Irbesartan

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Irbesartan on Prescriptsy

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Irbesartan is a prescription-only medicine used to treat high blood pressure (hypertension) and to slow the progression of kidney disease in patients with type 2 diabetes who also have hypertension (diabetic nephropathy).

It belongs to a class of medicines called angiotensin II receptor blockers (ARBs) and is available as tablets in strengths of 75 mg, 150 mg, and 300 mg.

Irbesartan works by blocking the action of angiotensin II, a hormone that constricts blood vessels and promotes salt and water retention.

By relaxing blood vessels and reducing fluid overload, irbesartan lowers blood pressure and protects the kidneys from progressive damage.

It is available as a generic medicine or under the brand name Aprovel.

Hypertension remains one of the most important modifiable risk factors for cardiovascular disease in the United Kingdom.

According to the British Heart Foundation, approximately one in three UK adults has high blood pressure, and a substantial proportion are either undiagnosed or inadequately treated.

Persistent elevation of blood pressure accelerates atherosclerosis and increases the risk of stroke, myocardial infarction, heart failure, chronic kidney disease, peripheral arterial disease, and vascular dementia.

In patients with type 2 diabetes, hypertension compounds the risk of microvascular and macrovascular complications, including diabetic nephropathy, which is the leading cause of end-stage renal disease requiring dialysis in the UK.

This page provides a comprehensive clinical overview of irbesartan, covering how it works, who should take it, dosage guidance, potential side effects, important safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about irbesartan

Before reading further, note these essential safety points about irbesartan.

• Irbesartan is a prescription-only medicine (POM) and must be used under medical supervision.
• Do not take irbesartan during pregnancy. It can cause serious harm to the unborn baby, particularly during the second and third trimesters.
• Regular blood tests for kidney function and potassium are required, especially in the first few weeks of treatment.
• Tell your prescriber if you have kidney artery disease, heart failure, diabetes, or if you are taking other medicines that affect potassium.
• Avoid regular use of NSAIDs (such as ibuprofen) with irbesartan unless advised by your prescriber.

Understanding hypertension and diabetic nephropathy

Blood pressure is the force exerted by circulating blood on the walls of the arteries.

It is measured in millimetres of mercury (mmHg) and recorded as systolic (during heart contraction) over diastolic (during heart relaxation).

NICE guideline NG136 defines hypertension as a clinic blood pressure of 140/90 mmHg or higher, confirmed by ambulatory or home monitoring showing an average of 135/85 mmHg or above.

Hypertension rarely causes symptoms until organ damage is advanced, which is why regular blood pressure screening is essential.

Diabetic nephropathy develops in approximately 30 to 40% of people with type 2 diabetes over time.

It is characterised by persistent albuminuria (protein leakage in the urine) and progressive decline in kidney function. Hypertension accelerates the rate of kidney deterioration.

Blocking the RAAS with an ACE inhibitor or ARB has been shown to reduce intraglomerular pressure, decrease proteinuria, and slow the rate of progression to end-stage renal disease, independently of the blood pressure-lowering effect.

This renoprotective action is a key reason why irbesartan is specifically indicated for diabetic nephropathy.

How irbesartan works: mechanism of action

The renin-angiotensin-aldosterone system is a hormonal cascade that regulates blood pressure and fluid balance.

When blood pressure or blood volume falls, the kidneys release renin, which converts angiotensinogen (produced by the liver) into angiotensin I.

Angiotensin-converting enzyme (ACE), found primarily in the lungs, then converts angiotensin I into angiotensin II.

Angiotensin II is a potent vasoconstrictor that raises blood pressure by narrowing arteries, stimulating the release of aldosterone (which promotes sodium and water retention by the kidneys), and increasing sympathetic nervous system activity.

Irbesartan selectively blocks the angiotensin II type 1 (AT1) receptor, preventing angiotensin II from exerting its hypertensive effects.

This produces relaxation of arterial smooth muscle, reduction of aldosterone secretion, decreased sodium and water retention, and lowering of systemic blood pressure.

Unlike ACE inhibitors, irbesartan does not affect the breakdown of bradykinin, a peptide that accumulates during ACE inhibition and is responsible for the characteristic dry cough seen in up to 15% of patients taking ACE inhibitors.

This makes ARBs a preferred alternative for patients who cannot tolerate an ACE inhibitor because of cough.

In the kidney, angiotensin II preferentially constricts the efferent arteriole of the glomerulus, maintaining high intraglomerular pressure that drives filtration but also causes progressive glomerular damage in the setting of diabetes.

By blocking angiotensin II, irbesartan dilates the efferent arteriole, reducing intraglomerular pressure and decreasing the leakage of protein (albumin) into the urine.

This haemodynamic effect, combined with anti-inflammatory and anti-fibrotic properties mediated through AT1 receptor blockade, underlies the renoprotective benefit demonstrated in clinical trials.

Clinical evidence and UK prescribing guidance

The IDNT (Irbesartan Diabetic Nephropathy Trial) demonstrated that irbesartan 300 mg daily reduced the risk of doubling of serum creatinine, end-stage renal disease, or death from renal causes by 20% compared with placebo and 23% compared with amlodipine in patients with type 2 diabetes and overt nephropathy.

This benefit was independent of the blood pressure-lowering effect.

The IRMA 2 (Irbesartan MicroAlbuminuria type 2 diabetes) trial showed that irbesartan 300 mg daily reduced the progression from microalbuminuria to macroalbuminuria by 70% compared with placebo, again independently of blood pressure reduction.

These landmark trials established irbesartan as a first-choice ARB for diabetic nephropathy and are reflected in NICE guideline NG136 and CKD guideline NG203, which recommend an ACE inhibitor or ARB for patients with diabetes and albuminuria.

The BNF notes irbesartan as having specific licensed indications for both hypertension and diabetic nephropathy in type 2 diabetes.

For hypertension without diabetes, NICE NG136 recommends an ACE inhibitor or ARB as step 1 treatment for patients under 55 who are not of Black African or African-Caribbean descent.

For patients aged 55 and over or of Black African or African-Caribbean descent, a calcium channel blocker is recommended first, with an ACE inhibitor or ARB added at step 2.

At step 3, the combination of all three classes is recommended.

Irbesartan compared with other ARBs and ACE inhibitors

Several ARBs are available in the UK, including losartan, candesartan, valsartan, olmesartan, and telmisartan. All share the same mechanism of action and produce broadly comparable blood pressure reduction.

The choice among them depends on individual patient factors, specific licensed indications, cost, and prescriber preference.

Irbesartan is distinguished by its strong evidence base for diabetic nephropathy (IDNT and IRMA 2 trials). Candesartan has evidence in heart failure (CHARM programme).

Losartan has evidence for stroke prevention in hypertensive patients with left ventricular hypertrophy (LIFE trial).

Compared with ACE inhibitors, ARBs have the advantage of a lower incidence of dry cough and angioedema.

ACE inhibitors have a slightly larger outcome evidence base from older trials (HOPE, EUROPA), but head-to-head comparisons (ONTARGET) have shown ARBs to be non-inferior.

In clinical practice, ACE inhibitors are often tried first due to their longer track record and lower cost, with ARBs offered if cough or angioedema develops.

Dual RAAS blockade (combining an ACE inhibitor with an ARB) is not recommended.

The ONTARGET trial showed that this combination increased the risk of hyperkalaemia, renal impairment, and hypotension without cardiovascular benefit.

Similarly, combining either class with aliskiren (a direct renin inhibitor) is contraindicated in patients with diabetes or renal impairment.

Dosage and administration

Irbesartan is taken once daily at the same time each day.

The usual starting dose for hypertension is 150 mg, increasing to 300 mg if blood pressure is not controlled after 4 to 6 weeks.

Patients aged 75 and over or those on haemodialysis should start at 75 mg. For diabetic nephropathy, the target dose is 300 mg daily.

Irbesartan may be taken with or without food. No dose adjustment is required for mild to moderate renal or hepatic impairment.

Blood pressure response should be assessed at follow-up visits, ideally using ambulatory or home blood pressure readings. Home readings should be consistently below 135/85 mmHg (or below 130/80 mmHg for patients with diabetes or CKD).

Side effects of irbesartan

Common side effects

Dizziness and fatigue are the most commonly reported effects, usually mild and occurring at the start of treatment.

Orthostatic hypotension (feeling light-headed when standing) may occur, particularly in patients who are volume-depleted or taking high-dose diuretics. These effects typically improve within the first few weeks.

Hyperkalaemia and renal effects

Hyperkalaemia (raised blood potassium) is an important risk, particularly in patients with diabetes, renal impairment, or those taking other potassium-raising drugs.

Symptoms of high potassium include muscle weakness, heaviness in the legs, fatigue, palpitations, and chest discomfort. Severe hyperkalaemia can cause cardiac arrest. Regular potassium monitoring is essential.

Renal function may decline in patients whose kidney perfusion depends on angiotensin II, including those with bilateral renal artery stenosis, severe heart failure, or significant volume depletion.

Renal function should be checked within 1 to 2 weeks of starting or increasing the dose.

Uncommon and rare side effects

Uncommon effects include nausea, diarrhoea, abdominal discomfort, and rash. Angioedema (swelling of the face, lips, tongue, or throat) is rare but can occur.

Patients who have experienced angioedema with an ACE inhibitor should be counselled that there is a small cross-reactivity risk with ARBs, although the incidence is much lower.

Hepatitis and jaundice have been reported very rarely.

When to seek urgent medical advice

Contact your GP or call NHS 111 if you experience persistent dizziness, unexplained muscle weakness, palpitations, or a skin rash.

Call 999 or attend A&E if you develop swelling of the face, lips, or throat (possible angioedema), difficulty breathing, signs of a heart attack or stroke, or collapse.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Pregnancy

Irbesartan must not be used during pregnancy. During the first trimester, it should be avoided, and alternative antihypertensives (labetalol, nifedipine modified-release, or methyldopa) should be used.

During the second and third trimesters, irbesartan is strictly contraindicated because of the risk of foetal renal failure, oligohydramnios, skull ossification defects, limb contractures, and neonatal death.

Women planning pregnancy should switch to a pregnancy-safe antihypertensive before conception.

Renal artery stenosis

Irbesartan must not be used in patients with bilateral renal artery stenosis or stenosis of the artery to a sole functioning kidney.

In these patients, the kidney relies on angiotensin II to maintain filtration pressure, and blocking the RAAS can cause acute kidney injury.

Volume depletion

Patients who are dehydrated or taking high-dose diuretics are at risk of symptomatic hypotension when starting irbesartan. Volume status should be corrected before initiation, or the starting dose should be reduced to 75 mg.

Drug interactions

NSAIDs reduce the efficacy of irbesartan and increase the risk of renal impairment and hyperkalaemia. Potassium supplements and potassium-sparing diuretics increase the risk of hyperkalaemia.

Lithium levels may rise with concurrent ARB use; monitoring is recommended.

Dual RAAS blockade with an ACE inhibitor or aliskiren is contraindicated in patients with diabetes or eGFR below 60.

Breastfeeding

Irbesartan is not recommended during breastfeeding due to insufficient safety data. Alternative antihypertensives with established lactation safety should be used.

How to get irbesartan in the UK

Irbesartan is a prescription-only medicine available through the NHS. Your GP can prescribe it following a clinical assessment.

Authorised online prescribers registered with the GPhC may also prescribe it after an appropriate consultation.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland. Generic irbesartan is widely available and cost-effective.

Living with hypertension and diabetes: lifestyle advice

Taking irbesartan is one component of cardiovascular risk management. Lifestyle measures play a crucial complementary role. Reduce salt intake to less than 6 g per day.

Eat a balanced diet rich in fruit, vegetables, wholegrains, and lean protein. If you have diabetes, follow your individualised dietary advice from your diabetes team.

Maintain a healthy weight and aim for regular physical activity (at least 150 minutes per week of moderate-intensity exercise).

Limit alcohol to no more than 14 units per week. Stop smoking.

Monitor your blood pressure at home with a validated upper-arm device and keep a record for your GP reviews.

If you have diabetes, attend your annual diabetes review, which includes checks of kidney function, blood pressure, cholesterol, blood glucose (HbA1c), eye screening, and foot examination.

Sources

• Irbesartan 150 mg Film-Coated Tablets, Summary of Product Characteristics (EMC)
• Irbesartan, British National Formulary (BNF)
• NICE NG136: Hypertension in adults: diagnosis and management
• NICE NG203: Chronic kidney disease: assessment and management
• High blood pressure (hypertension), NHS
• Diabetic kidney disease, NHS
• MHRA Yellow Card Scheme