Det finns ett nätverk i Europa av specialister i allmänmedicin och en skandinavisk subgrupp, vari ingår flera diabetes-engagerade allmänmedicinare.

Nedtill finns en färsk artikel som tar upp det som diskuterades på ett europeiskt möte för någon vecka sedan. 

 

Här ges förslag hur metformin ska användas vid ASCVD t ex med anledning av diskussion mellan Svensk Förening för Diabetologi och Svensk Förening för Kardiologi. Också utifrån olika aktuella riktlinjer kring typ 2 diabetes och hjärtkärlsjukdom, ESC (europeiska kardiologriktlinjer från 31/8 2019) och ADA/EASD (amerikanskt och europeiskt dokument 2020 från dec 2019)

 

Se också tidigare inlägg och diskussion på www

https://www.dagensdiabetes.se/index.php/alla-senaste-nyheter/3205-svenska-diabetesriktlinjer-galler-tills-vidare-med-anledning-av-nya-esc-riktlinjer-sfd-ordf-och-kardiologforeningens-ordforande-statement

 

På ett enkelt sätt så används i den färska artikeln nedtill definition av ”mycket hög risk” respektive ”hög ris” för kardiovaskulär sjukdom vid typ 2 diabetes. Mot slutet finns 8 stycken pedagogiska ”Boxar” för olika patientscenarier.

 

Nyhetsinfo

www red DiabetologNytt

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Impact on guidelines: the general practitioner point of view

Cos et al

 

Läs abstract fritt och hela artikeln

https://www.ncbi.nlm.nih.gov/pubmed/32105769

 

Abstract

Primary care physicians are uniquely placed to offer holistic, patient-centred care to patients with T2DM. While the

recent FDA-mandated cardiovascular outcome trials offer a wealth of data to inform treatment discussions, they

have also contributed to increasing complexity in treatment decisions, and in the guidelines that seek to assist in

making these decisions. To assist physicians in avoiding treatment inertia, Primary Care Diabetes Europe has

formulated a position statement that summarises our current understanding of the available T2DM treatment

options in various patient populations. New data from recent outcomes trials is contextualised and summarised for 

the primary care physician. This consensus paper also proposes a unique and simple tool to stratify patients into

‘very high’ and ‘high’ cardiovascular risk categories and outlines treatment recommendations for patients with

atherosclerotic cardiovascular disease, heart failure and chronic kidney disease. Special consideration is given to

elderly/frail patients and those with obesity. A visual patient assessment tool is provided, and a comprehensive set

of prescribing tips is presented for all available classes of glucose-lowering therapies. This position statement will

complement the already available, often specialist-focused, T2DM treatment guidelines and provide greater

direction in how the wealth of outcome trial data can be applied to everyday practice.

 

Some issues from the article

1. The importance of primary care providers in diabetes management

Type 2 diabetes mellitus (T2DM) accounts for approximately 90% of the diabetes cases worldwide and currently

represents one of our fastest growing health challenges [1]. Poor diabetes management can contribute to a host of

complications, particularly cardiovascular disease (CVD) and chronic kidney disease (CKD), leading to significant

impacts on patient mortality and quality of life, as well as economic burden [1]. Fortunately, drug development

efforts of recent years have seen a dramatic increase in the therapeutic tools available to healthcare practitioners

(HCPs) who treat patients with T2DM. Moreover, the requirement from the US Food and Drug Administration

(FDA) as of 2008 that glucose-lowering therapies must be subjected to rigourous cardiovascular safety evaluation

through dedicated cardiovascular outcome trials (CVOTs) has provided more information than ever on the efficacy

and safety of these new treatment options [2].

Despite these advances, many patients living with T2DM still fail to meet guideline targets to optimally control

their diabetes and its associated risk factors [3,4].

 

Primary care physicians (PCPs) are uniquely placed to provide effective T2DM care for several reasons. First, the

role of primary care physicians allows them to successfully adopt shared-decision making models of care, where

HCPs and patients co-develop treatment goals through dialogue and discussion around benefits and drawbacks of

various treatment options [5–7]. PCPs can also bring a more holistic approach to diabetes treatment through their

more frequent contacts and often long-term relationships with patients [8]. As generalists, PCPs are experts at

‘whole-person medicine’. Rather that viewing a patient as a collection of isolated disease states, the experienced

PCP can integrate multiple health needs and goals to recommend evidence-based and individually tailored

treatment plans [9].

The majority of routine management of T2DM occurs in primary care [10]. It is therefore critical that PCPs make

effective use of the wealth of clinical data for the various glucose lowering

 

3. Rationale for the Primary Care Diabetes Europe position statement

Clinical decision making in the primary care context is exceedingly complex, and PCPs strive to provide evidencebased

treatment recommendations that take into account the whole patient and all of their health challenges and

goals. PCPs face the challenge of the growing number of available therapies to treat T2DM as well as the

sometimes overwhelming amount of clinical data available for each. Also, the patient population with T2DM that is

typically seen in the primary care setting often differs quite substantially from that included in clinical trials,

making the applicability of the data from CVOTs to primary care patients difficult to gauge [44–47]. Primary care

HCPs also face the challenge of putting into practice the increasingly complex treatment guidelines, which are

often focused on specialists and sometimes lack input from the perspective of primary care.

For these reasons, many HCPs struggle with therapeutic inertia when treating T2DM [48–50], resulting in delayed

treatment intensification and failure to meet guideline-recommended targets [51,52]. For these reasons, Primary

Care Diabetes Europe (PCDE) has drafted a position statement on the pharmacological management of T2DM in

primary care [53]. The goal of this position statement is to provide a pragmatic tool for PCPs to aid in treatment

planning discussions with their patients. It is intended to complement rather than supplant national and

international guidelines by providing additional direction to the primary care HCP.

PCDE Is a non-profit organisation that aims to promote high standards of evidence-based care throughout Europe

and to promote diabetes education and research in the primary care setting. The PCDE author group adopted an

evidence-based and consensus approach in formulating this position statement.

 

4. Executive summary of the PCDE position statement

To assist in shared-decision conversations with patients, this position statement is a practical tool PCPs can use as

they provide evidence-based care to their patients. This tool is unique in several important ways. It introduces a

new, pragmatic approach to cardiovascular risk stratification, and then summarises the various treatment options

with respect to cardiovascular risk, with a particular focus on patients with chronic kidney disease, HF and those

with obesity. Specific recommendations are also included on care for patients with T2DM who are elderly/frail.

Treatment options are examined with respect to their applicability to these different patient populations, and a

comprehensive survey of mechanism of action, common side effects and prescribing tips is given by drug class. A

summary of the CVOT and other outcomes trial data is also included, outlining the various trials by study

population, endpoint and major results. Finally, the treatment recommendations by patient population are

gathered into an easy to use one-page visual patient assessment checklist.

offered comprehensive lifestyle counselling, and metformin as the first-line pharmacological therapy of choice.

However, the position statement notes that emerging data supports initiating dual pharmacotherapy at diagnosis

[54,55], and recommends this be considered in patients who are likely to benefit from better glycaemic control

and to gain the benefits of cardio-renal protective therapies earlier.

The authors have formulated simple pragmatic criteria to stratify patients into those at ‘very high’ cardiovascular

risk and those at ‘high’ cardiovascular risk. These criteria are shown in Box 1.

In addition to established CVD, which is well-recognised as a major risk factor for future cardiovascular events [56],

the authors define patients with other uncontrolled CVD risk factors, CKD as defined by eGFR and/or albuminuria,

and young age at diagnosis as being ‘very high risk’ based on the available evidence [57–59]. Since T2DM in and of

itself is considered to be a major risk factor for CVD, all other patients who do not meet any of these criteria are

considered to be at ‘high risk’.

The position statement then surveys the available data on the various treatment options based on this novel risk

stratification. Separate sections highlighting treatment considerations for patients with ASCVD, HF, CKD and

obesity are included. Specific recommendations for holistic management are also provided for treating patients

who are elderly or frail. A summary of these treatment recommendations is shown here in Boxes 2–7.

 

Box 1: Cardiovascular risk stratification in patients with T2D

Patients with T2DM are considered to be at very high cardiovascular risk  if they have any of the

following:

1. History of CVD (A)
2. Multiple uncontrolled CVD risk factors, including hypertension, hyperlipidaemia, obesity,

smoking and/or physical inactivity (A)

3. eGFR <60 mL/min/1.73 m2(B)
4. Albuminuria (B)
5. Age at diagnosis <40 years (C)

All other patients with T2DM are considered to be at high cardiovascular risk

 

Letters (A–C) denote level of evidence based on the ADA grading system: A, clear evidence from wellconducted,generalisable randomised controlled trials (RCTs), that are adequately powered, including

1) evidence from a well-conducted multicentre trial or meta-analysis that incorporated quality ratings in

the analysis, 2) compelling nonexperimental evidence, 3) supportive evidence from well-conducted RCTs

that are adequately powered; B, supportive evidence from a well-conducted cohort study or casecontrol

study; C, supportive evidence from poorly controlled or uncontrolled studies, or conflicting

evidence with the weight of evidence supporting the recommendation; E, expert opinion.

 

Box 2: Treatment recommendations for patients with ASCVD

  Metformin as first-line therapy (A)

  SGLT2i or GLP-1RA with proven cardiovascular benefit as second-line therapy (A)

  Consider initiating metformin + SGLT2i/GLP-1RA rather than stepwise (E)

  Use basal insulin with caution when other options have failed, and glycaemic targets are not

met (E)

 

Box 3: Treatment recommendations for patients with HF

 Metformin as first-line therapy (A)

 SGLT2i as second-line therapy (A)

 Avoid pioglitazone (A) and saxagliptin (A) and use basal insulin with caution (B)

 Consider initiating metformin + SGLT2i rather than stepwise (E)

 

Box 4: Treatment recommendations for patients with CKD

 Metformin as first-line therapy if eGFR >30 mL/min/1.73 m2(A)

 SGLT2i as second-line therapy in patients with >45 mL/min/1.73 m2(A), even when wellcontrolled

on metformin alone (E)

 GLP-1RA as third-line therapy or if previous treatments are not tolerated (A), followed by

DPP-4i (A)

 Reduce dose of glinides and reduce dose or discontinue SUs if eGFR <45 mL/min/1.73 m2 to

reduce the risk of hypoglycaemia (A)

 Consider initiating metformin + SGLT2i rather than stepwise (E), according to the approved

restrictions of dose and indications by eGFR

 Consult prescribing instructions for specific agents for dosing instructions based on eGFR (E)

 

 Box 5: Treatment recommendations for patients at high cardiovascular risk

 Metformin as first-line therapy (A)

 SGLT2i or GLP-1RA or DPP-4i as second-line therapy where cost is not prohibitive (A). Of these,

SGLT2i is preferred (E)

 Newer-generation SUs or glinides when drug cost must be minimised (A)

 Pioglitazone in patients with NAFLD and where insulin resistance predominates (A)

 Consider initiating metformin + SGLT2i/GLP-1RA/DPP-4i rather than stepwise (E)

 Basal insulin when other therapies have been explored and glycaemic targets are not met (E)

 Full basal–bolus insulin therapy only as a last resort (E)

 

 Box 6: Treatment recommendations for patients with obesity

 Metformin as first-line therapy (A)

 GLP-1RA or SGLT2i as second-line therapy (A)

 Where possible, avoid treatments that cause weight gain, including most SUs, glinides,

pioglitazone and insulin (A)

 If basal insulin is required, consider fixed-ratio insulin/GLP-1RA combinations (A)

 Consider initiating metformin + GLP-1RA/SGLT2i rather than stepwise (E)

 

Box 8: Treatment recommendations for elderly/frail patients

 Metformin as first-line therapy if tolerated and not contraindicated (A)

 DPP-4i is a safe and easy to use option (A)

 Avoid stringent glycaemic targets that increase risk of hypoglycaemia (E)

 Assess adherence and avoid injectable medications and medications dosed more than once

per day if necessary (E)

 Avoid GLP-1RA in frail patients (E)

In the text accompanying these treatment recommendations, a particular focus is placed on the data from CVOTs

to assist PCPs in sifting through this information. A comprehensive collection of the available CVOT data, including

study population and the results of the major endpoints is also summarised in tabular format.

Finally, the consensus treatment recommendations by risk stratification and patient characteristics are gathered

into an easy to use visual patient assessment tool to function as an ‘at a glance’ reminder for PCPs. Importantly,

the authors have also included a comprehensive summary of the mechanism of action, common side effects and

prescribing tips for all available classes of diabetes therapeutics. Together, this visual tool and the tabular summary

of prescribing tips should prove invaluable tools to PCPs focused on patient-centred care.

Overall, the goal of this consensus statement by PCDE is to offer practical treatment recommendations that can be

widely implemented by PCPs and inform shared-decision conversations with their patients. This approach can

serve to focus the understanding of the PCP and complement the available national and international treamtent

guidelines for T2DM.

 

 

5. Conclusion: From CVOT data to a patient-centred approach

 PCPs practicing today have a range of precision therapeutic tools available for the treatment of T2DM that could

not be imagined by physicians even a relatively short time ago [60]. With its 2008 Guidance to Industry, the US FDA

ushered in a new era of knowledge about the patient outcomes associated with use of these therapies in high-risk

populations. This era of knowledge, however, is also one of increasing complexity. CVOTs and other long-term

trials are providing more and more data on various patient outcomes. The relevance and importance of this wealth

of data to individual patients must be carefully assessed by physicians. To assist HCPs with applying this data,

treatment guidelines for T2DM have also become increasingly complex in recent years and are likely to continue to

become more intricate as more relevant knowledge is amassed.

 

It is incumbent on all HCPs who make treatment decisions with patients with T2DM to use these new precision

tools as wisely as possible. This can be a challenge to PCPs who not only must focus on a wide range of patient

goals and characteristics, but who are also tasked with adopting a shared decision model founded on evidencebased

discussions with their patients. As an adjunct to the comprehensive, often specialist-focused national and

international treatment guidelines, PCDE has formulated an easy to use consensus statement that summarises the

relevant data from CVOTs and other trials and applies it to the types of patients typically treated in primary care.

 

This position statement will provide PCPs worldwide an evidence-based tool they can use as a foundation for treatment discussions with their patients.