Clinical Decision Making Using Evidence-Based Practice

Categories: Case Study

Clinical Practice Question

Mary is a 45 year old African American that has a history of type 2 diabetes and a family history of cardiovascular disease. Mary also has obesity but is a compliant patient that implements a diabetic diet, exercises daily and takes 800 mg of metformin once a day. She is a concerned patient due to continued weight gain and hemoglobin A1c levels that have decreased but continue to be above the target level at 8.5, despite efforts to improve blood glucose levels.

Mary’s fasting blood glucose level is between 130-140 mg/dL. It is possible that Mary will develop cardiovascular disease if she continues to have uncontrolled type 2 diabetes. Mary has many risk factors that can predispose her to cardiovascular disease such as family history, ethnic background, age and weight. Therefore, multiple factors need to be taken into account with Mary’s health concerns. For Mary’s case, in patients with diabetes type 2, is the use of metformin combination therapy more effective than metformin monotherapy in regards to successful glycemic control?

Background

Type 2 diabetes affects millions of adults and is treatable with a combination of interventions and treatments.

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These treatments include diet, exercise and medication. Type 2 diabetes is more common and is caused by insulin resistance or when the body does not produce sufficient amounts of insulin. According to the World Health Organization (WHO), a higher body mass index (BMI) is associated with an increased risk of type 2 diabetes (World Health Organization, 2018). Obesity continues to be on the rise and with obesity comes an increased number of people that are diagnosed with diabetes type 2.

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Usually initial treatment for patients with diabetes type 2 includes lifestyle changes and monotherapy with metformin. Lifestyle changes and metformin were the exact treatment for Mary but she continued to have poor glycemic control. A second medication may be added when successful glycemic control is not reached within a three month period with metformin and lifestyle interventions (Wexler, Nathan, & Mulder, 2018). Mary has had type 2 diabetes for three years and continues to have poor glycemic control despite initial therapies.

Appraisal of the Most Relevant and Best Evidence

Maruther, Tseng, Hutfless, Wilson, Suarez-Cuervo, Berger, Chu, Iyoha, Segal, and Bolen (2016), conducted a systematic review in the article titled, “Diabetes medications as monotherapy or metformin-based combination therapy for type 2 diabetes.” The title clearly states that the article is discussing medication therapy for type 2 diabetes. This article is a systematic review which makes it a level one. The authors collected data from MEDLINE, EMBASE, and Cochrane databases. The study had an appropriate selection of evidence that included 179 trials and 25 observational studies that assessed monotherapy or either metformin-based combinations. Two reviewers evaluated the studies for quality and rated the strength of evidence. The findings of the article were clarified based on the study’s purpose which was to assess the effectiveness of monotherapy and metformin-based combinations. The researchers found that decreases in hemoglobin A1c levels were found in both monotherapies and metformin-based combinations (Maruthur et al., 2016). Mary is on metformin as a treatment therapy and evidence from this systematic review supported metformin as a first line treatment due to its beneficial effects on hemoglobin A1c (Maruthur et al., 2016). However, in this case for Mary she continues to have an increased hemoglobin A1c.

Rosenstock, Sean, Jelaska, Hantel, Pinnetti, Hach, and Woerle (2013) conducted a randomized, double-blind, placebo-controlled trial in the article titled, “Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycemia.” This study is considered a level two and the title clearly defines the purpose of the study. The sample was adequate with 495 participants with type 2 diabetes that has not been effectively controlled with metformin. The data collection process was adequate as the researchers screened the participants to ensure they met the inclusion criteria. The researchers found a reduction in hemoglobin A1c and body weight with an add-on therapy to metformin after 12 weeks verses an increase in A1c when they added on a placebo (Rosenstock et al., 2013). Due to Mary continuing to have an above target hemoglobin A1c and inability to lose weight, this study finds that a combination therapy with her standard metformin therapy may be the most effective in maintaining glycemic control.

White, Buchanan, Li, and Frederich (2014) conducted a randomized control trial in the article titled, “A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy.” This study is considered a level two and the title lucidly expresses what the researchers are aiming to achieve. The study had a sufficient sample size with 74 patients that were randomized to add-on therapy and 86 patients to placebo add-on therapy. The evidence was collected through a double-blind study comparing the use of an add-on therapy and a placebo add-on therapy. The study found that within a 12 week period there was a reduction in hemoglobin A1c in patients that received the metformin combination therapy verses an increase in the patients that received a placebo (White et al., 2014). This study also suggest that a combination therapy with metformin may be a beneficial treatment option for Mary in reducing hemoglobin A1c to a level within target range.

Integration of Evidence, Clinical Expertise, and Patient Preferences and Values

Some evidence suggests that metformin as a monotherapy does decrease hemoglobin A1c levels. In this case, Mary’s hemoglobin A1c did decrease, but continues to be above target levels. Other evidence suggests that a combination therapy when added to metformin therapy, lowers hemoglobin A1c levels in patients with type 2 diabetes where metformin monotherapy was unsuccessful. Glycemic control can reduce weight gain and likelihood of heart disease. According to Dr. Alan Garber, metformin combination therapy is the best for reducing hemoglobin A1c levels when used as an initial treatment for type 2 diabetes and also recommends that therapy be an individualized approach for each patient (Keller & Clinical Endocrinology News, 2016). Mary is a patient that is compliant with her treatment regimen and prefers to decrease her chances of cardiovascular disease and continued weight gain. Due to Mary’s concerns regarding weight gain and heart disease, a combination therapy to establish better glycemic control would benefit Mary.

Proposed Plan of Evaluation

After adding an adjunct medication for a combination therapy with metformin, Mary is to return for her 12 week checkup and will have her hemoglobin A1c retested at that time. The goal is to achieve a hemoglobin A1c level of < 6.5%. This plan will support existing evidence that metformin combination therapy will help achieve successful glycemic control. The A1c results in 12 weeks would support existing literature regarding metformin combination therapy if the A1c levels demonstrate a decrease. In addition, Mary will have to continue to comply with her lifestyle changes such as exercise and her diabetic diet.

References

  • Keller, D. M., & Clinical Endocrinology News. (2016, December 13). Starting with combination diabetes therapy beats initial monotherapy. Retrieved from https://www.mdedge.com/clinicalendocrinologynews/article/109382/diabetes/starting-combination-diabetes-therapy-beats
  • Maruthur, N. M., Tseng, E., Hutfless, S., Wilson, L. M., Suarez-Cuervo, C., Berger, Z., Bolen, S. (2016). Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes. Annals Of Internal Medicine, 164(11). Retrieved October 22, 2018, from http://ojoclinico.net/sitio/wp-content/uploads/2016/05/Maruthur-NM-Diabetes-Medications-Ann-Int-Med-2016.pdf
  • Rosenstock, J., Seman, L. J., Jelaska, A., Hantel, S., Pinnetti, S., Hach, T., & Woerle, H. J. (2013). Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes, Obesity and Metabolism, 15(12), 1154-1160. doi:10.1111/dom.12185
  • Wexler, D. (2018, July 23). Management of persistent hyperglycemia in type 2 diabetes mellitus (D. Nathan & J. Mulder, Eds.). Retrieved October 22, 2018, from https://www.uptodate.com/contents/management-of-persistent-hyperglycemia-in-type-2-diabetes-mellitus
  • White, J. L., Buchanan, P., Li, J., & Frederich, R. (2014). A randomized controlled trial of the efficacy and safety of twice-daily saxagliptin plus metformin combination therapy in patients with type 2 diabetes and inadequate glycemic control on metformin monotherapy. BMC Endocrine Disorders, 14(1). doi:10.1186/1472-6823-14-17
  • World Health Organization. (2018, October 05). 10 facts on diabetes. Retrieved October 22, 2018, from http://www.who.int/features/factfiles/diabetes/en/

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Clinical Decision Making Using Evidence-Based Practice. (2021, Oct 15). Retrieved from https://studymoose.com/clinical-decision-making-using-evidence-based-practice-essay

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