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Pharm > Lecture 5: Does This Drug Really Work? > Flashcards

Lecture 5: Does This Drug Really Work? Flashcards

1
Q

What occurs during Phase I of drug research?

A
  • Small cohort of patients (20 - 100)
  • Study how well tolerated the drug is and what are the pharmacokinetic properties of the drug
  • Patients are given a few different doses to determine this
  • See if patients experience any adverse side affects
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2
Q

What occurs during Phase II of drug research?

A
  • 100 - 200

* Addresses efficacy: See if any patients derive benefit from the drug

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3
Q

What occurs during Phase III?

A
  • 1000 - 6000 patients
  • Randomized control trials where patients receive placebo and drug
  • Both patients and clinicians are blind
  • If drug sees some benefit it will be approved
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4
Q

What studies occur after the phase III trials?

A

The drug will still continue to be monitored after being released

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5
Q

What are Clinical trials?

A

Controlled human studies to assess dosage, administration, safety, efficacy

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6
Q

What is tested in phase I?

A
  • Tolerable dosing ranges
  • Bioavailability
  • Excretion
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7
Q

What is tested in phase II?

A
  • Efficacy

* Safety in greater numbers

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8
Q

What is tested in Phase III?

A

•Double blinded trials against placebo

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9
Q

Which phase tests for pharmacokinetics?

A

Phase I

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10
Q

What are Meta-analyses?

A

An approach to combine data from multiple trials often after a drug has been approved

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11
Q

How are meta-analyses often displayed?

A

As forest plots

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12
Q

What is an event on a metaanalysis?

A

The amount of times an outcome occurs such as a patient getting diabetes

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13
Q

What data does Statin plots provide data on?

A
  • Number of trials
  • Size of each trial
  • Outcomes of trials
  • Overall summary of all trials
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14
Q

What is the Odds Ratio?

A

The ratio of the event rate in treatment vs control (which one is favored in individual trials vs overall)

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15
Q

What characteristics must a drug have for it to be useful?

A

It must have a beneficial effect but must also be tolerable in terms of toxicity

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16
Q

What is the Therapeutic Index?

A

The ratio of the median toxic dose and effective dose

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17
Q

What is described using a Quantal Dose-Response Curve?

A

Effect or toxicity

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18
Q

How is a Quantal Dose Response Curve different from quantitative effect curves?

A

Quantal Dose Response Curves shows the cumulative number of patients who have a predefined response to a drug

19
Q

What is the Effective Dose 50?

A

The dose that 50% of the patients will exhibit some beneficial response to a drug

20
Q

What is the Toxic Dose 50?

A

The dose that 50% of the patients will exhibit some adverse response to a drug

21
Q

Why is it good to have a big difference between the TD50 and the ED50?

A

Because then there is a bigger window to give patients that are not responding a slightly higher dose

22
Q

What does a big therapeutic index mean?

A

It means that the drug is tolerated with minimal toxicity and gives a lot of flexibility for dosing

23
Q

What is a drawback to the Therapeutic index?

A

There is a lot of variability in drug response for individuals

24
Q

What other consideration must be taken into account for effect and toxicity?

A

Conditions like diet, liver function and kidney function

25
Q

What should TI not be used for?

A

It should not be used as a rigid criteria for administration in a clinical setting

26
Q

What is relative risk reduction?

A

A common parameter used to describe how drugs will reduce the likelihood of some undesirable event

27
Q

What is an event?

A

Some outcome that is defined by whatever study is being performed ex. Heart attack or death

28
Q

What is All cause mortality?

A

An event that means death by any means

29
Q

What is the problem with relative risk reductions?

A

It doesn’t emphasize the real likelihood of risk in the general population and it may de-emphasize the risk of harms that may come up with taking the drug

30
Q

What can Relative Risk Reduction be seen as misleading?

A

Because it emphasizes the benefits but not the risks

31
Q

Why is the main reason relative risk reduction does not convey the risk?

A

It doesn’t capture the difference between a large reduction in something that is very infrequent versus something that is frequent

32
Q

Give an example of a downside to relative risk reduction?

A

A high relative risk reduction may be seen in a drug that prevents something very rare but it may also be seen in a drug that prevents something that occurs relatively frequently

33
Q

What is a more descriptive way to report the benefit of taking a drug?

A

Absolute Risk Reduction

34
Q

What does the Absolute Risk Reduction describe?

A

The absolute number of cases that are prevented by taking a drug (rather than relative to baseline)

35
Q

How do you interpret NNT?

A

The value given in the equation means that X number of people need to take the drug in order for one to benefit from it

36
Q

Why would an NNT be so high?

A

Because the incidence of the event (purple eyeballs) is already so low

37
Q

What NNT is optimal?

A

A low one like 1

38
Q

What does an NNT of one mean?

A

That just about everybody taking the drug will receive the desired benefit

39
Q

Why is a high NNT not good?

A

Because it mean that most people will not receive a benefit by taking a drug and be exposed to possible harms of the drug

40
Q

What value of NNH is good?

A

A high number needed to harm is good

41
Q

What does a negative absolute risk mean?

A

It means that an event has a higher rate in the experimental group, so you would describe 1/ARR as the NNH

42
Q

When would you say the NNH instead of NNT?

A

When the ARR is negative

43
Q

Why are some drugs with a high NNT given?

A

Because the potential outcomes that they are preventing are very severe like death

Pharm (31 decks)

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