58

Press Release

2010 Volume 15 No 1JEMDSA

Stellenbosch University awarded $65 000 in effort to improve

quality of care for diabetes patients in Western Cape1

A local research project in the Western Cape has been awarded a

substantial international grant to benefit local diabetes patients.1

This grant forms part of a long-term funding relationship to identify,

test and publish practical solutions to improve outcomes for people

with diabetes throughout the world.2 BRIDGES (Bringing Research

in Diabetes to Global Environments and Systems) is a programme

initiated by the International Diabetes Federation (IDF) and supported

by an educational grant from a leading pharmaceutical company,

Lilly.3 This seven year project, launched at the end of 2006, sees

$ 10 million being contributed internationally into research to find

practical diabetes care strategies and solutions for people living with

diabetes.4

The BRIDGES project seeks proposals from research bodies globally

which support cost effective and sustainable interventions that can

be adopted in real world settings, ultimately for the prevention and

control of diabetes.3

The first South African research project to be awarded funds from

BRIDGES was announced by the IDF earlier this month, and is one of

only nine projects selected globally during this round of proposals.

Stellenbosch University, in association with the Sub-Saharan African

Centre for Chronic Diseases and the Western Cape Department of

Health, has been awarded $ 65 000 towards a two-year community-

based research project to be conducted in Cape Town.1

The Western Cape has a large number of diabetic patients and this

number is expected to increase substantially over the next few years.

Most of these patients are cared for by nurses within the public

sector, with education about their disease often being supplied in a

makeshift and unpredictable manner.1

Diabetes and its related complications have grown exponentially

over the last few years. The increasing number of patients diagnosed

with diabetes each year results in increased costs placed on health

services to care for patients. Diabetes is expensive and complex and

ideally requires ongoing education and management on the part

of both the healthcare practitioner and the patient. Furthermore,

diabetes greatly affects a patient’s quality of life as it poses

many lifestyle demands and debilitating complications which can

sometimes be difficult for patients to live with.5

Entitled “Effectiveness of a group diabetic education programme

using motivational interviewing in underserved communities in

South Africa”, this project will take the form of a randomized control

trial, evaluating ways to improve the lives of thousands of diabetes

patients whose quality of care and health education to date has

generally been very poor.1

This research project, headed by principal investigator Robert Mash,

will evaluate the merits of structured group educational programmes

supported by appropriate educational materials and delivered

by health promoters who have been specifically trained in better

communication, installing in patients a degree of motivation, leading

to increased self management of their disease.1

Through BRIDGES, researchers in various cultural settings globally

can share insights and advice from their individual projects, leading

to findings that can lead to different settings.

“We at Lilly are proud to partner with the IDF and enable the

translation of findings learnt in clinical settings to those who can

benefit most, those people living with diabetes. Ground-breaking

ideas are urgently needed to help people with diabetes achieve

better outcomes and live a healthier and more fulfilling life. While

Lilly continually remains committed to medical research into this

disease, we realise that success in the management and education of

diabetes will not come through our research alone. We congratulate

Stellenbosch University and look forward to their shared findings

in this vital exploration of how to improve diabetes education and

management,” says Jacques Blaauw, Managing Director of Lilly

South Africa.

This research proposal, along with all other submissions, was peer-

reviewed and prioritized by a multi-disciplinary review committee,

managed by the IDF.6

References:

1. Bringing Research in Diabetes to Global Environments and Systems – International Diabetes Foundation. 2007 (http://www.idfbridges.org/supported-projects). Website accessed on 23 February 2010.

2. IDF and Eli Lilly and Company Partner to Uncover Practical Solutions for Better Diabetes Outcomes – Press Release. 5 December 2006 (http://www.idf.org/node/1351?unode=1D292091-67DA-48BB-81B0-73112469D36E). Website accessed on 23 February 2010.

3. Welcome to BRIDGES (http://www.idfbridges.org/). Website accessed on 23 February 2010.

4. BRIDGES IDF Grant Research Programme Fact Sheet (www.idf.org/webdata/docs/BRIDGES%20Fact%20Sheet.doc). Website accessed on 23 February 2010.

5. Katzenellenbogen L, Blaauw R, Steyn N. Assessment of the Perceived impact of Diabetes on Quality of Life in a Group of South African Diabetic Patients. December 2008 (http://etd.sun.ac.za/jspui/bitstream/10019/1947/3/Katzenellenbogen%2c%20L.pdf). Website accessed on 23 February 2010.

6. BRIDGES IDF Grant Research Programme Timeline of Key Dates (www.idf.org/.../BRIDGES%20Timeline%20of%20Grant%20Program.doc). Website accessed on 23 February 2010.

7. About Lilly (http://www.lillydiabetes.com/content/about-lilly.jsp). Website accessed on 23 February 2010.

LOCAL DIABETES RESEARCH PROJECT SELECTED FOR INTERNATIONAL FUNDING

60

Press Release

2010 Volume 15 No 1JEMDSA

Approved indication

Byetta® has been approved for use as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking either metformin or a sulphonylurea or both, and who have not achieved glycaemic control.1

The type of patient most likely to benefit from Byetta® is the patient who has not achieved glycaemic control with maximum tolerated levels of oral antidiabetic medicines, who is overweight and is at the stage where insulin therapy may need to be initiated in order to achieve glycaemic control. Exenatide improves glucose control in these patients and is associated with weight loss, unlike insulin therapy, which also improves glycaemic control, but often at the expense of weight gain.1

Mode of action

Incretin hormones increase the amount of insulin released from beta-cells of the pancreas following a meal. The most well-characterised incretin hormone is glucagon-like peptide-1 (GLP-1), which is considered to be the most important incretin released by the gut into the bloodstream in response to food.2

The primary function of GLP-1, therefore, is to enhance insulin secretion in the presence of elevated blood glucose levels. GLP-1 also offers additional benefits in the management of type 2 diabetes2,3,4:

• GLP-1 suppresses the release of glucagon from the pancreas. Since glucagon stimulates glucose release from the liver, decreasing the amount of glucagon helps to improve glucose control.

• GLP-1 may act on the brain to reduce appetite and in the stomach to slow the rate of gastric emptying so that nutrients are not absorbed too quickly into the blood stream.

Byetta® exhibits many of the same effects as the human incretin hormone, GLP-1.

Dosage

Byetta is administered by subcutaneous injection into the thigh, abdomen or upper arm.5

• Initial dose: 5 μg administered twice daily for at least one month.

• The dose may be increased to 10 μg twice daily.

Evidence of efficacy

The type of patient most likely to benefit from incretin mimetic therapy is the patient who has not achieved glycaemic control with maximum tolerated levels of oral antidiabetic medicines, who is overweight and who is at the stage where insulin therapy may need to be initiated in order to achieve glycaemic control. Exenatide improves glucose control in these patients and is associated with weight loss, unlike insulin therapy, which also improves glycaemic control, but often at the expense of weight gain.1

Exenatide in combination with metformin and a sulphonylurea has been shown to improve glycaemic control, as measured by a decrease in HbA1c compared to baseline.5 The treatment effect was comparable to insulin glargine in a 26-week study and biphasic insulin aspart in a 52-week study.5

Precautions• General Byetta® is contraindicated in patients with hypersensitivity to exetanide

or to any of its exipients, in patients with renal impairment (creatinine clearance <30 ml/min) and in patients with gastrointestinal disease such as gastroparesis, dysmotility and/or an atomical obstruction.5

Byetta® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.5

• Pregnancy&lactation Byetta® is contraindicated during pregnancy and lactation.5

Major adverse effects

Byetta® is commonly associated with gastrointestinal adverse effects, such as nausea, vomiting and diarrhoea.5

Drug interactions

The concurrent use of Byetta® with other diabetic medicines, including insulin, has not been studied.5

Byetta® slows gastric emptying and may therefore reduce the rate and extent of absorption of orally administered medicines. For oral medicines that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should take the medicine at least one hour before administering Byetta®.

Cost: SEP (Incl VAT)

Patientinformation

Byetta®5:

• Is administered subcutaneously by means of a fixed-dose pen device.

• Can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 or more hours apart).

• Should NOT be administered after a meal.

• Is not insulin and should not be taken instead of insulin.

Note If a dose of Byetta® is missed, skip the missed dose and continue with the next scheduled dose.5 Do not double a dose to make up for a missed dose.

Conclusion

Byetta® is an incretin mimetic and is a new option for treating patients with type 2 diabetes mellitus who are not yet insulin dependent.

CompiledbyAmayezaDrugInformationServices

References:1. Ed. Incretin therapy: a new treatment modality in the fight against the worldwide diabetes epidemic. Drug

Trends. SA Journal of Diabetes & Vascular Disease 2009;6(2):83-84.

2. Holst JJ, Gromada J. Role of incretin hormones in the regulation of insulin secretion in diabetic and nondiabetic humans. Am J Physiol Endocrinol Metab 2004;287.

3. Zander M, Christiansen A, Madsbad S, Holst JJ. Additive effect of glucagon-like peptide-1 and pioglitazone in patients with type 2 diabetes. Diab Care 2004;27:1910-1914.

4. D’Alessio D, Sandoval D, Seeley R. New ways in which GLP-1 can regulate glucose homeostasis. J Clin Invest 2007;115(12):3406-3408.

5. Byetta package insert.

New product review Byetta® (exenatide) – The First Incretin Mimetic

GLP-1 agonists (BYETTA) are now included in the ADA/EASD algorithm

for the metabolic management of type 2 diabetes1

ADA/EASD

ConSEnSuS STATEmEnT

Now, with BYETTA, HbA1c reduction and weight loss are both achievable goals

❍ Dosetwicedaily,within1hourbeforethe2mainmeals(atleast6hoursapart)

❍ Minimallyinvasiveneedle

❍ 1penlastsforafullmonth

❍ After1stmonth,switchto10mcgpen

�

�

�

�

“I take pills for my diabetes, but it’s still progressing and I continue to gain weight.”

“Isn’t there something that can help me gain control of both?”

BYETTA is indicated for treatment of type 2 diabetes

mellitus in combination with metformin, and/or

sulphonylureas in patients who have not achieved

adequate glycaemic control on maximally tolerated

doses of these oral therapies

Sustained HbA1c reductions2

Progressive weight loss2

Fixed-dose BD subcutaneous injection - 5 or 10 mcg

●

●

●

WeightHbA1c

For the duration of therapy

10 mcg

Month 1

5 mcg

S3 Byetta 5 µg, 10 µg. Reg. No. 41/34/0068, 41/34/0069. 0.25 mg exenatide per ml.For full prescribing information refer to the latest approved package insert.References: 1. Nathan ��, Buse �B, �avidson �B, et al. �edical management of hyperglycaemia in type 2 diabetes:1. Nathan ��, Buse �B, �avidson �B, et al. �edical management of hyperglycaemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy. �iabetes care. 2008;31(12):1-11. 2. Klonoff �C, Buse �B, Nielsen LL, Guan X, Bowlus CL, Holcombe �H, Wintle �E, �aggs �G. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr �ed Res Opin. 2008;24(1):275-286.Eli Lilly (S.A.) (Pty) Ltd. Reg. No. 1957/000371/07Private Bag X119, Bryanston, 2021Telephone: (011) 510 9300A1783 �ay 09

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62

Press Release

2010 Volume 15 No 1JEMDSA

The Ranbaxy Group is proud to announce the launch of Lipogen 10, 20, 40 and 80 (atorvastatin) in South Africa. Atorvastatin is the most widely prescribed statin in South Africa.

Lipogen is sugar free and is indicated as an adjunct to diet for reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein-B and triglyceride levels in patients with primary hypercholesterolaemia; mixed dyslipidaemia; and heterozygous familial hypercholesterolaemia.

Lipogen is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Therapy with lipid-lowering agents should be a component of multiple-risk-factor intervention in individuals that are at increased risk of atherosclerotic vascular disease due to hypercholesterolaemia.

The addition of Lipogen to the extensive range of drugs used in Cardio-Vascular Disease, positions Ranbaxy as the first global generic company to launch atorvastatin in South Africa.

The launch of Lipogen also represents the birth of an innovative new packaging concept in pharmaceutical products in South Africa. For the first time ever, the Lipogen packaging features Braille on the outer carton which means that the visually impaired community will now also have a means of distinguishing the pharmaceutical products prescribed and dispensed to them.

In addition, and concurrent with the launch of Lipogen, Ranbaxy, manufacturers of Lipogen introduces the company’s new packaging to the South African professional and community at large. In time, all new Ranbaxy products will be presented in the new packaging format as well as Braille.

According to Cathy Donaldson, President of Blind SA, an organisation that provides support, education and a range of resources to the blind community including Braille services, it’s wonderful news that Braille users will finally be able to use a medication with Braille packaging in South Africa.

“This is incredibly important for those blind individuals that are living alone. It’s initiatives like this that enable us users of Braille to become even more independent, and we would like to congratulate Ranbaxy SA on taking the initiative,” she concluded.

Opinion Leaders in Cardiology also consider the Braille inscription on the Lipogen packaging as an excellent initiative to assist blind patients in identifying their medication. These views were expressed by Dr. Jeff King, Cardiologist in private practice at Sunninghill Hospital and Prof. Danie Marx, Head of the Dept. of Cardiology at Universitas Hospital in Bloemfontein.

Dr. Jacques Snyman, Pharmacologist and New Business Development Director, Agility Healthcare Solutions commented that the Braille inscription on Ranbaxy’s new Lipogen packaging is a first in South Africa. “This form of packaging has been available in Europe for quite some time and is an excellent step forward to assist blind patients,” he concluded.

“Ranbaxy will gradually switch all their packaging to include Braille”, a Ranbaxy spokesman said.

Lipogen is available as LIPOGEN 10 Tablets, LIPOGEN 20 Tablets, LIPOGEN 40 Tablets and LIPOGEN 80 Tablets from 19 February 2010 at all leading pharmaceutical wholesalers, distributors and retail pharmacies. Each tablet of Lipogen contains a dosage of atorvastatin corresponding with the brand name of each strength.

The pricing of Lipogen is provided in the table below.

All strengths of Lipogen are blister packed in 30’s fully reimbursed by all medical aids.

For further information, please contact Gregory Sebalo, Lipogen Product Manager at Ranbaxy South Africa on +27 (0)12 643 2000 or your local Ranbaxy representative.

S4 Lipogen 10/20/40/80. Reg No.: 42/7.5/00556/7/8/9. Each film coated tablets contain atorvastatin calcium equivalent to atorvastatin 10/20/40/80 mg respectively. Sugar free. Antioxidants: Butylated hydroxy anisole and butylated hydroxy toluene. Pharmacological classification: A7.5 Serum-cholesterol reducers.

For full prescribing information, side-effects, warnings & precautions please refer to the package insert.

Ranbaxy (SA)(Pty)Ltd. 3rd floor, Outspan House, 1006 Lenchen Avenue North, Centurion. Tel: (012) 643 2000;

Fax: (012) 643 2001

Issued on behalf of Ranbaxy SA

For more information, please contact Isabel de Carvalho (082-826-1819) or Cheryl Adamson (082-444-2884)

Ranbaxy launches Lipogen

ProductActive Ingredient NAPPI Code

Strength Mg Pack Size Form

SEP Excl VAT

SEP Incl VAT

Lipogen 10 Atorvastatin 714071-001 10 30 Tabs 81.43 92.83Lipogen 20 Atorvastatin 714072-001 20 30 Tabs 106.14 121.00Lipogen 40 Atorvastatin 714073-001 40 30 Tabs 106.14 121.00Lipogen 80 Atorvastatin 714074-001 80 30 Tabs 106.14 121.00

64

Press Release

2010 Volume 15 No 1JEMDSA

Accord Healthcare is honoured and proud to introduce itself to

you. We are a multinational generics producer and marketer

that is now established in South Africa. Accord Healthcare’s

world class production plants are approved by the FDA (United

Sates), MHRA (United Kingdom), TGA (Australia), ANVISA

(Brazil) and MCC (South Africa).

Accord Healthcare would like to take the opportunity to

introduce you to the launch of it’s new products into the

South African markets, Amtas 5 & 10 (mg) tablets. Amtas is

indicated for the treatment of mild to moderate hypertension, as well as for the treatment of angina pectoris1.

Amtas is formulated and manufactured by Accord Healthcare’s group of companies, which include a small molecule generic R&D

company, as well as a finished product manufacturing company. Accord Healthcare’s technology specializations are in the advanced

fields of biopharmaceutical research and development involving recombinant DNA technology company, as well as backward

integration into chemical synthesis of Active Ingredients.

S3 Amtas 5; 10,

Reference:1: Amtas package insert.. Reg. Nos.: 41/7.1/0659, 41/7.1/0660

Accord Healthcare would also like to take the opportunity

to introduce you to the launch of it’s new products into

the South African markets, Rispacor 0,5, 1,2,3, & 4 (mg) tablets. Rispacor alleviates affective symptoms associated

with schizophrenia, acute and chronic schizophrenic

psychoses and related psychosis in which positive

symptoms and/or the negative symptoms are prominent.

  Rispacor is formulated and manufactured by Accord

Healthcare’s group of companies, which include a small

molecule generic R&D company, as well as a finished product manufacturing company. Accord Healthcare’s technology specializations

are in the advanced fields of biopharmaceutical research and development involving recombinant DNA technology company, as well

as backward integration into chemical synthesis of Active Ingredients.

Reference: 1: Rispacor package insert.

S5 Rispacor 0,5; 1; 2; 3 and 4

Reg. Nos. 42/2.6.5/0155, 42/2.6.5/0156, 42/2.6.5/0157, 42/2.6.5/0158 and 42/2.6.5/0159

Accord Healthcare now in South Africa

Rispacor 0,5, 1,2,3, & 4 (mg) tablets

Amtas 5 & 10 (mg) tablets

Rispacor 0,5, 1,2,3, & 4 (mg) tablets