Recent Developments in the Treatment of Hypertension

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Slide 1 :

Recent Developments in the Treatment of Hypertension The Value of Facts 1999

Slide 2 :

Objectives To review recent clinical trial evidence of efficacy for antihypertensive agents To present new data on the treatment of hypertensive patients with type 2 diabetes To discuss the emerging evidence for use of ACE inhibitors in diabetes To review recent safety data on antihypertensive agents

Slide 3 :

Documentation of Drug Safety and Efficacy Patients, clinicians and the health-care establishment expect adequate documentation A week-long treatment for an acute condition requires randomized trials that follow patients for > 1 week Lifelong treatments are ideally evaluated in lifelong trials, but evaluations in large populations over 4 to 5 years are typically accepted.

Slide 4 :

Antihypertensive Drugs: Documentation By the Time of Regulatory Approval BP lowering potential (N = 200-500 patients) Common side effects (symptoms) Any common early drug complications (events) Major changes in blood chemistry Major animal toxicity Known

Slide 5 :

Antihypertensive Drugs: Documentation By the Time of Regulatory Approval Effect on major CVD mortality/morbidity Optimal dose (risk-benefit balance) Uncommon early side effects or clinical complications ADRs and complications of long-term drug use Efficacy or safety in various subgroups Effect on pregnancy Drug interactions Unknown

Slide 6 :

Aim of Antihypertensive Therapy To prevent the cardiovascular complications of hypertension -- stroke, acute myocardial infarction, congestive heart failure -- not just to lower an elevated blood pressure.

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Eligibility criteria for meta-analysis Randomized placebo controlled trials Treatment duration of > 1 year Assessment of major disease endpoints Unconfounded by other therapies Psaty et al., JAMA 1997

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Definition of Treatment Strategies Multiple agents used in most trials Trials classified by first-line strategy -- High-dose diuretic therapy -- Low-dose diuretic therapy -- Beta-blocker therapy No eligible trials evaluating CCBs or ACE inhibitors Psaty et al., JAMA 1997

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Meta-analysis: Antihypertensives Event RR 95% CI High-dose diuretics Psaty et al., JAMA 1997 Stroke 0.49 0.39-0.62 CHF 0.17 0.07-0.41 CHD 0.99 0.83-1.18 Total mortality 0.88 0.75-1.03

Slide 11 :

Meta-analysis: Antihypertensives Event RR 95% CI Low-dose diuretics Psaty et al., JAMA 1997 Stroke 0.66 0.55-0.78 CHF 0.58 0.44-0.76 CHD 0.72 0.61-0.85 Total mortality 0.90 0.81-0.99

Slide 12 :

Meta-analysis: Antihypertensives Event RR 95% CI Beta-blockers Psaty et al., JAMA 1997 Stroke 0.71 0.59-0.85 CHF 0.58 0.40-0.84 CHD 0.93 0.80-1.09 Total mortality 0.95 0.84-1.07

Slide 13 :

Summary of Major Findings High-dose diuretic and ß-blocker therapies reduced the incidence of CHF and stroke Low-dose diuretic therapy reduced the incidence not only of CHF and stroke but also of CHD and total mortality High-dose versus low-dose diuretic comparison was confounded by patient age Psaty et al., JAMA 1997

Slide 14 :

Syst-Eur -- Nitrendipine in ISH Randomized, placebo-controlled, 2N = 4,695 Baseline, mean age 70 yrs, BP 174/85 mm Hg Median FU of 2 yrs, BP ??10/5 mm Hg Step-up drugs: enalapril (33%), HCTZ (20%) 237 randomized patients lost-to-follow-up Reduction in stroke: RR 0.58, 95% CI 0.40 - 0.83 CHF: RR 0.71, 95% CI 0.47 - 1.10 Staessen et al., Lancet 1997

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Slide 16 :

Captopril Prevention Project (CAPPP) Design Randomized, open Population 10,985 hypertensives, aged 25- 66 years, with DBP > 100 mm Hg Intervention Captopril (50-100 mg) vs clinician’s choice of a diuretic or a ß-blocker; diuretic or the other class as step-up Follow-up Average of 6.1 years Hansson et al., Lancet 1999

Slide 17 :

Stroke, MI, CV death Stroke 0.33 0.5 1 2 Relative Risk MI Death Captopril better Conventional treatm. better Captopril Prevention Project - CAPPP Diabetes Outcome Hansson et al., Lancet 1999

Slide 18 :

Limitations of CAPPP Captopril only given once or twice per day Flawed randomization process (envelopes) Baseline difference on BP unlikely explained by chance Potential differential evaluation of incident diabetes in the 2 groups due to lack of blinding Cutler, Lancet 1999

Slide 19 :

Antihypertensive Treatment in Type 2 Diabetes 1. Active treatment vs control (placebo) 2. More tight vs less tight BP control 3. Comparisons of active treatments

Slide 20 :

SHEP - CV Event Rate in ISH by Diabetes Status Curb et al., JAMA 1996 Annual cardiovascular event rate (%) No diabetes Diabetes 0 1 2 3 4 5 6 7 RR .66, 95%CI .55-.79 RR .66, 95%CI .46-.94

Slide 21 :

Syst-Eur -- Diabetic Cohort No. of Events Tuomilento et al., NEJM 1999 Mortality Stroke Cardiac Events Nitrendipine Placebo 0 5 10 15 20 25 30 26 16 15 5 15 NS p=0.02 7 NS

Slide 22 :

UK Prospective Diabetes Study 150/85 vs 180/105 mmHg BP Target Endpoint RR 95% CI Any endpoint 0.76 0.62-0.92 Diabetes death 0.68 0.49-0.94 Any death 0.82 0.63-1.08 MI 0.79 0.59-1.07 Stroke 0.56 0.35-0.89 PAD 0.51 0.19-1.37 Microvascular dis. 0.63 0.44-0.89 n = 758 vs 390 UKPDS Group, BMJ 1998

Slide 23 :

HOT - Rate of Major CV Events According to Randomized Groups BP goal mmHg p for trend 0.005 p for trend 0.5 Hansson et al., Lancet 1998 0 5 10 15 20 25 30 All n=18790 Diabetic n=1501 Rate/1000 person-years <90 <85 <80

Slide 24 :

FACET ABCD UKPDS CAPPP MIDAS Comparative Trials in Hypertensives with Type 2 Diabetes or Impaired Glucose Metabolism

Slide 25 :

FACET - Fosinopril versus Amlodipine Cardiovascular Events Trial Design Prospective randomized trial Patients Hypertension and type 2 diabetes Sample size 380 patients Intervention Fosinopril / amlodipine open label Outcomes - Primary: serum lipids - Secondary: CV events, BP Follow-up 2.5 to 3.5 years Tatti et al., Diabetes Care 1998

Slide 26 :

Tatti et al., Diabetes Care 1998 Cardiovascular Events in FACET Stroke AMI Rate per 100 person-years 0 1 2 3 4 5 10 14 13 27 10 4 p=.03 4 0 The figures at top of the bars indicate the number of events Any major CV event Hospit. Angina

Slide 27 :

ABCD Trial Design Double-blind randomized trial Enalapril vs nisoldipine Intensive vs moderate BP control Patients Type 2 diabetes, a normotensive and a hypertensive group Outcomes - Primary: renal function - Secondary: CV events, BP Follow-up 5 years Estacio et al., NEJM 1998

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