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Blood pressure control in the CONVINCE study
AJH–APRIL 2000 –VOL. 13, NO. 4, PART 2
POSTERS: Clinical Trials
Age (yrs.)
55–59
60–64
65–69
70–74
75ⴙ
MI % Stroke %
1.5 1.3
2.2 1.7
2.4 3.1
3.4 4.2
3.4 4.9
reductions in BP and coronary risk. The Framingham 5-year risk score is useful to predict CV complications in these patients. The risks of myocardial infarction and stroke are strongly age-dependent in hypertensive patients with LVH. Key Words: Clinical trial; hypertension; left ventricular hypertrophy; losartan B019 FEOLDIPINE IMPROVES LEFT VENTRICULAR HYPERTROPHY AND QUALITY OF LIFE IN STAGE 1 ISOLATED SYSTOLIC HYPERTENSION H.R. Black*, W.J. Elliott*, J.A. Strom*, P.R. Liebson*, M.I. Klibaner, and M.M. Schleman for the SISH Study Group. Department of Preventive Medicine, RUSH Medical College, Chicago, IL Stage 1 isolated systolic hypertension is common in the older population, but there are no data showing that pharmacological treatment is beneficial. A randomized, double-blind, parallel group, multicenter clinical trial was therefore performed in 171 patients (49% male, aged 66⫾7 years, 49% white, 30% Hispanic) with a baseline blood pressure of 149⫾7/83⫾6 mm Hg, comparing felodipine extended-release (2.5, 5, or 10 mg/d) or matching placebo. Two-dimensional echocardiograms and the Psychological General WellBeing (PGWB) Index, a validated quality-of-life instrument, were performed at baseline and after 52 weeks of treatment. Medications were increased by forced titration if the systolic BP was not ⬍ 140 mm Hg, or lowered by 10% compared to baseline. After 52 weeks of treatment, felodipine significantly lowered blood pressure (to 137.0⫾11.7/80.2⫾7.6 mm Hg, compared to 147.5⫾16.0/83.5⫾9.7 mm Hg with placebo, P ⬍ 0.01 for each), reduced the incidence of left ventricular hypertrophy (7% vs. 24%, P ⬍ 0.04), and improved quality of life compared to baseline (change in PGWB Index: 3.0⫾6.8 for felodipine vs. ⫺0.8⫾10.3 for placebo, P ⬍ 0.01). There were no clinically significant differences between treatments regarding tolerability or adverse effects. These data suggest that Stage 1 isolated systolic hypertension can be effectively and safely treated with felodipine, and that such treatment improves cardiac structure and quality of life. Larger and longer studies will be needed to prove that such treatment reduces cardiovascular event rates. Key Words: Clinical trial; placebo; elderly B020 BLOOD PRESSURE CONTROL IN THE CONVINCE STUDY H.R. Black*, W.J. Elliott,* G. Grandits, J.D. Neaton, and R.J. Anders, for the CONVINCE Research Group. Department of Preventive Medicine, RUSH-Presbyterian-St. Luke’s Medical Center, Chicago, IL
61A
Data from Part 1 of the Third National Health and Nutrition Educational Survey indicate that only 27.4% of Americans with hypertension have controlled blood pressure (BP, systolic ⬍ 140 mm Hg, AND diastolic ⬍ 90 mm Hg) during home measurements by trained nurses. We analyzed data from 16,602 hypertensive subjects from 15 countries enrolled in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial, to assess the prevalence of controlled hypertension at entry and after assignment to a stepwise program to reach a goal BP of ⬍ 140/90 mm Hg (“End of Titration”). Results of office-based BP measurements were collected from 661 clinical sites by faxed case report form and/or by transtelephonic interactive voice-response computer system: % Controlled Time in Study
n
systolic
diastolic
both
Entry End of titration 6 months 12 months 18 months
16,385 14,687 13,906 9,980 6,582
23.4 85.8 70.7 68.6 68.3
52.4 94.4 89.9 89.8 90.4
20.3 84.9 69.1 66.9 66.4
These data indicate that attaining control of systolic BP is more difficult than for diastolic BP, and suggest that the US national goal of having 50% of hypertensives with BP ⬍ 140/90 mm Hg may be achievable if forced titration is used. Interested investigators, free care and medications, and welleducated subjects may make attaining such a goal easier in the CONVINCE study than in the general population. Key Words: Controlled hypertension; prevalence; clinical trial B021 HEMODYNAMIC AND VOLUME CHANGES DURING INTENSIVE TREATMENT (Rx) FOR RESISTANT HYPERTENSION (ResHTN) S.J. Taler*, J. Augustine, J.C. Burnett, S.C. Textor*. Mayo Clinic, Rochester, MN Hypertension (HTN) resistant to multiple agents continues to pose a dilemma to clinicians. We characterized systemic hemodynamics (HD) and volume markers in 63 pts with ResHTN at entry and after 3 mos. of intensive drug adjustment. CV risk was high (32% diabetic, 46% hyperlipidemic) with multiple comorbidities. BP, noninvasive HD (thoracic bioimpedance TBI), renal function (Screat) and circulating volume markers (atrial natriuretic peptide ANP, plasma renin activity, PRA) were measured. An RN changed drug Rx at monthly visits under HTN specialist direction. Mean age was 66⫾2 yrs. BP fell from 171⫾2/88⫾2 to 142⫾2/76⫾1 mm Hg (p⬍0.01) with an increase from 3.6⫾0.1 to 4.1⫾0.1 meds/pt (p⬍0.01). Elevated ANP levels and rise in TBI (p⬍0.01) during Rx demonstrate occult volume excess despite diuretic Rx. During intensive Rx, diuretic doses increased (p⬍0.01) as did dihydropyridine calcium blocker use (p⬍0.01). Serum creat rose (1.4⫾0.1 to 1.6⫾0.1 mg/dL, p⬍0.01) without change in weight. Our results indicate that RH pts have increased
POSTERS: Clinical Trials
Age (yrs.)
55–59
60–64
65–69
70–74
75ⴙ
MI % Stroke %
1.5 1.3
2.2 1.7
2.4 3.1
3.4 4.2
3.4 4.9
reductions in BP and coronary risk. The Framingham 5-year risk score is useful to predict CV complications in these patients. The risks of myocardial infarction and stroke are strongly age-dependent in hypertensive patients with LVH. Key Words: Clinical trial; hypertension; left ventricular hypertrophy; losartan B019 FEOLDIPINE IMPROVES LEFT VENTRICULAR HYPERTROPHY AND QUALITY OF LIFE IN STAGE 1 ISOLATED SYSTOLIC HYPERTENSION H.R. Black*, W.J. Elliott*, J.A. Strom*, P.R. Liebson*, M.I. Klibaner, and M.M. Schleman for the SISH Study Group. Department of Preventive Medicine, RUSH Medical College, Chicago, IL Stage 1 isolated systolic hypertension is common in the older population, but there are no data showing that pharmacological treatment is beneficial. A randomized, double-blind, parallel group, multicenter clinical trial was therefore performed in 171 patients (49% male, aged 66⫾7 years, 49% white, 30% Hispanic) with a baseline blood pressure of 149⫾7/83⫾6 mm Hg, comparing felodipine extended-release (2.5, 5, or 10 mg/d) or matching placebo. Two-dimensional echocardiograms and the Psychological General WellBeing (PGWB) Index, a validated quality-of-life instrument, were performed at baseline and after 52 weeks of treatment. Medications were increased by forced titration if the systolic BP was not ⬍ 140 mm Hg, or lowered by 10% compared to baseline. After 52 weeks of treatment, felodipine significantly lowered blood pressure (to 137.0⫾11.7/80.2⫾7.6 mm Hg, compared to 147.5⫾16.0/83.5⫾9.7 mm Hg with placebo, P ⬍ 0.01 for each), reduced the incidence of left ventricular hypertrophy (7% vs. 24%, P ⬍ 0.04), and improved quality of life compared to baseline (change in PGWB Index: 3.0⫾6.8 for felodipine vs. ⫺0.8⫾10.3 for placebo, P ⬍ 0.01). There were no clinically significant differences between treatments regarding tolerability or adverse effects. These data suggest that Stage 1 isolated systolic hypertension can be effectively and safely treated with felodipine, and that such treatment improves cardiac structure and quality of life. Larger and longer studies will be needed to prove that such treatment reduces cardiovascular event rates. Key Words: Clinical trial; placebo; elderly B020 BLOOD PRESSURE CONTROL IN THE CONVINCE STUDY H.R. Black*, W.J. Elliott,* G. Grandits, J.D. Neaton, and R.J. Anders, for the CONVINCE Research Group. Department of Preventive Medicine, RUSH-Presbyterian-St. Luke’s Medical Center, Chicago, IL
61A
Data from Part 1 of the Third National Health and Nutrition Educational Survey indicate that only 27.4% of Americans with hypertension have controlled blood pressure (BP, systolic ⬍ 140 mm Hg, AND diastolic ⬍ 90 mm Hg) during home measurements by trained nurses. We analyzed data from 16,602 hypertensive subjects from 15 countries enrolled in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial, to assess the prevalence of controlled hypertension at entry and after assignment to a stepwise program to reach a goal BP of ⬍ 140/90 mm Hg (“End of Titration”). Results of office-based BP measurements were collected from 661 clinical sites by faxed case report form and/or by transtelephonic interactive voice-response computer system: % Controlled Time in Study
n
systolic
diastolic
both
Entry End of titration 6 months 12 months 18 months
16,385 14,687 13,906 9,980 6,582
23.4 85.8 70.7 68.6 68.3
52.4 94.4 89.9 89.8 90.4
20.3 84.9 69.1 66.9 66.4
These data indicate that attaining control of systolic BP is more difficult than for diastolic BP, and suggest that the US national goal of having 50% of hypertensives with BP ⬍ 140/90 mm Hg may be achievable if forced titration is used. Interested investigators, free care and medications, and welleducated subjects may make attaining such a goal easier in the CONVINCE study than in the general population. Key Words: Controlled hypertension; prevalence; clinical trial B021 HEMODYNAMIC AND VOLUME CHANGES DURING INTENSIVE TREATMENT (Rx) FOR RESISTANT HYPERTENSION (ResHTN) S.J. Taler*, J. Augustine, J.C. Burnett, S.C. Textor*. Mayo Clinic, Rochester, MN Hypertension (HTN) resistant to multiple agents continues to pose a dilemma to clinicians. We characterized systemic hemodynamics (HD) and volume markers in 63 pts with ResHTN at entry and after 3 mos. of intensive drug adjustment. CV risk was high (32% diabetic, 46% hyperlipidemic) with multiple comorbidities. BP, noninvasive HD (thoracic bioimpedance TBI), renal function (Screat) and circulating volume markers (atrial natriuretic peptide ANP, plasma renin activity, PRA) were measured. An RN changed drug Rx at monthly visits under HTN specialist direction. Mean age was 66⫾2 yrs. BP fell from 171⫾2/88⫾2 to 142⫾2/76⫾1 mm Hg (p⬍0.01) with an increase from 3.6⫾0.1 to 4.1⫾0.1 meds/pt (p⬍0.01). Elevated ANP levels and rise in TBI (p⬍0.01) during Rx demonstrate occult volume excess despite diuretic Rx. During intensive Rx, diuretic doses increased (p⬍0.01) as did dihydropyridine calcium blocker use (p⬍0.01). Serum creat rose (1.4⫾0.1 to 1.6⫾0.1 mg/dL, p⬍0.01) without change in weight. Our results indicate that RH pts have increased