10.5%), cardiovascular (8.7%), dermatologic (6.3%), and carcinogenic (6.3%) issues. Among the 87products for which the timing of marketing was available, the median time on the marker was 5.4 years with about one-third withdrawn within the first two years. It is hoped that the current review will stimulate other future research into this important topic. However, due to the intrinsic limitations of the descriptive analysis design, our observations are subject to the availability of data in the public domain. Readers are cautioned to be objective and careful when approaching data of this nature in order not to misinterpret the results due to potential data gaps.
OBJECTIVE -Epidemiological studies have demonstrated that older Mexican Americans are at high risk for type 2 diabetes and its complications. Type 2 diabetes leads to a more rapid decline in functional status among older Mexican Americans with diabetes. This study was designed to examine the impact of diabetes on change in self-reported functional status over a 2-year period among older Mexican Americans with diabetes.
RESEARCH DESIGN AND METHODS -We performed a longitudinal analysis with repeated measurements of functional limitations in a cohort of Mexican Americans aged Ն60 years in the Sacramento Area Latino Study on Aging (SALSA). Diabetes was diagnosed on the basis of self-report of physician diagnosis, medication use, and fasting plasma glucose. Functional status was measured by assessment of activities of daily living (ADL) and instrumental activities of daily living (IADL) at baseline and 1 and 2 years.RESULTS -Of 1,789 SALSA participants, 585 (33%) had diabetes at baseline. Diabetic subjects reported 74% more limitations than nondiabetic subjects in ADL (summary score for number of limitations, 0.99 vs. 0.57; P ϭ 0.002) and 50% more limitations in IADL (summary score for number of limitations, 7.83 vs. 5.25; P Ͻ 0.0001). The annual rate of increase in limitations of ADL and IADL was 0.046 and 0.033 (log scale) on each scale among diabetic subjects compared with 0.013 and 0.003 (log scale) among nondiabetic subjects (P Ͻ 0.0005). Complications of diabetes were found to increase ADL and IADL limitations among diabetic subjects. Longer duration of diabetes was also associated with an increase in ADL and IADL limitations.
Following the release of the framework for the Real-World Evidence (RWE) Program, the US Food and Drug Administration (FDA) is actively evaluating and exploring ways to optimize the utility of real-world data (RWD) and RWE to support regulatory decision making. For rare conditions, conducting traditional randomized clinical trials may not always be feasible, and RWD and RWE have played and will continue to play an important role. We use three case examples-cerliponase alfa, asfotase alfa, and uridine triacetate-to illustrate how RWD from disease registries, medical records with chart review, and literature, respectively, have been used to generate RWE to support regulatory decisions for selected rare diseases. These
Aim
To compare glycaemic control, hypoglycaemia and treatment discontinuation of insulin glargine 300 units/mL (Gla‐300) and insulin degludec (IDeg) in a real‐world study of insulin‐naïve adults with type 2 diabetes (T2D).
Materials and methods
DELIVER Naive D was a retrospective observational study that used electronic medical record data from the IBM Watson Health Explorys database. Insulin‐naïve adults with T2D who started Gla‐300 or IDeg between March 2015 and September 2017 were identified. Patients were active in the system for ≥12 months before and ≥6 months after starting Gla‐300 or IDeg and had HbA1c measurements during 6‐month baseline and 3‐ to 6‐month follow‐up. Outcomes were compared among 1:1 propensity score‐matched cohorts.
Results
In the matched cohorts (n = 638 each), the mean age was 59 years, approximately 53% were male, and mean HbA1c was 9.67% (82 mmol/mol). Mean (SD) HbA1c decreases were comparable in the Gla‐300 and IDeg cohorts (−1.67% [2.22] and −1.58% [2.20]; P = 0.51), as were HbA1c target attainment [<7% (53 mmol/mol): 23.8% and 27.4%; P = 0.20; <8% (64 mmol/mol): 55.0% and 57.1%; P = 0.63] and treatment discontinuation (29.2% and 32.6%; P = 0.14). Overall and inpatient/emergency department‐associated hypoglycaemia incidences and event rates were similar in both cohorts using fixed 6‐month or variable on‐treatment follow‐up.
Conclusions
Among real‐world insulin‐naïve adults with T2D, initiation of Gla‐300 or IDeg resulted in comparable improvements in glycaemic control and similar rates of hypoglycaemia. These real‐world data complement and confirm a randomized trial and other real‐world studies.
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