Kim Eagle , MD , and the editors of ACC . org , present relevant articles taken from various journals .
CLINICAL
NEWS
JOURNAL WRAP
Kim Eagle , MD , and the editors of ACC . org , present relevant articles taken from various journals .
Empagliflozin Slows Progression of Kidney Disease in Some Diabetes Patients
In patients with type 2 diabetes at high cardiovascular risk , empagliflozin , a sodium-glucose cotransporter 2 inhibitor , may be associated with a slower progression of kidney disease and lower rates of renal events , according to a report from the EMPA-REG OUTCOME trial presented June 14 at the American Diabetes Association ’ s 76 th Scientific Sessions in New Orleans and simultaneously published in the New England Journal of Medicine .
The trial assigned 7,020 patients at 590 sites in 42 countries to receive either empagliflozin ( at a dose of 10 mg or 25 mg ) or placebo once daily in addition to standard care . At baseline , the estimated glomerular filtration rate ( eGFR ) was 45 to 59 ml per minute per 1.73 m2 in 17.8 % of the patients and 30 to 44 ml per minute per 1.73 m2 in 7.7 %. Additionally , 28.7 % had microalbuminuria and 11.0 % had macroalbuminuria . More than 99 % of patients had established cardiovascular disease .
Christoph Wanner , MD , and colleagues assessed the renal microvascular outcomes , and found that incident or worsening nephropathy occurred in 12.7 % of patients in the empagliflozin group and 18.8 % of the placebo group , a significant relative reduction of 39 %. Progression to macroalbuminuria occurred in 11.2 % of the empagliflozin group and 16.2 % of the placebo group , a significant relative reduction of 38 %. Additionally , a doubling of serum creatinine level occurred in 1.5 % of the empagliflozin group compared to 2.6 % of the placebo group , while the initiation of renal-replacement therapy occurred in 0.3 % of the empagliflozin group and 0.6 % of the placebo group . There was no significant between-group difference in the rate of incident albuminuria .
The authors conclude that these findings cannot be generalized to patients with type 2 diabetes at lower cardiovascular risk or to black patients due to the small population included in the study . They explain that moving forward , further research is needed to validate these findings in broader populations at risk for adverse renal outcomes .
In an editorial comment , Julie R . Ingelfinger , MD , and Clifford J . Rosen , MD , write that while these findings “ appear encouraging ” they “ are not a ‘ home run ’ with regard to the management of diabetes . In the coming years , controlled and comparative effectiveness trials that uniformly combine newer agents with older agents may help to delineate an even more effective treatment plan for the millions of people who lives are affected by type 2 diabetes .”
Wanner C , Inzucchi SE , Lachin JM , et al . N Engl J Med . 2016 ; doi : 10.1056 / NEJ- Moa1515920
Fewer patients ( 4.7 %) died from cardiovascular causes in the liraglutide group , compared to the placebo group ( 6.0 %).
LEADER Trial Shows Benefit of Liraglutide for Type 2 Diabetes Patients
Patients with type 2 diabetes at high risk of cardiovascular events had lower rates of nonfatal myocardial infarction ( MI ), nonfatal stroke and death from any cause when taking liraglutide , compared to those taking placebo , according to results of the LEADER Trial presented June 13 at the American Diabetes Association ’ s 76 th Scientific Sessions in New Orleans and simultaneously published in the New England Journal of Medicine .
The trial , led by Steven P . Marso , MD , FACC , looked at 9,340 patients with type 2 diabetes who were randomly assigned to receive liraglutide or placebo . The median follow-up time was 3.8 years . Results showed that the primary outcome — the first occurrence of death from cardiovascular-related causes , nonfatal MI or nonfatal stroke — occurred in far fewer patients in the liraglutide group ( 13 %) than in the placebo group ( 14.9 %).
Further , fewer patients ( 4.7 %) died from cardiovascular causes in the liraglutide group , compared to the placebo group ( 6.0 %). Additionally , the rate of death from any cause was lower in those assigned to liraglutide ( 8.2 %) compared to placebo ( 9.6 %). However , the rates of MI , nonfatal stroke and hospitalization for heart failure were not significantly lower with liraglutide .
Moving forward , the researchers note that some limitations of the trial include a follow-up period of only 3.5 to five years and explain that additional data beyond that time period are needed . They caution that the trial recruited participants at high risk for cardiovascular disease , so observed benefits and risks may not apply to lower-risk patients .
Marso SP , Daniels GH , Brown-Frandsen K , et al . N Engl J Med . 2016 ; doi : 10.1056 / NEJ- Moa1603827
ACC . org / CSWN CardioSource WorldNews
15