Empagliflozin (Jardiance): effects, triple benefit and risks

Empagliflozin, known to many under the trade name Jardiance, is one of the most discussed medicines of recent years. Originally developed as an agent against type 2 diabetes, it has surprisingly also proven to be a protection for the heart and kidneys. This triple benefit makes it an important building block of modern treatment. But where advertising likes to emphasise the benefit, two risks clearly belong to the picture: genital and urinary tract infections as well as a rare but dangerous metabolic derailment called ketoacidosis, which can occur even with normal blood sugar. This guide explains both openly and factually. It does not replace medical advice but helps you ask informed questions.

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At a glance

  • Empagliflozin is an SGLT2 inhibitor: it excretes sugar through the urine and thereby lowers blood sugar, independently of insulin.
  • The agent offers a triple benefit with type 2 diabetes, chronic heart failure and chronic kidney disease.
  • A common side effect is genital and urinary tract infections, such as vaginal thrush, because more sugar is in the urine.
  • A rare but dangerous side effect is ketoacidosis, which can occur even with normal blood sugar.
  • With severe illness, longer fasting or before operations the agent often has to be paused, after medical consultation.

What is empagliflozin and how does it work?

Empagliflozin belongs to the active ingredient group of SGLT2 inhibitors, which are sometimes also called gliflozins. The abbreviation SGLT2 stands for a transport protein in the kidney that normally ensures that sugar is taken from the urine back into the blood. Empagliflozin blocks this protein specifically. The result: more sugar is excreted with the urine and the blood sugar level falls. Unlike many other diabetes agents, empagliflozin works completely independently of insulin. That is an important advantage, because thereby the risk of a hypoglycaemia is low with sole use. While agents that stimulate the release of insulin can also push the blood sugar below the normal value, empagliflozin only intervenes when sugar is present in the kidney's filtrate at all. The higher the blood sugar, the more sugar is excreted, and with normal values the effect correspondingly wears off. This self-regulating mechanism explains why a severe hypoglycaemia is rare under the agent alone.

The tablet is usually taken once a day, independently of meals. Common are strengths of 10 or 25 milligrams, whereby the exact dose depends on the disease and the kidney function and is always determined medically. Important to know is that the blood-sugar-lowering effect weakens with declining kidney function because the agent works through the kidney. The protection for the heart and kidneys remains, however, even then, which is why empagliflozin today is used far beyond pure diabetes treatment. Concrete dosage details belong in medical hands; this text is not a dosage recommendation.

More than a diabetes agent

Empagliflozin was originally developed against type 2 diabetes. In large studies an unexpected additional benefit for the heart and kidneys then emerged. Today the agent is therefore also prescribed to people without diabetes if a heart weakness or a chronic kidney disease is present. So do not be surprised if you get the agent although you have no diabetes. The reason lies in the protection for the heart and kidneys.

The triple benefit: diabetes, heart and kidney

The special thing about empagliflozin is its benefit in three large disease areas at once. With type 2 diabetes it helps to lower blood sugar, frequently in addition to other agents such as metformin. With chronic heart failure, that is a heart weakness, it can clearly lower the risk of having to go to hospital because of a worsening. And with chronic kidney disease it slows the progression of the loss of kidney function. This triple benefit was proven in large studies and also applies to people who have no diabetes at all. With heart failure the advantage showed above all in a lower number of hospital stays because of a worsening of the heart weakness, and that with patients both with and without sugar disease. With kidney disease the agent slowed the progression across a broad spectrum of kidney function. Precisely because chronic kidney diseases run for a long time without complaints, an agent that slows the course is of great value.

Responsible for the protective effect on heart and kidneys is not the sugar lowering alone. Empagliflozin drains the body slightly, thereby relieves the circulation and lowers the pressure in the kidneys. In addition there are further favourable effects on the metabolism of the heart muscle that are still being researched. Important is the overall picture: heart, kidneys and metabolism are closely connected, and an agent that acts positively in one of these systems can also relieve the others. Exactly this makes empagliflozin so valuable for many chronically ill people but never replaces the rest of the guideline-based treatment.

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Genital and urinary tract infections: the underestimated topic

One of the most common side effects of empagliflozin is gladly kept quiet in advertising but belongs to honest information: genital and urinary tract infections. The reason lies directly in the principle of action. Because the agent excretes sugar through the urine, a sugar-rich, moist environment arises in the genital and urinary tract area in which fungi and bacteria feel especially comfortable. In women this often shows as vaginal thrush with itching and discharge, in men as an inflammation of the glans. Urinary tract infections also occur more frequently. This side effect is no sign of a lack of hygiene but a direct consequence of the sugar-excreting effect of the agent and therefore in principle affects everyone who takes it. People who in the past have already tended towards such infections are somewhat more at risk and should pay particular attention to first signs.

The good news: these infections are as a rule well treatable and leave no lasting damage. Careful intimate hygiene and sufficient drinking can prevent them. If infections occur repeatedly, this should be discussed medically; sometimes a different agent is then sensible. Important is not to keep quiet about such complaints out of shame but to address them openly, because they belong to the treatment and can be well brought under control.

Rare emergency: Fournier's gangrene

In very rare cases a severe, rapidly progressing inflammation in the perineal area can develop from a genital infection, a so-called Fournier's gangrene. Warning signs are strong pain, swelling, redness and tenderness in the area of the genitals and anus, often accompanied by fever and a severe feeling of illness. This is a life-threatening emergency. If such complaints occur, call the emergency number 112 immediately or seek an emergency department without delay.

Ketoacidosis: dangerous despite normal blood sugar

The second important warning concerns the diabetic ketoacidosis, a dangerous over-acidification of the blood. Normally it occurs with strongly raised blood sugar. The tricky thing with SGLT2 inhibitors such as empagliflozin is that it can also arise with normal or only slightly raised blood sugar. Experts then speak of a euglycaemic ketoacidosis. Because the blood sugar value seems unremarkable, the danger is easily overlooked, by those affected as well as by those treating. Exactly for this reason it is so important to know the warning signs.

Among the warning signs of a ketoacidosis are nausea, vomiting, abdominal pain, a fast and deep breathing, excessive thirst, confusion and unusual exhaustion. Sometimes the breath smells fruity of acetone. Triggers are often stress situations such as severe infections, longer fasting, a very low-carbohydrate diet, strong fluid losses, alcohol or operations. If such symptoms occur, this is an emergency that must be clarified medically immediately. The agent should then not be taken further until the situation is clarified. It is helpful to keep in mind that a normal blood sugar value in this situation is no reason for an all-clear, because the over-acidification can exist precisely under SGLT2 inhibitors even without high sugar. Anyone who knows about this peculiarity can make the right decision faster in an emergency and should expressly point out to the treatment team that an SGLT2 inhibitor is being taken.

Sick-day rules: when to pause?

With severe acute illness with fever, vomiting or diarrhoea, with longer fasting, with strong fluid losses and before planned operations, empagliflozin should be paused after medical consultation because the risk of a ketoacidosis then rises. Before plannable procedures it is often stopped a few days beforehand. Discuss these so-called sick-day rules with your medical practice before such a case arises. But do not stop the agent permanently without consultation, because otherwise the protection for the heart and kidneys falls away.

Topic The most important in brief
Substance group SGLT2 inhibitor, excretes sugar through the urine
Use Type 2 diabetes, heart failure, kidney disease
Common side effect Genital and urinary tract infections, such as thrush
Rare danger Ketoacidosis, possible even with normal blood sugar
Pausing With severe illness, fasting, before operations

Further side effects and important notes

Besides the infections and the rare ketoacidosis there are further points one should know. Because empagliflozin drains the body slightly, a fluid deficiency can occur that makes itself noticeable through dizziness, low blood pressure and increased thirst. Especially older people and persons who additionally take draining agents are at risk here. Therefore it is important to drink enough, above all on hot days or with gastrointestinal infections. A hypoglycaemia is rare with sole use but can occur in combination with insulin or certain other diabetes agents. In such cases the dose of these additional agents is sometimes adjusted to lower the risk. It is worthwhile to know the signs of a hypoglycaemia such as trembling, sweating, ravenous hunger and difficulty concentrating, so that one can counteract in time.

A frequent pleasant side effect is a slight weight loss of usually one to two kilograms, because calories are excreted along with the sugar. This is, however, no reason to use the agent as a slimming aid; it is not intended and not approved for this. Also important: empagliflozin should not be stopped permanently on your own, because then the protective effect is lost and the underlying disease can worsen. A classic withdrawal syndrome does not exist, but the underlying disease needs a continuous treatment. Anyone who has concerns or side effects should therefore not simply leave the agent out but seek the conversation with the medical practice, which decides together with you about the further approach.

Make sure to drink enough

Because empagliflozin drains, it is important to drink enough, especially on hot days, with physical exertion or with gastrointestinal infections with vomiting or diarrhoea. Signs of a fluid deficiency are dizziness when standing up, tiredness and a dry mouth. If you additionally take draining agents or are older, special caution is advised. Talk with your medical practice about how much fluid is sensible in your situation.

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In sum, empagliflozin is a remarkable medicine that can benefit threefold with type 2 diabetes, heart weakness and kidney disease and means a real advance for many chronically ill people. Honest information belongs to the picture, though: the common genital and urinary tract infections and the rare but dangerous ketoacidosis should be known so that warning signs are recognised early and one reacts correctly. Advertising and product information understandably put the benefit in the foreground, but a complete picture only arises when the downsides are clearly named too. Exactly this complete picture is the basis for being able to trust the agent and at the same time accompany it attentively. With type 2 diabetes, a heart failure or a chronic kidney disease, empagliflozin is often an important building block that unfolds its strength in interplay with the rest of the treatment. Anyone who knows the benefits and risks can use the agent informed and safely.

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Frequently asked questions about empagliflozin (Jardiance)

Empagliflozin, usually prescribed under the trade name Jardiance, belongs to the SGLT2 inhibitors. It blocks a transport protein in the kidney that takes sugar from the urine back into the blood. As a result more sugar is excreted and the blood sugar falls. The effect is insulin-independent, which is why the risk of a hypoglycaemia is low with sole use. In addition the agent relieves the heart and kidneys.
In the approval studies it surprisingly emerged that empagliflozin not only lowers blood sugar but also protects the heart and kidneys. It drains slightly, relieves the circulation and slows the progression of a kidney weakness. With heart weakness it lowers the risk of hospital stays. This effect also exists without diabetes.
Empagliflozin is approved for three areas of use: type 2 diabetes, chronic heart failure and chronic kidney disease. With diabetes it lowers blood sugar, often in addition to metformin. With heart and kidney disease it is prescribed also without diabetes. Dose and combination are determined by the medical practice.
Because empagliflozin excretes sugar through the urine, a sugar-rich, moist environment arises in the genital area in which fungi multiply more easily. Genital and urinary tract infections such as vaginal thrush or an inflammation of the glans are therefore among the more common side effects. They are mostly well treatable. Hygiene and sufficient drinking prevent them.
A ketoacidosis is a dangerous over-acidification of the blood that normally goes along with strongly raised blood sugar. Under SGLT2 inhibitors it can also occur with normal blood sugar, which makes it tricky. It is rare but an emergency. Warning signs are nausea, vomiting, abdominal pain, fast deep breathing and unusual exhaustion.
With severe acute illness with fever, vomiting or diarrhoea, with longer fasting, with strong fluid losses and before operations the agent should be paused after medical consultation because the ketoacidosis risk then rises. Before plannable procedures it is often stopped a few days beforehand. Discuss these rules in advance with your medical practice.
Through the draining effect a fluid deficiency with dizziness, low blood pressure and thirst can occur. Especially older people and persons with additional draining agents are at risk. A hypoglycaemia is rare with sole use but can occur with insulin or certain diabetes agents. Sufficient drinking should be ensured.
Because sugar and thereby calories are excreted with the urine, a slight weight loss of about one to two kilograms often occurs. This is a side effect, not an indication. Empagliflozin is not a slimming agent and should never be used for this. The treatment is guided by diabetes, heart or kidney disease.
No, empagliflozin should not be stopped permanently on your own because then the protection for the heart and kidneys falls away and the blood sugar can rise. A classic withdrawal syndrome does not exist, but the underlying disease can worsen. A temporary pause with illness or before operations is to be distinguished from this and always to be discussed medically.

Sources

  • Gelbe Liste: Empagliflozin, use, effect, side effects
  • DocCheck Flexikon: Empagliflozin and SGLT-2 inhibitor
  • AMBOSS: SGLT2 inhibitors, side effects and euglycaemic ketoacidosis
  • Pharmazeutische Zeitung / AkdÄ: empagliflozin with heart failure (EMPEROR)
  • MMW / Springer Medizin: empagliflozin with chronic kidney disease (EMPA-KIDNEY)
  • Deutsches Ärzteblatt / EMA: warning signs of an atypical ketoacidosis under SGLT2 inhibitors
  • Sick-day rules (SGED-SSED) and diabetologie-online: genital infections under SGLT2 inhibitors

This guide serves general information and does not replace medical advice, diagnosis or treatment. It contains no dosage recommendation. Take empagliflozin only on medical prescription, do not pause or end it on your own and discuss warning signs and sick-day rules with your medical practice or pharmacy.