The Efficacy And Safety Of Saxagliptin When Added To Metformin Therapy Article Review
The current practice in pharmacologic therapy for diabetes mellitus type 2 involves the use of one drug. Metformin is the most commonly used first-line agent in managing type 2 diabetes. Metformin therapy is often prescribed alongside exercise and diet therapy (DeFronzo, et al., 2009). The drug works by reducing the production of glucose by the liver cells. In addition, the drug functions by improving the sensitivity of insulin. One of the challenges currently facing the use of metformin monotherapy is that the drug’s efficacy to manage diabetes has been found to decrease with the increase in resistance. Apart from metformin, saxagliptin is also used in managing diabetes mellitus type 2. The mechanism by which the drug functions is complementary to the functioning of metformin. Consequently, findings from current studies suggest that prescribing the two drugs together is more effective in managing diabetes type 2.
The proposed intervention involves prescribing metformin in combination with saxagliptin for patients who fulfil certain conditions: no history of alcohol or drug abuse, no cardiovascular event within six months before the prescription, and other specified conditions. This intervention is not commonly used in the current practice. Even though the use of saxagliptin monotherapy for glycemic control in people with diabetes mellitus type 2 is a common practice especially where patients cannot tolerate metformin, the therapy involving the combination of metformin with saxagliptin is not commonly used. Therefore, the new aspect of saxagliptin brings a new method of pharmacotherapy for diabetes mellitus type 2. The therapy proposed by the new study is new in the sense that it involves the use of both metformin and saxagliptin in managing diabetes type 2. This new method is likely to improve the treatment of diabetes type 2 in the sense that it is will show improvement in glycemic indicators when prescribed to patients with inadequately-controlled type 2 diabetes with metformin monotherapy. It will help improve pharmacologic therapy for diabetes among patients whose ability to tolerate metformin has gone down or have inadequate glycemic control despite being on metformin monotherapy.
The study by DeFronzo and colleagues confirmed that this practice would be effective in improving diabetes therapy. This study was a randomized and double-blind. Furthermore, the study was placebo-controlled. A total of 743 patients, both men and women took part in the study. All the patients had diabetes type 2 diabetes and were taking stable does of metformin for not less than 8 weeks prior to screening. All the patients also had a BMI of not less than 40kg/m2. All the patients also had a C-peptide concentration of not less than 1.0ng/ml. Patients who had symptoms of poorly-controlled diabetes, a history of any other anti-hyperglycemic medication or insulin use 8 weeks prior to the commencement of the study, and a history of diabetic ketoacidosis were excluded from the study. Furthermore, patients were excluded from the study if they had a history of alcohol or drug abuse within the previous year. Patients with active liver disease, abnormality in hepatic, endocrine, and renal functioning were also excluded from the study.
After the recruitment of the study subjects, the subjects were randomly assigned to four groups. Three of the groups received varying doses of saxagliptin (2.5, 5, or 10mg) while the remaining group received the placebo for 24 weeks. All the groups were given metformin in addition to the dose of saxagliptin or placebo depending on the group. This treatment was carried out after the pre-study had been done in which all the eligible subjects were given placebo and metformin. After the 24 weeks of the treatment given to each group, the patients who met the rescue criteria qualified to enter a treatment extension that lasted for 42 months. The efficacy of the use of a combination of metformin and saxagliptin therapy for managing diabetes type 2 was assessed by comparing the baseline measurements of A1C, fasting plasma glucose, post-prandial glucose, and the percentage of patients who fall at the glycemic target to the measurements after the 24 weeks of the study.
The use of metformin-saxagliptin combination therapy showed improvements in the glycemic indicators during the trial. However, adverse events were recorded in the study. Indeed, the saxagliptin treatment groups recorded higher percentage of adverse events than the placebo-treated group. However, no design issues that can influence the result were witnessed in the study. The results were expressed in terms that can be used easily in nursing practice. Besides, they were addressed in statistical terms in order to show the level of efficacy of the proposed therapy. The new findings are likely to change the current practice in management of diabetes type 2 in the sense that is will influence a shift in focus from metformin monotherapy to a combined therapy of both metformin and saxagliptin in managing diabetes type 2 among patients who are on metformin monotherapy but exhibit inadequate diabetes control. The patients involved in the study are similar to those I encounter in practice. Indeed, most patients I have encountered receiving metformin but have inadequate diabetes control tend meet the inclusion criteria used in the study. Based on the findings from the study and the methodology used in the study, I would change my practice. In this case, I would adopt a practice in which diabetic patients are first put on metformin monotherapy in combination with exercise and diet therapy. However, a combination of metformin and saxagliptin would be introduced when the patients show inadequate glycemic control.
I would apply the findings of this study to the following case study: A 64-years-old diabetic man who has been taking 2000 mg/day of metformin for the last 10 days complains of frequent urination. His laboratory test results reveal the following: A1C =9.0 and fasting C-peptide concentration = 3ng/ml. his BMI is also 36 Kg/m2. The patient has no history of alcohol or drug abuse.
The patent in the above case study meets all the criteria used in the selection of patients in the study. Therefore, my patient is a good candidate for the treatment. Consequently I expect that a similar result to the findings of the study would be made if I use this new therapy with my patient.
DeFronzo, R. A., Hissa, M. N., Garber, A. J., Gross, J. L., Duan, R. Y., Ravichandran, S., & Chen, R. S. (2009). The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes care, 32(9), 1649-1655.