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Design features that may mitigate risk for hypoglycemia include use of a mid-protocol bolus feature and establishment of a low BG threshold for temporary interruption of infusion. Computer-guided dosing may improve target attainment without exacerbating risk for hypoglycemia. Column assignment (MR) within a tabular user-interpreted algorithm or multiplier may be specified initially according to patient characteristics and medical condition with revision during treatment based on patient response. We hypothesize that a strictly increasing sigmoidal relationship between MR-dependent IR and BG may reduce risk for hypoglycemia, in comparison to a linear relationship between multiplier-dependent IR and BG. Guidelines are needed that curb excessive up-titration of MR and recommend periodic pre-emptive trials of MR reduction. Future research should foster development of recommendations for "protocol maxima" of IR appropriate to patient condition.

The standard term of a patent is 20 years from the date of filing. However, the time required for a pharmaceutical product to pass through research and development, and clinical trials to obtain regulatory approval can often be more than 10 years. This effectively shortens the life of the patent leaving the patentee with little or no monopoly over the pharmaceutical product by the time it reaches market. The solution to this loss of patent monopoly in many countries is to provide an extension to compensate for loss of patent term due to obtaining regulatory approval of a product. This article provides a summary of some of the issues, challenges and implications of patent term extensions in various countries.

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Background: Dipeptidyl peptidase-4 inhibitors (DPP-4i) plus basal insulin is noninferior to insulin monotherapy for glycemic control in medical–surgical patients, but data in postoperative cardiac surgery patients are sparse. Objective: To compare glucose control in postoperative cardiac surgery patients with prediabetes or diabetes receiving a DPP-4i plus insulin versus other antihyperglycemic regimens. Methods: We retrospectively identified patients with prediabetes or diabetes who underwent cardiac surgery at our hospital between May 2016 and June 2017. Included patients were stratified into cohorts: (1) DPP-4i plus insulin and (2) other antihyperglycemic regimens. Blood glucose levels were collected on postoperative days 2 to 7. Uncontrolled glucose (≥2 measurements <80 or >180 mg/dL in 1 day), hyperglycemia (>2 measurements ≥180 mg/dL in 1 day), and hypoglycemia (any measurement <70 mg/dL) were compared between cohorts using logistic regression adjusted for home antihyperglycemics. Results: We included 135 cardiac surgery patients, of which 65 received DPP-4i plus insulin. Eighty-two patients received antihyperglycemics at home. Uncontrolled glucose occurred in 61 (45.2%) patients; while hyperglycemia and hypoglycemia occurred in 50 (37.0%) and 24 (17.8%) patients, respectively. There was no difference in the adjusted odds of uncontrolled glucose (odds ratio [OR] = 1.43; 95% confidence interval [CI] = 0.65-3.11), hyperglycemia (OR = 1.20; 95% CI = 0.52-2.78), or hypoglycemia (OR = 0.69; 95% CI = 0.27-1.75) for those receiving DPP-4i plus insulin versus other regimens. Conclusion: Glucose control was no different among postoperative cardiac surgery patients receiving a DPP-4i plus insulin versus other regimens. DPP-4i use was not associated with hypoglycemia.