Values, preferences and burden of treatment for the initiation of GLP-1 receptor agonists and SGLT-2 inhibitors in adult patients with type 2 diabetes: a systematic review

González-González, José Gerardo; González-Colmenero, Alejandro Díaz; Millán-Alanís, Juan Manuel; Lytvyn, Lyubov; Solis, Ricardo Cesar; Mustafa, Reem A.; Palmer, Suetonia C.; Li, Sheyu; Qin, Hao; Alvarez‐Villalobos, Neri Alejandro; Vandvik, Per Olav; Rodríguez-Gutiérrez, René

doi:10.1136/bmjopen-2021-049130

Cited by 5 publications

(3 citation statements)

References 39 publications

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“…TCZ requires IV or subcutaneous administration; patients' values or preferences regarding injection and oral medicine also may affect the decision-making. 30 To compare the clinical effectiveness of TCZ to other pharmacological therapies or no treatment, we should consider both direct and indirect evidence. The evidence synthesis by 1 included systematic review 18 omitted the direct comparison from the TANGO trial that directly compared TCZ versus AZA.…”

Section: Conclusion and Implications For Decision-or Policy-makingmentioning

confidence: 99%

Tocilizumab for Neuromyelitis Optica Spectrum Disorder

Qin¹,

Grobelna²

2023

cjht

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Patients with neuromyelitis optica spectrum disorder treated with tocilizumab may experience decreased risks of relapse or disability progression compared to before treatment, but it is uncertain whether these changes can be entirely attributed to tocilizumab (TCZ) treatment. TCZ might be better than azathioprine for patients with neuromyelitis optica spectrum disorder in reducing relapse risk. TCZ might improve or have no impact on pain and fatigue measures for patients with neuromyelitis optica spectrum disorder. Adverse events were common during TCZ treatment, but patients treated with TCZ may experience adverse events at a similar or lower rate to those treated with azathioprine. One evidence-based guideline suggests that TCZ can be used as 1 of the second-line drugs to prevent long-term relapse for patients with neuromyelitis optica spectrum disorder who have no response to other immunosuppressants. We did not find any studies that compared TCZ to other immunosuppressants or any studies on the cost-effectiveness of TCZ for treating neuromyelitis optica spectrum disorder that met the inclusion criteria for this report.

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Section: Conclusion and Implications For Decision-or Policy-makingmentioning

confidence: 99%

Tocilizumab for Neuromyelitis Optica Spectrum Disorder

Qin¹,

Grobelna²

2023

cjht

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“…When adding PCSK9 inhibitors or ezetimibe, the previous lipid-lowering drug (maximally tolerated statins) would remain unchanged. Many people may prefer oral medicines to injectable drugs 23. Implementing injection medications may introduce various barriers and need effective communication with patients 2425 Table 2.…”

Section: Understanding the Recommendationsmentioning

confidence: 99%

PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations

Qin

Aertgeerts

Guyatt

et al. 2022

BMJ

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Clinical question In adults with low density lipoprotein (LDL) cholesterol levels >1.8 mmol/L (>70 mg/dL) who are already taking the maximum dose of statins or are intolerant to statins, should another lipid-lowering drug be added, either a proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor or ezetimibe, to reduce the risk of major cardiovascular events? If so, which drug is preferred? Having decided to use one, should we add the other lipid-lowering drug? Current practice Most guidelines emphasise LDL cholesterol targets in their recommendations for prescribing PCSK9 inhibitors and/or ezetimibe in adults at high risk of experiencing a major adverse cardiovascular event. However, to achieve these goals in very high risk patients with statins alone is almost impossible, so physicians are increasingly considering other lipid-lowering drugs solely for achieving LDL cholesterol treatment goals rather than for achieving important absolute cardiovascular risk reduction. Most guidelines do not systematically assess the cardiovascular benefits of adding PCSK9 inhibitors and/or ezetimibe for all risk groups across primary and secondary prevention, nor do they report, in accordance with explicit judgments of assumed patients’ values and preferences, absolute benefits and harms and potential treatment burdens. Recommendations The guideline panel provided mostly weak recommendations, which means we rely on shared decision making when applying these recommendations. For adults already using statins, the panel suggests adding a second lipid-lowering drug in people at very high and high cardiovascular risk but recommends against adding it in people at low cardiovascular risk. For adults who are intolerant to statins, the panel recommends using a lipid-lowering drug in people at very high and high cardiovascular risk but against adding it in those at low cardiovascular risk. When choosing to add another lipid-lowering drug, the panel suggests ezetimibe in preference to PCSK9 inhibitors. The panel suggests further adding a PCSK9 inhibitor to ezetimibe for adults already taking statins at very high risk and those at very high and high risk who are intolerant to statins. How this guideline was created An international panel including patients, clinicians, and methodologists produced these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel identified four risk groups of patients (low, moderate, high, and very high cardiovascular risk) and primarily applied an individual patient perspective in moving from evidence to recommendations, though societal issues were a secondary consideration. The panel considered the balance of benefits and harms and burdens of starting a PCSK9 inhibitor and/or ezetimibe, making assumptions of adults’ average values and preferences. Interactive evidence summaries and decision aids accompany multi-layered recommendations, developed in an online authoring and publication platform ( www.magicapp.org ) that also allows re-use and adaptation. The evidence A linked systematic review and network meta-analysis (14 trials including 83 660 participants) of benefits found that PCSK9 inhibitors or ezetimibe probably reduce myocardial infarctions and stroke in patients with very high and high cardiovascular risk, with no impact on mortality (moderate to high certainty evidence), but not in those with moderate and low cardiovascular risk. PCSK9 inhibitors may have similar effects to ezetimibe on reducing non-fatal myocardial infarction or stroke (low certainty evidence). These relative benefits were consistent, but their absolute magnitude varied based on cardiovascular risk in individual patients (for example, for 1000 people treated with PCSK9 inhibitors in addition to statins over five years, benefits ranged from 2 fewer strokes in the lowest risk to 21 fewer in the highest risk). Two systematic reviews on harms found no important adverse events for these drugs (moderate to high certainty evidence). PCSK9 inhibitors require injections that sometimes result in injection site reactions (best estimate 15 more per 1000 in a 5 year timeframe), representing a burden and harm that may matter to patients. The MATCH-IT decision support tool allows you to interact with the evidence and your patients across the alternative options: https://magicevidence.org/match-it/220504dist-lipid-lowering-drugs/ . Understanding the recommendations The stratification into four cardiovascular risk groups means that, to use the recommendations, physicians need to identify their patient’s risk first. We therefore suggest, specific to various geographical regions, using some reliable risk calculators that estimate patients’ cardiovascular risk based on a mix of known risk factors. The largely weak recommendations concerning the addition of ezetimibe or PCSK9 inhibitors reflect what the panel considered to be a close balance between small reductions in stroke and myocardial infarctions weighed against the burdens and limited harms. Because of the anticipated large variability of patients’ values and preferences, well informed choices warrant shared decision making. Interactive evidence summaries and decision aids linked to the recommendations can facilitate such shared decisions. The strong recommendations against adding another drug in people at low cardiovascular risk reflect what the panel considered to be a burden without important benefits. The strong recommendation for adding either ezetimibe or PCSK9 inhibitors in people at high and very high cardiovascular risk reflect a clear benefit. The panel recognised the key uncertainty in the evidence concerning patient values and preferences, namely that what most people consider important reductions in cardiovascular risks, weighed against burdens and harms, remains unclear. Finally, availability and costs will influence decisions when healthcare systems, clinicians, or people consider adding ezetimibe or PCSK9 inhibitors.

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“…This should help avoid inconsistent and emotive decision making and maximise health outcomes for patients within available resources. This is particularly important in patients with diabetes given the growing burden in terms of both morbidity and mortality as well as costs (Fifer et al, 2018;Muñoz-Velandia et al, 2019;González-González et al, 2021), and should be part of general moves towards a quality health service as part of universal healthcare (WHO, 2018). Prioritising investment in one disease area where there are concerns with costs and value will necessarily have a detrimental impact on other disease areas.…”

Section: Conclusion and Recommendationsmentioning

confidence: 99%

Enhancing Choices Regarding the Administration of Insulin Among Patients With Diabetes Requiring Insulin Across Countries and Implications for Future Care

et al. 2022

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There are a number of ongoing developments to improve the care of patients with diabetes across countries given its growing burden. Recent developments include new oral medicines to reduce cardiovascular events and death. They also include new modes to improve insulin administration to enhance adherence and subsequent patient management thereby reducing hypoglycaemia and improving long-term outcomes. In the case of insulins, this includes long-acting insulin analogues as well as continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion systems, combined with sensor-augmented pump therapy and potentially hybrid closed-loops. The benefits of such systems have been endorsed by endocrine societies and governments in patients with Type 1 diabetes whose HbA1c levels are not currently being optimised. However, there are concerns with the low use of such systems across higher-income countries, exacerbated by their higher costs, despite studies suggesting their cost-effectiveness ratios are within accepted limits. This is inconsistent in higher-income countries when compared with reimbursement and funding decisions for new high-priced medicines for cancer and orphan diseases, with often limited benefits, given the burden of multiple daily insulin injections coupled with the need for constant monitoring. This situation is different among patients and governments in low- and low-middle income countries struggling to fund standard insulins and the routine monitoring of HbA1c levels. The first priority in these countries is to address these priority issues before funding more expensive forms of insulin and associated devices. Greater patient involvement in treatment decisions, transparency in decision making, and evidence-based investment decisions should help to address such concerns in the future.

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Values, preferences and burden of treatment for the initiation of GLP-1 receptor agonists and SGLT-2 inhibitors in adult patients with type 2 diabetes: a systematic review

Cited by 5 publications

References 39 publications

Tocilizumab for Neuromyelitis Optica Spectrum Disorder

Tocilizumab for Neuromyelitis Optica Spectrum Disorder

PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations

Enhancing Choices Regarding the Administration of Insulin Among Patients With Diabetes Requiring Insulin Across Countries and Implications for Future Care

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