Diabetes drug is also effective in heart failure – a healing practice

Diabetes medication is effective for heart failure

Chronic heart failure (Heart failureOne of the most common diseases in Western countries. In Germany alone, the number of patients is estimated at between two and three million. The disease is not yet curable, but it is treatable. Diabetes medication can help, too.

“ Dapagliflozin (brand name Forxiga) has been approved since November 2012 for adults with type 2 diabetes who cannot adequately lower a high blood sugar level by diet and exercise, the Institute for Quality and Efficiency in Health Care (IQWiG) explains on its website) website “gesundheitsinformation.deSince March 2019, the drug has also been available for overweight adults with type 1. Diabetes. The drug is also effective in chronic, symptomatic heart failure with reduced pump function.

Optimal standard treatment setting

Like IQWiG in an existing device Message Writes, that the active ingredient dapagliflozin, which has been approved against type 2 diabetes since 2012, has also been approved to treat adults with chronic heart failure with symptoms of reduced ejection fraction (pumping function) of the heart since November 2020.

In an early evaluation of benefits, IQWiG examined the advantages and disadvantages of this active ingredient for people with the disease.

The Federal Joint Committee (G-BA) has identified an improved standard treatment to compare that of dapagliflozin; It should be possible to adapt the primary / concomitant medication in compliance with the guidelines to the specific needs of those affected.

According to the National Healthcare Guidelines (NVL), patients with symptomatic heart failure and low ejection fraction should be given a combination of an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), beta blockers and, if necessary, mineralocorticoid receptor antagonists (MRA).

Furthermore, switching from ACE inhibitors / angiotensin receptor blockers to sacubitril / valsartan should be recommended for those affected who continue to exhibit symptoms despite treatment with these drugs as directed.

The therapeutic potential has not been exhausted

In its file, the manufacturer presented a randomized, parallel, placebo-controlled, co-enrollment study with a DAPA-HF scoring study with a total of 4,744 adults with symptomatic heart failure and reduced ejection fraction with mild to severe limitations in performance (NYHA Classes II to IV)).

The optimal comparative treatment was carried out only with limitations in the study, because only a small proportion of the study population received the recommended combination of sacubitril / valsartan and only a few of them received the recommended treatment change from ACE inhibitors / angiotensin receptor blockers to sacopitril / valsartan.

From today’s perspective, according to the National Care Guidelines, not all treatment options were exhausted in a large portion of the study population.

In addition, it remains unclear in the manufacturer’s file how many patients have actually been indicated for switching to sacopitril / valsartan. Therefore, the reliability of the data reaches a maximum of one reference point.

Fewer (severe) side effects

According to IQWiG, only positive effects could be seen generally with dapagliflozin treatment: of patients with milder severity of chronic heart failure with reduced ejection fraction (NYHA II severity) and additional treatment with dapagliflozin, more than the placebo group survived. However, this feature was not found in patients with higher severity scores.

Other benefits of dapagliflozin were less hospitalized due to severe heart failure and fewer (serious) side effects such as infection. Diseases of the respiratory system and the thoracic cavity (pleura and middle pleura) also occur less frequently, but it cannot be excluded that these side effects may also be due to symptoms of the underlying disease, such as shortness of breath.

However, the consent study did not provide any usable data on health-related endpoint status and quality of life related to health.

Complementary treatment brings survival benefits

In short, according to experts, there is a hint of a non-quantifiable portion for patients with chronic symptomatic heart failure with reduced ejection fraction Additional benefit With dapagliflozin in addition to the optimal standard treatment, compared to the optimal standard therapy alone.

“The data indicate that supplemental treatment with dapagliflozin has a survival advantage for many patients with severe heart failure and at the same time has less severe side effects,” explains Volker Vervolje of IQWiG’s Medicines Evaluation Division.

“However, it cannot be said how enormous this advantage actually is, given that the German supply situation has not been adequately portrayed in the consent study. The example demonstrates how important consideration of the local context is also in international studies.” (Ad)