RESULTS OF CLINICAL TRIALS: OVERVIEW

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Transcript RESULTS OF CLINICAL TRIALS: OVERVIEW

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‫اصول درمان هیپرتانسیون یا‬
‫بیماری پر فشاری خون‬
DR. SHAHRZAD SHAHIDI
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PROFESSOR OF NEPHROLOGY
THE ALMIGHTY
Pardons & Grants me heaven
Even if I don't know a single letter about:
Crutz Feld Jacob’s Disease
Tsutsugamushi Fever
Crigler-Najjar Syndrome
South American equine encephalitis &
Many & much more rarer topics
BUT …….
THE ALMIGHTY
Will drag me to hell and will not pardon
My ignorance of even the minute details of HTN
My indifference to apply the current knowledge
My negligence in screening for HTN, TOD
My despondency about preventing TOD
My inadequacy in maintaining my patients
as normo-tensive as possible –
(This is applicable to all common diseases)
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RESULTS OF BP SCREENINGS
 Recheck in 2 yrs if nml
 Recheck in 1 yr if Pre–HTN
 Stage 1 - Confirm in 2 mos
 Stage 2 - Confirm in 1 mo
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 If > 180 / 110, treat now
GOALS OF THERAPY
 Reduce CVD & renal morbidity & mortality.
 Achieve SBP goal especially in persons >50 years
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of age.
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PATIENT EVALUATION
Evaluation of patients with documented HTN has three
objectives:
1. Assess lifestyle and identify other CV risk factors or
concomitant disorders that affects prognosis and
guides treatment.
2. Reveal identifiable causes of high BP.
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3. Assess the presence or absence of target organ damage
and CVD.
LABORATORY TESTS
 Routine Tests
 ECG
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Urinalysis
Blood glucose, & hematocrit
Serum K, Cr, or the corresponding estimated GFR, Ca
Lipid profile, after 9- to 12-hour fast, that includes HDL &
LDL & TG
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 Optional tests
 Measurement of urinary albumin excretion or Alb/Cr ratio
 More extensive testing for identifiable causes is not
generally indicated unless BP control is not achieved
LIFESTYLE MODIFICATION:
EFFECT ON BP
Weight reduction
Approximate SBP reduction
(range)
5 –20 mmHg/10 kg weight loss
Dietary sodium reduction
2–8 mmHg
Physical Activity
4–9 mmHg
Moderation of alcohol
consumption
2–4 mmHg
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Modification
BETA-BLOCKERS
• Are not a preferred initial therapy for HTN.
• May be considered in younger people,
particularly:
• Intolerance or contraindication to ACEI & ARB
• Women of child-bearing potential
• People with evidence of increased sympathetic drive
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• If therapy is initiated with a beta-blocker & a
second drug is required, add a calciumchannel blocker rather than a thiazide-like
diuretic to reduce the person’s risk of
developing DM.
DIURETICS
• When using further diuretic therapy
for resistant HTN:
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Monitor blood Na, K & renal function
within 1 month & repeat as required
thereafter.
FOR ADEQUATE CONTROL OF B.P.
Do you think we can control most of the
patients of HTN with:
One drug
Two drugs
Three drugs
Can’t control
In most of the patients
Two drugs are required for adequate control
More so if the initial BP is 20/10 above the goal
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2/3 of patients with HTN will
need at least 2 medicines for
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BP control
HTN – Why Combinations ?
 If goal BP is not achieved by a single drug in full dose
 Then adding another agent will help achieve the goal BP
 Two agents sometimes nullify each others side effects
 Fixed dose combinations will reduce the no. of tablets
 Once daily formulations are good for compliance
 Sustained release or LA formulations for 24 h BP control
 If 3 drugs can’t achieve goal BP : Resistant HTN
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2013 ESH/ESC Guidelines for the management of HTN
Green continuous : preferred combinations
Green dashed: useful combination
Black dashed lines: possible but less well tested combinations
Red : not recommended combination.
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 In patients with resistant HTN,
adding drugs to drugs should be
done with attention to results & any
compound overtly ineffective or
minimally effective should be
replaced, rather than retained in an
automatic step-up multiple-drug
approach
Osterberg, L. et al. N Engl J Med 2005
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Adherence to Medication According to
Frequency of Doses
PEARLS
For resistant HTN – sit down & take a good Hx:
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• How much water, coffee, milk, juice, tea, ice –
anything liquid do you drink daily.
• Food preferences & salt intake
• Drugs/Alcohol
• Compliance
CAUSES OF RESISTANT HTN
 Improper BP measurement
 Excess Na intake
 Inadequate diuretic therapy
 Medication
• Inadequate doses
• Drug actions & interactions:
NSAIDs, illicit drugs, sympathomimetics, OCP
• OTC drugs & herbal supplements
 Excess alcohol intake
JNC 7 Express. JAMA. 2003
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 Identifiable causes of HTN
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•Steroids
•Ketamine
•Estrogens
•Desflurane
•NSAIDS
•Carbamazepine
•Phenylpropanolamines
•Bromocryptine
•Cyclosporine/Tacrolimus
•Metoclopramide
•Erythropoietin
•Antidepressants
•Sibutramine
•Methylphenidate
• Venlafaxine
•Buspirone
•Ergotamine
•Clonidine
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DRUG-INDUCED HTN:
PRESCRIPTION MEDICATIONS
DRUG-INDUCED HTN: STREET
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Cocaine
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Ma huang “herbal ecstasy”
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Nicotine
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Anabolic steroids
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Narcotic withdrawal
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Methylphenidate
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Phencyclidine
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Ketamine
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Ergot-containing herbal products
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St John’s wort
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DRUGS & HERBAL PRODUCTS
SUBSTANCES ASSOCIATED WITH
HTN
• Sodium Chloride
• Ethanol
•Licorice
• Tyraminecontaining foods
(with MAOI)
Chemicals
•Lead
•Mercury
•Thallium & other
heavy metals
•Lithium salts
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Food Substances
FOLLOW-UP & MONITORING
JNC 7 Express. JAMA. 2003
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 Patients should return for follow-up &
adjustment of medications every 1-2 months
until the BP goal is reached
 After BP at goal & stable, follow-up visits at
3- to 6-month intervals
 More frequent visits for stage 2 HTN or with
complicating comorbid conditions
 Continue to encourage self BP monitoring
 Serum K & Cr monitored 1–2 times per year
NON - ADHERENCE
Misunderstanding of Condition
Denial of illness / Asymptomatic
Lack of patient involvement in care plan
Unexpected adverse effects of medicine
Too many f / u visits, lab requests
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KEYS TO ACHIEVING BP CONTROL
• BP checks at every patient care encounter
–Including optometry, OB-GYN, etc
• BP clinic (Non-MD clinic)
–Free & frequent visits, walk ins welcome
–Removing all barriers for patients
• Simple algorithm – easy for providers & patients
–One BP goal (<140/90) for all patients
–Emphasis on combination pills (lisinopril / HCTZ)
–Emphasis on getting to target BP control quickly
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• Feedback on Performance / Transparency
NEW FEATURES AND KEY
MESSAGES
 The most effective therapy prescribed by the
careful clinician will control HTN only if
patients are motivated.
 Motivation improves when patients have
positive experiences with, & trust in, the
clinician.
 The responsible physician’s judgment remains
paramount.
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 Empathy builds trust & is a potent motivator.
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CASES
CASE 1: DIAGNOSIS
AB is a 56 yo female with no significant PMH.
Her BMI is 26 & she has a FHx positive for Type 2 DM.
Her BP measured on 2 consecutive clinic visits is 132/84.
What is AB’s BP classification?
Normal
Prehypertensive
Stage 1 Hypertension
Stage 2 Hypertension
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1.
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4.
CASE 1: THERAPY
What therapy should be initiated for AB?
Enalapril 5 mg PO daily
Hydrochlorothiazide 25 mg PO daily
No therapy is indicated
Lifestyle modifications including weight
loss & DASH eating plan should be
encouraged
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1.
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4.
CASE 1: GOAL OF THERAPY
What is the goal of lifestyle modification in AB?
Goal BP < 140/90, the goal is to get to goal
Goal BP < 130/80, the goal is to get to goal
Improve patients quality of life
Prevent onset of hypertension
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1.
2.
3.
4.
CASE 1: 5 YEARS LATER
AB, now 59 y, returns to clinic with marginal success
at lifestyle changes. Her BP has repeatedly measured
around 146/92. What is AB’s BP classification?
Normal
Prehypertensive
Stage 1 Hypertension
Stage 2 Hypertension
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1.
2.
3.
4.
CASE 1: 5 YEARS LATER
AB, now 59, returns to clinic with marginal
success at lifestyle changes. Her BP has
repeatedly measured around 146/92. What
should be done?
Enalapril 5 mg PO daily
Hydrochlorothiazide 25 mg PO daily
No therapy is indicated
Reinforce lifestyle modifications
including weight loss and the DASH
eating plan.
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1.
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4.
CASE 2: GOAL OF THERAPY
CD is a 50 yo black male with diet controlled
type 2 diabetes. Consecutive BP measurements
during recent clinic visits are 162/98 and 158/96.
He is diagnosed with Stage 2 Hypertension.
What is the goal of therapy for CD?
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1. Goal BP <140/90
2. Goal BP <130/80
3. Slow the progression of diabetic renal disease by
reducing BP to <125/80
4. Improve patients quality of life
CASE 2: THERAPY
What therapy should be initiated for CD?
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1. A 6 month trial of lifestyle changes
should be initiated immediately
2. Hydrochlorothiazide 25 mg PO daily
3. Enalapril 10 mg PO daily
4. Enalapril / Hydrochlorothiazide 5/12.5
mg PO daily
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