Postgraduate medicine
-
Postgraduate medicine · May 2021
Randomized Controlled TrialEffect of a change in lasmiditan dose on efficacy and safety in patients with migraine.
Background: Lasmiditan is a selective serotonin (1F) receptor agonist approved for acute treatment of migraine with 3 doses: 50, 100, and 200 mg. Objective: To help provide dosing insights, we assessed the efficacy and safety of lasmiditan in patients who treated two migraine attacks with the same or different lasmiditan doses. Methods: Integrated analyses used data from the migraine attack treated in either of two controlled, Phase 3, single attack studies (SAMURAI/SPARTAN), and after the first attack treated in the open-label GLADIATOR extension study. ⋯ Conclusion: A positive efficacy-TEAE balance exists for patients increasing their lasmiditan dose for treatment of a subsequent migraine attack. These results could be important for optimizing dosing for individual patients. Clinicaltrials.gov: SAMURAI (NCT02439320); SPARTAN (NCT02605174); GLADIATOR (NCT02565186).
-
Postgraduate medicine · May 2020
Randomized Controlled TrialTriple fixed-dose combination empagliflozin, linagliptin, and metformin for patients with type 2 diabetes.
Fixed-dose combination (FDC) therapy can improve outcomes in type 2 diabetes (T2D). We evaluated the bioequivalence of 2 doses of an FDC of extended-release metformin (metformin XR), empagliflozin, a sodium-glucose co-transporter 2 inhibitor, and linagliptin, a dipeptidyl peptidase-4 inhibitor, versus corresponding free tablet combinations. ⋯ The evaluated doses of empagliflozin/linagliptin/metformin XR FDC tablets were bioequivalent to the corresponding free combinations. Based on these two bioequivalence studies and existing phase 3 data, the FDA has recently approved this triple FDC to improve glycemic control in adults with T2D.
-
Postgraduate medicine · May 2020
Randomized Controlled Trial Multicenter StudyLinagliptin in patients with type 2 diabetes and cardiovascular and/or renal disease: results from a cardiovascular and renal outcomes trial.
Review of: Rosenstock J, Perkovic V, Johansen, OE, et al. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321:69-79. ⋯ Additionally, progression of albuminuria occurred less frequently in patients who received linagliptin versus placebo (HR 0.86 [0.78-0.95]). Overall, no new safety findings were identified for linagliptin, and no increased risk of hypoglycemia was observed for linagliptin versus placebo. Together, these findings from the CARMELINA trial reaffirm treatment guidelines for choosing additional therapies for patients with T2DM at elevated CV and/or renal risk, and provide new information on the role of linagliptin in the management of T2DM.
-
Postgraduate medicine · Apr 2020
Randomized Controlled TrialBlood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal?
This study aimed to assess various types of safety lancets in terms of blood volume and pain perception during capillary blood sampling, a routine finger-puncture procedure for obtaining a small amount of human blood for running various screening and diagnostic tests. ⋯ NCT04001348. (https://clinicaltrials.gov/ct2/show/NCT04001348?term=NCT04001348&draw=2&rank=1).
-
Postgraduate medicine · Aug 2019
Randomized Controlled Trial Multicenter StudyIcosapent ethyl reduces atherogenic markers in high-risk statin-treated patients with stage 3 chronic kidney disease and high triglycerides.
Objective: Patients with chronic kidney disease (CKD) have increased cardiovascular disease (CVD) risk, likely driven by atherogenic and inflammatory markers beyond low-density lipoprotein cholesterol (LDL-C). The objective of this hypothesis-generating post hoc subgroup analysis was to explore the effects of icosapent ethyl at 2 or 4 g/day (prescription pure ethyl ester of the omega-3 fatty acid eicosapentaenoic acid [EPA]) on atherogenic lipid, apolipoprotein, inflammatory parameters (high-sensitivity C-reactive protein [hsCRP], lipoprotein-associated phospholipase A2 [Lp-PLA2]), and oxidative parameters (oxidized-LDL [ox-LDL]) in statin-treated patients from ANCHOR with stage 3 CKD. Methods: The 12-week ANCHOR study evaluated icosapent ethyl in 702 statin-treated patients at increased CVD risk with triglycerides (TG) 200-499 mg/dL despite controlled LDL-C (40-99 mg/dL). ⋯ Safety and tolerability were similar to placebo. Conclusions: In patients with stage 3 CKD at high CVD risk with persistent high TG despite statins, icosapent ethyl 4 g/day reduced potentially atherogenic and other cardiovascular risk factors without raising LDL-C, with safety similar to placebo. These findings suggest prospective investigation may be warranted.