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MeReC Monthly No.17
Interaction between clopidogrel and PPIs Concomitant use of a proton pump inhibitor (PPI) with clopidogrel should be avoided unless considered essential. This is due to concerns that PPIs may reduce the effectiveness of clopidogrel. Product information for all clopidogrel-containing medicines is being amended to reflect this.1 Action
What is the background to this? The US Food and Drug Administration (FDA) has also recently updated information about the ongoing safety review of clopidogrel , which we discussed in MeReC Stop Press Blog No. 271. Neither the EMEA statement nor the FDA information makes reference to any individual PPI being any more or less likely to interact with clopidogrel than any other. The outcome studies do not fully reflect the pharmacokinetics of PPIs, and so more evidence is required before any specific recommendations can be made on the risk associated with individual PPIs. On the basis of pharmacokinetic data, other GI therapies (e.g. H2RAs, antacids) would not be expected to interact with clopidogrel. However, there are currently no substantial data from clinical outcome studies to support this. The CHMP has recommended that the product information for all clopidogrel-containing medicines should be amended to discourage concomitant use of PPI and clopidogrel-containing medicines unless absolutely necessary.2 What does NICE say? NICE guidance on clopidogrel and modified-release dipyridamole in the prevention of occlusive vascular events, which applies to patients who have had an occlusive vascular event or have symptomatic peripheral arterial disease, recommends clopidogrel alone only for those who are intolerant of low-dose aspirin. Aspirin intolerance is defined as proven hypersensitivity to aspirin-containing medicines or a history of severe dyspepsia induced by low-dose aspirin. For more details see MeReC Stop Press Blog Nos. 354 and 372. Further information on the use of clopidogrel is available on the cardiovascular floors of NPCi.
A meta-analysis of randomised controlled trials (RCTs)1 suggests a small benefit of intensive glucose control in people with type 2 diabetes in reducing coronary heart disease (CHD), but not stroke or death. However, the benefit is not as great as that achieved by blood pressure (BP) control or lipid lowering. It remains uncertain whether intensive glucose control (e.g. the addition of hypoglycaemic drugs to reduce HbA1c to levels significantly below that often achieved in clinical practice) offers any significant benefit beyond that achievable by implementing other interventions to reduce cardiovascular (CV) risk (i.e. smoking cessation, exercise, losing weight, controlling BP, lowering cholesterol, taking metformin). What does this study claim? So what? This MA suggests that intensive glycaemic control may have a small benefit in reducing the risk of CHD, but no significant effect on reducing stroke or all-cause mortality. Futhermore, concerns have been raised about the methodology of the MA and its findings may not be generalisable to clinical practice (see MeReC Rapid Review Blog No. 351 for details). Intensive glycaemic control can be considered, where necessary, in addition to other interventions for reducing CV risk, but any potential benefits need to be considered against the increased risk of hypoglycaemia and drug-specific adverse effects. For example, glitazones increase the risk of heart failure, double the risk of bone fracture in women and there is some evidence to suggest that rosiglitazone, in particular, may be associated with an increased risk of MI. More information can be found on the type 2 diabetes floor of NPCi.
NICE clinical guideline (CG87)1 partially updates recommendations for the management of type 2 diabetes, with new recommendations about blood glucose control with sitagliptin▼, vildagliptin▼, pioglitazone▼, rosiglitazone, exenatide▼ and insulin therapy. This updates and replaces CG66. What has changed? The new recommendations advocate the same level of HbA1c for the addition of extra glucose-lowering drugs as defined in the earlier guideline. That is a value of >6.5% (48 mmol/mol), or other higher level agreed with the individual, for people on one glucose-lowering drug and >7.5% (59 mmol/mol), or other higher level agreed with the individual, for people on two or more glucose-lowering drugs or insulin. However, as we continue to say, the role of tight glycaemic control remains controversial (see previous article) and clinicians should focus on interventions to reduce CV risk in people with type 2 diabetes (e.g. smoking cessation, lowering blood pressure, lowering cholesterol). The new recommendations are discussed in more detail in MeReC Stop Press Blog No. 355 and the quick reference guide contains a helpful updated algorithm for blood-glucose lowering therapy. The National Institute for Health and Clinical Excellence (NICE) is associated with MeReC Publications published by the NPC through a funding contract. This arrangement provides NICE with the ability to secure value for money in the use of NHS funds invested in its work and enables it to influence topic selection, methodology and dissemination practice. NICE considers the work of this organisation to be of value to the NHS in England and Wales and recommends that it be used to inform decisions on service organisation and delivery. This publication represents the views of the authors and not necessarily those of the Institute. NPC materials may be downloaded / copied freely by people employed by the NHS in England for purposes that support NHS activities in England. Any person not employed by the NHS, or who is working for the NHS outside England, who wishes to download / copy NPC materials for purposes other than their personal use should seek permission first from the NPC. National Prescribing Centre, The Infirmary, 70 Pembroke Place, Liverpool, L69 3GF Tel: 0151 794 8146 Fax: 0151 794 8139
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