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
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
- 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
- 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.
- 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:
- History of CVD (A)
- Multiple uncontrolled CVD risk factors, including hypertension, hyperlipidaemia, obesity,
smoking and/or physical inactivity (A)
- eGFR <60 mL/min/1.73 m2(B)
- Albuminuria (B)
- 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.
- 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.