Sunday August 31, 2008
New drug for diabetics
A diabetes drug that offers sitagliptin with metformin in a single tablet has been approved for use in Malaysia.
MERCK, Sharp & Dohme (MSD) Malaysia recently announced the approval of an oral tablet combining a dipeptidyl peptidase-4 (DPP-4) inhibitor, sitagliptin, and metformin for the treatment of type 2 diabetes in Malaysia.
Prof Datuk Dr Wan Mohamed Wan Bebakar ... There is a need for Malaysians to pay more attention to type 2 diabetes because of the health complications associated with the disease. The drug, approved by the Drug Control Authority of Malaysia in May 2008, is indicated as initial therapy to improve blood sugar control in patients with type 2 diabetes who are not adequately controlled with diet and exercise alone.
It is also indicated as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with a combination of sitagliptin plus metformin.
It is also indicated in combination with a sulfonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents (metfomin, sitagliptin, or a sulfonylurea) as most patients eventually require multiple medications with different mechanisms of action to help address core defects of type 2 diabetes.
In type 2 diabetes, the body may not make enough insulin which helps the body use the available glucose (beta-cell dysfunction), and/or the insulin that the body produces may not work as well as it should (insulin resistance) and/or the liver may make/release too much glucose into the circulation (hepatic glucose overproduction).
Together, this results in the build-up of glucose in the blood, potentially leading to serious medical problems. The drug provides comprehensive coverage of core defects associated with type 2 diabetes – beta-cell dysfunction, insulin resistance and overproduction of glucose by the liver.
Reducing complications
“Evidence suggests that lowering and controlling blood sugar reduce the risk of complications of diabetes, which include kidney disease, blindness and vascular or neurological problems that can lead to amputation and increased mortality,” said consultant endocrinologist Prof Dr Chan Siew Pheng.
“There is therefore a need for use of multiple medications with different mechanisms of action which are able to help address the core defects associated with this condition, but with acceptable tolerability and safety profiles when used in combination,” she added.
There are currently more than 246 million people with diabetes worldwide (almost 6% of the world’s population), and if nothing is done to slow the epidemic, the number may reach 380 million people by 2025. More than 98% of the nearly 1.2 million Malaysians with diabetes have type 2 diabetes. Unfortunately, more than half are not aware that they have the disease.
The number of patients admitted into government hospitals due to diabetic complications had increased 100% from 21,872 in 1995 to 41,375 in 2005.
“There is a need for Malaysians to pay more attention to type 2 diabetes because of the health complications associated with the disease. Patients need to look beyond medical treatment options and seriously consider a change in their lifestyle activities as well as diet.
“Malaysians need to learn to take care of their own health and be disciplined about keeping to healthy diet and regular exercise,” said Prof Datuk Dr Wan Mohamed Wan Bebakar.
Indications
In clinical trials, the new drug provided reduction in glucose levels with the additional benefits of weight loss and fewer episodes of hypoglycaemia when compared to treatment with metformin plus a sulfonylurea.
It was generally well-tolerated, with gastrointestinal side-effects, including nausea, vomiting, abdominal pain and diarrhoea, similar to metformin alone.
Consistent with metformin prescribing information, the new drug is contraindicated in patients with renal disease or renal dysfunction, congestive heart failure requiring a pharmacological agent, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
It is not indicated for use in patients with type 1 diabetes. It is also contraindicated in patients with known hypersensitivity to sitagliptin, metformin hydrocholoride, or any other component of the drug.
The safety and efficacy in pregnant or nursing women and in paediatric patients has not been established. Therefore, the new drug should not be used in these patients. Lactic acidosis, a rare, but serious, metabolic complication, may occur during treatment.
Prof Dr Chan Siew Pheng ... There is a need for the use of multiple medications with different mechanisms of action which are able to help address the core defects associated with diabetes, but with acceptable tolerability and safety profiles when used in combination. The drug
The new drug harnesses the comprehensive modes of action of two effective treatments – the incretin-enhancing power of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and the proven glucose-lowering benefits of metformin.
Sitagliptin works by enhancing the body’s own ability to lower blood sugar. Combining both sitagliptin and metformin in a single tablet provides additional glucose-lowering efficacy with a similar safety and tolerability profile compared to metformin alone.
This unique new therapy enables physicians to deliver comprehensive coverage against core defects of type 2 diabetes.
Type 2 diabetes
Type 2 diabetes is a condition in which the body has elevated blood sugar or glucose. With type 2 diabetes, the body may not make enough insulin (which helps the body use glucose); the insulin that the body produces may not work as well as it should; or the body may release too much glucose from stored sources.
Patients with diabetes, when uncontrolled for a prolonged period of time, can develop heart disease, kidney disease, blindness, vascular or neurological problems that can lead to amputations, and they can suffer increased mortality.
Diabetes is expected to cause 3.8 million deaths worldwide in 2007, about 6% of total global mortality, about the same as HIV/AIDS, making it the fourth leading cause of death globally.
References:
1. International Diabetes Federation. Facts & Figures. Content Reviewed: 4 June 2008. Available at http://www.idf.org/home/index.cfm?node=37
2. Malaysian Diabetes Association. Diabetes Facts & Figures. Content Reviewed: 3 June 2008. Malaysian Diabetes Asscociation website. Available at http://www.diabetes.org.my/article.php?aid=5
3. Malaysian Diabetes Association. Be responsible, Malaysians told. Content Reviewed: 3 June 2008. Malaysian Diabetes Association website. Available at http://www.diabetes.org.my/article.php?aid=151
4. Goldstein BJ, Feinglos MN, Lunceford JK, et al. Effect of initial combination therapy with sitagliptin, a dipeptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care 2007; 30: 1979-1987.
5. Nauck M, Meininger G, Sheng D, et al, for the 024 Study Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared to the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007;9:194–205.
6. JANUMET WPC 10-2007
7. International Diabetes Federation. Facts & Figures. Content Reviewed: 4 June 2008. Available at http://www.idf.org/home/index.cfm?node=41
RSS
