Comparative Effectiveness of Sulfonylurea and Metformin Monotherapy on Cardiovascular Events in Type 2 Diabetes Mellitus

Roumie, Christianne L.; Hung, Adriana M.; Greevy, Robert A.; Grijalva, Carlos G.; Liu, Xulei; Murff, Harvey J.; Elasy, Tom A.; Griffin, Marie R.

doi:10.7326/0003-4819-157-9-201211060-00003

Cited by 270 publications

(207 citation statements)

References 50 publications

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“…Finally, we do not agree with the recommendation made by C. Rhee and K. KalantarZadeh that the use of metformin should be restricted in patients with chronic kidney disease (CKD), particularly in view of the increasing evidence base that supports metformin safety in patients with CKD 4,5 . We eagerly await further pharmacokinetic studies on the safety and efficacy of metformin in these patients.…”

contrasting

confidence: 56%

Clarifying the relationship between metformin, acute kidney injury and lactic acidosis

et al. 2018

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contrasting

confidence: 56%

Clarifying the relationship between metformin, acute kidney injury and lactic acidosis

et al. 2018

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“…More recently, several large observational studies have buttressed the notion of cardiovascular benefits from metformin, showing improved outcomes with the biguanide as compared with sulfonylurea monotherapy both for cardiovascular events and all-cause mortality (8)(9)(10). Admittedly, it cannot be known from such data whether event rates are decreased by metformin or increased by sulfonylureas, which are, of course, associated with hypoglycemia.…”

mentioning

confidence: 92%

Is It Time to Change the Type 2 Diabetes Treatment Paradigm? No! Metformin Should Remain the Foundation Therapy for Type 2 Diabetes

Inzucchi

2017

Diabetes Care

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Most treatment guidelines, including those from the American Diabetes Association/European Association for the Study of Diabetes and the International Diabetes Federation, suggest metformin be used as the first-line therapy after diet and exercise. This recommendation is based on the considerable body of evidence that has accumulated over the last 30 years, but it is also supported on clinical grounds based on metformin’s affordability and tolerability. As such, metformin is the most commonly used oral antihyperglycemic agent in the U.S. However, based on the release of newer agents over the recent past, some have suggested that the modern approach to disease management should be based upon identification of its etiology and correcting the underlying biological disturbances. That is, we should use interventions that normalize or at least ameliorate the recognized derangements in physiology that drive the clinical manifestation of disease, in this circumstance, hyperglycemia. Thus, it is argued that therapeutic interventions that target glycemia but do not correct the underlying pathogenic disturbances are unlikely to result in a sustained benefit on the disease process. In our field, there is an evolving debate regarding the suggested first step in diabetes management and a call for a new paradigm. Given the current controversy, we provide a Point-Counterpoint debate on this issue. In the point narrative that precedes the counterpoint narrative below, Drs. Abdul-Ghani and DeFronzo provide their argument that a treatment approach for type 2 diabetes based upon correcting the underlying pathophysiological abnormalities responsible for the development of hyperglycemia provides the best therapeutic strategy. Such an approach requires a change in the recommendation for first-line therapy from metformin to a GLP-1 receptor agonist. In the counterpoint narrative below, Dr. Inzucchi argues that based on the medical community’s extensive experience and the drug’s demonstrated efficacy, safety, low cost, and cardiovascular benefits, metformin should remain the “foundation therapy” for all patients with type 2 diabetes, barring contraindications. —William T. Cefalu Chief Scientific, Medical & Mission Officer, American Diabetes Association

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“…In most cases, such misclassification tends to reduce the effect of a medication and will produce conservative results [75,76]. Although ITT analysis is the most commonly used approach in this literature review, it is worth considering results arising from both AT and ITT analyses in evaluating the clinical effects of glucose-lowering agents, in light of the strengths and limitations inherent in each approach [58,60,65,70].…”

Section: Temporality Considerations In Administrative Databasesmentioning

confidence: 99%

Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations

et al. 2014

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Background Recent years have witnessed a growing body of observational literature on the association between glucose-lowering treatments and cardiovascular disease. However, many of the studies are based on designs or analyses that inadequately address the methodological challenges involved. Methods We reviewed recent observational literature on the association between glucose-lowering medications and cardiovascular outcomes and assessed the design and analysis methods used, with a focus on their ability to address specific methodological challenges. We describe and illustrate these methodological issues and their impact on observed associations, providing examples from the reviewed literature. We suggest approaches that may be employed to manage these methodological challenges.Results From the evaluation of 81 publications of observational investigations assessing the association between glucose-lowering treatments and cardiovascular outcomes, we identified the following methodological challenges: 1) handling of temporality in administrative databases; 2) handling of risks that vary with time and treatment duration; 3) definitions of the exposure risk window; 4) handling of exposures that change over time; and 5) handling of confounding by indication. Most of these methodological challenges may be suitably addressed through application of appropriate methods. Conclusions/interpretation Observational research plays an increasingly important role in the evaluation of the clinical effects of diabetes treatment. Implementation of appropriate research methods holds the promise of reducing the potential for spurious findings and the risk that the spurious findings will mislead the medical community about risks and benefits of diabetes medications.

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Comparative Effectiveness of Sulfonylurea and Metformin Monotherapy on Cardiovascular Events in Type 2 Diabetes Mellitus

Cited by 270 publications

References 50 publications

Clarifying the relationship between metformin, acute kidney injury and lactic acidosis

Clarifying the relationship between metformin, acute kidney injury and lactic acidosis

Is It Time to Change the Type 2 Diabetes Treatment Paradigm? No! Metformin Should Remain the Foundation Therapy for Type 2 Diabetes

Observational studies of the association between glucose-lowering medications and cardiovascular outcomes: addressing methodological limitations

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