Results of the pilot study for the Hypertension in the Very Elderly Trial

Bulpitt, Christopher J.; Beckett, Nigel; Cooke, Jonathan; Dumitraşcu, Dan L.; Gil‐Extremera, Blas; Nachev, C; Nunes, Maria Inês; Peters, Ruth; Staessen, Jan A.; Thijs, Lutgarde

doi:10.1097/00004872-200312000-00030

Cited by 259 publications

(159 citation statements)

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“…The risks and benefits of treatment with antihypertensive agents are uncertain in patients older than 80 years (23). Gueyffier et al suggested that antihypertensive treatment could prevent stroke, major cardiovascular events, and heart failure, but not cardiovascular death based on a meta-analysis of data from 1,670 patients aged 80 years or older (24).…”

Section: Discussionmentioning

confidence: 99%

Design and Baseline Characteristics of an Observational Study in Japanese Patients with Hypertension: Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH)

et al. 2007

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Section: Discussionmentioning

confidence: 99%

Design and Baseline Characteristics of an Observational Study in Japanese Patients with Hypertension: Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH)

et al. 2007

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“…It has been reported that drug treatment may be less effective or even harmful in patients with hypertension aged 80 years or older (2,3). Furthermore, isolated systolic hypertension, a typical characteristic of elderly hypertension, has been considered not a treatment target but rather a physiologic change related to aging.…”

Section: Introductionmentioning

confidence: 99%

Current Status and Characteristics of Hypertension Control in Community Resident Elderly Korean People: Data from a Korean Longitudinal Study on Health and Aging (KLoSHa Study)

et al. 2008

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“…Briefly, despite the fact that PHARM evaluated only short-term trials (weeks), the absolute risk of events (events per 1000 patient years) observed in PHARM fell well within the range of the absolute event rates in long-term trials, [17][18][19][20][21][22][23][24][25][26][27][28][29] for patients within the chronological age and magnitude of systolic BP defined by the PHARM population baseline values. For example, the total all cause mortality rate in PHARM was 3.4 per 1000 patient years, only slightly less than that reported by the CDC Division of Vital Statistics 30 for the year 2003 for this age group in the general population of the United States and total stroke events in PHARM was 3.1 per 1000 patient years, slightly greater than that seen in the MRC trial 20 and the Australian trial 19 in hypertensive populations.…”

Section: Establishment Of Contextmentioning

confidence: 99%

The risks associated with short-term placebo-controlled antihypertensive clinical trials: a descriptive meta-analysis

DeFelice¹,

Willard²,

Lawrence

et al. 2008

J Hum Hypertens

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Short-term (4-8 weeks) placebo-controlled trials are used to evaluate new antihypertensive drug treatment. To evaluate the consequences of such practice, a descriptive meta-analysis was conducted, consisting of blinded review of original case report forms for all patients who died or left a study before its completion for all short-term, placebo-controlled hypertension trials submitted to the Food and Drug Administration from 1973 through 2001. There were 93 marketing applications or supplements involving 590 individual trials that involved 86 137 randomized patients (64 438 randomized to experimental drug and 21 699 randomized to placebo) with 12 658 patient years of observation. There were 9636 dropouts (mean time to dropout was 28 days) and relative risk (RR (placebo/drug)) ¼ 1.33 (95% confidence limits, 1.28, 1.39; Po10 À16 ). As expected, lack of blood pressure (BP) control was far more common in patients randomized to placebo; therapeutic failure, RR ¼ 2.53 (2.35, 2.73; Po10 À15 ) and hypertensive emergency, RR ¼ 2.75 (2.19, 3.57; Po10 À15 ). When administrative dropouts and dropouts resulting from inadequate BP control were excluded, the remaining 38% of dropouts were disproportionately more from drug (2810 drug, 816 placebo), RR ¼ 0.80 (0.74, 0.86; Po10 À8 ). There were 43 deaths, RR ¼ 0.72 (0.33, 1.45; P ¼ 0.37); 40 strokes, RR ¼ 1.43 (0.68, 2.81; P ¼ 0.33) and 77 myocardial infarctions, RR ¼ 1.06 (0.62, 1.75; P ¼ 0.82). Irreversible harm (a combination of death, stroke and myocardial infarction, 160 total events) was equally distributed between the drug and placebo groups, RR ¼ 1.03 (0.71, 1.47; P ¼ 0.86).

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Results of the pilot study for the Hypertension in the Very Elderly Trial

Abstract: The preliminary results support the need for the continuing main HYVET trial. It is possible that treatment of 1000 patients for 1 year may reduce stroke events by 19 (nine non-fatal), but may be associated with 20 extra non-stroke deaths.

Cited by 259 publications

References 12 publications

Design and Baseline Characteristics of an Observational Study in Japanese Patients with Hypertension: Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH)

Design and Baseline Characteristics of an Observational Study in Japanese Patients with Hypertension: Japan Hypertension Evaluation with Angiotensin II Antagonist Losartan Therapy (J-HEALTH)

Current Status and Characteristics of Hypertension Control in Community Resident Elderly Korean People: Data from a Korean Longitudinal Study on Health and Aging (KLoSHa Study)

The risks associated with short-term placebo-controlled antihypertensive clinical trials: a descriptive meta-analysis

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