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Dapagliflozin (Forxiga°) and chronic heart failure

FEATURED REVIEW An alternative to the sacubitril + valsartan combination, with the serious adverse effects common to all gliflozins.
Full review (3 pages) available for download by subscribers.

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  •  POSSIBLY HELPFUL  Dapagliflozin has been shown to be of value in heart failure, after a follow-up of 18 months, solely in patients with a greatly reduced ventricular ejection fraction and who remain symptomatic despite "optimised" therapy, usually consisting of an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) combined with a diuretic of the aldosterone antagonist class. When dapagliflozin is added to this treatment, patients should be carefully monitored for the occurrence of adverse effects, including urinary tract and genital infections, dehydration and renal failure.The potential value of adding dapagliflozin rather than replacing the ACE inhibitor or ARB with sacubitril + valsartan has not been evaluated.

Gliflozins increase the amount of glucose passing from the blood into the urine. In the early 2010s, their initial evaluation in diabetes revealed a modest glucose-lowering effect, no proven efficacy against the complications of diabetes, and disproportionate risks. Prescrire therefore considered their harm-benefit balance to be unfavourable.

Later, a trial evaluating empagliflozin in patients with diabetes and prior cardiovascular events showed a reduction in cardiovascular mortality, but no reduction in the cardiovascular complications commonly associated with diabetes. In contrast, another trial that evaluated canagliflozin showed a reduction in the incidence of certain cardiovascular events, but with no reduction in mortality. Gliflozins also have a natriuretic effect, and some have also been evaluated in renally impaired patients with or without diabetes. Dapagliflozin appeared to reduce all-cause mortality in patients with decreased glomerular filtration, but this effect was not due to fewer deaths from renal or cardiovascular causes. In patients with heart failure, dapagliflozin reduced the incidence of serious complications of heart failure, but with no robust evidence of an effect on mortality (see "Dapagliflozin (Forxiga°) and chronic heart failure", full text available for subscribers below).

A messy patchwork of evidence has thus formed over roughly a decade. But over the same period, a variety of serious adverse effects have emerged, including Fournier’s gangrene, toe amputations, renal failure and diabetic ketoacidosis. As of late 2021, it is not possible to identify the patients who are likely to derive genuine benefit from gliflozin therapy.

 ©Prescrire 1 December 2021

Source: "Dapagliflozin (Forxiga°) and chronic heart failure. An alternative to the sacubitril + valsartan combination, with the serious adverse effects common to all gliflozins" Prescrire International 2021; 30 (232): 285-287. Subscribers only.

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