Drug Information Bulletin, 14 _05

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Drug Information Bulletin

(Electronic)Drug Information Centre (DIC)

Indian P harmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: [email protected] Site: http://www.ipabengal.org

Contact: 09830136291 Volume: 05 Number: 14 16th July 2011

National Essential Medicines List-2011 available at CDSCO website

The first Essential Drug List was published

in the year of 1996, which was

subsequently revised in the year of 2003having 354 medicines. The 2011 edition of

NEML contain 348 medicines out of which181 has been earmarked for Primary,Secondary & Tertiary health care set up,

106 for the secondary and Tertiary and 61for Tertiary care. Overall 47 medicineshave been deleted from the 2003 edition

and 43 new medicines have been includedin the 2011 list.It may be noted that though the first

edition has been published almost 14 yearsback no serious efforts were found for itsimplementation. Hope serious initiative will

be taken to implement it in the health carefacilities in India. For details:

www.cdsco.nic.in

New Drug: Saxagliptin

Onglyza (Bristol-Myers Squibb)

5 mg tablets

Approved indication: type 2 diabetes

Australian Medicines Handbook section10.1.3

Incretins help to lower blood glucose aftera meal. This effect can be prolonged byinhibiting their metabolism. Sitagliptin and

saxagliptin are drugs which do this byinhibiting the enzyme dipeptidyl peptidase4 (DPP4) (see 'Incretin mimetics and

enhancers' Aust Prescr 2008;31:102-8).

Saxagliptin is taken once a day. After

absorption, the drug suppresses DPP4activity for 24 hours. Saxagliptin ismetabolised by cytochrome P450 3A4 to aless potent active metabolite. Thepharmacokinetics of saxagliptin cantherefore be affected by other drugs which

Content

National Essential Medicines List-2011 available at CDSCO website New Drug: Saxagliptin

Risk of oral clefts in children born to mothers taking Topiramate

Linagliptin approved for type 2 diabetes From aspirin to anaesthesia, drugs to be tracked

Forthcoming Events Readers Column

5 thYear
mailto:[email protected]://www.ipabengal.org/http://www.cdsco.nic.in/http://www.cdsco.nic.in/http://www.ipabengal.org/mailto:[email protected]


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act on P450 3A4. For example, inhibition

by ketoconazole increases theconcentration of saxagliptin and decreases

the concentration of its active metabolite.Saxagliptin has a half-life of 2.5 hours andits main metabolite has a half-life of 3.1hours. The drug and its metabolites aremainly excreted in the urine. It should notbe used in patients with moderate or

severe renal impairment.

Saxagliptin has been studied as an add-on

treatment for patients with type 2 diabetesthat had not been controlled by a singledrug. It was added to metformin in a

placebo-controlled study of 743 patients. After 24 weeks of treatment, the 191

patients who took metformin withsaxagliptin 5 mg had a reduction of 0.69%in their concentrations of glycated

haemoglobin (HbA1c). There was a rise of0.13% in the patients who added aplacebo to metformin. Saxagliptin also

significantly reduced fasting bloodglucose.1

The relative benefits of increasing the doseof a sulfonylurea or adding saxagliptin

were assessed in a study of 768 patients. All the patients were given glibenclamide7.5 mg daily for four weeks. Patientswhose diabetes was not controlled were

then randomised to increase the dose to10 mg daily or add saxagliptin 2.5 or 5 mg.

After 24 weeks the mean HbA1cconcentration had increased by 0.08% inthe glibenclamide group, but decreased by0.54% in patients who added saxagliptin

2.5 mg and by 0.64% in those who added5 mg. The combination of treatments had

a statistically significantly greater effect onfasting blood glucose than increasing thedose of glibenclamide.2 The mean

reduction from baseline was 0.4 mmol/Lwith compared with an increase of 0.04mmol/L with glibenclamide.

Saxagliptin has also been added to the

treatment of patients whose diabetes hasnot been controlled by a thiazolidinedione.

In this study, 565 patients takingpioglitazone or rosiglitazone wererandomised to add saxagliptin 2.5 mg, 5mg or a placebo. After 24 weeks theHbA1c concentration had fallen by 0.66%with 2.5 mg, 0.94% with 5 mg and 0.3%

with placebo. The reductions in fastingblood glucose were also significantlygreater with saxagliptin.3

One study used saxagliptin and metforminin 1306 patients who were starting

treatment for the first time. After 24 weeksthe combination reduced the

concentrations of HbA1c and fasting bloodglucose more than either drug alone.Metformin with saxagliptin 5 mg reduced

HbA1c by 2.5% compared to 2.0% withmetformin and 1.7% with saxagliptin 10mg alone.4

During the trials 3.3% of the patientsdiscontinued saxagliptin 5 mg because of

adverse effects compared with 1.8% of theplacebo groups. Reasons for stopping

treatment included lymphopenia, rashesand increased creatinine concentrations.Hypoglycaemia was reported by 5.2% ofpatients when saxagliptin 5 mg was added

to metformin,1 14.6% when added toglibenclamide2 and 2.7% when added to athiazolidinedione.3 In the thiazolidinedionestudy 8.1% of the patients developedperipheral oedema when saxagliptin 5 mgwas added to their treatment.3

Saxagliptin's main role is likely to be as an

add-on therapy. Its modest efficacy willnot bring every patient's diabetes undercontrol. The proportion of patients

achieving HbA1c concentrations under 7%after adding saxagliptin 5 mg was 43.5%with metformin,1 22.8% with

glibenclamide2 and 41.8% with athiazolidinedione.3 Continuing diet and


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exercise is therefore important. Although

saxagliptin has been approved for use withmetformin as an initial drug treatment, it is

not usual practice to begin treatment witha combination of drugs. As diabetes is achronic disease, it will be years before theclinical effectiveness and safety ofsaxagliptin can be confirmed.

References*

1. DeFronzo RA, Hissa MN, Garber AJ,

Luiz Gross J, Yuyan Duan R,Ravichandran S, et al. The efficacyand safety of saxagliptin when

added to metformin therapy inpatients with inadequately

controlled type 2 diabetes withmetformin saxagliptin 2.5 mg and0.5 mmol/L with saxagliptin 5 mg,alone. Diabetes Care 2009;32:1649-

55.2. Chacra AR, Tan GH, Apanovitch A,

Ravichandran S, List J, Chen R, etal. Saxagliptin added to asubmaximal dose of sulphonylurea

improves glycaemic controlcompared with uptitration of

sulphonylurea in patients with type2 diabetes: a randomised controlledtrial. Int J Clin Pract 2009;63:1395-406.

3. Hollander P, Li J, Allen E, Chen R;CV181-013 Investigators.Saxagliptin added to athiazolidinedione improves glycemiccontrol in patients with type 2diabetes and inadequate control on

thiazolidinedione alone. J ClinEndocrinol Metab 2009;94:4810-9.

4. Jadzinsky M, Pftzner A, Paz-Pacheco E, Xu Z, Allen E, Chen R, etal. Saxagliptin given in combination

with metformin as initial therapyimproves glycaemic control inpatients with type 2 diabetes

compared with either monotherapy:a randomized controlled trial.

Diabetes Obes Metab 2009;11:611-

22.

Source: Aust Prescr 2011;34:89-91

Risk of oral clefts in children born tomothers taking Topiramate

The Food and Drug Administration (FDA) isinforming the public of new data that showthat there is an increased risk for thedevelopment of oral clefts in infants of

women treated with topiramate(Topamax and generic products) duringpregnancy.

Topiramate is an anticonvulsant used totreat epilepsy. It is approved for use to

prevent migraine headaches. Topiramate isbeing placed in Pregnancy Category Dindicating positive evidence of human fetalrisk but with potential benefits that may be

acceptable in certain situations despite itsrisks.Reference: FDA Drug Safety

Communication, 4 March 2011 athttp://www.fda.gov/Drugs/Drug Safety

WHO training co

Linagliptin approved for type 2diabetesThe Food and Drug Administration (FDA)has approved linagliptin (Tradjenta)

tablets for use with diet and exercise, toimprove blood glucose control in adultswith Type 2 diabetes which is the mostcommon form of the disease, affectingbetween 90 and 95% of the 24 milliondiabetics in the United States.

Linagliptin was demonstrated to be safeand effective in eight double-blind,placebo-

controlled clinical studies involving about3800 patients with Type 2 diabetes.

Linagliptin has been studied as astandalone therapy and in combinationwith other type 2 diabetes therapies

including metformin, glimepiride, andpioglitazone.
http://www.fda.gov/Drugs/Drughttp://www.fda.gov/Drugs/Drug


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Linagliptin has not been studied in

combination with insulin, and should notbe used to treat people with type 1

diabetes or in those who have diabeticketoacidosis.Reference: FDA News Release, 2 May2011 at http://www.fda.gov

From aspirin to anaesthesia, drugs to

be tracked

The Union health ministry has constituted

a task force under the chairmanship of H G

Koshia, Commissioner, Food and Drugs

Control Administration (FDCA), Gujarat, for

developing software that could be used to

track drugs - right from manufacturers to

retailers - to check the menace ofcounterfeit drugs in the country. A step in

this direction came from the Allahabad

High Court in the criminal writ petition (no

16212/2008 Brahmaji vs State of UP and

others) for developing a drug tracking

system. Addressing the press after the

third meeting with various stakeholders

from the south, M Mitra, deputy drugs

controller of India, said: "This task force

was set up by the ministry to collectinformation on ways to implement the

track and trace system in the country, for

which there has been a mixed response

from the industry."The task force

comprises nine members from different

ministries and from the drug controller

offices, including Dr B Jagashetty, Drugs

Controller, Karnataka, M Mitra, Deputy

Drugs Controller, India, Vishawajit Ringe,

Senior Technical Director, NationalInformatics Centre, representatives from

department of consumer affairs and legal

affairs, department of commerce, the

under secretary of drugs quality control,

ministry of health and family welfare,

Rishikant Singh (legal), CDSCO, and E

Reddy, assistant drugs controller. The task

force will examine the feasibility of

networking and tracking the drugs

distribution system in the country. It will

indicate the requirements for the software

for drug tracking system to be developed

by National Informatics Centre (NIC). It

aims to examine different IT tools and

methodologies and select the most suitable

for implementation in the country. It willalso suggest if bar coding and Unique

identification number (UID) can in any way

help in the networking of the drugs

distribution with respect to manufacturing,

import and export. The task force will also

examine and suggest the requirements for

different stake holders like manufacturers,

distributors and retailers. The team will

recommend amendments in the drugs and

cosmetics rules with respect to drug

distribution system and tracking.

Source: Express News Service, The New IndianExpress

Forthcoming Event:

Readers Column:

Dear Team,

I must congratulate to you all for coming ouwith a good quality & highly informativeInformation bulletin periodically

I thank you to give me an opportunity to gemyself enriched & exposed to suchprofessional knowledge.

My all good wishes are with you!

Best Regards

Shantanu Shome

Dr. Reddy's Laboratories LimitedHyderabad
http://www.fda.gov/http://www.fda.gov/

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Drug Information Bulletin, 14 _05