Twynsta Studies Flashcards
What is the primary endpoint for LittleJohn?
Change in the in-clinic seated trough DBP from baseline to end of the study.
What is the percentage reduction of peripheral oedema for Twynsta compare to that of Amlodipine alone?
71%
What is the number of patients enrolled in the littlejohn trial?
1461
What is the study design of littlejohn trial?
8 weeks of randomised, double blind, double dummy, placebo controled, international multi-centre, parallel-group, 4*4 factorial study
What is the inclusion creteria for LittleJohn trial?
male of female > 18 years of age, with stage 1 or 2 hypertension, DBP 95-119mmHg
What is the study design for White trail?
Same as littlejohn, but with 24hr ABPM monitoring
- Part of the littlejohn trial
- 562 (about 40% of littlejohn trial)
- ABPM
- 24 hour BP control combination therapy compared to mono therapy
What is the primary and secondary endpoint of the White trial?
Primary: mean 24 hour DBP reduction from baseline after 8 weeks of treatment
Secondary:
- mean SBP reduction from baseline after 8 weeks of treatment
- change in DBP and SBP from baseline based on race and age
- mean 24 blood pressure responsive control rate
What is the key messages from the White trial?
- Twynsta provides more BP reductions compared to the respective monotherapies over the 24 hour dosing interval
- 8/10 patients achieved blood pressure control of 130/80mmHg on Twynsta 80/10mg
- Significantly less peripheral oedema with Twynsta compared to amlodipine 10mg monotherapy
What is the aim of TEAMSTA severe study?
To compare the efficacy and tolerability of the fixed dose combination of Twynsta 80/10mg compared to respective monotherapies in severe hypertension.
What is the study design of TEAMSTA severe?
858 patients >18yrs
Severe HT: >=180/95
8 weeks randomised, double blind, parallel
3 arms: telmisartan 80, amlodipine 10, twynsta 80/10
What is the primary and secondary endpoint of TEAMSTA study?
Primary: mean change in seated trough SBP after 8 weeks of treatment
Secondary:
- Change in seated trough SBP after 1, 2,4,6 weeks of treatments
- DBP, SBP control after 1, 2, 4, 6 weeks
- Overall BP goal achievement after 1,2,4,6 weeks of treatments
What is the key results from TEAMSTA severe study?
- Twynsta 80/10mg provided significantly greater reduction from baseline in trough SBP compared to either monotherapy
- The mean reduction in trough SBP with Twynsta 80/10mg was 47.5mmHg
- Twynsta 80/10mg is well tolerated with a lower adverse event rate in peripheral oedema
What is the primary/secondary endpoint for Littlejohn?
Primary: change in in-clinic DBP from baseline
What is the study design of Accomplish trial?
-
What is the study design of On Target trial?
2 parallel, randomised, double blinded trial
In which year and what journal paper was ONTARGET published?
New England journal of Medicine in 2008
What’s the baseline characteristics of patients included in the study?
25620 >=55 CAD Cerebrovascular disease Peripheral vascular disease Diabetes with end organ damage
69% patients with HT
38% patients with T2D
Who designed the ONTARGET trial?
Salim Yusuf
What was the primary / secondary outcome of the ONTARGET study?
Primary: Death from CV event, MI, Stroke, hospitalization from CHF
Secondary: Death from CV event, MI, Stroke, same as HOPE study
What was the main result from the ONTARGET trial?
- Telmisartan 80mg is non-inferior to Ramipril 10mg.
- More patients discontinued in ramipril due to cough and angiodema
- More patients discontinued in telmisartan due to hypotension
- More patients discontinued in combination group due to hypotension, syncope and renal dysfunction.
What is the study aim for Ragot?
Compare BP lowering effect of Telmisartan compare to perindopril on DBP using self BP measurement.
What is the number of patients enrolled in Ragot?
441
Length of Ragot?
12 weeks
Treatment arms of Ragot?
Telmisartan 40/80 and Perindopril 4/8
Result of Ragot?
- Significantly better BP reduction in the last 6 hours of blood pressure control
- Significantly more patients controlled on the lower dose of Telmisartan
- Less incidence of cough in Micardis than Coversyl
What is the study aim for Lacourciere?
Compare the efficacy of Micardis to Diovan on BP control during the last 6 hrs of the dosing interval as well as 24hrs after missed a dose
How many patients were in the Lacourciere trial?
930 with mild to moderate hypertension
Length of the Lacourciere trial?
8 weeks
What is the key result from Lacourciere?
- Significantly greater reduction in BP than Diovan especially in the last 6 hours of the dosing interval
- Significantly more effective than Diovan in controlling BP over the 24 hrs following missed a dose
What is the study aim of Littlejohn?
Determine the efficacy and safety of telmisartan/amlodipine combination compared to the respective monotherapies in mild to moderate hypertension
What is the key result of littlejohn?
- Twynsta provides more powerful BP reduction than respective monotherapies
- 80/10 is the most effective combination (36.9mmHg reduction in initial SBP 170-180)
- Significantly less peripheral oedema than amlodipine 10mg monotherapy (71%)
What is the study objective for Wald?
To examing the effects of combining drugs and doubling doses in bp lowering medication
What is the study design for Wald?
10,968 patients of 42 randomised trials
meta-analysis
What is the main result from Wald?
- Additional effect of combining 2 classes of drug is approximately 5 times more effective than doubling of 1 drug
- Reduction of coronary heart disease events by 40%
- Reduction of stroke by 54%
