Diapositive 1

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Intervention proposed for the gaps of clinical
target in hypertension
Stéphane Rinfret, MD, MSc, FRCPC Cardiologist and
epidemiologist Centre hospitalier de lUniversité
de Montréal
HOW CAN I MAKE A DIFFERENCE IN HYPERTENSION
MANAGEMENT? A MULTIDISCIPLINARY SYMPOSIUM FOR
HEALTH CARE PROFESSIONALS October 19th 2007 CHUQ
Pavillon Hôtel-Dieu de Québec
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Disclosures

• S Rinfret received grant support and consulting
  fees from Pfizer Canada

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The importance of hypertension in primary care

• In Canada in 2005
• 91 of the 22 million medical visits for
  hypertension were done in primary care
• 70,7 million prescriptions for antihypertensive
  agents were carried out in 2005
• In constant increase since 2001
• IMS Health, Canada (2006)

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The importance of hypertension in primary care

• In Québec, in 2005
• Close to one million people were affected
• 15 of the population over the age of 12
• 43 of people 65 and over
• Statistics Canada, The Canadian Community Health
  Survey (CCHS), 2005
• Out of all the chronic health problems in primary
  care
• Hypertension is the most frequent

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Hypertension in the World
of hypertension
Marques-Vidal P et Tuomilehto J. J Hum Hypertens
199711213220.
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Hypertension remains the principal cause of death
in the world-wide population
Smoking Hypercholesterolemia Insufficient
weight Unprotected sex Low intake of fruits and
vegetables Elevated BMI Lack of physical
activity Alcoholism Contaminated water, poor
sanitation and hygiene
of Deaths (millions)
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Hypertension in Canada
22 of Canadian adults between the ages of 18 to
70 are hypertensive
Hypertension that has been treated and controlled
Hypertension that has been diagnosed but neither
treated nor controlled
Joffres MR, Hamet P, MacLean DR , Gilbert JL,
Fodor G. Distribution of Blood Pressure and
Hypertension in Canada and the United States. AmJ
Hypertens 2001 14 1099 1105
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Knowledge and attitudes towards hypertension
Arch Intern Med 2003 163 681-7
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Hypertension remains uncontrolled in the vast
majority of hypertensive patients (BP140/90 mmHg)
Uncontrolled hypertension( of the total number
of hypertensive patients between the ages of 35
and 64) Uncontrolled hypertension is defined as
BP 140/90 mmHg
Wolf-Maier K, et al. 2004
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ARB vs. BB vs. CCB vs. ACEI vs. Diur
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Multiple antihypertensive agents are needed to
achieve target BP
1
2
3
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UKPDS United Kingdom Prospective Diabetes
StudyABCD Appropriate Blood Pressure Control
in DiabetesMDRD Modification of Diet in Renal
DiseaseHOT Hypertension Optimal Treatment IDNT
Irbesartan Diabetic Nephropathy Trial AASK
African American Intervention Study of Kidney
Disease
Bakris GL, et al. 2000 Lewis EJ, et al. 2001
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Effects of an antihypertensive treatment on the
BPS and BPD of patients with HTN - main trials
The pressure measurements taken at the beginning
(B) and during the treatment (T) are indicated
for each trial. The dashed horizontal lines
represent the target pressure measurements for
the treatments according to international
guidelines.
Mancia G, Grassi G. J Hypertens 2002201461-64.
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Hypertension in primary care

• Hypertension is one of the most frequent problems
  in primary care
• First
• Stange, et al 1998
• Second
• Rosser, NAPCRG, 2002
• Of 8 486 visits in primary care clinic of la Cité
  de la Santé
• HT is the first Dx in 8 of the visits (MT
  Lussier, personal communication)

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Hypertension in primary care

• Patients followed in primary care
• 2 to 6 visits/year
• 10 minutes/visit
• 2,3 health problems/visit
• Stange et al,1998
• Lussier et al, 1999

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Hypertension in primary care

• During the visits, when precdribing CV
  medications, there is little discussion on
• adherence (4,5)
• difficulties in adhering to the drug regimen
  (3,8)
• proposed solutions (1,1)
• the effects of non compliance (3,0)
• Richard, Lussier 2002

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Hypertension in primary care

• Drug adherence is a complex phenomenon
• HT is asymptomatic
• Non-adherence one of the main difficulties of
  the practice
• Beaulieu et Leclere, 1993
• Few tools to support adherence
• In between visits, patients are left by
  themselves

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Economic impact of non-compliance
Sokol et al Medical Care Volume 43, Number 6,
June 2005

• HMO plan covered patients
• US
• 06/97 to 06/99
• 7981 patients with HTN

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 The principal problem in the treatment of the
diseases today is the lack of adherance that the
patients have to the pharmalogical treatments 
(AHA 2004)
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Multidisciplinary intervention studies
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The Impact of a Multidisciplinary, Information
Technology Supported Program on Blood Pressure
Control in Primary Care (The Loyal Study)
S Rinfret, M-T Lussier, F Duhamel, S Cossette, L
Lalonde, A Peirce, C Tremblay, F Ali, M-C
Guertin, J LeLorier, J Turgeon and P Hamet
 Late Breaking and Featured Clinical
Trial Session October 24th, 2007
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Funding and Disclosures

• Funding
• Sponsored by Pfizer Canada
• Supplementary support by
• CIHR RxD RCT grant (with Pfizer Canada)
• Fonds de la recherche en santé du Québec

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Background

• Although the positive effects of optimal blood
  pressure (BP) control on morbidity and mortality
  have been clearly established, the majority of
  hypertensive patients are inadequately
  controlled.
• We hypothesized that a multidisciplinary,
  information technology (IT) supported program
  empowering patients to be responsible for
  monitoring their BP and adherence and
  facilitating communication between physicians,
  pharmacists, nurses and patients would have a
  positive impact on BP levels.

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Study Design Methodology
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Trial Design
Intervention group (n250) Computerised
telephone-based reminder and BP monitoring system
Randomization 11
Control group (n250) Usual care
Visit 1 Study Enrolment Baseline ABPM (-1 to
-7 days)
Visit 2 ABPM return, Randomization (day 0)
Usual Care FU visits Throughout Study
Study End ABPM (365 days 21 days)
Final Visit

• Randomization was stratified according to
• newly diagnosed and untreated hypertension vs.
  treated and uncontrolled hypertension
• b) presence or absence of current pharmacological
  treatment for concomitant disease(s)

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Intervention group

• Usual care
• Log book
• BP monitor
• Access to an IT-based telephone BP and adherence
  monitoring system
• Facilitated communication between physicians,
  pharmacists, nurses and patients

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LOYAL multidisciplinary intervention

• E-mail alerts to the nurse about
• Drug adherence
• Blood pressure

Download of pharmacy data into the system
Nurse intervention with the patient, or with the
physician
Pharmacist can intervene
Monthly reports To physicians on BP And adherence

• Patient provide the system, using voice
  recognition technology, with
• Weekly BP measures
• Self reported adherence
• System supports the patients in order to improve
  adherence
• Daily reminders to take the medication
• Reminders to refill or renew the medication

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How did the IT system work?

• The system collected data from patients via
  telephone and pharmacy data electronically and
  provided nurses, pharmacists and physicians
  monthly reports on patients BP levels and
  adherence.
• The system alerted nurses by e-mail if BP targets
  were not achieved or in the event of
  non-adherence.
• Nurses then contacted patients, provided
  counseling and/or referred patients to their
  physician as appropriate following a
  pre-determined algorithm.

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Primary Efficacy Endpoint

• Mean change (?) in the mean 24-hour systolic and
  diastolic BP between baseline and 12 months,
  measured using ambulatory BP monitoring (ABPM)

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Secondary Efficacy Endpoints

• 1. ? daytime SBP and DBP ABPM
• 2. ? nocturnal SBP and DBP ABPM
• 3. ? office SBP and DBP
• 4. Proportion of subjects who achieve BP target
• 5. Drug adherence, by continuous medication
  availability (CMA)
• 6. Drug adherence by gaps in medication
  availability (CMG)
• 7. Medication changes
• 8. Number of anti-hypertensive agents

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Challenges of a clinical trial

• Collaboration between the academic sector and the
  realities of primary care
• Many IT suppliers in the pharmacies
• Non-scientific considerations
• Pontential to drive the patients towards a
  particular chain of pharmacies
• Expectations of the different partners

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Practical issues

• Operation costs
• Impact on QOL (Big Brother effect?)
• LOYAL patient motivated patient, more compliant
  (?)
• Implementation GMF?

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La maladie ne se guérit point en prononçant le
nom du médicament, mais en prenant le médicament.

• -Sankara
• Extrait de Viveka Chudamani

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Le médicament reste le principal symbole de la
puissance du médecin.

• -Denis Jaffe Extrait de La guérison est en soi

La non-observance lui rappelle sa grande
faiblesse !
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 Late Breaking and Featured Clinical
Trial Session October 24th, 2007