2 diabetes mellitus (T2DM), is becoming an important health problem worldwide.

It may be associated with oxidative stress and low grade chronic inflammation; both of them could contribute to its pathogenesis.

The use of antioxidant and/or anti-inflammatory drugs, therefore, represents a promising attempt for treatment and/or prevention of this disease.

Objectives To evaluate the role of paracetamol (acetaminophen), the non-steroidal anti-inflammatory drug (diclofenac sodium) and their combination in type-2 diabetic patients not achieving target glycated hemoglobin (HbA1c) through monitoring of the glycemic control and other parameters.

Patients and Methods Sixty nine, type-2 diabetic patients consulting the Center for Diabetes and Endocrinology in Maysan were included in this study after meeting a set of inclusion criteria.

Their HbA1c was more than 7% despite the continuous use of oral antihyperglycemic drugs.

They were randomly divided into three groups.

Group I was treated with paracetamol 1000mg tablet once daily for one month.

Group II was treated with diclofenac sodium 100mg sustained-release (SR) capsule once daily for one month and group III was treated with the combination of both paracetamol and diclofenac sodium.

Lipid profile, liver function tests, renal function tests, HbA1c, C-reactive protein CRP, C-peptide and fasting / random plasma glucose level (FPG/RPG) were performed for each patient before starting treatment.

Total antioxidant capacity (TAC) was also measured before starting paracetamol treatment and after one month of its treatment.

Blood samples were taken from all the 69 patients before, one month and three months after the start of paracetamol, diclofenac sodium or their combination for measurement of HbA1c, C-reactive protein, C-peptide level and more frequently plasma glucose level (fasting/random).

Another sixty patients of similar inclusion criteria were also followed for three months but without intervention treatment with paracetamol or diclofenac and served as a control group.

Results One month treatment with paracetamol (n=24) resulted in a clear beneficial effect when measured two months after cessation of paracetamol.

Paracetamol significantly reduced HbA1c by 7.32% and random plasma glucose RPG by 22%, and greatly increased C-peptide by 443% in comparison to pre-treatment level.

TAC measured once after one month of treatment increased by 20.2%.

Unexpectedly, CRP was reduced significantly by 63.9% two months after cessation of paracetamol.

Treatment with diclofenac sodium (n=24) also reduced HbA1c by 9.4%, CRP by 62.1% and RPG by 40% two months after cessation of diclofenac sodium.

C-peptide, on the other hand, increased by 262.5% two months after cessation of diclofenac treatment.

Compared with paracetamol, diclofenac caused slightly more reducing effect on HbA1c and RPG but less effect on C-peptide level.

Combination of both paracetamol and diclofenac sodium (n=21) did not result in a clear synergistic effect where the combination caused an increase in the effect on HbA1c and CRP but a decrease in the effect on C-peptide and RPG compared with each drug given individually.

The control, non- intervention group did not show significant changes in the levels of HbA1c over the three month period.

Measurement of Homeostasis Model of Assessment-ß C-peptide (HOMA- ß C-peptide) in a limited number of patients indicate that paracetamol, and also diclofenac sodium, significantly improve ß-cell function; but their combination is not additive.

Conclusion Paracetamol 1000mg tablet, diclofenac sodium 100mg SR capsule or their combination when administered once daily for one month seem to be effective in achieving a good glycemic control in patients not achieving target HbA1c.

Type-2 diabetic patients with poor response to oral antihyperglycemic drugs may, therefore, be given a trial of paracetamol or diclofenac sodium treatment for one month before switching to insulin.

The use of their combination is not advisable in T2DM because they did not clearly add to the effect of each drug given alone.

Main Subjects

Pharmacology

No. of Pages

102

Table of Contents

• APA
• MLA
• AMA

Language

English

Data Type

Arab Theses

Record ID

BIM-745100