Safety and Efficacy of Oral Human Parathyroid Hormone (1-34) in Hypoparathyroidism: An Open-Label Study.

The standard treatment of primary hypoparathyroidism (hypoPT) with oral calcium supplementation and calcitriol (or an analog), intended to control hypocalcemia and hyperphosphatemia and avoid hypercalciuria, remains challenging for both patients and clinicians. In 2015, human parathyroid hormone (hPTH) (1-84) administered as a daily subcutaneous injection was approved as an adjunctive treatment in patients who cannot be well controlled on the standard treatments alone. This open-label study aimed to assess the safety and efficacy of an oral hPTH(1-34) formulation as an adjunct to standard treatment in adult subjects with hypoparathyroidism. Oral hPTH(1-34) tablets (0.75 mg human hPTH(1-34) acetate) were administered four times daily for 16 consecutive weeks, and changes in calcium supplementation and alfacalcidol use, albumin-adjusted serum calcium (ACa), serum phosphate, urinary calcium excretion, and quality of life throughout the study were monitored. Of the 19 enrolled subjects, 15 completed the trial per protocol. A median 42% reduction from baseline in exogenous calcium dose was recorded (p = .001), whereas median serum ACa levels remained above the lower target ACa levels for hypoPT patients (>7.5 mg/dL) throughout the study. Median serum phosphate levels rapidly decreased (23%, p = .0003) 2 hours after the first dose and were maintained within the normal range for the duration of the study. A notable, but not statistically significant, median decrease (21%, p = .07) in 24-hour urine calcium excretion was observed between the first and last treatment days. Only four possible drug-related, non-serious adverse events were reported over the 16-week study, all by the same patient. A small but statistically significant increase from baseline quality of life (5%, p = .03) was reported by the end of the treatment period. Oral hPTH(1-34) treatment was generally safe and well tolerated and allowed for a reduction in exogenous calcium supplementation, while maintaining normocalcemia in adult patients with hypoparathyroidism. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Retrospective Evaluation of Glycemic Control With Basal-Bolus or Neutral Protamine Hagedorn Insulin Regimens in Patients Receiving Continuous Enteral Nutrition Therapy in Medicine Wards.

Reasonable glycemic control is difficult to achieve in patients with diabetes mellitus (DM) receiving continuous enteral nutrition therapy (CENT). There are no solid evidence-based medicine guidelines regarding this issue in these patients. The purpose of this study was to determine if the use of a basal-bolus insulin regimen is more effective than neutral protamine Hagedorn (NPH) insulin alone in controlling blood glucose in non-critically ill patients with DM receiving CENT. We performed a retrospective, records-based review comparing basal-bolus with NPH insulin regimen in these patients, hospitalized in the internal medicine wards in our hospital. Number of hypoglycemic episodes, mean blood glucose, and time-to-target (time needed to reach 3 successive glucose readings in the appropriate target of 140-180 mg/dL) were evaluated in each regimen. Mean blood glucose was 199.22 mg/dL (95% confidence interval [CI], 179.8-218.5 mg/dL) in the basal-bolus vs 190.73 mg/dL (95% CI, 172.1-209.2 mg/dL) in the NPH insulin regimen ( P = .538). Time-to-target was an average of 3.65 ± 1.75 days in the basal-bolus group and 4.33 ± 2.42 days in the NPH group ( P = .364). There were no statistically significant differences in frequency of hypoglycemia ( P = .364). Rate of death was high (around 40%) in both groups. We conclude that hospitalized hyperglycemic patients receiving CENT can be treated by either basal-bolus or NPH insulin regimens. However, the overall glucose levels remain elevated during hospitalization irrespective of the insulin therapy. There is an urgent need to define glucose targets in this population of patients and to evaluate prospectively head-to-head different insulin protocols.