General Flashcards
What was the name of the journal Strugnell was published in?
When was it published and who were the authors of the paper?
American Journal of Nephrology, March 2019
Stephen Strugnell, Stuart Sprague, Akhtar Ashfaq and Charlie Bishop
What is the title of the Strugnell paper?
Rationale for Raising Current Clinical Practice Guidelines Target for Serum 25-Hydroxyvitamin D in Chronic Kidney Disease
(Strugnell): What kind of study was it? What was the purpose of the study?
Ad hoc study based on our FDA indication study — secondary analysis of two studies to identify minimum level of mean serum 25D required to control SHPT in CKD 3 and CKD 4 patients.
(Strugnell): How long was the study?
26 weeks
(Strugnell): how many per protocol patients were in the study? How many intent to treat patients?
356 per protocol patients
429 intent to treat patients
(Strugnell): As mean serum total 25 hydroxyvitamin D approached the highest level, what happened to PTH?
The observed reduction in PTH appeared to attenuate (attenuate means to reduce or lessen an amount)
(Strugnell): what is the optimal PTH level in patients CKD 3 and 4?
The optimal PTH level remains undefined.
(Strugnell): The gradual elevation of 25D with ERC to levels as high as 92.5 ng/ml over a 26 week period had what type of adverse effects?
The were no adverse effects on calcium, phosphorus, FGF23, eGFR, VMR, or urine CA:CR ratio.
(Strugnell): Fig 1 - Analysis by CKD Stage
Fill in the blank:
Rayaldee increases _______ high enough resulting in higher ________ effectively reducing plasma ________.
25D, 1,25D, PTH
(Strugnell) Fig 2: Plasma iPTH Response
What happened to mean plasma iPTH during treatment in Quintiles 1 and 2? What kind of subjects were in those two quintiles? What happened to mean plasma iPTH in the 3 higher quintiles?
Mean plasma iPTH trended upward in Quintiles 1 and 2, which were mostly placebo subjects. iPTH decreased (p<.05) progressively in the higher 3 quintiles (Table 3; Fig 2a).
(Strugnell): Fig 2 Plasma iPTH Response
Fill in the blanks:
Quintile 3- Mean plasma iPTH started at ______ and declined to ______ post treatment.
Quintile 4 - Mean plasma iPTH started at ______ and declined to ______ post treatment.
Quintile 5 - Mean plasma iPTH started at _____ and declined to _______ post treatment.
Quintile 3: mean plasma iPTH started at 142.3 pg/ml and declined to 115 pg/ml post treatment.
Quintile 4: mean plasma iPTH started at 135. 5 pg/ml and declined to 101 pg/ml post treatment.
Quintile 5: mean plasma iPTH started at 146.7 pg/ml and declined to 97 pg/ml post treatment.
(Strugnell): Fig 2 Plasma iPTH response
As the 25D levels are increased, what happened to the PTH response?
The PTH response became more robust
(Strugnell): Fig 3 - Plasma, iPTH Response Rates
Fig 3, shows 5 groups of patients broken down by post treatment 25D quintiles and the impact on iPTH by quintile. The proportion of per protocol patients achieving an iPTH response defined as a decrease greater than or equal to 30% from pre-treatment baseline (Y-axis) by post treatment 25D quintile (X-axis).
What percent of subjects had a greater than or equal to 30% decrease in plasma iPTH for Quintiles 1 and 2? What were their post treatment serum 25D levels?
For Quintile 3?
For Quintile 4?
For Quintile 5?
8.5% for Q1 and Q2, where mean posttreatment serum 25D levels were at 13.9 and 26.2 ng/ml.
27.8% for Q3, where mean posttreatment serum 25D levels were 50.8 ng/ml.
42.3% for Q4, where mean posttreatment serum 25D levels were 68.9 ng/ml.
57.7% for Q5, where mean posttreatment serum 25D levels were 92.5 ng/ml.
(Strugnell): Fig 3 - Plasma, iPTH Response Rates
What happened to the response rates in Quintiles 3 - 5?
The response rates doubled in Quintiles 3-5.
(Strugnell): Fig 3 - Plasma, iPTH Response Rates
Fill in the blank
ERC therapy produced exposure dependent reductions in plasma iPTH only when mean serum total 25D reached at least _______ ng/ml.
50.8 ng/ml
