Archive for the ‘Clinical trials’ Category
Share Our Mission to Heal
Holy Cross Hospital is seeking studio audience members for A Mission to Heal, a new show all about the heart.
Needed: 75 audience members for each show; Mix of demographics. No children under 18; Community groups are encouraged to have representation in the audience, as well as community leaders.
Where
A studio in Davie, FL. Details will be provided to audience members upon selection.
When
September 30, 2010; Refreshments will be served.
The show is not “live” but it is being recorded “live” so it will be edited and shown at a later date. Audience members should dress comfortably for long periods of sitting. No white blouses, shirts, hats or sweaters.
Please email info@holy-cross.com and put A Mission to Heal in the subject field OR call 954-776-3244 if you are interested in being part of the studio audience.
Please provide your full name, phone number, e-mail address, age range (20s, 30s, 40s, 50+) and race/ethnicity. Someone will be in touch to let you know if you have been selected and provide additional information.
Do statins make you immortal?
My blogs over the past week have been concerned about the screening of asymptomatic patients for coronary artery disease and whether we make a difference in their morbidity and mortality if we find it.
That’s really all we are concerned with: Can we, as physicians, change a patient’s outcome by putting in place a medicine or a lifestyle? What good is it to find a problem if you can’t act on it?
To date, what we do when we find a patient who we believe to be at risk is tell them to stop smoking, control their blood pressure and their diabetes. And, we put them on statins. As those that read my blogs know, statins are our first line of defense against progression of coronary artery disease when a patient already has an infarct, angioplasty or coronary artery bypass surgery.
An article was published in Arch Intern Med 2010;170:1024-1031 which addresses this question. It is titled Statins and All-Cause Mortality in High -Risk Primary Prevention: A Meta-Analysis of 11 Randomized Controlled Trials involving 65,229 Participants.
This represents over 244,000 person- years of follow up. The average LDL cholesterol was 138 mg/dl and the results of giving statins yielded an average LDL of 94 mg/dl. An average of 3.7 years of follow up occurred in these studies and there was no evidence of benefit in these findings (7 fewer deaths for every 10,000 person years of treatment).
Although compelling, I believe that this study is flawed by the short follow up. Remember, this is not a randomized clinical trial which is the highest level of significance; it is a Meta-Analysis and only collates the data already collected in like studies.
Statins were approved because they were tested in randomized clinical trials against placebo and there was always a statistically significant reduction in a triple endpoint of unstable angina, myocardial infarction and death. Death however is usually the least affected because we are much better at preventing it if patients who are affected by an acute event present to hospitals. Patients who are found to be “at risk” will continue to be offered statins and the data shows that the lower the LDL is driven, the lower the vent rate. There seems to be no plateau. Every time a study drives the number lower, the event rate follows and some studies have the LDL as low as 50 mg/dl. The study known as TNT, or Treating to new targets,
showed this result in a study with over 10,000 patients.
The real study we want to do can not be done because it is not ethical anymore. Withholding statins from patients would never pass muster. It could be done in patients who refuse statins but the numbers would never be great enough. We will just have to accept the premise for the time being until science moves ahead of need.
When is a drug a risk?
In my last blog I discussed the origins of a class of drugs known as angiotensin receptor blockers. I have had an opportunity to work with all of these compounds at one time or another. It started with the very first in class losartan developed by Merck when it was still a “number” and not yet given a chemical name.
One of the most interesting things about these compounds is that they were the first drug with “no side effects.” What I mean by that: when drugs are tested, the side effect profile is the number of side effects in the drug class minus the side effects in the placebo class. These were generally equal. These drugs are very well-tolerated–much more so than their sister compounds, the angiotensin converting enzyme inhibitors.
These drugs were widely tested in many disease states and we participated in many of those trials. That is how this Meta analysis came to be. Remember a Meta analysis is a study that combines many different patients across a wide array of studies but uses the same compound.
As reported in The Lancet Oncology, this report found a 25% increase in lung cancer occurrence with this drug class compared with placebo. There was no increase in prostate or breast cancer. There was no significant increase in cancer deaths in the two groups. The number of patients need to treat to developed one cancer was 105 patients treated for four years.
This observation has been seen before in the CHARM study which used the compound candesartan. We contributed to this study. An excess of cancer deaths was seen but felt to be due to “chance”. This Meta analysis study combined the date for 61,950 patients from five trials. 87.5% received the compound telmisartan and the rest losartan or candesartan.
Here is the “kicker”. The 25% number is the RELATIVE RISK. The actual numbers were 7.2% vs. 6.0%. Only lung cancer was more prevalent 0.9% vs. 0.7%.
What does this all mean? What is the perspective here? Next blog…
About the Institute
Browse by Category
- Acute Coronary Syndrome (14)
- Adult Stem / Cell Treatment (10)
- Angioplasty (4)
- Aortic Aneurysms /Stents / Grafts (13)
- Atherosclerotic Heart Disease (12)
- Atrial Fibrillation (11)
- Cardiac Imaging (4)
- Cardiac Surgery (19)
- Carotid Disease (7)
- Cholesterol (51)
- Chronic Angina (13)
- Clinical trials (3)
- Coronary Artery Disease (34)
- diabetes (15)
- Heart Failure (30)
- High Blood Pressure (22)
- Myocardial Infarction (36)
- Pacemaker / AICDs (9)
- Peripheral Artery Disease (5)
