QUALITY USE OF CARDIOVASCULAR MEDICATION Dr Mark Abelson
Dec 26, 2015
QUALITY USE OF CARDIOVASCULAR MEDICATION
Dr Mark Abelson
Prescription Drugs and Drug Trials
• Drug development- basic science research in a laboratory- chemical patented (20 years)- laboratory testing- Phase 1 trials – tested for safety and efficacy in animals- Phase 2 trials – tested for safety in normal humans- Phase 3 trials – show effective (better than placebo or current standard treatment) and safe in many thousands of patients around the world (double blind
• Drug launched (5 years patent remaining)- post marketing surveillance
• $ +100 million • Register with FDA / MCC (years)
“Alternative” Drugs• Vitamins• Minerals• Cholesterol vaporises• Tissue salts NO RESEARCHNO EVIDENCE OF EFFICACYNO PRODUCTION CONTROLNO REGISTRATION PROCESS
Trials done consistently show NO benefit eg. Folate, anti-oxidant vitamins
Conspiracy Theory
• Doctors and Universities – bribed / kick backs from pharmaceutical companies?
• Lack of patient trust?• Only want “natural” treatment ( death?)
Commonly Used Drugs• Statins -reduce cholesterol
- Zocor, Simvastatin, Lipitor, Aspavor, Crestor, Prava, Lescol – primary prevention (at risk but currently asymptomatic)
benefit in high risk persons or
- secondary prevention (known with coronary artery disease)30% reduction in future heart attack and stroke
• Aspirin - reduces blood stickiness – primary (little benefit) or secondary prevention (25% )
• ACE-I / ARB – lower BP, improve heart failure- Prexum, Coversyl, Lisinopril, Zetomax, Pharmapres, Enalapril, Cozaar, Zartan, Diovan
Commonly Used Drugs
• Beta Blockers – reduce heart rate (angina) and BP, heart failure- Concor, Bilocor, Bisocor, Carloc, Dilatrend
• Calcium Channel blockers – reduce heart rate and BP- Verahexal, Calcicard, Ravamil, Amloc, Norvasc, Zildem
New Comers
• Coralin – reduces heart rate without decreasing BP and no BB side effects (lethargy, impotence)- angina and heart failure
• Dabigatran – thins blood like Warfarin but no INR (blood) testing needed- atrial fibrillation
Guideline recommendations for BP goals
– <140/90mmHg for essential hypertension– <130/80mmHg for hypertensive patients with
diabetes
• Most patients with hypertension will require two or more antihypertensive agents to achieve BP goal
Guidelines Committee. J Hypertens 2003; 21: 1011-53.Guidelines Committee. J Hypertens 2003; 21: 1011-53.Chobanian AV, et al. JAMA 2003; 289: 2560-72.Chobanian AV, et al. JAMA 2003; 289: 2560-72.
*ESH/ESC: European Society of Hypertension/European Society of Cardiology*ESH/ESC: European Society of Hypertension/European Society of Cardiology
**JNC 7: Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, seventh **JNC 7: Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, seventh reportreport
Combination therapy needed to achieve target SBP goals
INVEST; data on file.INVEST; data on file.ALLHAT Collaborative Research Group. JAMA 2002; 288: 2981-97.ALLHAT Collaborative Research Group. JAMA 2002; 288: 2981-97. Brenner BM, et al. N Engl J Med 2001; 345: 861-9.Brenner BM, et al. N Engl J Med 2001; 345: 861-9.Lewis EJ, et al. N Engl J Med 2001; 345: 851-60.Lewis EJ, et al. N Engl J Med 2001; 345: 851-60.Adapted from Bakris GL, et al. Am J Kidney Dis 2000; 36: 646-61.Adapted from Bakris GL, et al. Am J Kidney Dis 2000; 36: 646-61.
Number of antihypertensive drugsNumber of antihypertensive drugs
Trial/SBP achievedTrial/SBP achieved
INVEST (136mmHg)INVEST (136mmHg)
ALLHAT (138mmHg)ALLHAT (138mmHg)
IDNT (138mmHg)IDNT (138mmHg)
RENAAL (141mmHg)RENAAL (141mmHg)
UKPDS (144mmHg)UKPDS (144mmHg)
ABCD (132mmHg)ABCD (132mmHg)
MDRD (132mmHg)MDRD (132mmHg)
HOT (138mmHg)HOT (138mmHg)
AASK (128mmHg)AASK (128mmHg)
1 2 3 4
Hypertension: a risk factor forcardiovascular morbidity and mortality
Kannel WB. JAMA 1996; 275: 1571-6.
Risk ratioRisk ratio 2.02.0 2.22.2 3.83.8 2.52.5 2.02.0 3.73.7 4.04.0 3.03.0
Excess riskExcess risk 22.722.7 11.611.6 9.19.1 3.83.8 4.94.9 5.35.3 10.410.4 4.24.2
NormalHypertensive
5050
4040
3030
2020
1010
00
Bien
nial
age
-adj
uste
dBi
enni
al a
ge-a
djus
ted
rate
per
100
0ra
te p
er 1
000
MenWomen MenWomen MenWomen MenWomen
Coronary artery disease Stroke
Peripheralarterial disease
Cardiac failure
MRFIT: association of systolic BP and diabetes with cardiovascular risk
Stamler J, et al. Diabetes Care 1993; 16: 434-44.Stamler J, et al. Diabetes Care 1993; 16: 434-44.
DiabeticDiabetic
00
5050
100100
150150
200200
250250
300300
<120<120 120-139120-139 140-159140-159 160-179160-179 180-199180-199 200+200+
Non-diabeticNon-diabetic
CVD
dea
ths
CVD
dea
ths
per
10,
000
pers
on-y
ears
per
10,
000
pers
on-y
ears
Systolic BP (mmHg)Systolic BP (mmHg)
Early morning BP surge coincides with peak incidences of stroke and myocardial infarction
McInnes G. J Am Soc Hypertens 2008;2:S16–22.
Time of day
180
160
140
120
100
80
60
40
20
0
18.00 0.00 06.00 12.00
50
45
40
35
30
25
20
15
10
5
0
Cere
brov
ascu
lar e
vent
s(p
er 2
hou
rs)
MI (
per h
our)
Stroke (n=1,167)
MI (n=2,999) Early morningBP surge