RESUMEN
BACKGROUND: When compared with conventional weight loss strategies, bariatric surgery results in substantially greater durable weight loss and rates of disease remission. OBJECTIVE: The ENGAGE CVD (Effectiveness of Gastric Bypass versus Gastric Sleeve for Cardiovascular Disease) cohort study aimed to provide population-based, comprehensive, rigorous evidence for clinical and policy decision making regarding the choice between gastric bypass and gastric sleeve for overall cardiovascular disease (CVD) risk reduction, risk factor remission, and safety. METHODS: The cohort had 22,095 weight loss surgery patients from a large integrated health care system in Southern California assembled from 2009 to 2016 who were followed up through 2018. Bariatric surgery patients were followed up for the length of their membership in the health care system. Of the patients who had at least five years of follow-up (surgery between 2009 and 2013), 85.86% (13,774/16,043) could contribute to the outcome analyses for the ENGAGE CVD cohort. RESULTS: Patients in the ENGAGE CVD cohort were 44.6 (SD 11.4) years old, mostly women (17,718/22,095; 80.19%), with 18.94% (4185/22,095) non-Hispanic black and 41.80% (9235/22,095) Hispanic, and had an average BMI of 44.3 (SD 6.9) kg/m2 at the time of surgery. When compared with patients who did not contribute data to the 5-year outcome analysis for the ENGAGE CVD cohort (2269/16,043; 14.14%), patients who contributed data (13,774/16,043; 85.86%) were older (P=.002), more likely to be women (P=.02), more likely to be non-Hispanic white (P<.001), more likely to have had an emergency department visit in the year before surgery (P=.006), less likely to have a mental illness before surgery (P<.001), and more likely to have had a CVD event at any time before surgery (P<.001). CONCLUSIONS: This study had one of the largest populations of gastric sleeve patients (n=13,459). The 5-year follow-up for those patients who had surgery between 2009 and 2013 was excellent for a retrospective cohort study at 85.86% (13,774/16,043). Unlike almost any study in the literature, the majority of the ENGAGE CVD cohort was racial and ethnic minority, providing a rare opportunity to study the effects of bariatric surgery for different racial and ethnic groups, some of whom have the highest rates of severe obesity in the United States. Finally, it also used state-of-the-art statistical and econometric comparative effectiveness methods to mimic the effect of random assignment and control for sources of confounding inherent in large observational studies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/14936.
RESUMEN
BACKGROUND: An integrated health care system with its own regional health plan located in Texas implemented a pharmacist-led diabetes medication management program (MMP) to treat type 2 diabetic patients (baseline A1c > 7.5%). The MMP formed collaborative practice agreements with the system's physicians to allow ambulatory care pharmacists to modify and adjust diabetic drug regimens when appropriate. Enrolled MMP patients received personalized visits with ambulatory care pharmacists and a copay waiver on diabetes medications. OBJECTIVE: To study the outcomes of an outpatient, pharmacist-led MMP, along with a copay waiver on diabetes drugs, in treating adults with type 2 diabetes mellitus over a 2-year period compared with standard care practice. METHODS: This retrospective study employed a quasi-experimental design and used medical claims, pharmacy claims, eligibility data, and electronic medical records. Patients aged 18 to 62 years, who were diagnosed with type 2 diabetes mellitus, and had at least 1 diabetes-related pharmacy claim in the year before the MMP, as well as continuous enrollment in the health plan, were included. Patients enrolled in the pharmacist-led MMP for at least 2 years (n =75) were matched to standard care patients (n =75) on age, gender, baseline A1c, insulin use, and physical comorbidity. The primary outcome was the 2-year change in A1c. Secondary outcomes included inpatient costs, outpatient costs, and pharmacy costs from the baseline period (year before enrollment) compared with the follow-up period (second year of enrollment). RESULTS: After matching MMP patients (n = 75) to control patients (n = 75), the baseline A1c (9.30 and 9.26), the mean age (53.0 and 53.3, respectively), the Selim Physical Score (3.32 and 3.26, respectively), and the use of insulin (56.0% and 56.0%, respectively) were similar in both groups. MMP patients had a greater mean reduction in A1c compared with standard care patients (-1.24 vs. -0.59, P = 0.009) from baseline to after 2 years. After 2 years, the A1c for MMP patients was significantly lower compared with control patients (8.06 vs.8.67, respectively, P = 0.014). There was also a difference in A1c after 1 year for MMP patients versus control patients (8.18 and 8.69, respectively, P = 0.012). CONCLUSIONS: A pharmacist-led diabetes MMP, combined with a diabetes drug copay waiver, was effective in significantly reducing A1c over a 2-year period for type 2 diabetic patients in this regional health plan.