Diabetes drug effective for heart failure
Chronic heart failure (heart failure) is one of the most common diseases in Western countries. In Germany alone, the number of patients is estimated at two to three million. The disease is not yet curable, but it is treatable. A diabetes medication can also help.
“Dapagliflozin (trade name Forxiga) has been approved since November 2012 for adults with type 2 diabetes mellitus who cannot sufficiently reduce their high blood sugar level with diet and exercise,” explains the Institute for Quality and Efficiency in Health Care (IQWiG) at its Website “Gesundheitsinformation.de”. Since March 2019, the drug has also been available for overweight adults with type 1 diabetes mellitus. And the drug is also effective in symptomatic chronic heart failure with reduced pump function.
Optimized standard therapy established
As IQWiG writes in a current press release, the active ingredient dapagliflozin, which has been approved for type 2 diabetes since 2012, has also been approved for the treatment of adults with symptomatic chronic heart failure with a reduced ejection fraction (pump function) of the heart since November 2020.
In an early benefit assessment, IQWiG examined the advantages and disadvantages of this active ingredient for people with this disease.
The Federal Joint Committee (G-BA) has defined an optimized standard therapy for the comparison of a dapagliflozin treatment; It should be possible to adapt the guideline-compliant basic / accompanying medication to the respective needs of those affected.
According to the National Health Care Guideline (NVL), patients with symptomatic heart failure and reduced ejection fraction should be given a combination of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB), a beta blocker and, if necessary, a mineralocorticoid receptor antagonist ( MRA).
Furthermore, a change from ACE inhibitors / ARBs to sacubitril / valsartan should be recommended to those affected who continue to show symptoms despite treatment with these drugs in accordance with the guidelines.
Therapeutic options not exhausted
In its dossier, the manufacturer presented a placebo-controlled randomized parallel group study with the registration study DAPA-HF with a total of 4,744 adults with symptomatic heart failure and a reduced ejection fraction with mild to severe limitations in performance (NYHA classes II to IV).
The optimized comparator therapy was only implemented with restrictions in the study, however, because only a small proportion of the study population received the recommended combination of sacubitril / valsartan and only a few received the recommended therapy change from ACE inhibitors / ARBs to sacubitril / valsartan.
From today’s perspective, according to the National Care Guideline, not all therapeutic options were exhausted in a large part of the study population.
In addition, it remains unclear in the manufacturer’s dossier for how many patients a switch to sacubitril / valsartan would actually have been indicated. Therefore, the reliability of the data reaches a maximum of one reference point.
Less (severe) side effects
According to the IQWiG, only positive effects can be seen overall with dapagliflozin treatment: Of the patients with milder severity of chronic heart failure with a reduced ejection fraction (severity NYHA class II) and additional treatment with dapagliflozin, more survived than in the placebo group. However, this advantage was not found in patients with higher degrees of severity.
Other advantages of dapagliflozin treatment were fewer hospital admissions for acute heart failure and fewer (serious) side effects such as infections. Diseases of the respiratory tract and thoracic cavity (pleura and middle pleura) also occurred less frequently, but it cannot be ruled out that these side effects may also be due to the symptoms of the underlying disease, for example shortness of breath (dyspnoea).
However, the approval study did not provide any usable data on the endpoints health status and health-related quality of life.
Complementary treatment brings survival benefit
In summary, according to the experts, there is a hint of a non-quantifiable additional benefit for patients with symptomatic chronic heart failure with a reduced ejection fraction of treatment with dapagliflozin in addition to the optimized standard therapy compared to the optimized standard therapy alone.
“The data indicate that supplementary treatment with dapagliflozin has a survival advantage for many patients with pronounced heart failure and, at the same time, less severe side effects,” explains Volker Vervölgyi from the Drug Assessment Department at IQWiG.
“How big this advantage actually is cannot be said, however, since the German supply situation is not adequately depicted in the approval study. The example shows how important it is that the local context is also considered in international studies. “(Ad)
Author and source information
This text complies with the requirements of specialist medical literature, medical guidelines and current studies and has been checked by medical professionals.
This article is for general guidance only and is not intended to be used for self-diagnosis or self-treatment. He can not substitute a visit at the doctor.