Swedish
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Compliance in the Physicians' Health Study

Endast registrerade användare kan översätta artiklar
Logga in Bli medlem
Länken sparas på Urklipp
StatusAvslutad
Sponsorer
National Heart, Lung, and Blood Institute (NHLBI)

Nyckelord

Abstrakt

To evaluate the relationships of compliance in taking aspirin or aspirin placebo with the risk of major cardiovascular endpoints, using data collected in the Physicians' Health Study.

Beskrivning

BACKGROUND:

The Physicians' Health Study was a randomized, double-blind placebo-controlled primary prevention trial designed to test whether 325 mg aspirin every other day reduced risks of cardiovascular disease and whether 50 mg beta-carotene on alternate days decreased cancer incidence among 22,071 male U.S. physicians, aged 40-84 years in 1982. Compliance with study pills, the use of non-study aspirin and platelet active drugs, specific side effects of aspirin, the incidence of conditions indicating aspirin use, and study outcomes were assessed at six month intervals during the first year and annually thereafter. The blinded aspirin component of the trial was terminated early and participants were unblinded on January 25, 1988, due to the emergence of a statistically extreme benefit of aspirin on both fatal and nonfatal myocardial infarction, as well as the extraordinarily low cardiovascular mortality rates among study participants.

DESIGN NARRATIVE:

Separate dose-response relationships were estimated in the aspirin and in the placebo group to determine whether compliance in the placebo group was associated with lower risk, as had been found in some previous trials. Rates of cardiovascular endpoints in the placebo group relative to the aspirin group were adjusted for time-varying compliance with study tablets, and the use of non-study aspirin and platelet active drugs. In addition, baseline characteristics of the population and longitudinal assessment of side-effects and new conditions suggesting aspirin therapy were used as predictors of compliance in taking study pills separately in the aspirin and placebo groups. Similar longitudinal analyses determined predictors of the use of non-study aspirin and platelet active drugs. The analyses were intended to supplement the already published intent-to-treat analyses. They provided observational evidence concerning dose of aspirin and the risks of major cardiovascular endpoints. Examining modification of the aspirin effect in reducing risk of myocardial infarction according to level of compliance aided in the generalizability of results to less motivated populations. Evaluating determinants of good study compliance should be of benefit to future large scale clinical trials.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Datum

Senast verifierad: 04/30/2000
Först skickat: 05/24/2000
Beräknad anmälan inlämnad: 05/24/2000
Först publicerad: 05/25/2000
Senaste uppdatering skickad: 03/14/2016
Senaste uppdatering publicerad: 03/15/2016
Faktiskt startdatum för studien: 01/31/1991
Beräknat slutfört datum: 12/31/1992

Tillstånd eller sjukdom

Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Infarction

Fas

-

Urvalskriterier

Kön som är berättigade till studierMale
Accepterar friska volontärerJa
Kriterier

No eligibility criteria

Gå med på vår
facebook-sida

Den mest kompletta databasen med medicinska örter som stöds av vetenskapen

  • Fungerar på 55 språk
  • Växtbaserade botemedel som stöds av vetenskap
  • Örter igenkänning av bild
  • Interaktiv GPS-karta - märka örter på plats (kommer snart)
  • Läs vetenskapliga publikationer relaterade till din sökning
  • Sök efter medicinska örter efter deras effekter
  • Organisera dina intressen och håll dig uppdaterad med nyheterna, kliniska prövningar och patent

Skriv ett symptom eller en sjukdom och läs om örter som kan hjälpa, skriv en ört och se sjukdomar och symtom den används mot.
* All information baseras på publicerad vetenskaplig forskning

Google Play badgeApp Store badge