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More studies with more patients are required to achieve a firm recommendation on this matter. 9.3. Antiplatelett treatment The decision to prescribe aspirin a in primary care of DM 2 patients must take into consideration the benefits of the drug as it reduces the number of cardiovascular events and the risk of adverse effects (mainly, digestive and haemorrhage). The results of the RCT meta-analysis in primary care show that the benefit of aspirin is closely related to baseline cardiovascular risk (178), thus the patients with higher baselinel cardiovascular risk are those who benefit more from the treatment. The meta-analysis includes five RCTs in primary care which also contain a minority of diabetic patients (between 2% and 17%); the HOT (179) and PPP (180) studies are the ones which include more diabetic patients (8% and 17%, respectively, in contrast to the 2% of other studies. However, the meta-analysis does not provide data on the effectiveness of aspirin in the diabetic patient’s subgroup. The SIGN guide, based on the results of this study (178) and another metaanalysis (181) has specified the cut-off of cardiovascular risk to be over 15% to consider primary prevention with aspirin (182). The only specific study on aspirin in DM is the ETDRS study (183) which included 3,711 patients suffering from DM types 1 and 2 with retinopathy, half of whom were under secondary prevention. The treatment with aspirin during seven years did not reduce the incidence of AMI, strode or cardiovascular death in these patients. A meta-analysis on the effectiveness of aspirin in contrast to placebo in primary prevention (184) included a total of nine RCTs which provided data on diabetic patients. In this subgroup no statistically significant differences were found in the incidence of severe vascular events (non-fatal AMI, non-fatal stroke or vascular death), [RRR 7% (CI 95%: -1% to +15%)]. Two RCTs were later published in primary prevention that include diabetic patients. In the analysis of the PPP diabetic population subgroup (180) (1,031 diabetics aged ³50 without prior cardiovascular disease), a slight and insignificant reduction of severe vascular events was observed [RR 0.90 (CI 95%: 0.50-1.62%)], far smaller than that observed in primary prevention of patients with other risk factors, though where a significant reduction of the risk was observed (185). The authors state that due to the limitations of the study (open and with a limited number of patients, as it was interrupted prematurely), the results are not conclusive. In another RCT carried out in primary prevention on women (186), which included approximately a 10% of diabetic women, a reduction of cerebrovascular disease was observed, though none related to AMI nor the main variable of cardiovascular events. SR of RCT 1+ CPG 4 RCT 1+ SR of RCT 1+ RCT 1+ 78 CLINICAL PRACTICE GUIDELINES IN THE NHS
The RCTs and the meta-analysis are coherent as regards the increase of the bleeding risk with the aspirin treatment (178; 184). As regards diabetic patients with microalbuminuria, a population with higher cardiovascular mortality than the diabetic population without microalbuminuria, a clinical trial stated that an intensive long-term treatment which included habit changes and a pluripharmacological treatment (aspirin and statins, among others), was beneficial for these patients (108). SR of RCT and RCT 1+ 9.4. Treatment with statins In the evidence evaluation three SRs (187-189) and two subsequent clinical trials (190; 191) have been taken into consideration. The reviews (187; 188) include diabetic and non-diabetic patients as well as an analysis of diabetic subgroups. The first SR (187) includes four RCTs in primary prevention (AFCAPS, ALLHAT-LLT, HHS, ASCOT-LLA) and two in mixed populations (PROSPER and HPS). It observed a risk difference in the main variable (combined result of cardiovascular mortality, stroke, cerebrovascular accident and global mortality) favourable to the treatment with statins [ARR -0.03 (CI 95%: -0.04 to -0.01)]. The results are highly influenced by the HPS study, carried out across high-risk patients. The second SR (188) includes the same studies, though the variable assessed is coronary events (coronary mortality, non-fatal myocardial infarction or coronary revascularization, with a favourable effect to the treatment with statins [RR 0.79 (CI 95%: 0.7-0.89) NNT 37 (24-75) to 4.5 years]. The third review (189) analyses only the effects of fibrates and combines trials carried out only across diabetic patients with other trials that have mixed population groups (diabetic and non-diabetic patients), although it does analyse diabetic subgroups. It also combines primary prevention studies with secondary prevention studies. The global result of the review (combining all the studies) shows a relative risk for coronary events of 0.84 (CI 95%: 0.74-0.96). Analysing only the studies of primary prevention, an HR favourable to fibrates of 0.79 (NNT 26 after 10 years), although it does not offer confidence intervals and in one of the primary prevention studies, the diabetic patients belong to a subgroup. The FIELD study (192), included in the systematic review, is the only clinical trial carried out with fenofibrate in type 2 diabetic population in primary and secondary prevention, with low HDL values (38.5 mg/dl) and slightly high triglycerides values (170 mg/dl). It includes a 22% of patients with prior cardiovascular disease. No differences were observed in the main variable of the study (coronary mortality or non-fatal AMI), although there were differences in a secondary variable of total global cardiovascular events, at the expense mainly of non-fatal AMI and revascularization procedures. These differences in the secondary variable were more evident in the primary prevention patients. Nevertheless, SR of RCT (Subgroups) 1+ SR of RCT (subgroups) 1+ RCT 1+ CLINICAL PRACTICE GUIDELINE ON TYPE 2 DIABETES 79
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Clinical Practice Guideline on type
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A bibliographic record of this work
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Table of Contents Presentation 9 Au
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11. Diabetic foot. Assessment, prev
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Presentation Care practice is becom
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Other collaborations Rosa Rico Itur
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13. Which drug combination strategi
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Summary of recommendations Defi nit
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D CPG B B B B A daily single dose
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A B CPG Hypertense patients with DM
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Treatment for diabetic foot ulcers
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1. Introduction Effective care for
Page 31 and 32: 3. Methodology Methodology. Evidenc
Page 33 and 34: 4. Epidemiology and sanitary impact
Page 35: However, the quality of the assista
Page 38 and 39: 5.2. Risk factors for the developme
Page 40 and 41: 5.2.8. Diet and alcohol Type of die
Page 42 and 43: 5.2.12. Heart failure The associati
Page 44 and 45: The ADA does not recommend it for c
Page 46 and 47: Figure 1. DM 2 diagnostic algorithm
Page 48 and 49: 46 CLINICAL PRACTICE GUIDELINES IN
Page 50 and 51: 6.1. Impaired Fating Glucoseucose (
Page 52 and 53: 1++ An intensive intervention on li
Page 54 and 55: Different SRs (81-84) have assessed
Page 56 and 57: 7.1.4. Other dietary interventions
Page 58 and 59: Exchange system This system is base
Page 60 and 61: duration and intensity). Performing
Page 62 and 63: [RR 0.75 (CI 95%: 0.60-0.93)], and
Page 64 and 65: The optimum dose in most patients i
Page 66 and 67: without heart failure. In this stud
Page 68 and 69: B B B B Metillinides can play a ro
Page 70 and 71: Recommendations B A A B B B B When
Page 72 and 73: 8.2. Insulin therapy 8.2.1. Associa
Page 74 and 75: Slow-acting insulin analogues vs. N
Page 77 and 78: 9. Screening and treatment of macro
Page 79: The validity and applicability of a
Page 83 and 84: 1+ In primary prevention, aspirin b
Page 85 and 86: 9.5.2. Pharmacological treatment of
Page 87: Recommendations B/D A B CPG Patient
Page 90 and 91: incidence was 0.3% after the first
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Page 94 and 95: Summary of evidence 1++ In hyperten
Page 96 and 97: An SR on drugs to treat diabetic ne
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Page 101 and 102: 11. Diabetic foot. Assessment, prev
Page 103 and 104: 11.2.2. Peripheral arterial disease
Page 105 and 106: 11.4. Other preventive measures The
Page 107 and 108: B D CPG B Diabetic foot screening m
Page 109 and 110: 11.5.4. Antibiotic treatment for in
Page 111: 2+ The culture has a limited value
Page 114 and 115: • Promote healthy lifestyles: die
Page 116 and 117: In another recent RCT (289), sMBG w
Page 118 and 119: 12.3. Contents and methods of an ed
Page 120 and 121: Assessment of self-management recor
Page 122 and 123: 13.4. Referral criteria to medical
Page 125 and 126: Appendices Appendix 1. Levels of Ev
Page 127 and 128: Appendix 2. DM 2 diet Estimating ca
Page 129 and 130: CLINICAL PRACTICE GUIDELINE ON TYPE
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CLINICAL PRACTICE GUIDELINE ON TYPE
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GPL-1 Analogues Biguanides Glitazon
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Devices FLEXPEN (Novo Nordisk): OPT
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Treatment for an unconscious patien
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Appendix 6. Assessment of macro- an
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Appendix 8. Use of monofilament Mon
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Indicators of final outcomes • Nu
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Impaired Glucose Tolerance (IGT): I
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IGT INSIGHT Trial IV LDL LH LIFE Tr
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Bibliography 1. Estrategia en diabe
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33. Iso H, Date C, Wakai K, Fukui M
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64. Screening for type 2 diabetes.
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97. Thomas DE, Elliott EJ, Naughton
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129. Lincoff AM, Wolski K, Nicholls
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157. Natarajan S, Liao Y, Cao G, Li
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185. de GG. Low-dose aspirin and vi
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214. Rahman M, Pressel S, Davis BR,
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245. NZGG. Management of type 2 dia
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279. Norris SL, Nichols PJ, Caspers
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