clinical trial summaries

[oreosandsake]

did a search, didn't find anything that had the legwork already done

was wondering if anyone had a link, or was interested in starting a thread with quick and accurate summaries.

something in this format

TRIAL: HOPE, PROFESS, ESPRIE

TOPIC: CAD, CHF, HTN, COPD

Q of INTEREST: What is the best drug combo for secondary stroke prevention...

END POINTS: death, MI, etc

SPECIFIC INTERVENTIONS/RX: lifestyle mods, ACEI, statin, PTCA, steroids..

RESULTS/IMPLICATIONS: intervention A had a 40% decrease in end points over placebo, and 30% decrease in end points over intervention B

MISC: Side effect profile of aggrenox (severe headache) and no significant benefit in stroke prophylaxis vs plavix/Aspirin...


really hope this catches on!

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[oreosandsake]

Trial: Heart Outcomes Prevention Evaluation (HOPE)

TOPIC: Rx to improve Cardiovascular outcomes in pt's with risk factors of hyperlipidemia, diabetes, tobacco abuse, and hypertension.

Q:What is the role that the renin-angiotensin-aldosterone system plays in cardiovascular risk.

end points: primary outcome was occurrence of MI, stroke, or cardiovascular death. Secondary outcomes included death from any cause, the need for interventional revascularization (PCTA, CABG), hospitalization for unstable angina, development of heart failure, or diabetic complications. Tertiary outcomes included worsening angina, cardiac arrest, heart failure, unstable angina, or development of diabetes.

interventions: Can angiotensin-converting enzyme (ACE) inhibitor (ramipril) improve cardiovascular outcomes among high-risk patients with known cardiovascular disease?

Results: primary outcomes (reduction in MI, stroke, cardiovascular death) were all significantly improved in the treatment group (P < .05); it appeared that all types of patients benefited from being on the ACE inhibitor on subset analyses.

CONCLUSION: The researchers in the HOPE trial concluded: "ramipril, an ACE inhibitor, is beneficial in a broad range of patients without evidence of LV systolic dysfunction or heart failure who are at high risk for cardiovascular events. Treatment with ramipril reduced the rates of death, MI, stroke, coronary revascularization, cardiac arrest, and heart failure, as well as the risk complications related to diabetes and diabetes itself."

MISC: results considered not d/t reduction in bp, since most patients enrolled in the study did not have hypertension at baseline. Also, I believe this is where the "ACEI are reno-protective in DM" comes from.

 

[chromophobe]

AFFIRM - NEJM 2002.
Data:4,060 patients with AF randomised to rate control v. rhythm control. Mortality did not differ, but hospitalisations and ADRs were increased in the rhythm control group.
Conclusion:Management of atrial fibrillation with the rhythm-control strategy offers no survival advantage over the rate-control strategy, and there are potential advantages, such as a lower risk of adverse drug effects, with the rate-control strategy. Anticoagulation should be continued in this group of high-risk patients.

ALLHAT - JAMA 2002.
Data:[FONT=verdana, arial, helvetica, sans-serif] 33,357 hypertensives with at least 1 CHD risk factor randomised to thiazide (.chlorthalidone), CCB (amlodipine) or ACEI ([FONT=verdana, arial, helvetica, sans-serif]lisinopril). There was also an alpha-blocker arm that was terminated early due to increase in CHF risk. Mortality over 4.9 years did not differ between groups. Thiazide arm had significantly decreased CHF.
.[FONT=verdana, arial, helvetica, sans-serif] . [FONT=verdana, arial, helvetica, sans-serif]Conclusion: Thiazide-type diuretics are superior in preventing 1 or more major forms of CVD and are less expensive. They should be preferred for first-step antihypertensive therapy..[FONT=verdana, arial, helvetica, sans-serif]
.

 

[oreosandsake]

RALES

Aldosterone receptor blockade with spironolactone has been demonstrated to reduce mortality in patients with severe heart failure due to systolic dysfunction who had symptoms at rest in the prior 2 months. The RALES trial evaluated spironolactone added to a standard heart failure medical regimen in patients over the age of 65 years with New York Heart Association class III/IV heart failure. This trial demonstrated a 27% reduction in cardiac-related mortality. There was also a reduction in heart failure symptoms and hospitalization.

CHF - spirinolactone decreases mortality.

misc: amlodipine, nitrates, digoxin, magnesium do not decrease mortality in CHF.

 

[anon-y-mouse]

This is a nice effort, but sadly I am too lazy to contribute. However, the margins of "Step Up to Medicine" (especially in the first chapter) have great 1 liner summaries on each of the trials. The only one I can ever remember is "ESSENCE"... because it sounds sensual, like 'love', i.e. lovenox.