The process of estimating the cost of surgery: Providing a practical framework for surgeons.

Over the last decades, health care costs have been increasing at an alarming, exponential rate which is considered unsustainable. Surgical care utilizes one-third of health care costs. Estimating, evaluating, and understanding the cost of surgery is a vital step towards cost management and reduction. Current cost estimation studies and cost-effectiveness studies have vast disparities in their methodology, with published costs of Operating Room varying from as low as $7 and as high as $113 per minute. Costs in surgery are distinguished as direct and indirect. Allocation of direct costs involves identification, measurement, and valuation processes. Allocation of indirect costs involves the allocation of capital and overhead costs and of indirect department costs. Annualised capital costs and overhead hospital costs are then allocated to surgery by either the cost-centre allocation or the activity-based allocation frameworks. Indirect department costs are allocated to a specific surgery by weighted service allocation or hourly rate allocation or inpatient day allocation, or marginal markup allocation. The growing societal, financial and political pressure for cost reduction has brought cost analysis to the forefront of healthcare discussions. Thus, we believe that almost every single surgeon will eventually enter the field of healthcare economics by necessity. This review aims to provide surgeons with a practical framework for engaging in cost estimation studies.

GLP-1 receptor agonists and SGLT2 inhibitors for older people with type 2 diabetes: A systematic review and meta-analysis.

AIMS: To assess the cardiovascular effects of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose co-transporter-2 (SGLT2) inhibitors in older people with type 2 diabetes. METHODS: PubMed, Embase, and Cochrane library were searched up to November 2020 for cardiovascular outcomes trials with GLP-1 RAs or SGLT2 inhibitors that reported results for older patients with type 2 diabetes. Random-effects meta-analyses were conducted for different age subgroup categories. RESULTS: A total of 11 studies (93,502 patients) were included. Consistent with their effect in the overall population, in patients ≥65 years, GLP-1 RAs reduced major adverse cardiovascular events (MACE) (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.80-0.92), cardiovascular death, stroke, and myocardial infarction. In the same age subgroup, SGLT2 inhibitors reduced MACE (HR, 0.90; 95% CI, 0.83-0.98) but had a neutral effect on its components. They also reduced heart failure hospitalization (HR, 0.62; 95% CI, 0.51-0.76), an effect that was not evident in patients <65 years, and the composite renal endpoint (HR, 0.57; 95% CI, 0.43-0.77). Meta-analyses for patients ≥75 years yielded similar results. CONCLUSIONS: In older adults with diabetes, GLP-1 RAs reduced MACE and its components. SGLT2 inhibitors reduced MACE, and heart failure and renal outcomes.

Care of Patients with Alzheimer's Disease.

INTRODUCTION: Alzheimer's disease is one of the irreversible dementias and leads to death. About 10% of people over 60 years and 20% of people over 80 will have Alzheimer's sometime in their lives. In the case of Alzheimer's disease, care can turn into an extremely large and unevenly distributed burden. The burden that caregivers are called upon to lift is particularly high at the physical, psychological, and social levels. PURPOSE: The purpose of this study was to describe the characteristics and needs of caregivers and even informal ones, that is, patients in the patient's family or friendly environment who voluntarily or unintentionally offer unpaid care to patients with Alzheimer's disease. MATERIAL AND METHODS: The present study was conducted using the Carer Well-Being and Support Questionnaire (CWSv2) at Thessaloniki Psychiatric Hospital between October and December 2019. For the statistical analysis, the SPSS package 23 was used. RESULTS: Alzheimer-type dementia is a condition with gradual, inevitable, and uncontrollable deterioration. So, it was expected that those involved in the care of these patients would be afraid of what their patient future care would be. Consequently, there is a high correlation coefficient between the two relevant variables (Fisher's Exact Test: 31,426; Sig: 0.007). Caregivers need to be alert at all times in order to fulfill their role and care for their loved one. There is a strong correlation index between the two variables (Fisher's Exact Test: 32,761; Sig: 0.003). The situation of a lack or distorted form of communication between patients and caregivers may also create or exacerbate caregivers' anxiety, causing them feelings of depression and deadlock that is also reflected in the relevant correlation index (Fisher's Exact Test: 30,053; Sig: 0.001). Women were more in need for additional help, with the two variables being marginally statistically significant (Fisher's Exact Test: 5.373; Sig: 0.05). CONCLUSIONS: Taking into account the results, as reflected through the elaboration of the closed and open questions of this tool, new structures and services should be created in order to facilitate caregivers' job.

Carvedilol for prevention of variceal bleeding: a systematic review and meta-analysis.

BACKGROUND: Beta-blockers are used for prophylaxis of variceal bleeding. Our aim was to assess the efficacy and safety of carvedilol for primary or secondary prevention of variceal bleeding in patients with cirrhosis. METHODS: We searched Medline, Embase, CENTRAL and gray literature sources for randomized controlled trials (RCTs) comparing carvedilol with placebo or any active intervention. We synthesized data using random effects models. We summarized the strength of evidence using GRADE criteria. RESULTS: We included 13 trials with 1598 patients. Carvedilol was as efficacious as endoscopic variceal ligation (EVL) (4 RCTs, risk ratio [RR] 0.74, 95% confidence interval [CI] 0.37-1.49) or propranolol (3 RCTs, RR 0.76, 95%CI 0.27-2.14) for primary prevention of variceal bleeding. Likewise, carvedilol was as efficacious as EVL (3 RCTs, RR 1.10, 95%CI 0.75-1.61), non-selective beta-blockers (NSBBs) plus isosorbide-5-mononitrate (2 RCTs, RR 1.02, 95%CI 0.70-1.51) or propranolol (2 RCTs, RR 0.39, 95%CI 0.15-1.03) for secondary prevention of variceal bleeding. Carvedilol was associated with lower all-cause mortality compared to EVL (3 RCTs, RR 0.51, 95%CI 0.33-0.79). There was no difference in any other efficacy outcome. Finally, there were no significant differences in the safety profiles compared with EVL and NSBBs. Our confidence in the effect estimates for all outcomes was very low. CONCLUSION: Carvedilol is as efficacious and safe as standard-of-care interventions for the primary and secondary prevention of variceal bleeding.

Systematic review with network meta-analysis: the impact of medical interventions for moderate-to-severe ulcerative colitis on health-related quality of life.

BACKGROUND: Patient-reported outcomes are important in the assessment of efficacy of intervention for ulcerative colitis (UC). AIM: To compare the impact of interventions for moderate-to-severe UC on health-related quality of life (HRQL). METHODS: We searched Medline, Embase, CENTRAL and grey literature sources through October 2017. We included randomised controlled trials (RCTs) that compared infliximab, adalimumab, golimumab, vedolizumab or tofacitinib to each other or placebo. Outcomes included the change in quality of life scores and the proportion of patients with improvement in quality of life. We performed random-effect pairwise and network meta-analysis. We assessed confidence in estimates using the CINeMA (Confidence in Network Meta-Analysis) framework. RESULTS: Fourteen RCTs assessed HRQL using the Inflammatory Bowel Disease Questionnaire (IBDQ) (14 trials), the Short Form questionnaire-36 (SF-36) (seven trials) or the European Quality of Life-5 Dimensions questionnaire (EQ-5D) (three trials). At induction (13 trials), low to very low confidence evidence suggested that all agents significantly improved both generic and disease-specific HRQL scores compared to placebo. However, only infliximab (MD 18.58; 95% CI 13.19-23.97) and vedolizumab (MD 18.00; 95% CI 11.08-24.92) showed clinically meaningful improvement in IBDQ score. Differences among individual interventions were imprecise. For maintenance (four trials), very low confidence evidence suggested that vedolizumab, tofacitinib and adalimumab maintained improvement in HRQL. CONCLUSIONS: Induction treatment with infliximab, adalimumab, golimumab, vedolizumab or tofacitinib improves quality of life compared to placebo. Evidence on maintenance therapy is sparse and uncertain. Head-to-head comparisons could enhance confidence in conclusions about differences between drugs in terms of HRQL.

Camera recognition with deep learning.

In this paper, camera recognition with the use of deep learning technique is introduced. To identify the various cameras, their characteristic photo-response non-uniformity (PRNU) noise pattern was extracted. In forensic science, it is important, especially for child pornography cases, to link a photo or a set of photos to a specific camera. Deep learning is a sub-field of machine learning which trains the computer as a human brain to recognize similarities and differences by scanning it, in order to identify an object. The innovation of this research is the use of PRNU noise patterns and a deep learning technique in order to achieve camera identification. In this paper, AlexNet was modified producing an improved training procedure with high maximum accuracy of 80%-90%. DIGITS showed to have identified correctly six cameras out of 10 with a success rate higher than 75% in the database. However, many of the cameras were falsely identified indicating a fault occurring during the procedure. A possible explanation for this is that the PRNU signal is based on the quality of the sensor and the artefacts introduced during the production process of the camera. Some manufacturers may use the same or similar imaging sensors, which could result in similar PRNU noise patterns. In an attempt to form a database which contained different cameras of the same model as different categories, the accuracy rate was low. This provided further proof of the limitations of this technique, since PRNU is stochastic in nature and should be able to distinguish between different cameras from the same brand. Therefore, this study showed that current convolutional neural networks (CNNs) cannot achieve individualization with PRNU patterns. Nevertheless, the paper provided material for further research.

Tofacitinib for induction of remission in ulcerative colitis: systematic review and meta-analysis.

BACKGROUND: The aim of the study was to assess the efficacy and safety of tofacitinib and its impact on quality of life in patients with moderate-to-severe ulcerative colitis. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials comparing tofacitinib with placebo or any active comparator. We searched Medline, Embase, the Cochrane Library and gray literature for articles published up to May 2017. We synthesized data using a fixed-effect model. We conducted subgroup analysis based on prior exposure to anti-tumor necrosis factor (TNF). We summarized the strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: We included three trials with 1220 participants. Compared with placebo, tofacitinib was effective in inducing clinical remission (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.29-6.44, I2: 41%, GRADE: moderate), clinical response (OR 2.95, 95%CI 2.21-3.95, I2: 0%, GRADE: high), mucosal healing (OR 2.70, 95%CI 1.81-4.03, I2: 0%, GRADE: high). Tofacitinib was effective in both anti-TNF-naïve and -experienced patients. Tofacitinib had a favorable effect on quality of life. There were no significant differences in the safety profile in terms of the incidence of any or serious adverse events compared to placebo. The risk for infections was increased (OR 1.51, 95%CI 1.05-2.19, I2: 0%, GRADE: moderate), but the incidence of serious infections did not differ between tofacitinib and placebo. CONCLUSION: In patients with moderate-to-severe ulcerative colitis, short-term treatment with tofacitinib is effective for induction of remission and improvement of quality of life.

Comparative Benefits and Harms of Basal Insulin Analogues for Type 2 Diabetes: A Systematic Review and Network Meta-analysis.

Background: Basal insulin analogues aim for protracted glycemic control with minimal adverse effects. Purpose: To assess the comparative efficacy and safety of basal insulin analogues for adults with type 2 diabetes mellitus (T2DM). Data Sources: Several databases from inception to April 2018 without language restrictions, ClinicalTrials.gov to April 2018, references of reviews, and meeting abstract books. Study Selection: Randomized trials lasting at least 12 weeks that compared efficacy (change in hemoglobin A1c [HbA1c] level from baseline [primary outcome]; percentage of patients with HbA1c level <7% at end of study and change in body weight [secondary outcomes]) and safety (hypoglycemia) of basal insulin analogues. Data Extraction: Two authors independently extracted data and assessed risk of bias for each outcome. All authors evaluated overall confidence in the evidence. Data Synthesis: Thirty-nine trials (26 195 patients) assessed 10 basal insulin analogues. Low- to very-low-quality evidence indicated that thrice-weekly degludec (Deg-3TW) was inferior to most other regimens for reducing HbA1c level, with mean differences ranging from 0.21% (vs. degludec, 100 U/mL [Deg-100]) to 0.32% (vs. glargine, 300 U/mL [Glar-300]). High- to moderate-quality evidence suggested that detemir had a favorable weight profile versus all comparators, and Glar-300 was associated with less weight gain than glargine, 100 U/mL (Glar-100); Deg-100; degludec, 200 U/mL (Deg-200); Deg-3TW; and LY2963016. Low- and very-low-quality evidence suggested that Deg-100, Deg-200, and Glar-300 were associated with lower incidence of nocturnal hypoglycemia than detemir, Glar-100, LY2963016, and neutral protamine lispro (NPL). Incidence of severe hypoglycemia did not differ among regimens, except NPL, which was associated with increased risk versus Deg-100, detemir, Glar-100, and Glar-300. Limitations: Results are based mostly on indirect comparisons. Confidence in summary estimates is low or very low due to individual-study limitations, imprecision, or inconsistency. Conclusion: Low-quality evidence suggests that basal insulin analogues for T2DM do not substantially differ in their glucose-lowering effect. Low- and very-low-quality evidence suggests some regimens may be associated with lower risk for nocturnal hypoglycemia (Deg-100, Deg-200, and Glar-300) or less weight gain (detemir and Glar-300). Primary Funding Source: None. (PROSPERO: CRD42016037055).

Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of artificial pancreas treatment in non-pregnant outpatients with type 1 diabetes. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, Cochrane Library, and grey literature up to 2 February 2018. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials in non-pregnant outpatients with type 1 diabetes that compared the use of any artificial pancreas system with any type of insulin based treatment. Primary outcome was proportion (%) of time that sensor glucose level was within the near normoglycaemic range (3.9-10 mmol/L). Secondary outcomes included proportion (%) of time that sensor glucose level was above 10 mmol/L or below 3.9 mmol/L, low blood glucose index overnight, mean sensor glucose level, total daily insulin needs, and glycated haemoglobin. The Cochrane Collaboration risk of bias tool was used to assess study quality. RESULTS: 40 studies (1027 participants with data for 44 comparisons) were included in the meta-analysis. 35 comparisons assessed a single hormone artificial pancreas system, whereas nine comparisons assessed a dual hormone system. Only nine studies were at low risk of bias. Proportion of time in the near normoglycaemic range (3.9-10.0 mmol/L) was significantly higher with artificial pancreas use, both overnight (weighted mean difference 15.15%, 95% confidence interval 12.21% to 18.09%) and over a 24 hour period (9.62%, 7.54% to 11.7%). Artificial pancreas systems had a favourable effect on the proportion of time with sensor glucose level above 10 mmol/L (-8.52%, -11.14% to -5.9%) or below 3.9 mmol/L (-1.49%, -1.86% to -1.11%) over 24 hours, compared with control treatment. Robustness of findings for the primary outcome was verified in sensitivity analyses, by including only trials at low risk of bias (11.64%, 9.1% to 14.18%) or trials under unsupervised, normal living conditions (10.42%, 8.63% to 12.2%). Results were consistent in a subgroup analysis both for single hormone and dual hormone artificial pancreas systems. CONCLUSIONS: Artificial pancreas systems are an efficacious and safe approach for treating outpatients with type 1 diabetes. The main limitations of current research evidence on artificial pancreas systems are related to inconsistency in outcome reporting, small sample size, and short follow-up duration of individual trials.

Once-weekly dipeptidyl peptidase-4 inhibitors for type 2 diabetes: a systematic review and meta-analysis.

OBJECTIVE: To assess the efficacy and safety of omarigliptin and trelagliptin, novel dipeptidyl peptidase-4 inhibitors administered once-weekly (DPP-4i QW). METHODS: We systematically searched for placebo- and active-controlled randomized trials in adults with type 2 diabetes mellitus. RESULTS: Fifteen primary studies with 5709 participants were included. DPP-4i QW were more effective than placebo in reducing hemoglobin A1c (HbA1c) (Weighted Mean Difference (WMD) -0.63%; 95% CI -0.80, -0.46; I2 = 84%) and had a similar glucose-lowering effect with daily DPP-4i (WMD 0.01%; -0.08, 0.11%; I2 = 34%). Omarigliptin was less effective compared with oral antidiabetic agents, other than daily DPP-4i, (WMD 0.24%; 0.10, 0.38; I2 = 12%). Omarigliptin did not affect body weight (WMD versus placebo 0.60 kg; 0.25, 0.96; I2 = 0%). Risk for any hypoglycemia was similar between DPP-4i QW and placebo (Odds Ratio 1.32; 0.78, 2.22; I2 = 0%). Incidence of other adverse events did not differ between DPP-4i QW and control. CONCLUSIONS: DPP-4i QW were superior to placebo and similar to daily DPP-4i in terms of glycemic control, and were not associated with any specific adverse events. There is limited comparative effectiveness evidence against other agents, while their effect on hard clinical safety outcomes is unknown.

Fixed ratio combinations of glucagon like peptide 1 receptor agonists with basal insulin: a systematic review and meta-analysis.

PURPOSE: Basal insulin controls primarily fasting plasma glucose but causes hypoglycaemia and weight gain, whilst glucagon like peptide 1 receptor agonists induce weight loss without increasing risk for hypoglycaemia. We conducted a systematic review and meta-analysis of randomised controlled trials to investigate the efficacy and safety of fixed ratio combinations of basal insulin with glucagon like peptide 1 receptor agonists. METHODS: We searched Medline, Embase, and the Cochrane Library as well as conference abstracts up to December 2016. We assessed change in haemoglobin A1c, body weight, and incidence of hypoglycaemia and gastrointestinal adverse events. RESULTS: We included eight studies with 5732 participants in the systematic review. Switch from basal insulin to fixed ratio combinations with a glucagon like peptide 1 receptor agonist was associated with 0.72% reduction in haemoglobin A1c [95% confidence interval -1.03 to -0.41; I 2 = 93%] and 2.35 kg reduction in body weight (95% confidence interval -3.52 to -1.19; I 2 = 93%), reducing also risk for hypoglycaemia [odds ratio 0.70; 95% confidence interval 0.57 to 0.86; I 2 = 85%] but increasing incidence of nausea (odds ratio 6.89; 95% confidence interval 3.73-12.74; I 2 = 79%). Similarly, switching patients from treatment with a glucagon like peptide 1 receptor agonist to a fixed ratio combination with basal insulin was associated with 0.94% reduction in haemoglobin A1c (95% confidence interval -1.11 to -0.77) and an increase in body weight by 2.89 kg (95% confidence interval 2.17-3.61). CONCLUSIONS: Fixed ratio combinations of basal insulin with glucagon like peptide 1 receptor agonists improve glycaemic control whilst balancing out risk for hypoglycaemia and gastrointestinal side effects.

Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial.

OBJECTIVE: To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece. DESIGN: Open-label cluster randomised controlled trial. SETTING: Primary and secondary care practices across Greece. PARTICIPANTS: 5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients). INTERVENTION: Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care. OUTCOME MEASURES: The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24 weeks. RESULTS: Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms -6.9, 95% CI -21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI -15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy. CONCLUSIONS: The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making. TRIAL REGISTRATION NUMBER: NCT01861756. Pre-results.

Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes.

This systematic review and meta-analysis provides an update on the efficacy and safety of vildagliptin for treatment of type 2 diabetes mellitus (T2DM). We searched MEDLINE, COCHRANE, EMBASE and the drug manufacturer's website for randomised controlled trials of vildagliptin in patients with T2DM. Sixty-nine studies (28,006 patients) were included in the meta-analysis. Compared with placebo vildagliptin reduced HbA1c (weighted mean difference WMD -0.69 %; 95 % CI -0.83 to -0.56 %; I (2) = 82 %), and it was as effective as other antidiabetic agents (WMD -0.01 %; 95 % CI -0.16 to 0.14 %; I (2) = 93 %), without increasing the risk for hypoglycemia (OR 0.83; 95 % CI 0.59 to 1.16; I (2) = 0 % vs. placebo, and OR 0.19; 95 % CI 0.15 to 0.24; I (2) = 78 % versus active comparators). However, it was associated with an increase in the incidence of arthralgia compared with other comparators (OR 1.23; 95 % CI 1.02 to 1.48; I (2) = 0 %). On the contrary, vildagliptin did not increase the incidence of pancreatitis (OR 0.97; 95 % CI 0.37 to 2.53; I (2) = 0 %), serious adverse events (OR 0.98; 95 % CI 0.88 to 1.09; I (2) = 0 %) or death (OR 1.10, 95 % CI 0.75 to 1.61; I (2) = 0 %). Finally, odds ratio (OR) for heart failure, and overall cardiovascular and cerebrovascular events was 0.77 (95 % CI 0.46 to 1.30; I (2) = 0 %) and 0.91 (95 % CI 0.73 to 1.14; I (2) = 0 %), respectively. Vildagliptin is an effective and safe therapeutic option for patients with T2DM, both as monotherapy and as add-on treatment.

Accuracy of magnetic resonance imaging in diagnosis of liver iron overload: a systematic review and meta-analysis.

BACKGROUND & AIMS: Guidelines advocate use of magnetic resonance imaging (MRI) to estimate concentrations of iron in liver, to identify patients with iron overload, and to guide titration of chelation therapy. However, this recommendation was not based on a systematic synthesis and analysis of the evidence for MRI's diagnostic accuracy. METHODS: We conducted a systematic review and meta-analysis to investigate the diagnostic accuracy of MRI in identifying liver iron overload in patients with hereditary hemochromatosis, hemoglobinopathy, or myelodysplastic syndrome; liver biopsy analysis was used as the reference standard. We searched MEDLINE and EMBASE databases, the Cochrane Library, and gray literature, and computed summary receiver operating curves by fitting hierarchical models. We assessed methodologic quality using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. RESULTS: Our final analysis included 20 studies (819 patients, total). Sensitivity and specificity values varied greatly, ranging from 0.00 to 1.00 and from 0.50 to 1.00, respectively. Because of substantial heterogeneity and variable positivity thresholds, we calculated only summary receiver operating curves (and summary estimate points for studies that used the same MRI sequences). T2 spin echo and T2* gradient-recalled echo MRI sequences accurately identified patients without liver iron overload (liver iron concentration > 7 mg Fe/g dry liver weight) (negative likelihood ratios, 0.10 and 0.05 respectively). However, these MRI sequences are less accurate in establishing a definite diagnosis of liver iron overload (positive likelihood ratio, 8.85 and 4.86, respectively). CONCLUSIONS: Based on a meta-analysis, measurements of liver iron concentration by MRI may be accurate enough to rule out iron overload, but not to definitely identify patients with this condition. Most studies did not use explicit and prespecified MRI thresholds for iron overload, therefore some patients may have been diagnosed inaccurately with this condition. More studies are needed of standardized MRI protocols and to determine the effects of MRI surveillance on the development of chronic liver disease and patient survival.

Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of antidiabetic drugs. PURPOSE: To assess the efficacy and safety of SGLT2 inhibitors in adults with type 2 diabetes. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Library from inception through April 2013 without language restrictions; regulatory authorities' reports; and gray literature. STUDY SELECTION: Randomized trials comparing SGLT2 inhibitors with placebo or other medication for type 2 diabetes. DATA EXTRACTION: Three reviewers extracted or checked data for study characteristics, outcomes of interest, and risk of bias, and 3 reviewers summarized strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. DATA SYNTHESIS: Sodium-glucose cotransporter 2 inhibitors were compared with placebo in 45 studies (n = 11 232) and with active comparators in 13 studies (n = 5175). They had a favorable effect on hemoglobin A1c level (mean difference vs. placebo, -0.66% [95% CI, -0.73% to -0.58%]; mean difference vs. active comparators, -0.06% [CI, -0.18% to 0.05%]). Sensitivity analyses incorporating unpublished data showed similar effect estimates. Compared with other agents, SGLT2 inhibitors reduced body weight (mean difference, -1.80 kg [CI, -3.50 to -0.11 kg]) and systolic blood pressure (mean difference, -4.45 mm Hg [CI, -5.73 to -3.18 mm Hg]). Urinary and genital tract infections were more common with SGLT2 inhibitors (odds ratios, 1.42 [CI, 1.06 to 1.90] and 5.06 [CI, 3.44 to 7.45], respectively). Hypoglycemic risk was similar to that of other agents. Results for cardiovascular outcomes and death were inconclusive. An imbalance in incidence of bladder and breast cancer was noted with dapagliflozin compared with control. LIMITATION: Most trials were rated as high risk of bias because of missing data and last-observation-carried-forward methods. CONCLUSION: Sodium-glucose cotransporter 2 inhibitors may improve short-term outcomes in adults with type 2 diabetes, but effects on long-term outcomes and safety are unclear. PRIMARY FUNDING SOURCE: None.

The protective role of the Mediterranean diet on the prevalence of metabolic syndrome in a population of Greek obese subjects.

BACKGROUND: Obesity is a rapidly expanding epidemic in Western societies, with rates of more than 30% across Europe, and it is associated with an increased risk of metabolic disturbances. Previous reports have documented an association of reduced physical activity and abstinence from the traditional Mediterranean diet (MD) with increased mortality rate and prevalence of obesity in a population of Greek subjects. OBJECTIVE: The aim of the present study was to evaluate and analyze the dietary habits in a population of Greek overweight and obese subjects and to investigate the potential associations between those patterns and the prevalence of metabolic syndrome components. METHODS: The study recruited 226 consecutive adult (30 men, 169 women) overweight or obese (body mass index >25 kg/m(2)) individuals attending the Metabolic Diseases Unit. Medical history, dietary history, and anthropometric parameters were recorded during the first visit. Fasting blood samples were collected for biochemistry assaying. RESULTS: According to the nutrient intake history and Mediterranean Diet Scale (MDS), participants were divided into 3 groups: those adhering to the MD and those not following the MD, who were further subdivided into the high-carbohydrate (HC) and high-fat (HF) diet groups according to the source of maximum energy intake. Adherence to the MD was associated with a lower prevalence of metabolic syndrome (27.3%, 69.2%, and 60.4% in MD, HC, and HF respectively, p = 0.006), lower low-density lipoprotein cholesterol (p = 0.009, MD vs. HF), and lower postchallenge glucose values (p = 0.028, MD vs. HF). CONCLUSIONS: Adherence to the MD seems to be declining among Greek overweight and obese subjects, a phenomenon that is associated with an increase in the prevalence of the metabolic syndrome.