Cookie policy

This cookie policy (“Policy”) describes what cookies are and how and they’re being used by the clinicalpathways.io website (“Website” or “Service”) and any of its related products and services (collectively, “Services”). This Policy is a legally binding agreement between you (“User”, “you” or “your”) and Dr QuickNotes LTD (“Dr QuickNotes LTD”, “we”, “us” or “our”). You should read this Policy so you can understand the types of cookies we use, the information we collect using cookies and how that information is used. It also describes the choices available to you regarding accepting or declining the use of cookies. For further information on how we use, store and keep your personal data secure, see our Privacy Policy.

What are cookies?

Cookies are small pieces of data stored in text files that are saved on your computer or other devices when websites are loaded in a browser. They are widely used to remember you and your preferences, either for a single visit (through a “session cookie”) or for multiple repeat visits (using a “persistent cookie”).

Session cookies are temporary cookies that are used during the course of your visit to the Website, and they expire when you close the web browser.

Persistent cookies are used to remember your preferences within our Website and remain on your desktop or mobile device even after you close your browser or restart your computer. They ensure a consistent and efficient experience for you while visiting the Website and Services.

Cookies may be set by the Website (“first-party cookies”), or by third parties, such as those who serve content or provide advertising or analytics services on the Website (“third party cookies”). These third parties can recognize you when you visit our website and also when you visit certain other websites.

What type of cookies do we use?

Necessary cookies

Necessary cookies allow us to offer you the best possible experience when accessing and navigating through our Website and using its features. For example, these cookies let us recognize that you have created an account and have logged into that account to access the content.

Functionality cookies

Functionality cookies let us operate the Website and Services in accordance with the choices you make. For example, we will recognize your username and remember how you customized the Website and Services during future visits.

Analytical cookies

These cookies enable us and third party services to collect aggregated data for statistical purposes on how our visitors use the Website. These cookies do not contain personal information such as names and email addresses and are used to help us improve your user experience of the Website.

What are your cookie options?

If you don’t like the idea of cookies or certain types of cookies, you can change your browser’s settings to delete cookies that have already been set and to not accept new cookies. To learn more about how to do this or to learn more about cookies, visit internetcookies.org

Please note, however, that if you delete cookies or do not accept them, you might not be able to use all of the features the Website and Services offer.

Changes and amendments

We reserve the right to modify this Policy or its terms relating to the Website and Services at any time, effective upon posting of an updated version of this Policy on the Website. When we do, we will revise the updated date at the bottom of this page. Continued use of the Website and Services after any such changes shall constitute your consent to such changes.

Acceptance of this policy

You acknowledge that you have read this Policy and agree to all its terms and conditions. By accessing and using the Website and Services you agree to be bound by this Policy. If you do not agree to abide by the terms of this Policy, you are not authorized to access or use the Website and Services.

Contacting us

If you would like to contact us to understand more about this Policy or wish to contact us concerning any matter relating to our use of cookies, you may send an email to support@productivemedic.com

This document was last updated on December 30, 2020

error: Alert: Content is protected !!

SVG pop-op

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box J: High blood glucose levels despite oral diabetes medication

Further clinical investigation is required when a person has persistently raised blood glucose levels, despite being treated with oral glucose-lowering medications, to understand if the cause is due to disease-related complications or whether an alternative diagnosis should be considered.

  • Clinical records should be consulted to check the duration of T2DM since diagnosis
  • BMI should be checked, with dietary advice and support provided to manage overweight/obesity
  • Tests should be conducted to identify whether the person is beta-cell deficient and needs insulin replacement therapy. Insulin resistance may occur in people who have a normal BMI as well as those who have overweight/obesity
  • Urinary or blood ketones should be checked (including after food) to identify any signs of DKA
  • Assessment for LADA may be appropriate through antibody testing (GADA, IA2 and ZnT8)

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box I: Age/frailty/dementia

Glucose-lowering therapies should be prescribed with the individual's age, degree of frailty and cognitive function in mind.

  • Age:most SGLT2i therapies do not give specific ages for discontinuation in adults (please refer to the individual SmPC for prescribing guidance relating to age)
  • Frailty: CVOTS demonstrated the delayed progression of CKD, HF, MACE, and hypoglycaemia risk (unless used with insulin and or SUs). Moderately or severely frail people may be at risk of weight loss resulting in sarcopenia, candidiasis and UTIs, possible urinary incontinence, fluid volume depletion, and subsequent DKA. Regular monitoring and sick day education are important in this group
  • Cognitive decline: pre-clinical trials have shown delays in the development of Alzheimer’s disease and vascular dementia with SGLT2i therapies, but more robust clinical data are required. When used in individuals with impaired cognitive function, the benefits and challenges of SGLT2i therapies reflect those seen in frail individuals

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box H: Foot disease (limb ischaemia or ulceration)

One SGLT2i trial has demonstrated an imbalance in lower limb amputations (toe amputations). Subsequent SGLT2i trials, systematic reviews and meta-analyses have found no compelling evidence of a significant association with lower limb amputations.

  • Those living with diabetic foot disease or peripheral vascular disease have inherently high CV risk and would benefit from therapies proven to reduce CV risk (such as SGLT2is)
  • The osmotic diuretic effects of SGLT2i therapies are likely to be beneficial for those with limb-dependent oedema, even with active ulceration. Discussion with the local diabetes foot MDT is warranted if SGLT2is are considered suitable in this situation
  • As with all people living with T2DM, SGLT2i users should check their feet regularly, follow preventative care and report any foot infection or ulceration to their HCP

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box G: Drug-drug interactions

  • SGLT2i therapies may be prescribed alongside other commonly used medications for the treatment of T2DM without clinically relevant interactions
  • The label for each of the approved SGLT2is advises caution and monitoring of volume status when prescribed in combination with diuretic medicines due to potential dehydrating and hypotensive effects
  • Some large-scale SGLT2i RCTs (e.g. CANVAS Program) and real-world studies (e.g. CVD-REAL 2) included people taking diuretics and showed CV and renal events to be reduced/slowed, regardless of diuretic use
  • People taking insulin or insulin secretagogues (e.g. SU) should lower the dosage of these medicines initially when starting SGLT2i therapy to reduce the risk of hypoglycaemia

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box F: Genital and urinary infections

SGLT2i therapy may be associated with an increased risk of genital mycotic infections (vulvovaginitis and balanitis) and urinary tract infections (UTIs).

  • Infections are more common in women than men and usually occur early in treatment, but generally respond well to standard topical or oral treatments and most people are able to continue taking their SGLT2i therapy
  • Glycosuria may cause urinary symptoms, including more frequent voiding
  • Mycotic genital infections should be treated with antifungal medications and UTIs managed with standard antibiotics
  • The risk of infections is reduced by maintaining good genital hygiene
  • Fournier’s Gangrene is a very rare but serious soft tissue infection of the genital area. Urgent medical attention should be sought if a person receiving SGLT2i therapy experiences severe pain, tenderness, worsening redness or widespread swelling in the genital or perineal area

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box E: Diets and eating disorders

  • Conditions leading to restricted food intake or severe dehydration may predispose SGLT2i users to DKA
  • Low carbohydrate, very low calorie and ketogenic diets are not recommended for SGLT2i recipients due to an increased risk of DKA
  • SGLT2i therapy is not recommended for people living with T2DM and a co-morbid eating disorder (e.g. anorexia nervosa)
  • Individuals with T2DM who follow an intermittent fasting diet (e.g. 5:2 diet) require a diabetes therapy review, with some therapies (including SGLT2is) being reduced in dosage or suspended on fasting days
  • Please refer to advice on DKA for further information on the risk of DKA secondary to SGLT2i therapy: D

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box D: Diabetic ketoacidosis

DKA is a rare but serious complication that can occur in people treated with SGLT2is. Clinicians should be aware of the signs of DKA and the people who may be considered at greatest risk.

  • SGLT2i therapies reduce insulin secretion and shift energy metabolism toward lipid oxidation, which can cause DKA during intercurrent illness as stress hormones increase insulin resistance and reduced oral intake can lead to starvation ketosis or increased ketone concentration (due to dehydration)
  • Euglycaemic DKA (normal glucose and raised ketones) can occur in an insulin resistant individual when taking an SGLT2i therapy
  • Key signs of DKA include excessive thirst, polyuria, dehydration, shortness of breath, abdominal pain, leg cramps, nausea and vomiting, mental confusion and drowsiness, ketones on the person’s breath (pear-drop smell), ketones in the blood or urine
  • Groups that should not be treated with an SGLT2i include those with T2DM and age-related pancreatic dysfunction and Type 3c diabetes or previous DKA.
  • Clear sick day guidance should be provided for people with T2DM (verbal and written format) with SGLT2i therapy suspended during intercurrent illness
  • Individuals should be made aware of the signs and symptoms of DKA and know how/when to seek medical advice from an HCP

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box C: Renal disease, eGFR and reduced glucose-lowering

Some SGLT2is have shown cardiorenal benefits independent of their glucose lowering effect and have been granted extended licenses specifically for these indications (please refer to the individual SmPC for prescribing guidance).

  • eGFR should be checked before starting therapy, with ongoing monitoring implemented according to CKD stage
  • A reversible reduction in eGFR of up to 30% may occur when initiating therapy, which will usually stabilise with time and should not be a cause for concern as overall decline in eGFR will be slowed with ongoing treatment
  • No additional eGFR monitoring is required unless the person is unwell or it is otherwise indicated (e.g. starting another therapy likely to impact on kidney function)
  • Due to SGLT2i mechanism of action, glucose-lowering efficacy is inversely proportional to the degree of renal impairment. Therefore, the glucose lowering effect will be reduced when the eGFR falls <45 mL/min/1.73 m2 and may be absent in those with severe renal impairment

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box B: Sick day guidance

Sick day guidance should be followed when a person with diabetes is suffering from an acute dehydrating illness or is unable to eat and/or drink normally. The guidance is intended for people taking oral T2DM therapies and insulins, with the aim of reducing the risk of DKA and blood glucose fluctuation during periods of illness. Advice should be given on what constitutes a ‘sick day’, with clear explanation of when and why specific medications should be paused. Access to glucose and ketone testing should be offered to individuals where this is deemed necessary.

Guidance should include:

  • During periods of acute illness, blood glucose levels should be monitored and medical assistance must be sought if levels are persistently high or low
  • If the person is vomiting, the following medications should be temporarily stopped (the SADMANS mnemonic may be a helpful reminder):
    • SGLT2is, ACEis, Diuretics, Metformin, ARBs, NSAIDs and SUs
  • Maintain normal hydration and food, where possible
  • Check for urinary ketones:
    • If a dipstick test shows ketones to be moderate (or above) or blood tests show that levels are >3 mmol/mol, (where blood ketone testing is available) immediate attendance at the Emergency Department is required
  • Once vomiting has ceased or the individual is feeling better, oral medications can be restarted

Considerations for Prescribing SGLT2i Therapy in Type 2 Diabetes Mellitus

The clinical summary below aims to offer practical advice for healthcare professionals when prescribing SGLT2i therapies for the treatment of T2DM. Please refer to the relevant individual SmPC before prescribing any SGLT2i therapy: Canagliflozin | Dapagliflozin | Empagliflozin | Ertugliflozin

Box A: ADA/EASD and ABCD recommendations for SGLT2i therapy prescribing

  • The latest ADA Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2022 can be accessed online at: https://diabetesjournals.org/care/article/45/Supplement_1/S125/138908/9-Pharmacologic-Approaches-to-Glycemic-Treatment
  • SGLT2i therapies are recommended as second-line therapy for adults with T2DM, after metformin, or first-line in cases of intolerance to metformin
  • SGLT2is may be prescribed in combination with other glucose-lowering therapies, including GLP-1 RAs and insulin
  • The decision to prescribe an SGLT2i therapy should be made independently of the baseline or target HbA1c for high-risk individuals with established T2DM in cases where the aim of treatment is to reduce MACE, HHF, CV mortality or CKD progression

T2DM populations most likely to benefit from SGLT2i prescribing:

  • Established CVD or high CV risk
  • CKD with albuminuria or high renal risk
  • History of HF
  • Inadequate glycaemic control with a need to minimise hypoglycaemia
  • Inadequate glycaemic control and a requirement for weight loss or minimisation of weight gain
Dapagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 45 = 10mg| < 45 = not recommended for glycaemic control
Indication: Chronic HFrEF with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate
Indication: Chronic Kidney Disease with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate

SOURCE: @Visualmedapp

Dapagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 45 = 10mg| < 45 = not recommended for glycaemic control
Indication: Chronic HFrEF with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate
Indication: Chronic Kidney Disease with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate

SOURCE: @Visualmedapp

Canagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 60 = 100mg, titrate → 300mg if required | 45 - 59 = Use 100mg only | < 45 = not recommended for glycaemic control
Indication: T2D + Diabetic Kidney Disease
↓eGFR: ≥ 30 = Initiate and continue 100mg | < 30* = Continue but do not initiate 100mg | Dialysis = STOP
*With urinary albumin/creatinine ratio > 30 mg/mol

SOURCE: @Visualmedapp

Empagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 60 = Initiate 10mg, titrate → 25mg if required | 45 - 60 = Continue 10mg only but do not initiate | < 45 = STOP
Indication: T2D AND estalished cardiovascular disease
↓eGFR: ≥ 60 = Initiate 10mg, titrate → 25mg if required | 30 - 60 = Initiate or continue 10mg only | < 30 = STOP
Indication: Chronic HFrEF with or without T2D
↓eGFR: ≥ 20 = Initiate or continue 10mg | < 20 = STOP

SOURCE: @Visualmedapp

Ertugliflozin | Dose | Safety | Side-effects | NICE
↓eGFR: Initiate only if eGFR ≥ 60 = 5mg, titrate → 15mg if required | < 45 = STOP

SOURCE: @Visualmedapp

Empagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 60 = Initiate 10mg, titrate → 25mg if required | 45 - 60 = Continue 10mg only but do not initiate | < 45 = STOP
Indication: T2D AND estalished cardiovascular disease
↓eGFR: ≥ 60 = Initiate 10mg, titrate → 25mg if required | 30 - 60 = Initiate or continue 10mg only | < 30 = STOP
Indication: Chronic HFrEF with or without T2D
↓eGFR: ≥ 20 = Initiate or continue 10mg | < 20 = STOP

SOURCE: @Visualmedapp

Dapagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 45 = 10mg| < 45 = not recommended for glycaemic control
Indication: Chronic HFrEF with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate
Indication: Chronic Kidney Disease with or without T2D
↓eGFR: ≥ 15 = 10mg| < 15 = Continue but don't initiate

SOURCE: @Visualmedapp

Canagliflozin | Dose | Safety | Side-effects | NICE
Indication: T2D glycaemic control
↓eGFR: ≥ 60 = 100mg, titrate → 300mg if required | 45 - 59 = Use 100mg only | < 45 = not recommended for glycaemic control
Indication: T2D + Diabetic Kidney Disease
↓eGFR: ≥ 30 = Initiate and continue 100mg | < 30* = Continue but do not initiate 100mg | Dialysis = STOP
*With urinary albumin/creatinine ratio > 30 mg/mol

SOURCE: @Visualmedapp