ABSTRACT
BACKGROUND: Identifying risk factors for conversion to diabetes among individuals with obesity and prediabetes is important for preventing diabetes. PURPOSE: We assessed conversion rates to diabetes 5 years after three types of metabolic surgery and examined predictors of diabetes development. METHODS: We accessed data of individuals with prediabetes, defined as fasting glucose (FG) 100-125 mg/dL (5.6-6.9 mmol/L) or HbA1c 5.7-6.4% at baseline (preoperatively), who underwent metabolic surgeries in Clalit Health Services during 2002-2011. RESULTS: Of 1,756 individuals with prediabetes, 819 underwent gastric banding (GB), 845 sleeve gastrectomy (SG), and 92 Roux-en-Y gastric bypass (RYGB). Mean age was 41.6 years and 73.5% were women. Five years post-surgery, 177 (10.1%) had developed diabetes. Conversion rates by type of surgery were 14.4%, 6.3%, and 6.5% for GB, SG, and RYGB, respectively (p < 0.001). Conversion was more rapid following GB than SG or RYGB (χ2(2) = 29.67, p < 0.005). In a multiple-logistic-regression model, predictors of diabetes development 5 years postoperatively were (1) weight loss during the first postoperative year and (2) preoperative levels of both FG and HbA1c within the prediabetes range. Baseline weight, age, and sex, were not associated with conversion to diabetes. Conversion rates were lower (4.7%) five years postoperatively for patients who lost > 25% of their baseline weight, compared to those who lost less than 15% of their weight during the first postoperative year: (14.0% < 0.001). CONCLUSIONS: Our findings emphasize the importance of preoperative glycemic control and weight loss during the first year postoperatively, for the long-term prevention of diabetes in patients with prediabetes undergoing metabolic surgery.
Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2/etiology , Obesity, Morbid/surgery , Postoperative Complications/etiology , Prediabetic State/physiopathology , Adult , Bariatric Surgery/methods , Biomarkers/blood , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/epidemiology , Female , Follow-Up Studies , Humans , Logistic Models , Male , Middle Aged , Obesity, Morbid/complications , Obesity, Morbid/physiopathology , Postoperative Complications/blood , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Prediabetic State/etiology , Risk Factors , Weight LossABSTRACT
PURPOSE: DiaRem is a clinical scoring system designed to predict diabetes remission (DR) 1-year post-Roux-en-Y gastric bypass (RYGB). We examined long-term (2- and 5-year) postoperative DR prediction by DiaRem and an advanced-DiaRem (Ad-DiaRem) score following RYGB, sleeve gastrectomy (SG), and gastric banding (GB). METHODS: We accessed data from a computerized database of persons with type 2 diabetes and BMI ≥ 30 kg/m2 who underwent RYGB, SG, or GB, and determined DR status 2- and 5-year postoperative according to preoperative DiaRem and the Ad-DiaRem calculated scores. RESULTS: Among 1459 patients with 5-year postoperative diabetes status data, 53.6% exhibited DR. For RYGB, Ad-DiaRem trended to exhibit mildly improved predictive capacity 5-year postoperatively compared to DiaRem: Areas under receiver operating characteristic [AUROC] curves were 0.85 (0.76-0.93) and 0.78 (0.69-0.88), respectively. The positive predictive values (PPVs) detecting > 80% of those achieving DR (i.e., sensitivity ≥ 0.8) were 78.2% and 73.2%, respectively, and higher Ad-DiaRem scores more consistently associated with decreased DR rates. Following SG, both scores had an AUROC of 0.82, but Ad-DiaRem still had a higher PPV for predicting > 80% of those with 5-year postoperative DR (76.2% and 71.0%). Predictive capacity parameters were comparatively lower, for both scores, when considering DR 5-year post-GB (AUROC: 0.73 for both scores, PPV: 66.3% and 64.3%, respectively). CONCLUSIONS: Ad-DiaRem provides modest improvement compared to DiaRem in predicting long-term DR 5-years post-RYGB. Both scores similarly provide fair predictive capacity for 5-year postoperative DR after SG.
Subject(s)
Bariatric Surgery , Diabetes Mellitus, Type 2 , Bariatric Surgery/adverse effects , Bariatric Surgery/methods , Bariatric Surgery/statistics & numerical data , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Diabetes Mellitus, Type 2/surgery , Humans , Models, Statistical , Obesity/complications , Obesity/epidemiology , Obesity/surgery , Treatment OutcomeABSTRACT
PURPOSE: To analyse the mortality associated with intravitreal injections of bevacizumab for age-related macular degeneration (AMD) in patients previously diagnosed with stroke or transient ischaemic attack (TIA). METHODS: We reviewed bevacizumab-treated AMD patients with a diagnosis of stroke or TIA prior to their first bevacizumab injection (n = 948). Those patients, naïve to any anti-vascular endothelial growth factor (anti-VEGF) at the time of stroke/TIA, were then compared to age- and gender-matched patients who had a stroke/TIA at the same time and had never been exposed to anti-VEGF. Survival analysis was performed using adjusted Cox regression. The main outcome measure was survival. Adjusted variables were age, smoking, alcohol abuse, hypertension, diabetes mellitus, obesity, ischaemic heart disease, congestive heart failure and liver cancer. RESULTS: Age and gender distribution of bevacizumab-treated patients and controls were similar (mean age: 83.4 versus 83.7 years, p = 0.3; 51.7% males versus 52.5% males, p = 0.7). The adjusted mortality in patients who received bevacizumab within 3 months after stroke/TIA was significantly different than in patients non-exposed to bevacizumab (OR = 6.92, 95%, CI 1.88-25.43, p < 0.01). Within 6 months after stroke/TIA, the difference in adjusted mortality showed a strong trend (OR = 2.00, 95%, CI 0.96-4.16, p = 0.064). Within 12 months, it was insignificant (OR = 1.30, 95%, CI 0.75-2.26, p = 0.348). CONCLUSION: We found increased mortality within three months after a cerebrovascular event in patients treated with bevacizumab for AMD compared to patients for whom there was no record of a prescription to any anti-VEGF agent.
Subject(s)
Bevacizumab/administration & dosage , Macular Degeneration/drug therapy , Stroke/mortality , Visual Acuity , Aged, 80 and over , Angiogenesis Inhibitors/administration & dosage , Female , Follow-Up Studies , Humans , Israel/epidemiology , Macular Degeneration/complications , Macular Degeneration/physiopathology , Male , Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors , Retrospective Studies , Risk Factors , Stroke/complications , Survival Rate/trends , Treatment OutcomeABSTRACT
BACKGROUND: Intraocular injections of antivascular endothelial growth factor (VEGF) agents are currently the main therapy in age-related macular degeneration (AMD). The safety of bevacizumab, an anti-VEGF compound frequently delivered off label, is debated, particularly for high-group risks. We aim to analyze the mortality associated with intravitreal injections of bevacizumab for AMD in patients previously diagnosed with acute myocardial infarct (MI). METHODS: In a national database, we identified bevacizumab-treated AMD patients with a diagnosis of MI prior to their first bevacizumab injection, delivered between September 2008 and October 2014 (n = 2100). We then generated sub-groups of patients treated within 3 months (n = 11), 6 months (n = 24), 12 months (n = 52), and 24 months (n = 124) after MI. Those patients were compared to age- and gender-matched members that had a MI at the same time and had never been exposed to anti-VEGF. Survival analysis was performed using propensity score-adjusted Cox regression. RESULTS: Bevacizumab-treated patients were slightly and insignificantly older than controls (mean age 83.25 vs 83.19 year, P = .75). Gender distribution was similar. In a Cox regression adjusted with propensity score, the following differences in mortality were found: within 3 months between MI and initiation of bevacizumab treatment, OR = 6.22 (95% C.I 1.08-35.97, P < .05); within 6 months, OR = 2.37 (95% C.I 0.93-6.02, P = .071); within 12 months, OR = 3.00 (95% C.I 1.44-6.28, P < .01); within 24 months after MI, OR = 2.24 (95% C.I 1.35-3.70, P < .01); and MI any time prior to first bevacizumab injection, OR = 1.71 (95% C.I 1.53-1.92, P < .001). CONCLUSIONS: We report increased mortality associated with the use of intravitreal bevacizumab in AMD patients after MI, compared to age- and gender-matched post-MI patients with no exposure to any anti-VEGF agent. Caution should be taken while offering bevacizumab to AMD patients after MI.
Subject(s)
Bevacizumab/adverse effects , Myocardial Infarction/mortality , Population Surveillance/methods , Wet Macular Degeneration/drug therapy , Aged, 80 and over , Angiogenesis Inhibitors , Bevacizumab/administration & dosage , Cause of Death/trends , Female , Follow-Up Studies , Humans , Intravitreal Injections/adverse effects , Israel/epidemiology , Male , Myocardial Infarction/complications , Receptors, Vascular Endothelial Growth Factor/antagonists & inhibitors , Retrospective Studies , Survival Rate/trends , Time Factors , Visual Acuity , Wet Macular Degeneration/complications , Wet Macular Degeneration/diagnosisABSTRACT
BACKGROUND: The aim of this study is to analyze mortality in patients treated with bevacizumab for wet AMD. METHODS: We conducted a retrospective case-control study between patients who received intravitreal injections of bevacizumab as the sole treatment for exudative AMD between September 2008 and October 2014 (n = 5385) and age and gender matched controls (n = 10,756). All individuals included in the study were reviewed for sociodemographic data and comorbidities. Survival analysis was performed using adjusted Cox regression, using relevant adjusted variables. RESULTS: During follow-up (maximum: 73 months), 1063 (19.7%) individuals after bevacizumab died compared with 1298 (12.1%) in the control group (P < .001). After adjusted Cox survival regression, mortality differed significantly between the groups, Odds ratio = 1.69, (95% C.I. 1.54-1.84), P < .001. CONCLUSIONS: We found an increased long-term mortality in individuals with wet AMD treated with bevacizumab compared to a same age and gender group without wet AMD.
Subject(s)
Angiogenesis Inhibitors/therapeutic use , Bevacizumab/therapeutic use , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/mortality , Aged , Aged, 80 and over , Case-Control Studies , Female , Follow-Up Studies , Humans , Intravitreal Injections , Israel/epidemiology , Male , Odds Ratio , Retrospective Studies , Risk Factors , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Visual Acuity/physiologyABSTRACT
AIMS/HYPOTHESIS: Not all people with type 2 diabetes who undergo bariatric surgery achieve diabetes remission. Thus it is critical to develop methods for predicting outcomes that are applicable for clinical practice. The DiaRem score is relevant for predicting diabetes remission post-Roux-en-Y gastric bypass (RYGB), but it is not accurate for all individuals across the entire spectrum of scores. We aimed to develop an improved scoring system for predicting diabetes remission following RYGB (the Advanced-DiaRem [Ad-DiaRem]). METHODS: We used a retrospective French cohort (n = 1866) that included 352 individuals with type 2 diabetes followed for 1 year post-RYGB. We developed the Ad-DiaRem in a test cohort (n = 213) and examined its accuracy in independent cohorts from France (n = 134) and Israel (n = 99). RESULTS: Adding two clinical variables (diabetes duration and number of glucose-lowering agents) to the original DiaRem and modifying the penalties for each category led to improved predictive performance for Ad-DiaRem. Ad-DiaRem displayed improved area under the receiver operating characteristic curve and predictive accuracy compared with DiaRem (0.911 vs 0.856 and 0.841 vs 0.789, respectively; p = 0.03); thus correcting classification for 8% of those initially misclassified with DiaRem. With Ad-DiaRem, there were also fewer misclassifications of individuals with mid-range scores. This improved predictive performance was confirmed in independent cohorts. CONCLUSIONS/INTERPRETATION: We propose the Ad-DiaRem, which includes two additional clinical variables, as an optimised tool with improved accuracy to predict diabetes remission 1 year post-RYGB. This tool might be helpful for personalised management of individuals with diabetes when considering bariatric surgery in routine care, ultimately contributing to precision medicine.
Subject(s)
Diabetes Mellitus, Type 2/surgery , Gastric Bypass , Obesity, Morbid/surgery , Adiposity/physiology , Adult , Blood Glucose/analysis , Diabetes Mellitus, Type 2/blood , Female , France , Humans , Insulin Resistance/physiology , Lipids/blood , Male , Middle Aged , Obesity, Morbid/blood , Prognosis , Remission Induction , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Different bariatric surgeries have demonstrated different effectiveness for weight loss and glucose control in obese persons with diabetes, over a short follow-up time. The aim of this study was to compare weight loss, glucose control, and diabetes remission in individuals with type 2 diabetes, after three types of bariatric surgery: gastric banding (GB), sleeve gastrectomy (SG), and Roux-en-Y gastric bypass (RYGB), with 5 years follow-up. METHODS: A retrospective study was conducted on bariatric surgeries performed during 2002-2011 in a large nationwide healthcare organization. RESULTS: Of 2190 patients, 64.8 % were women. The operations performed were 1027 GB, 1023 SG, and 140 RYGB. Mean BMI ± SD at baseline, 1 year postoperatively, and 5 years postoperatively were 43.5 ± 6.18, 37.1 ± 6.35, and 35.5 ± 6.48 for GB; 43.6 ± 6.42, 34.4 ± 6.08, and 35.3 ± 6.7 for SG; and 42.8 ± 5.81, 32.8 ± 4.9, and 34.1 ± 5.09 for RYGB. Mean HbA1c ± SD at baseline, 1 year postoperatively, and 5 years postoperatively were 7.6 + 1.58, 6.5 + 1.22, and 6.8 + 1.48 for GB; 7.7 + 1.63, 6.4 + 1.18, and 6.7 + 1.57 for SG; and 8.0 + 1.78, 6.3 + 0.98, and 7.04 + 1.42 for RYGB. At 1 year follow-up, 53.2 % had achieved remission; at 5 years, 54.4 %. Remission rates at 5 years were similar for the three surgeries. Five-year remission was inversely associated with baseline HbA1c and with treatment with insulin at baseline and positively associated with BMI. CONCLUSIONS: For all three surgeries, diabetes remission was higher than the baseline after 5 years; mean BMI and HbA1c decreased considerably during the first year postoperatively and remained lower than basal values throughout follow-up. Early improvements were greatest for RYGB, though the advantage over the other operations diminished with time.
Subject(s)
Bariatric Surgery/statistics & numerical data , Diabetes Mellitus, Type 2 , Obesity, Morbid/surgery , Weight Loss , Bariatric Surgery/methods , Blood Glucose/metabolism , Female , Follow-Up Studies , Humans , Israel , Male , Medical Records , Middle Aged , Retrospective StudiesABSTRACT
BACKGROUND: The study goal was to assess indices of continuity of care in the primary care setting and their association with health outcomes and healthcare services utilization, given the reported importance of continuity regarding quality of care and healthcare utilization. METHODS: The study included a random sample of enrollees from Clalit Health Services 19 years-of-age or older who visited their primary care clinic at least three times in 2009. Indices of continuity of care were computed, including the Usual Provider Index (UPC), Modified Modified Continuity Index (MMCI), Continuity of Care Index (COC), and Sequential Continuity (SECON). Quality measures of preventive medicine and healthcare services utilization and their costs were assessed as outcomes. RESULTS: 1,713 randomly sampled patients were included in the study (mean age: 48.9 ± 19.2, 42% males). Continuity of care indices were: UPC: 0.75; MMCI: 0.81; COC: 0.67; SECON: 0.70. After controlling for patient characteristics in a multivariate analysis, a statistically significant association was found between higher values of UPC, COC, and SECON and a decrease in the number and cost of ED visits. Higher MMCI values were associated with a greater number and higher costs of medical consultation visits. Continuity of care indices were associated with BMI measurements, and inversely associated with blood pressure measurements. No association was found with other quality indicators, e.g., screening tests for cancer. CONCLUSIONS: Several continuity of care indices were associated with decreased number and costs of ED visits. There were both positive and negative associations of continuity of care indices with different aspects of healthcare utilization. The relatively small effects of continuity might be due to the consistently high levels of continuity in Clalit Health Services.