Gliclazide diabetes treatment launched in convenient, low-risk dosage
15 June 2010
Bristol Laboratories Ltd. has launched Zicron™ 40mg, the first ever gliclazide treatment at this fixed dosage for type 2 diabetes, providing flexibility and dose accuracy in gliclazide therapy. When treatment needs to start at the lowest possible licensed dose to reduce the risks of hypoglycaemia, a pack of Zicron™ provides an accurate way to titrate dosage to each individual patients requirements.
To date, patients have had to break 80mg gliclazide tablets in half which can be very inaccurate1 and may increase the risks of hypoglycaemia especially in patients placed on intensive glucose lowering and combination therapies2.
Priti Ramachandran MR Pharms, Vice President of Regulatory Affairs and Business Development, from Bristol Laboratories said: "Zicron™ eliminates the need for thousands of patients to halve their own tablets, and is ideal for older patients who potentially may be frail or sight impaired. New low dose Zicron™ is convenient and easy for patients to take."
"With its smaller dosage, Zicron™ is an ideal starting medication for all patients requiring gliclazide therapy, as it offers flexible control of insulin and glucose levels with the potential to move on to an 80mg presentation when required. It is also ideal for those patients for whom tight monitoring and fine-tuned dosage adjustment will be required on an ongoing basis, such as those with mild to moderate hepatic or renal impairment."
The Zicron™ launch will be supported with PR activity and a product launch communication in various publications targeted at Healthcare Professionals including pharmacists, prescribing nurses and GPs with a special interest in diabetes.
Anti-oxidant effects
In contrast to other currently marketed sulfonylurea drugs, gliclazide has been shown to have specific anti-oxidant properties which provide additional secondary benefits in Type 2 Diabetes patients; these anti-oxidant benefits are independent of gliclazide's effects on glycaemic control. 3 Compared with other sulfonylurea drugs, gliclazide helps to preserve pancreatic β-cells4 which may help slow the time to progression of insulin therapy. 5
Reduced mortality risks compared with Glimepride
These anti-oxidant effects may also account for observed improvements in cardiovascular disease and all-cause mortality risks when long term gliclazide therapy is compared with other sulfonylurea drugs6 . Whilst most large long term studies have tended to group gliclazide and glimepiride together during analysis, a 2009 cohort analysis of 65,000 type 2 diabetes patients7 found that patients treated with gliclazide had a significantly lower risk of mortality compared with patients treated with glimepiride.
Effective glycaemic control
Like other sulphonylureas, the most common side effect of gliclazide is hypoglycaemia, and the risks are directly related to the dosage used. To reduce the risks of hypoglycaemia, it is recommended that patients start gliclazide therapy on a 40mg once or twice daily dosage, with active monitoring and dosage adjustments upwards until the desired blood glucose control has been achieved.
Dosage
Zicron™ is licensed for treatment at 40mg - 320mg daily; low doses of 40mg may be taken once or twice daily, with higher doses taken twice daily with main meals.
This launch in a new low-dose format offers patients all the therapeutic benefits of gliclazide with the added benefits of tight glycaemic control through accurate and flexible dose titration.
Patients will no longer be required to break 80mg gliclazide tablets in half, which may be both inaccurate and difficult for many older patients, causing problems with compliance and dosage accuracy.
It is important to note that modified release tablets may not be broken in half at all, as this adversely affects the release profile, and modified release tablets are also associated with a 9.3% increased incidence of hypoglycaemia8 .
Zicron™ 40mg......the benefits:
- Flexible and accurate low dose form of gliclazide
- Easy adjustment of dosage to achieve intensive glycaemic control
- Reduced risks of hypoglycaemia through increased accuracy of dosage
- Reduced risks of all cause mortality vs. glimepiride
- Anti-oxidant benefits vs. other sulphonylureas
- Easy to take for all patients- no need to break tablets in half
- Aids patient compliance and dosage accuracy
- Cost effective therapy - £3.36 for 28 tablets
Zicron™ 40mg may be suitable for:
- New patients requiring sulfonylurea monotherapy
- Patients progressing to combination therapy, when metformin monotherapy fails
- Elderly patients and other individuals where hypoglycaemia is a concern
Further information and an online product presentation can be found at www.zicron.info
Bristol Laboratories Ltd. is a leading player in the supply of quality generics, with its manufacturing facility in the UK for global use. Its product licences cover a broad range of therapeutic categories like cardiovascular, anti-allergic, anti-diabetes, anti-depressants and many more.
References:
1 J.M. Rosenberg , J.P. Nathan F. Plakogiannis. Weight Variability of Pharmacist-Dispensed Split Tablets. . J Am Pharm Assoc 2002;42:200.
2 UK Prospective Diabetes Study Group: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352:837-853, 1998
3 R.C. O'Brian et al. In vitro and in vivo antioxidant properties of gliclazide. Journal of Diabetes and Its Complications 14 (2000) 201-206.
4 S. Del Guerra et al. Effects of exposure of human islet beta-cells to normal and high glucose levels with or without gliclazide or glibenclamide. Diabetes & Metabolism 35 (2009) 293-298
5 Satoh J, Takahashi K, Takizawa Y, et al. Comparison of period until insulin treatment between diabetic patients treated with gliclazide and glibenclamide. Diabet Res Clin Pract. 2005;70:291-297.
6 S.P. Johnsen et al. Risk and Short-Term Prognosis of Myocardial Infarction Among Users of Antidiabetic Drugs. American Journal of Therapeutics 13, 134-140 (2006) Link to Study
7 Khalangot et al. Glibenclamide-related excess in total and cardiovascular mortality risks: Data from large Ukrainian observational cohort study. Diabetes research and clinical practice 86(2009) 247- 253 Link to Study
8 Lu CH, Chang CC, Chuang LM et al. Double-blind, randomized, multicentre study of the efficacy and safety of gliclazide-modified release in the treatment of Chinese type 2 diabetic patients. Diabetes, Obesity & Metabolism 2006;8(2):184-191