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Evaluation of clinical activity and safety of Daflon 500 mg in type 2 diabetic female patients

Identifieur interne : 003193 ( Pmc/Corpus ); précédent : 003192; suivant : 003194

Evaluation of clinical activity and safety of Daflon 500 mg in type 2 diabetic female patients

Auteurs : Sherine Maher Rizk ; Nagwa Ali Sabri

Source :

RBID : PMC:3731024

Abstract

Background

The incidence of cardiovascular disease in patients with type 2 diabetes mellitus is approximately twice as high as in the non-diabetic population.

Aim

To investigate the hypoglycemic and hypocholesterolemic effects of Daflon® 500 mg (DF) administration together with its tolerability and efficacy in reducing the cardiovascular metabolic risk factors in female patients with type 2 diabetes.

Methods

In a well-adequate controlled single-blinded randomized parallel design the tolerability and the efficacy of Daflon® (500 mg) either alone or with oral hypoglycemic, twice daily for 45 days, was studied in 36 female patients with type 2 diabetes.

Results

None of the patients in the studied groups were reported to have any adverse events throughout the treatment period (45 days), liver and kidney function tests were within normal limits and there was no significant difference between the pre-treatment (day 0) and post-treatment (day 45) values. Female patients receiving Daflon® either alone or with oral hypoglycemic showed significant decrease in serum glucose; fructosamine; total cholesterol; LDL–cholesterol; triglycerides; malondialdehydes (as index of lipid peroxidation) and C-reactive protein (CRB) levels along with increase in the levels of nitric oxide and blood glutathione.

Conclusion

This study has shown that Daflon® (500 mg, twice daily for 45 days) is helpful in reducing glucose level and the risk of cardiovascular disease in type 2 diabetic patients.

Recommendation

Further clinical trials are essential for strengthening the evidence base on the role of this drug in the cardiovascular risk in diabetic patients.


Url:
DOI: 10.1016/j.jsps.2009.08.008
PubMed: 23964162
PubMed Central: 3731024

Links to Exploration step

PMC:3731024

Le document en format XML

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<name sortKey="Rizk, Sherine Maher" sort="Rizk, Sherine Maher" uniqKey="Rizk S" first="Sherine Maher" last="Rizk">Sherine Maher Rizk</name>
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<name sortKey="Sabri, Nagwa Ali" sort="Sabri, Nagwa Ali" uniqKey="Sabri N" first="Nagwa Ali" last="Sabri">Nagwa Ali Sabri</name>
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<sec>
<title>Background</title>
<p>The incidence of cardiovascular disease in patients with type 2 diabetes mellitus is approximately twice as high as in the non-diabetic population.</p>
</sec>
<sec>
<title>Aim</title>
<p>To investigate the hypoglycemic and hypocholesterolemic effects of Daflon
<sup>®</sup>
500 mg (DF) administration together with its tolerability and efficacy in reducing the cardiovascular metabolic risk factors in female patients with type 2 diabetes.</p>
</sec>
<sec>
<title>Methods</title>
<p>In a well-adequate controlled single-blinded randomized parallel design the tolerability and the efficacy of Daflon
<sup>®</sup>
(500 mg) either alone or with oral hypoglycemic, twice daily for 45 days, was studied in 36 female patients with type 2 diabetes.</p>
</sec>
<sec>
<title>Results</title>
<p>None of the patients in the studied groups were reported to have any adverse events throughout the treatment period (45 days), liver and kidney function tests were within normal limits and there was no significant difference between the pre-treatment (day 0) and post-treatment (day 45) values. Female patients receiving Daflon
<sup>®</sup>
either alone or with oral hypoglycemic showed significant decrease in serum glucose; fructosamine; total cholesterol; LDL–cholesterol; triglycerides; malondialdehydes (as index of lipid peroxidation) and C-reactive protein (CRB) levels along with increase in the levels of nitric oxide and blood glutathione.</p>
</sec>
<sec>
<title>Conclusion</title>
<p>This study has shown that Daflon
<sup>®</sup>
(500 mg, twice daily for 45 days) is helpful in reducing glucose level and the risk of cardiovascular disease in type 2 diabetic patients.</p>
</sec>
<sec>
<title>Recommendation</title>
<p>Further clinical trials are essential for strengthening the evidence base on the role of this drug in the cardiovascular risk in diabetic patients.</p>
</sec>
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<email>nagwa_sabri@yahoo.com</email>
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Department of Biochemistry, Faculty of Pharmacy, Cairo University, Cairo, Egypt</aff>
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Department of Clinical Pharmacy, Ain Shams University, Cairo, Egypt</aff>
<author-notes>
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Corresponding author.
<email>nagwa_sabri@yahoo.com</email>
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<year>2009</year>
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<pub-date pub-type="ppub">
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<year>2009</year>
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<volume>17</volume>
<issue>3</issue>
<fpage>199</fpage>
<lpage>207</lpage>
<history>
<date date-type="received">
<day>15</day>
<month>11</month>
<year>2008</year>
</date>
<date date-type="accepted">
<day>10</day>
<month>5</month>
<year>2009</year>
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<permissions>
<copyright-statement>© 2009 King Saud University. Production and hosting by Elsevier B.V. All rights reserved.</copyright-statement>
<copyright-year>2009</copyright-year>
<copyright-holder></copyright-holder>
</permissions>
<abstract>
<sec>
<title>Background</title>
<p>The incidence of cardiovascular disease in patients with type 2 diabetes mellitus is approximately twice as high as in the non-diabetic population.</p>
</sec>
<sec>
<title>Aim</title>
<p>To investigate the hypoglycemic and hypocholesterolemic effects of Daflon
<sup>®</sup>
500 mg (DF) administration together with its tolerability and efficacy in reducing the cardiovascular metabolic risk factors in female patients with type 2 diabetes.</p>
</sec>
<sec>
<title>Methods</title>
<p>In a well-adequate controlled single-blinded randomized parallel design the tolerability and the efficacy of Daflon
<sup>®</sup>
(500 mg) either alone or with oral hypoglycemic, twice daily for 45 days, was studied in 36 female patients with type 2 diabetes.</p>
</sec>
<sec>
<title>Results</title>
<p>None of the patients in the studied groups were reported to have any adverse events throughout the treatment period (45 days), liver and kidney function tests were within normal limits and there was no significant difference between the pre-treatment (day 0) and post-treatment (day 45) values. Female patients receiving Daflon
<sup>®</sup>
either alone or with oral hypoglycemic showed significant decrease in serum glucose; fructosamine; total cholesterol; LDL–cholesterol; triglycerides; malondialdehydes (as index of lipid peroxidation) and C-reactive protein (CRB) levels along with increase in the levels of nitric oxide and blood glutathione.</p>
</sec>
<sec>
<title>Conclusion</title>
<p>This study has shown that Daflon
<sup>®</sup>
(500 mg, twice daily for 45 days) is helpful in reducing glucose level and the risk of cardiovascular disease in type 2 diabetic patients.</p>
</sec>
<sec>
<title>Recommendation</title>
<p>Further clinical trials are essential for strengthening the evidence base on the role of this drug in the cardiovascular risk in diabetic patients.</p>
</sec>
</abstract>
<kwd-group>
<title>Keywords</title>
<kwd>Diabetes mellitus</kwd>
<kwd>Daflon
<sup>®</sup>
</kwd>
<kwd>Cardiovascular disease risk</kwd>
</kwd-group>
</article-meta>
</front>
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