journal reporting pravin
TRANSCRIPT
Journal Reporting
Dr. Pravinkumar Wahane
JR II, Dept. of Pharmacology
BJGMC, Pune
Michaela Diamant, Luc Van Gaal, Stephen Stranks, Justin Northrup, Dachuang Cao, Kristin Taylor,
Michael Trautmann
Lancet 2010; 375: 2234–43
Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomized trial
Introduction Management of diabetes:
Symptomatic glucocentric approach
Targeting pathophysiological principles, blood-glucose lowering, reduce bodyweight
Treatments needed that are
Convenient
Control both fasting & postprandial glucose level,
Reduce risk of hypoglycemia,
Avoid counterproductive side-effects
Introduction GLP-1) receptor agonists – exenatide controls both
fasting and postprandial glucose with weight loss & low risk of hypoglycemia
Once weekly formulation of exenatide developed,- goal of sustained glycaemic control alongside increased convenience of standard once-a week dosing
Associated with HbA1c reduction, weight loss & low hypoglycemic risk in randomized clinical trials
Introduction Study aims to test hypothesis that improvement
in HbA1c concentration achieved with once-weekly exenatide is better than once a day insulin glargine titrated to glucose targets
Materials & Methods Phase 3 , Multicentre trial of 26 week duration
from May 2008 to May 2009 at 72 study sites across USA, EU, Russia, Australia, Korea, Taiwan & Mexico
Materials & Methods Inclusion Criteria Type II DM pts. 18 yrs & above with suboptimum
glycaemic control despite maximum tolerated doses of Metformin or combined Metformin and Sulphonylurea treatment for 3 months or longer
HbA1c Conc.- 7.0 – 11.0 %
BMI – 25-35 kg/m2
Stable body weight for 3 months or more
Materials & Methods Exclusion Criteria > 3 episodes of major hypoglycemia within 6
months of screening
Treatment with systemic glucocorticoids within 4 weeks of screening
Treatment > 2 weeks with Insulin, Thiazoledinediones, α glucosidase inhibitors, DPP 4 inhibitors within 3 months of screening
Prescription & Non prescription drugs weight loss drugs within 3 months of screening
Study Procedure Pt. assigned to once weekly Exenatide or once
daily insulin Glargine titrated to blood glusose lowering regimens by computer generated randomization sequence
1 st group – Subcut. Inj. Of 2 mg Exenatide once weekly for 26 weeks
2 nd Group – Insulin Glargine Starting from 10 IU to maintain BGL 4.0 to 5.5 mmol/L for 26 weeks
Pts. Contd. Their Metformin/ Metformin + Sulphonylurea dosing till week 26
Study Procedure Pt. on Met+ Sulphonylurea T/t with confirmed
Hypoglycemia – advised to reduce Sulphonylureas
Blood glucose profiles measured at : Before & 2 hrs. after morning, Midday, Evening meals, Bedtime & at 3 AM
A/E – Those occurring after Randomization or worsening during study
Safety End points:- Adverse events, clinical lab. Assesments, Vital signs & Hypoglycemia
Study Procedure
Primary Endpoints: Change in Hb1Ac at week 26 compared to
baseline
Secondary Endpoints: Pts. Achieving HbA1c < 7.0 % & < 6.5 %
Fasting Serum Glucose Concentration
Self Monitored Serum Glucose Concentration
Study Procedure
Study Procedure
Secondary Endpoints (contd): Body Weight
Fasting Serum lipid Concentration
Urinary Albumin – Creatinine Ratio
High Sensetivity C Reactive Protein
Statistical Analysis Data analysed a/c to intention to treat principle
Predefined subgroup analysis of groups based on Hb1Ac level
Categorical variables analyzed – Fisher test
Continuous variables analyzed – t- test
SAS (version 9.1) used for analysis of data
Results
Results
Results
Results
Results
Results
Discussion
Exenatide once weekly > insulin glargine titrated to target glucose level in reduction of HbA1c levels
Exenatide more effective in weight reduction
Insulin Glargine – Fasting Glucose levels
Exenatide - Postprandial Glucose levels
Hypoglycemic events more common in pts. Receiving Sulphonylurea & in Glargine group
Conclusion
Once weekly Exenatide is better than Insulin glargine titrated to glucose level in pts. for whom risk of hypoglycemia, weight gain and convenience are particular concerns
Comments
Clinical trial registration No. – mentioned
Title – gives an idea about the objective but not about the dosing pattern of Insulin glargine
Introduction – Background information and purpose of study mentioned
Materials and Methods - Ethical approval & informed consent has been obtained
Place of study, design , randomization method and inclusion/exclusion criteria mentioned
Comments
Source of Drug – Mentioned
Results – Statistical tests applied mentioned, appropriate tables and figures included
Discussion – Results not repeated, Relevant studies mentioned, Limitations of study mentioned
Conclusion – Gives possible future implication of study
Support and Conflict of Interest – Mentioned
A comparative study of the effect of clonidine and tramadol on post spinal anesthesia shivering
Shukla U, Malhotra T, Prabhakar T.
Ind J Anesth; Vol 55; Issue 3;242-6; May- June 2011
Introduction
Regional anesthesia – used for elective & emergency operations
Shivering – 40- 70 % pts. Undergoing surgery under regional anesthesia
Results in ↑ metabolic rate, ↑ O2 consumption, ↑ CO2 production, ventilation & cardiac output
Also causes – wound infection, surgical bleeding, lactic acidosis, ↑ IOP, Arterial hypoxemia
Introduction
It is thought to be due to peri-operative hypothermia d/t neuraxial anesthesia induced inhibition of thermoregulatory mechanism
Pharmacological and Non Pharmacological methods available to control shivering
Study aims to compare efficacy, potency & hemodynamic effects of Clonidine v/s Tramadol in shivering
Materials & Methods
Prospective double – blind randomized study
Ethics committee approval and written informed consent were obtained from pts.
Inclusion Criteria 80 ASA grade I pts of either sex aged 18- 40
years scheduled for elective abdominal/ orthopedic/ gynecological surgeries included
Materials & Methods
Exclusion Criteria Known hypersensitivity to clonidine & Tramadol
Known H/o alcohol or substance abuse
H/o hyperthyroidism, cardiovascular diseases, psychological disorders, severe diabetes or autonomic neuropathies
Materials & MethodsGroup C
40 pts
Clonidine 0.5 ug/kg IV
Group T
40 pts
Tramadol 0.5 mg/kg IV
Materials & Methods
Axillary temp. recorded before commencement of spinal anesthesia, then every 5 min from baseline for 1 hour & then every 15 min for rest of observation period
Grading of shivering (Wrench) Grade 1,2,3,4.
Time(min) of start of shivering after spinal anesth Time (min) of disappearance of shivering Response rate (min) after treatment
Materials & Methods
T/t with Clonidine/ Tramadol reconsidered if shivering not subsided by 15 min
Side effects recorded
Sedation score recorded (Filos)
Statistical Analysis
Student t test & Chi- square test applied for interpretation of results
P value < 0.05 was considered statistically significant
Statistical analysis done using computerized software
Results
Results
No statistically significant difference in heart rate, mean blood pressure, axillary temp . O2 saturation between two groups
Nausea, vomiting, diarrhea higher in Tramadol Group than in Clonidine group
Discussion
Zavaherforoush et. al found clonidine more effective than pathedine & fentanyl for treating post spinal anesthesia shivering in elective LSCS
Meracadante S et. al also found the same results
Conclusion: Clonidine offers better control over post spinal
anesthesia shivering & thermodynamics than Tramadol along with fewer side effects
Comments
Clinical Trial Registration No. – Not mentioned
Title - Gives idea about study objective, but not about the study design
Introduction - Background information along with purpose of study mentioned
Materials and Methods – Ethics Committee approval obtained, informed consent taken
Site of study – not mentioned
Comments
Study Design, Inclusion & Exclusion criteria mentioned
Source of drug, Method of randomization - not mentioned
Results- Statistical tests employed mentioned briefly, Name of Statistical Software used has not been mentioned
Discussion – Introduction & Results repeated, Limitations of study mentioned
Support & Conflict of Interest mentioned as NIL