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  1. 1. Intervention proposed for the gaps of clinical target in hypertension Stéphane Rinfret, MD, MSc, FRCPC Cardiologist and epidemiologist Centre hospitalier de l’Université 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
  2. 2. Disclosures <ul><li>S Rinfret received grant support and consulting fees from Pfizer Canada </li></ul>
  3. 3. <ul><li>In Canada in 2005 </li></ul><ul><li>91% of the 22 million medical visits for hypertension were done in primary care </li></ul><ul><li>70,7 million prescriptions for antihypertensive agents were carried out in 2005 </li></ul><ul><ul><ul><li>In constant increase since 2001 </li></ul></ul></ul><ul><ul><ul><ul><li>IMS Health, Canada (2006) </li></ul></ul></ul></ul>The importance of hypertension in primary care
  4. 4. <ul><li>In Québec, in 2005 </li></ul><ul><ul><li>Close to one million people were affected </li></ul></ul><ul><ul><ul><li>15% of the population over the age of 12 </li></ul></ul></ul><ul><ul><ul><li>43% of people 65 and over </li></ul></ul></ul><ul><ul><ul><ul><li>Statistics Canada, The Canadian Community Health Survey (CCHS) , 2005 </li></ul></ul></ul></ul><ul><li>Out of all the chronic health problems in primary care </li></ul><ul><ul><li>Hypertension is the most frequent </li></ul></ul>The importance of hypertension in primary care
  5. 5. Hypertension in the World Marques-Vidal P et Tuomilehto J. J Hum Hypertens 1997;11:213–220. % of hypertension 0 5 10 15 20 25 30 35 0 5 10 15 20 25 30 35 Germany Australia Scotland Egypt Finland Taïwan Spain Canada United-States India China Men Women Both
  6. 6. 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) High Blood Pressure 0 1 2 3 4 5 6 7 Developping countries Developped countries
  7. 7. Hypertension in Canada 22% of Canadian adults between the ages of 18 to 70 are hypertensive 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 Hypertension that has been diagnosed but neither treated nor controlled Hypertension that has been treated and controlled 21% Hypertension that has been treated but remains uncontrolled 22% 13% 9% Hypertension and diabetes 43% Undiagnosed hypertension
  8. 8. Knowledge and attitudes towards hypertension Arch Intern Med 2003 ; 163: 681-7
  9. 9. 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 Hypertension remains uncontrolled in the vast majority of hypertensive patients (BP≥140/90 mmHg) Wolf-Maier K, et al . 2004 0 20 40 60 80 100 Spain Switzerland Germany Italy England Canada USA
  10. 10. ARB vs. BB vs. CCB vs. ACEI vs. Diur
  11. 11. Multiple antihypertensive agents are needed to achieve target BP 1 2 3 4 Bakris GL, et al. 2000; Lewis EJ, et al . 2001 UKPDS = United Kingdom Prospective Diabetes Study ABCD = Appropriate Blood Pressure Control in Diabetes MDRD = Modification of Diet in Renal Disease HOT = Hypertension Optimal Treatment IDNT = Irbesartan Diabetic Nephropathy Trial AASK = African American Intervention Study of Kidney Disease AASK TAM <92 Target BP (mmHg) UKPDS TAD <85 ABCD TAD <75 MDRD TAM <92 HOT TAD <80 Trial Average number of anti-hypertensive agents needed to attain the target BP IDNT TAS/TAD 135/85
  12. 12. 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 2002;20:1461-64. Effects of an antihypertensive treatment on the BPS and BPD of patients with HTN - main trials
  13. 14. Hypertension in primary care <ul><li>Hypertension is one of the most frequent problems in primary care </li></ul><ul><ul><li>First </li></ul></ul><ul><ul><li>Stange, et al 1998 </li></ul></ul><ul><ul><li>Second </li></ul></ul><ul><ul><li>Rosser, NAPCRG, 2002 </li></ul></ul><ul><li>Of 8 486 visits in primary care clinic of la Cité de la Santé </li></ul><ul><ul><li>HT is the first Dx in 8% of the visits (MT Lussier, personal communication) </li></ul></ul>
  14. 15. <ul><li>Patients followed in primary care </li></ul><ul><ul><li>2 to 6 visits/year </li></ul></ul><ul><ul><li>10 minutes/visit </li></ul></ul><ul><ul><li>2,3 health problems/visit </li></ul></ul><ul><ul><ul><li>Stange et al,1998 </li></ul></ul></ul><ul><ul><ul><li>Lussier et al, 1999 </li></ul></ul></ul>Hypertension in primary care
  15. 16. <ul><li>During the visits, when precdribing CV medications, there is little discussion on: </li></ul><ul><ul><li>adherence (4,5%) </li></ul></ul><ul><ul><li>difficulties in adhering to the drug regimen (3,8%) </li></ul></ul><ul><ul><li>proposed solutions (1,1%) </li></ul></ul><ul><ul><li>the effects of non compliance (3,0%) </li></ul></ul><ul><ul><ul><li>Richard, Lussier 2002 </li></ul></ul></ul>Hypertension in primary care
  16. 17. <ul><li>Drug adherence is a complex phenomenon </li></ul><ul><ul><li>HT is asymptomatic </li></ul></ul><ul><li>Non-adherence : one of the main difficulties of the practice </li></ul><ul><ul><li>Beaulieu et Leclere, 1993 </li></ul></ul><ul><li>Few tools to support adherence </li></ul><ul><li>In between visits, patients are left by themselves… </li></ul>Hypertension in primary care
  17. 18. Economic impact of non-compliance Sokol et al Medical Care • Volume 43, Number 6, June 2005 <ul><li>HMO plan covered patients </li></ul><ul><li>US </li></ul><ul><li>06/97 to 06/99 </li></ul><ul><li>7981 patients with HTN </li></ul>
  18. 19. « 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)
  19. 20. Multidisciplinary intervention studies Yes, active intervention    Rudd P et al Am J Hypertens. 2004; 17(10):921-7 ?     LOYAL Yes    Rogers MAM et al Ann Intern Med 2001;134:1024-1032 Yes  Friedman RH et al AJH 1996:9:285-92 Yes  Okamoto MP; Nakahiro RK. Pharmacotherapy 2001; 21(11):1337-44 Yes McPherson CPet al, Am J Manag Care 2002: 8(6):543-55 Yes   Borenstein JE Pharmacotherapy 2003; 23(2):209-216. No  Hamet P et al Exp Clin Cardiol 2002; 7 (4): 165-172 Significant reduction in BP? ABPM Feedback to heath prof IT RCT Study
  20. 21. 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
  21. 22. Funding and Disclosures <ul><li>Funding </li></ul><ul><li>Sponsored by Pfizer Canada </li></ul><ul><li>Supplementary support by </li></ul><ul><ul><li>CIHR Rx&D RCT grant (with Pfizer Canada) </li></ul></ul><ul><ul><li>Fonds de la recherche en santé du Québec </li></ul></ul>
  22. 23. Background <ul><li>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. </li></ul><ul><li>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. </li></ul>
  23. 24. Study Design & Methodology <ul><li>Patients unlikely to complete study or </li></ul><ul><li>With chronic atrial fibrillation or </li></ul><ul><li>Pregnant or </li></ul><ul><li>Participating in another clinical trial </li></ul>Exclusion criteria <ul><li>Consenting male and female patients > 18 years of age </li></ul><ul><li>Mean 24 hour BP > 130/80 and </li></ul><ul><li>mean daytime values > 135/85mm Hg </li></ul>Inclusion criteria <ul><li>22 Family Physicians </li></ul><ul><li>8 community primary care clinics Laval, Canada </li></ul><ul><li>32 pharmacies </li></ul>Recruitment sites 12 months Follow-up May 2004 to February 2007 Enrolment period RCT with PROBE design (Prospective, Randomized, Open label, Blinded Endpoints) NCT00374829; ISRCTN Register, ISRCTN75436659 Design type
  24. 25. Trial Design Visit 1 Study Enrolment & Baseline ABPM (-1 to -7 days) Intervention group (n=250) Computerised telephone-based reminder and BP monitoring system Control group (n=250) Usual care Randomization 1:1 Usual Care & FU visits Throughout Study <ul><li>Randomization was stratified according to: </li></ul><ul><li>newly diagnosed and untreated hypertension vs. treated and uncontrolled hypertension </li></ul><ul><li>b) presence or absence of current pharmacological treatment for concomitant disease(s) </li></ul>Visit 2 ABPM return, Randomization (day 0) Study End ABPM (365 days + 21 days) Final Visit
  25. 26. Intervention group <ul><ul><li>Usual care + </li></ul></ul><ul><ul><li>Log book </li></ul></ul><ul><ul><li>BP monitor </li></ul></ul><ul><ul><li>Access to an IT-based telephone BP and adherence monitoring system </li></ul></ul><ul><ul><li>Facilitated communication between physicians, pharmacists, nurses and patients </li></ul></ul>
  26. 27. LOYAL multidisciplinary intervention <ul><li>Patient provide the system, using voice recognition technology, with : </li></ul><ul><li>Weekly BP measures </li></ul><ul><li>Self reported adherence </li></ul><ul><li>System supports the patients in order to improve adherence: </li></ul><ul><li>Daily reminders to take the medication </li></ul><ul><li>Reminders to refill or renew the medication </li></ul><ul><li>E-mail alerts to the nurse about: </li></ul><ul><li>Drug adherence </li></ul><ul><li>Blood pressure </li></ul>Nurse intervention with the patient, or with the physician Download of pharmacy data into the system Pharmacist can intervene Monthly reports To physicians on BP And adherence
  27. 28. How did the IT system work? <ul><li>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 . </li></ul><ul><li>The system alerted nurses by e-mail if BP targets were not achieved or in the event of non-adherence. </li></ul><ul><li>Nurses then contacted patients, provided counseling and/or referred patients to their physician as appropriate following a pre-determined algorithm . </li></ul>
  28. 29. Primary Efficacy Endpoint Mean change ( Δ ) in the mean 24-hour systolic and diastolic BP between baseline and 12 months, measured using ambulatory BP monitoring (ABPM)
  29. 30. Secondary Efficacy Endpoints <ul><li>1. Δ daytime SBP and DBP ABPM </li></ul><ul><li>2. Δ nocturnal SBP and DBP ABPM </li></ul><ul><li>3. Δ office SBP and DBP </li></ul><ul><li>4. Proportion of subjects who achieve BP target </li></ul><ul><li>5. Drug adherence, by continuous medication availability (CMA) </li></ul><ul><li>6. Drug adherence by gaps in medication availability (CMG) </li></ul><ul><li>7. Medication changes </li></ul><ul><li>8. Number of anti-hypertensive agents </li></ul>
  30. 31. Challenges of a clinical trial <ul><li>Collaboration between the academic sector and the realities of primary care </li></ul><ul><li>Many IT suppliers in the pharmacies </li></ul><ul><li>Non-scientific considerations </li></ul><ul><ul><li>Pontential to drive the patients towards a particular chain of pharmacies </li></ul></ul><ul><ul><li>Expectations of the different partners </li></ul></ul>
  31. 32. Practical issues <ul><li>Operation costs </li></ul><ul><li>Impact on QOL (“Big Brother” effect?) </li></ul><ul><li>LOYAL patient = motivated patient, more compliant (?) </li></ul><ul><li>Implementation – GMF? </li></ul>
  32. 33. « La maladie ne se guérit point en prononçant le nom du médicament, mais en prenant le médicament. » -Sankara Extrait de Viveka Chudamani
  33. 34. « 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 ! »
  34. 35.   Late Breaking and Featured Clinical Trial Session October 24th, 2007