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Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4

(2018) DIABETES CARE. 41(3). p.547-553
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Abstract
OBJECTIVE : This study was conducted to define a safe, effective dose regimen for metformin in moderate and severe chronic kidney disease (CKD; stages 3A/3B and 4, respectively), after the lifting of restrictions on metformin use in patients with diabetes with moderate-to-severe CKD in the absence of prospective safety and efficacy studies. RESEARCH DESIGN AND METHODS : Three complementary studies were performed: 1) a dose-finding study in CKD stages 1-5, in which blood metformin concentrations were evaluated during a 1-week period after each dose increase; 2) a 4-month metformin treatment study for validating the optimal metformin dose as a function of the CKD stage (3A, 3B, and 4), with blood metformin, lactate, and HbA(1c) concentrations monitored monthly; and 3) an assessment of pharmacokinetic parameters after the administration of a single dose of metformin in steady-state CKD stages 3A, 3B, and 4. RESULTS : First, in the dose-finding study, the appropriate daily dosing schedules were 1,500 mg (0.5 g in the morning [qam] +1 g in the evening [qpm]) in CKD stage 3A, 1,000 mg (0.5 g qam + 0.5 g qpm) in CKD stage 3B, and 500 mg (qam) in CKD stage 4. Second, after 4 months on these regimens, patients displayed stable metformin concentrations that never exceeded the generally accepted safe upper limit of 5.0 mg/L. Hyperlactatemia (>5 mmol/L) was absent (except in a patient with myocardial infarction), and HbA(1c) levels did not change. Third, there were no significant differences in pharmacokinetic parameters among the CKD stage groups. CONCLUSIONS : Provided that the dose is adjusted for renal function, metformin treatment appears to be safe and still pharmacologically efficacious in moderate-to-severe CKD.
Keywords
LACTIC-ACIDOSIS, PHARMACOKINETICS, PLASMA, OVERDOSE

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MLA
Lalau, Jean-Daniel, Farshad Kajbaf, Youssef Bennis, et al. “Metformin Treatment in Patients with Type 2 Diabetes and Chronic Kidney Disease Stages 3A, 3B, or 4.” DIABETES CARE 41.3 (2018): 547–553. Print.
APA
Lalau, J.-D., Kajbaf, F., Bennis, Y., Hurtel-Lemaire, A.-S., Belpaire, F., & De Broe, M. E. (2018). Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4. DIABETES CARE, 41(3), 547–553.
Chicago author-date
Lalau, Jean-Daniel, Farshad Kajbaf, Youssef Bennis, Anne-Sophie Hurtel-Lemaire, Frans Belpaire, and Marc E De Broe. 2018. “Metformin Treatment in Patients with Type 2 Diabetes and Chronic Kidney Disease Stages 3A, 3B, or 4.” Diabetes Care 41 (3): 547–553.
Chicago author-date (all authors)
Lalau, Jean-Daniel, Farshad Kajbaf, Youssef Bennis, Anne-Sophie Hurtel-Lemaire, Frans Belpaire, and Marc E De Broe. 2018. “Metformin Treatment in Patients with Type 2 Diabetes and Chronic Kidney Disease Stages 3A, 3B, or 4.” Diabetes Care 41 (3): 547–553.
Vancouver
1.
Lalau J-D, Kajbaf F, Bennis Y, Hurtel-Lemaire A-S, Belpaire F, De Broe ME. Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4. DIABETES CARE. 2018;41(3):547–53.
IEEE
[1]
J.-D. Lalau, F. Kajbaf, Y. Bennis, A.-S. Hurtel-Lemaire, F. Belpaire, and M. E. De Broe, “Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4,” DIABETES CARE, vol. 41, no. 3, pp. 547–553, 2018.
@article{8544208,
  abstract     = {OBJECTIVE : This study was conducted to define a safe, effective dose regimen for metformin in moderate and severe chronic kidney disease (CKD; stages 3A/3B and 4, respectively), after the lifting of restrictions on metformin use in patients with diabetes with moderate-to-severe CKD in the absence of prospective safety and efficacy studies. 
RESEARCH DESIGN AND METHODS : Three complementary studies were performed: 1) a dose-finding study in CKD stages 1-5, in which blood metformin concentrations were evaluated during a 1-week period after each dose increase; 2) a 4-month metformin treatment study for validating the optimal metformin dose as a function of the CKD stage (3A, 3B, and 4), with blood metformin, lactate, and HbA(1c) concentrations monitored monthly; and 3) an assessment of pharmacokinetic parameters after the administration of a single dose of metformin in steady-state CKD stages 3A, 3B, and 4. 
RESULTS : First, in the dose-finding study, the appropriate daily dosing schedules were 1,500 mg (0.5 g in the morning [qam] +1 g in the evening [qpm]) in CKD stage 3A, 1,000 mg (0.5 g qam + 0.5 g qpm) in CKD stage 3B, and 500 mg (qam) in CKD stage 4. Second, after 4 months on these regimens, patients displayed stable metformin concentrations that never exceeded the generally accepted safe upper limit of 5.0 mg/L. Hyperlactatemia (>5 mmol/L) was absent (except in a patient with myocardial infarction), and HbA(1c) levels did not change. Third, there were no significant differences in pharmacokinetic parameters among the CKD stage groups. 
CONCLUSIONS : Provided that the dose is adjusted for renal function, metformin treatment appears to be safe and still pharmacologically efficacious in moderate-to-severe CKD.},
  author       = {Lalau, Jean-Daniel and Kajbaf, Farshad and Bennis, Youssef and Hurtel-Lemaire, Anne-Sophie and Belpaire, Frans and De Broe, Marc E},
  issn         = {0149-5992},
  journal      = {DIABETES CARE},
  keywords     = {LACTIC-ACIDOSIS,PHARMACOKINETICS,PLASMA,OVERDOSE},
  language     = {eng},
  number       = {3},
  pages        = {547--553},
  title        = {Metformin treatment in patients with type 2 diabetes and chronic kidney disease stages 3A, 3B, or 4},
  url          = {http://dx.doi.org/10.2337/dc17-2231},
  volume       = {41},
  year         = {2018},
}

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