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Three new treatment options for type 2 diabetes recommended by NICE
May 25, 2016 | NICE
Tens of thousands of people with type 2 diabetes will be eligible for new treatments under new guidance from NICE. -
NICE backs freer use of SGLT2 inhibitors for diabetes
May 25, 2016 | PM Live
By Phil Taylor
The National Institute of Health and Care Excellence (NICE) has recommended that SGLT2 inhibitors on the UK market can be used earlier on in patients with diabetes. -
First real-world evidence comparing an SGLT2 inhibitor with DPP-4 inhibitors
Mar 15, 2016 | European Pharmaceutical Review
By Victoria White
Results of a new analysis of data from real-world clinical practice show that, in adults with type 2 diabetes, use of Janssen’s once-daily oral medication Invokana (canagliflozin) is associated with significantly greater improvements in blood glucose control compared to dipeptidyl peptidase-4 (DPP-4) inhibitors. -
Canagliflozin Slows Progression of Renal Function Decline Independently of Glycemic Effects
May 10, 2017 | Journal of the American Society of Nephrology
By Hiddo J. L. Heerspink et al.
Sodium-glucose cotransporter 2 inhibition with canagliflozin decreases HbA1c, body weight, BP, and albuminuria, implying that canagliflozin confers renoprotection. We determined whether canagliflozin decreases albuminuria and reduces renal function decline independently of its glycemic effects in a secondary analysis of a clinical trial in 1450 patients with type 2 diabetes receiving metformin and randomly assigned to either once-daily canagliflozin 100 mg, canagliflozin 300 mg, or glimepiride uptitrated to 6–8 mg. End points were annual change in eGFR and albuminuria over 2 years of follow-up. -
Canagliflozin – Invokana – Slows Progression of Kidney Function Decline in Diabetes
Jun 13, 2016 | MedicalResearch.com
Q&A with Doctor Hiddo Lamber Heerspink -
John Anderson, MD, Q2: Thoughts on SGLT-2 Inhibitors (VIDEO)
Mar 17, 2014 | Diabetes in Control
Q&A with John Anderson, MD -
Type 2 Diabetes Treatment Invokamet XR Approved
Sep 21, 2016 | Pharmacy Times
By Jennifer Barrett
The FDA has just approved Janssen’s Invokamet XR, a once-daily, fixed-dose combination of canagliflozin (Invokana) and extended-release metformin hydrochloride, for first-line treatment for type 2 diabetes in adults as an adjunct to diet and exercise. -
Invokana displays benefits for kidney function decline in type 2 diabetes, study claims
Aug 24, 2016 | Diabetes.co.uk
By Jack Woodfield
Invokana (canagliflozin) has been found in a new trial to be more effective than Amaryl (glimepiride) at slowing the progression of renal disease in type 2 diabetes patients. -
SGLT2 inhibitors help people with type 2 diabetes live longer and healthier, study says
Mar 20, 2017 | Diabetes.co.uk
By Jack Woodfield
SGLT2 inhibitors, used to treat type 2 diabetes, reduced the rate of being admitted to hospital for heart failure or death from heart failure by 39 per cent, a worldwide study has found. -
EMA instructs warning about SGLT2 inhibitors to appeal on labels
May 10, 2017 | Diabetes.co.uk
By Jack Woodfield
The European Medicines Agency (EMA) has determined that sodium-glucose co-transporter 2 (SGLT2) inhibitors, which treat type 2 diabetes, should state an increased risk of lower-limb amputation in the prescribing information.
Professor Carole Longson, Director of NICE Center for Health Technology Evaluation
Richard Agular, co-author of analysis on INVOKANA
Hiddo J.L. Heerspink, study in Journal of American Society of Nephrology
John Anderson, past president of the American Diabetes Association
Jack Woodfield, journalist at Diabetes.co.uk
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Three new treatment options for type 2 diabetes recommended by NICE
May 25, 2016 | NICE
Tens of thousands of people with type 2 diabetes will be eligible for new treatments under new guidance from NICE.
The drugs will help to control blood sugar in those patients who cannot take more commonly prescribed medicines meaning their condition remains stable for longer.
An estimated 31,000 people may be eligible for the three recommended treatments: canagliflozin (Invokana), dapagliflozin (Forxiga) and empagliflozin (Jardiance).
The three drugs can all be used on their own if a person can’t use metformin, sulfonylurea or pioglitazone, and diet and exercise alone isn’t controlling their blood glucose levels.
In the UK, almost 3.5 million people who have been diagnosed with diabetes and it’s estimated that about 90% of adults with the condition have type 2 diabetes.
Type 2 diabetes causes elevated blood sugar levels which damages blood vessels leading to increased risk of heart attack, stroke and limb amputation.
Sugar levels rise because their body doesn’t produce enough insulin – the hormone which controls the amount of glucose in blood – or their body doesn’t use insulin effectively.
Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “Type 2 diabetes is long-term condition that has a serious impact on people who live with it, and the treatments given should be tailored for the individual.
“For many people whose blood glucose levels aren’t controlled by diet and exercise alone, metformin is the first drug treatment that they’ll be offered. But some people may experience nausea and diarrhoea, and they may not be able to take it if they have kidney damage. For people who can’t take a sulfonylurea or pioglitazone, then the three drugs recommended in this guidance can be considered. This is as an alternative to the separate group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors.
“The committee agreed that people with diabetes and their clinicians would value having an additional treatment option to help manage their type 2 diabetes – which this positive guidance provides.”
Getting the right treatment to manage diabetes is important. If blood glucose levels are not managed effectively it causes tissue damage which can also result in blindness, kidney failure, and foot ulcers which can lead to amputation. Type 2 diabetes is more common in people of African, African Caribbean and South Asian family origin.
Ruth Waxman, who has type 2 diabetes and was a patient expert for the NICE guidance, said: “I am delighted with the decision by NICE to recommend three more drugs for diabetes. Since I’ve been taking one of these drugs – dapagliflozin – my blood sugars have improved immensely and I am no longer stressed or anxious when I have the HbA1c test as I know the results will be good.
“I am more confident, I feel better and have a more positive outlook knowing I can control my diabetes more efficiently and I am able to cope better with having diabetes.
“The fear of taking insulin or other injectables has disappeared. It’s good to know that people with type 2 diabetes will now have more treatment options.”
Simon O’Neill, Director of Health Intelligence and Professional Liaison at Diabetes UK, said: “We welcome the new guidance on using the SGLT-2 group of Type 2 diabetes medications as a monotherapy.
“This gives people with Type 2 diabetes and their healthcare team more options when metformin is not appropriate. We know that different people with Type 2 diabetes may respond favourably to different medications. So this guidance offers more choice for clinicians to individualise the care they provide, which can have a significant impact on the quality of life of some people with Type 2 diabetes.”
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NICE backs freer use of SGLT2 inhibitors for diabetes
May 25, 2016 | PM Live
By Phil Taylor
The National Institute of Health and Care Excellence (NICE) has recommended that SGLT2 inhibitors on the UK market can be used earlier on in patients with diabetes.
The new guidance allows the drugs to be used first-line for people who cannot tolerate metformin, and in whom sulfonylureas or Takeda's Actos (pioglitazone) are not considered appropriate.
Importantly the recommendations put the SGLT2 inhibitors on a par with another newer class of diabetes drug - DPP-4 inhibitors such as MSD's Januvia (sitagliptin) and AstraZeneca's Onglyza (saxagliptin).
The guidance applies to Johnson & Johnson's Invokana (canagliflozin), AstraZeneca's Forxiga (dapagliflozin) and Boehringer Ingelheim/Eli Lilly's Jardiance (empagliflozin). They work in a different way to current oral antidiabetic drugs, blocking the re-absorption of glucose by the kidney and increasing the amount of glucose secreted in the urine.
Previously, NICE guidance only backed use of the drugs in combination with metformin, either alone or in combination with a sulfonylurea or insulin, but now the recommendations allow clinicians "the freedom to prescribe SGLT 2 inhibitors when they feel it is appropriate".
NICE estimates that around 31,000 of the 3 million people in the UK with diabetes may be eligible for treatment with the SGLT2 inhibitors, which it says cost on average around £475 per year and are as cost-effective as DPP-4 inhibitors.
It is well recognised that individualised care is critical in diabetes because there is no 'one size fits all' treatment, said Prof Carole Longson, director of NICE's Centre for Health Technology Evaluation, noting that SGLT2 inhibitors are now "an alternative to the separate group of drugs called DPP-4 inhibitors".
"The committee agreed that people with diabetes and their clinicians would value having an additional treatment option to help manage their type 2 diabetes - which this positive guidance provides," she added.
While the growth of the SGLT2 inhibitor class has been held back somewhat by safety concerns such as ketoacidosis, data published last year on Jardiance showing it was able to lower cardiovascular risk - the first diabetes drug to do so - has reinforced confidence in the class.
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First real-world evidence comparing an SGLT2 inhibitor with DPP-4 inhibitors
Mar 15, 2016 | European Pharmaceutical Review
By Victoria White
Results of a new analysis of data from real-world clinical practice show that, in adults with type 2 diabetes, use of Janssen’s once-daily oral medication Invokana (canagliflozin) is associated with significantly greater improvements in blood glucose control compared to dipeptidyl peptidase-4 (DPP-4) inhibitors.
These new real-world findings are the first to compare the effectiveness of a sodium glucose co‐transporter 2 (SGLT2) inhibitor with DPP-4 inhibitors.
The analysis evaluated the glycaemic control of people with type 2 diabetes treated with Invokana versus DPP-4 inhibitors over a period of nine months. Of the 1,439 people with type 2 diabetes and available A1C values included in the analysis, those treated with Invokana had a mean reduction in A1C of 0.92 percent compared to baseline, versus a mean reduction of 0.63 percent among those treated with a DPP-4 inhibitor. Additionally, a significantly greater percentage of patients taking Invokana achieved treatment goals of A1C less than 8 percent and less than 7 percent. Similar results were observed in a post-hoc analysis of those treated with Invokana versus the DPP-4 inhibitor, sitagliptin. A1C, or haemoglobin A1C, is used as a measure of average blood glucose over the past two to three months.Findings important in identifying therapeutic options with the best potential
“This real world analysis complements findings from the pivotal trials that informed the approval of Invokana as it provides insights to physicians on how these medicines are performing post-approval for people living with type 2 diabetes,” said Richard Aguilar, M.D., Medical Director of Diabetes Nation. “These new findings are important in light of the need to identify therapeutic options with the best potential for achieving treatment goals, especially since they are estimated to remain unmet for up to one-half of people with type 2 diabetes.”
In Phase 3 clinical trials, compared to the DPP-4 inhibitor sitagliptin, Invokana 300 mg resulted in significantly greater reductions in A1C, and also greater reductions in body weight and systolic blood pressure.
“Invokana is the number-one prescribed SGLT2 inhibitor with more than 7 million prescriptions and growing, and our research continues exploring the performance of this medicine across diverse patients with type 2 diabetes to help physicians and patients make informed treatment decisions,” said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. “Coupled with results from randomised clinical trials of Invokana, real-world evidence is important to providers and payers because it demonstrates the quality outcomes that can be achieved in everyday clinical practice.”
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Canagliflozin Slows Progression of Renal Function Decline Independently of Glycemic Effects
May 10, 2017 | Journal of the American Society of Nephrology
By Hiddo J. L. Heerspink et al.
Sodium-glucose cotransporter 2 inhibition with canagliflozin decreases HbA1c, body weight, BP, and albuminuria, implying that canagliflozin confers renoprotection. We determined whether canagliflozin decreases albuminuria and reduces renal function decline independently of its glycemic effects in a secondary analysis of a clinical trial in 1450 patients with type 2 diabetes receiving metformin and randomly assigned to either once-daily canagliflozin 100 mg, canagliflozin 300 mg, or glimepiride uptitrated to 6–8 mg. End points were annual change in eGFR and albuminuria over 2 years of follow-up. Glimepiride, canagliflozin 100 mg, and canagliflozin 300 mg groups had eGFR declines of 3.3 ml/min per 1.73 m2 per year (95% confidence interval [95% CI], 2.8 to 3.8), 0.5 ml/min per 1.73 m2 per year (95% CI, 0.0 to 1.0), and 0.9 ml/min per 1.73 m2 per year (95% CI, 0.4 to 1.4), respectively (P<0.01 for each canagliflozin group versus glimepiride). In the subgroup of patients with baseline urinary albumin-to-creatinine ratio ≥30 mg/g, urinary albumin-to-creatinine ratio decreased more with canagliflozin 100 mg (31.7%; 95% CI, 8.6% to 48.9%; P=0.01) or canagliflozin 300 mg (49.3%; 95% CI, 31.9% to 62.2%; P<0.001) than with glimepiride. Patients receiving glimepiride, canagliflozin 100 mg, or canagliflozin 300 mg had reductions in HbA1c of 0.81%, 0.82%, and 0.93%, respectively, at 1 year and 0.55%, 0.65%, and 0.74%, respectively, at 2 years. In conclusion, canagliflozin 100 or 300 mg/d, compared with glimepiride, slowed the progression of renal disease over 2 years in patients with type 2 diabetes, and canagliflozin may confer renoprotective effects independently of its glycemic effects.
Full Text: http://jasn.asnjournals.org/content/early/2016/08/18/ASN.2016030278.full
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Canagliflozin – Invokana – Slows Progression of Kidney Function Decline in Diabetes
Jun 13, 2016 | MedicalResearch.com
Doctor Hiddo Lambers Heerspink
Department of Clinical Pharmacy and Pharmacology
University Medical Center Groningen
the NetherlandsMedicalResearch.com: What is the background for this study? What are the main findings?
Response: SGLT2 inhibitors, including canagliflozin, have beneficial effects on multiple cardiovascular and renal risk parameters. This suggests that SGLT2 inhibitors may confer cardiovascular and renal protection. A recent large clinical trial with the SGLT2 inhibitor empagliflozin demonstrated marked reductions in cardiovascular morbidity and mortality and suggested possible renoprotective effects. Whether SGLT2 inhibition slows the progression of kidney function decline independent of its glucose-lowering effect, however, is unknown. We therefore assessed whether canagliflozin slows the progression of kidney function decline by comparing the effects of canagliflozin versus glimepiride on eGFR and albuminuria.
MedicalResearch.com: What should readers take away from your report?
Response: Canagliflozin slows the progression of kidney function decline compared to glimepirde at almost equal glycemic control suggesting that the beneficial effects of canagliflozin on kidney function are independent of its glycemic effects.MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Large scale trials using clinically meaningful hard renal endpoints are required to definitively demonstrate the renoprotective effects of SGLT2 inhibitors. The CREDENCE trial is one such trial testing whether canagliflozin 100 mg/d delays the time to a halving of kidney function, dialysis/renal transplantation or cardiovascular death.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: 2016 ADA abstract June 11, 2016
Differential Effects of Dapagliflozin on Cardiovascular Risk Factors at Varying Degrees of Renal Function
Authors: HIDDO J.L. HEERSPINK, RAISA KURLYANDSKAYA, JOHN XU, C. DAVID SJÖSTRÖM, Groningen, Netherlands, Gothenburg, Sweden, Gaithersburg, MD Disclosures H.J. Heerspink: Consultant; Author; AbbVie Inc., Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., AstraZeneca, ZN-Pharma. Research Support; Author; AstraZeneca. R. Kurlyandskaya: Employee; Author; AstraZeneca. J. Xu: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca. C. Sjöström: Employee; Author; AstraZeneca. Stock/Shareholder; Author; AstraZeneca.
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John Anderson, MD, Q2: Thoughts on SGLT-2 Inhibitors (VIDEO)
Mar 17, 2014 | Diabetes in Control
Transcript of Video
Reporter: There has been a couple of new breakthrough products that have come out for diabetes, one of them is the new SGLT-2 products. There seems to be some concern about safety and efficacy. There is one in the market today, and one can imagine that in the next few years there will be six or seven of them. Have you had any experience with the SGLT-2 and what are your thoughts?
Anderson: I have talked to a lot of investigators about SGLT-2 inhibitors. The efficacy is pretty good and so we have seen that in some of the trials. A lot of the concerns revolve around the mechanism of action, I've heard that. Some of the other concerns revolve around what we call the nuisance system symptoms of UTIs, mycoticinfections, but those are usually pretty small, and the drop-out rate, when you look at the phase-3 trials are small when you look at those types of things. so again with any new product and particularly a whole new class of agents, its going to take clinicians to get use to using these with their patients and trying to figure out where is the best place, and whats the best patient for those products.
http://www.diabetesincontrol.com/john-anderson-md-q2-thoughts-on-sglt-2-inhibitors/
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Type 2 Diabetes Treatment Invokamet XR Approved
Sep 21, 2016 | Pharmacy Times
By Jennifer Barrett
The FDA has just approved Janssen’s Invokamet XR, a once-daily, fixed-dose combination of canagliflozin (Invokana) and extended-release metformin hydrochloride, for first-line treatment for type 2 diabetes in adults as an adjunct to diet and exercise.
Invokamet XR is available in 4 dosages in tablets containing canagliflozin 50 mg or 150 mg, and metformin XR 500 mg or 1000 mg. The recommended dosing is 2 tablets taken once a day during the morning meal.
“Invokamet XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1C levels,” said John Anderson, MD, in a press release. “As with Invokamet, physicians can prescribe the XR formulation to adults when they are first diagnosed with type 2 diabetes or as additional therapy for people whose A1C levels are not well controlled with either agent alone.”
Invokamet is the first fixed-dose tablet to combine the sodium glucose co-transporter 2 inhibitor, canagliflozin, and immediate-release metformin hydrochloride. It initially received approval from the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled with metformin or canagliflozin, or who are already being treated with both medications separately. In May 2016, the drug’s indication was expanded to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.
Studies have shown a significantly greater reduction in HbA1C levels with Invokamet XR treatment than with metformin alone. Canagliflozin aids the patients’ kidneys in depleting sugar levels through urination, and metformin decreases glucose production in the liver and improves the body’s response to insulin.
Type 2 diabetes treatment guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology, as well as from the American Diabetes Association, all recommend dual therapy for patients with high HbA1C levels, and Invokamet XR aligns with their recommendation.
Invokamet XR carries a Boxed Warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. Other serious adverse effects associated with the drug are dehydration, ketoacidosis, kidney problems, hyperkalemia, serious urinary tract infections, and hypoglycemia. Patients who have kidney problems or are on dialysis should not take Invokamet XR. -
Invokana displays benefits for kidney function decline in type 2 diabetes, study claims
Aug 24, 2016 | Diabetes.co.uk
By Jack Woodfield
Invokana (canagliflozin) has been found in a new trial to be more effective than Amaryl (glimepiride) at slowing the progression of renal disease in type 2 diabetes patients.
Both of these drugs are intended to lower blood sugar levels. Invokana is an SGLT2 inhibitor, which helps by removing excess sugar through urine, while Amaryl, a sulphonylurea, stimulates the release of insulin from the pancreas into the blood.
In this four-year study, researchers at the University of Groningen, the Netherlands measured the effects of canagliflozin on kidney function decline in 1,450 patients with type 2 diabetes who were taking metformin.
Patients were randomised to receive either 100mg or 300mg of canagliflozin or glimepiride once daily between August 2009 and January 2013.
A subgroup of participants was also evaluated who had urinary albumin-to-creatinine ratios of 30mg/g or more at the beginning of the study.
Researchers evaluated changes in albuminuria and estimated glomerular filtration rate (eGFR), which are both measures of kidney function.
Overall, 46 participants in the glimepiride group reached the endpoint of the 30 per cent eGFR decline. This compared to 32 patients in the canagliflozin group.
The canagliflozin groups also had better HbA1c and blood pressure levels compared to the glimepiride group.
Lead author Hiddo J.L. Heerspink, Ph.D, explained: "Since glycemic control was only modestly different between canagliflozin and glimepiride, our results suggest that potential kidney protective effects of canagliflozin may be unrelated to glycemic control.
"Our results are especially important since many patients with diabetes are at risk of progressive kidney function loss, and canagliflozin may offer a new and improved therapeutic opportunity for these patients."
One of the limitations of this study was that it was not designed to compared the renoprotective effects of canagliflozin against glimepridie.
The authors added that "the lack of a placebo arm in this study means that no definitive conclusions can be drawn regarding whether canagliflozin is renoprotective or whether glimepiride worsens the progression of kidney disease".
The findings appear in the Journal of the American Society of Nephrology. -
SGLT2 inhibitors help people with type 2 diabetes live longer and healthier, study says
Mar 20, 2017 | Diabetes.co.uk
By Jack Woodfield
SGLT2 inhibitors, used to treat type 2 diabetes, reduced the rate of being admitted to hospital for heart failure or death from heart failure by 39 per cent, a worldwide study has found.
SGLT2 inhibitors are a relatively new type of drug class which was approved for treating type 2 diabetes in 2013. They work by helping the kidneys to lower blood sugar levels.
Now a study of more than 300,000 people across six countries has demonstrated significant health benefits of the oral medication compared to other medicines used to treat type 2 diabetes.
Bruce Cooper, Vice President and Head of Global Medical Affairs at AstraZeneca, said: "Real-world data from this study provide striking evidence that the newer SGLT-2i class of medicines cuts the rate of hospitalisations for heart failure and death by approximately half.
"CVD-REAL is the first study to observe these effects of SGLT-2i treatment in a much broader and lower risk group of type 2 diabetes patients than previously evaluated in clinical trials."
The SGLT2 inhibitors investigated during the CVD-REAL study were Forxiga (dapagliflozin), Jardiance (empagliflozin) and Invokana (canagliflozin).
More than 90 per cent of people studied were on either Forxiga, mainly prescribed in Europe, or Invokana, primarily taken in the US. Eighty-seven per cent of those studied had no history of cardiovascular disease.
The type 2 diabetes treatments that the SGLT2s were compared against included insulin and DPP-4 inhibitors as well as metformin.
SGLT-2 drugs were shown to lower the combined risk of hospitalisation for heart failure and death from any cause by 46 per cent. The reduction of admittance to hospital for heart failure or death from heart failure was 39 per cent.
Researcher, Dr Mikhail Kosiborod, who is a cardiologist based ay Saint Luke's Mid America Heart Institute located in Kansas City said: "The fact that the results are remarkably consistent from country to country regardless of which compound predominates, that certainly seems to suggest that it's a class effect."
The findings were presented at the American College of Cardiology 66th Annual Scientific Session. -
EMA instructs warning about SGLT2 inhibitors to appeal on labels
May 10, 2017 | Diabetes.co.uk
By Jack Woodfield
The European Medicines Agency (EMA) has determined that sodium-glucose co-transporter 2 (SGLT2) inhibitors, which treat type 2 diabetes, should state an increased risk of lower-limb amputation in the prescribing information.
SGLT2 inhibitors help to reduce blood glucose levels by excreting excess sugar through urine. They have been approved as a type 2 diabetes treatment in the UK since 2013.
This warning has been made following an EMA investigation into two ongoing clinical trials with canagliflozin (marketed as Invokana) in patients at high risk of cardiovascular events. Both trials found an increased risk of amputation, mostly of toes, among users of the drug.
But the warning specifies that the lower-limb amputation risk would be an "uncommon side effect", occurring in between one and 10 per 1,000 patients.
In the Canagliflozin Cardiovascular Assessment Study (CANVAS) trial, the rate of amputations per every 1,000 patients was equivalent to seven for 100mg/day of canagliflozin and five for 300 mg/day. This compared with three per 1,000 patients taking placebo.
The CANVAS-R trial, a related study of renal end points, also found a small increase in amputations among canagliflozin users. However, no such increase was observed in 12 other completed clinical trials of the drug.
"The mechanism by which canagliflozin may increase the risk of amputation is still unclear," according to a statement from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
"An increased risk has not been seen in studies with other medicines in the same class, dapagliflozin (Forxiga) and empagliflozin (Jardiance). However, data available to date are limited and the risk may also apply to these other medicines. Further data are expected from ongoing studies with canagliflozin, dapagliflozin, and empagliflozin."
The PRAC has recommended that a warning about lower-limb amputation risk should be included in the prescribing information for all SGLT2 inhibitors.
Clinicians are advised to consider ceasing SGLT2 inhibitor treatment if a patient is developing foot problems, such as ulcers or infections.
Professor Carole Longson, Director of NICE Center for Health Technology Evaluation
Richard Agular, co-author of analysis on INVOKANA
Hiddo J.L. Heerspink, study in Journal of American Society of Nephrology
John Anderson, past president of the American Diabetes Association
Jack Woodfield, journalist at Diabetes.co.uk
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