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Twynsta Studies Flashcards

1
Q

What is the primary endpoint for LittleJohn?

A

Change in the in-clinic seated trough DBP from baseline to end of the study.

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2
Q

What is the percentage reduction of peripheral oedema for Twynsta compare to that of Amlodipine alone?

A

71%

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3
Q

What is the number of patients enrolled in the littlejohn trial?

A

1461

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4
Q

What is the study design of littlejohn trial?

A

8 weeks of randomised, double blind, double dummy, placebo controled, international multi-centre, parallel-group, 4*4 factorial study

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5
Q

What is the inclusion creteria for LittleJohn trial?

A

male of female > 18 years of age, with stage 1 or 2 hypertension, DBP 95-119mmHg

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6
Q

What is the study design for White trail?

A

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
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7
Q

What is the primary and secondary endpoint of the White trial?

A

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

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8
Q

What is the key messages from the White trial?

A
  • 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
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9
Q

What is the aim of TEAMSTA severe study?

A

To compare the efficacy and tolerability of the fixed dose combination of Twynsta 80/10mg compared to respective monotherapies in severe hypertension.

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10
Q

What is the study design of TEAMSTA severe?

A

858 patients >18yrs
Severe HT: >=180/95
8 weeks randomised, double blind, parallel
3 arms: telmisartan 80, amlodipine 10, twynsta 80/10

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11
Q

What is the primary and secondary endpoint of TEAMSTA study?

A

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

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12
Q

What is the key results from TEAMSTA severe study?

A
  • 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
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13
Q

What is the primary/secondary endpoint for Littlejohn?

A

Primary: change in in-clinic DBP from baseline

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14
Q

What is the study design of Accomplish trial?

A

-

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15
Q

What is the study design of On Target trial?

A

2 parallel, randomised, double blinded trial

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16
Q

In which year and what journal paper was ONTARGET published?

A

New England journal of Medicine in 2008

17
Q

What’s the baseline characteristics of patients included in the study?

A 
25620
>=55 
CAD
Cerebrovascular disease
Peripheral vascular disease
Diabetes with end organ damage

69% patients with HT
38% patients with T2D

18
Q

Who designed the ONTARGET trial?

A

Salim Yusuf

19
Q

What was the primary / secondary outcome of the ONTARGET study?

A

Primary: Death from CV event, MI, Stroke, hospitalization from CHF
Secondary: Death from CV event, MI, Stroke, same as HOPE study

20
Q

What was the main result from the ONTARGET trial?

A
  • 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.
21
Q

What is the study aim for Ragot?

A

Compare BP lowering effect of Telmisartan compare to perindopril on DBP using self BP measurement.

22
Q

What is the number of patients enrolled in Ragot?

A

441

23
Q

Length of Ragot?

A

12 weeks

24
Q

Treatment arms of Ragot?

A

Telmisartan 40/80 and Perindopril 4/8

25
Q

Result of Ragot?

A
  • 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
26
Q

What is the study aim for Lacourciere?

A

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

27
Q

How many patients were in the Lacourciere trial?

A

930 with mild to moderate hypertension

28
Q

Length of the Lacourciere trial?

A

8 weeks

29
Q

What is the key result from Lacourciere?

A
  • 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
30
Q

What is the study aim of Littlejohn?

A

Determine the efficacy and safety of telmisartan/amlodipine combination compared to the respective monotherapies in mild to moderate hypertension

31
Q

What is the key result of littlejohn?

A
  • 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%)
32
Q

What is the study objective for Wald?

A

To examing the effects of combining drugs and doubling doses in bp lowering medication

33
Q

What is the study design for Wald?

A

10,968 patients of 42 randomised trials

meta-analysis

34
Q

What is the main result from Wald?

A
  • 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%

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