JC Pharmaceutical Ltd.

Presents

Viglip
Vildagliptin 50 mg tablet

Viglip is indicated
in the treatment
of type 2 diabetes.

Efficacy profile of Vildagliptin

Vildagliptin is a new anti-diabetic agent
that enhances pancreatic islet cell responsiveness
to glucose. An extensive clinical program involving
approximately 22,000 patients and 7000 patient-years
of exposure to vildagliptin has shown that the agent is
well tolerated and efficacious in improving glycemic
control in patients with type 2 diabetes mellitus (T2DM).
Monotherapy trials have shown that 80% HbA1c
lowering is accompanied by body weight-neutral
and lipid-neutral effects, low risk of edema, and
low risk of hypoglycemia (Mathieu C.et al., 2008) .

Comparison with metformin

Vildagliptin is as superior as Metformin. In a
noninferiority trial, 780 patients (HbA1c 7.5%11.0%,
average 8.7%) were randomized to vildagliptin 50 mg
bid (n = 526) or metformin 1000 mg bid (n = 254) for
52 weeks. Mean changes in HbA1c were 1.0% with
vildagliptin (p < 0.001) and 1.4% with metformin
(p < 0.001) (Pi-Sunyer FX..et al., 2007)

Comparison with rosiglitazone

Vildagliptin is more superior than
Rosiglitazone. In a noninferiority trail,
786 patients (HbA1c 7.5%-11.0%, mean 8.7%)
were randomized to vildagliptin 50 mg bid
(n = 519) or rosiglitazone 8 mg qd (n = 267)
for 24 weeks. Mean changes in HbA1c from
baseline were 1.3% with vildagliptin vs
1.1% with rosiglitazone (Pi-Sunyer FX. et al.,2007).

Safety profile of Vildagliptin

Safety data were obtained from a total of 3,784 patients
exposed to vildagliptin at a daily dose of 50 mg (once
daily) or 100 mg (50 mg twice daily or 100 mg once daily)
in controlled trials of at least 12 weeks duration. Of these
patients, 2,264 patients received vildagliptin as monotherapy
and 1,520 patients received vildagliptin in combination
with another medicinal product. Adverse side effects
reduce uoto 80%. The majority of adverse reactions in
these trials were mild and transient, not requiring treatment
discontinuations. No association was found between
adverse reactions and age, ethnicity, duration
of exposure or daily dose (Lukashevich V. et al., 2009).

The above mention studies proved that Vildagliptin isHighly effective

Well absorbed orally
Higher safety profile

Prescribing Information
Indication: Prescribed for Type 2 diabetes mellitus alone or along with other medications.
Contraindication: Contraindicated in patients with Type 1 diabetes, diabetic ketoacidosis, severe liver impairment,
during pregnancy (cat. B) & breast feeding.
Dosage: 50mg twice daily or maximum 100mg per day, with Metformin or Thiazolidinedione: 50mg twice daily,
with Sulfonylurea: 50mg per day in the morning.
Mode of administration: It comes as a tablet to take by mouth with food.
Side effects: Most common: low blood sugar level, tremor, headache, weight gain, fluid retention, dizziness & weakness.
Other precaution: Avoid excess dosage.
Storage: Store it at room temperature & keep away from children.

Ahrn B, Schweizer A, Dejager S, Villhauer EB, Dunning BE, Foley JE.

"Mechanisms Of Action Of The Dipeptidyl Peptidase-4 Inhibitor Vildagliptin
In Humans. - Pubmed - NCBI".[Online] Available at: Ncbi.nlm.nih.gov.
[Accessed15 May 2016].
Chantal Mathieu, Evy Degrande. "Vildagliptin: A New Oral Treatment For
Type 2 Diabetes Mellitus". Vascular Health and Risk Management 4.6 (2008)
: 1349-60. [Online] Available at:http://www.ncbi.nlm.nih.gov/pmc/article
/PMC2663430/ [Accessed 15 May 2016].
Pi-Sunyer FX, Schweizer A, Mills D, Dejager S."Efficacy And Tolerability
Of Vildagliptin Monotherapy In Drug-Nave Patients With Type 2 Diabetes.
-Pubmed - NCBI". [Online] Available at: Ncbi.nlm.nih.gov. [Accessed15
-May 2016].
Lukashevich V, Del Prato S, Araga M, Kothny W. "Efficacy And Safety Of
Vildagliptin In Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Dual Combination Of Metformin And Sulpho... - Pubmed - NCBI".
[Online] Available at: Ncbi.nlm.nih.gov. [Accessed 15 May 2016].

JC Pharmaceutical Ltd.
32, Kalabagan, Dhaka-1205
E.mail: jc.phrma@gmail.com
Tel: 01985473217