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Old 11-28-2004, 01:52 PM   #1
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ALLHAT trial results

I have copied parts of the results of this government sponsored trial, and pasted it here. It appears that some antihypertensive medications were associated with heart failure/complications. I take ace inhibitors myself, and will be talking to my doctor. The entire page that I copied this from is here
http://www.nhlbi.nih.gov/new/press/02-12-17.htm

ALLHAT Trial

Less costly, traditional diuretics work better than newer medicines to treat high blood pressure and prevent some forms of heart disease, according to results from the largest hypertension clinical trial ever conducted. The long-term, multi-center trial, which was supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, compared the drugs for use in starting treatment for high blood pressure.

Findings of the "Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial," or ALLHAT, appear in two articles in the December 18, 2002, issue of The Journal of the American Medical Association.

"ALLHAT was conducted in a variety of practice settings and included many primary care clinics," said Dr. Barry Davis, Director of the ALLHAT Clinical Trials Center and Professor of Biometry at the University of Texas-Houston Health Science Center. "It also included high proportions of women, seniors, minorities, and those with type 2 diabetes. Thus, the high blood pressure results add crucial information about how well such patients do on the different drugs."

The ALLHAT blood pressure study was a randomized, double-blind trial. It involved 42,418 participants aged 55 and older, and was conducted at 623 clinics and centers across the United States and in Canada, Puerto Rico, and the U.S. Virgin Islands. About 7,000 US veterans participated in the study through 69 Department of Veterans Affairs clinics.

Participants were randomly assigned to receive one of four drugs–a diuretic (chlorthalidone); a calcium channel blocker (amlodipine); an angiotensin converting enzyme (ACE) inhibitor (lisinopril); and an alpha-adrenergic blocker (doxazosin). They received additional antihypertensive drugs if their doctor thought it necessary to control their blood pressure.

The alpha-adrenergic blocker arm of the study was stopped in March 2000 because those on the drug had 25 percent more cardiovascular events and were twice as likely to be hospitalized for heart failure as users of the diuretic.

All three classes of drugs reported on in the December 18 issue of JAMA — diuretics, calcium channel blockers, and ACE inhibitors — have been previously shown to lower blood pressure and reduce cardiovascular complications. In head-to-head comparisons, the diuretics were shown to be superior in treating high blood pressure and preventing cardiovascular events.

As reported in JAMA, after about 5 years of followup, compared to participants who were taking the diuretic, those on the calcium channel blocker had —

On average, about a 1 mm Hg higher systolic blood pressure

38 percent higher risk of developing heart failure and 35 percent higher risk of being hospitalized for the condition

Compared to participants who were taking the diuretic, those on the ace inhibitors had

On average, about a 2 mm Hg higher systolic blood pressure–and 4 mm Hg higher in African Americans

15 percent higher risk of stroke

40 percent higher risk of stroke for African Americans

19 percent higher risk of developing heart failure

11 percent greater risk of being hospitalized or treated for angina (chest pain)

10 percent greater risk of having to undergo a coronary revascularization (such as coronary artery bypass surgery)


"The take-home message is that doctors should begin drug treatment for high blood pressure with a diuretic," said Dr. Paul Whelton, Senior Vice-President for Health Sciences at Tulane University in New Orleans, LA, and an ALLHAT Regional Coordinator. "A great majority of patients can tolerate a diuretic but, for those who can't, then a calcium-channel blocker, an ACE-inhibitor, or a beta blocker may be used to start treatment.

"ALLHAT's findings also indicate that most patients will need more than one drug to adequately control their blood pressure, and one of the drugs used should be a diuretic," he continued.

"Those who are now on a calcium channel blocker or an ACE inhibitor or another hypertension drug besides a diuretic should not stop taking their medication," he added. "But they should certainly talk with their doctor about adding or switching to a diuretic for their treatment."

"ALLHAT's findings refine the current clinical guidelines that recommend starting therapy for hypertension with a diuretic or a beta blocker," said Dr. Jeffrey Cutler, NHLBI Senior Advisor. "The new findings will allow doctors to achieve better blood pressure control and, more importantly, better cardiovascular health for their patients. And, it will do this at a more affordable price for their patients.

"I want to stress," he continued, "that people should not stop or change their blood pressure-lowering medication on their own. They should talk with their doctor about the treatment that's best for them."

 
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Old 11-28-2004, 03:46 PM   #2
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Re: ALLHAT trial results

So the like 90% of us that are on everything else but the diuretic are screwed! What class in the study is a beta blocker? I didnt see that listed....

 
Old 11-28-2004, 04:43 PM   #3
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Re: ALLHAT trial results

That's the good news! They are in a class of their own (beta blockers), and weren't involved in the trial. I take beta blockers too.

 
Old 11-29-2004, 05:02 AM   #4
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Re: ALLHAT trial results

Jack,
I agree wholeheartedly: calcium channel blockers have NO place in the treatment of hypertension other than to enrich its producers!
I also have found through bitter experience that NOTHING works as well, or as safely as a thiazide diuretic.
(I might not be completely representative because I am quite salt-sensitive.)

Probably NO study in the history of science has raised more red-flags than the ALLHAT study...now if only our DOCTORS would read the thing and take it to heart!

Last edited by Lenin; 11-29-2004 at 05:03 AM.

 
Old 11-29-2004, 06:33 AM   #5
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Re: ALLHAT trial results

Thanks Lenin,

I was shocked and dismayed at the results of this trial! I never new that it existed. Prior to a heart attack, I had been taking beta blockers for rapid heart rate and high BP. Both were being controlled just fine (I do get fatigue as a side effect of beta blockers though, and it's totally normal). Then when I was released from the hospital after the attack, I was placed on an ace inhibitor (Altace). When I got home I did lots of research on ace inhibitors, and found that all heart attack survivors were started on them. The medical literature, at several websites said that doctors/research scientest, didn't know why, but heart attack survivors lived longer if these meds were given. So, I never questioned taking this type of med.

My BP has been running a little low the last 5 weeks or so and I may speak with my cardiologist about trying it w/o altace.

Our family doctor must have knew about this trial. About a month ago, my wife's BP went up and stayed at around 165/105. I told her before her appointment with him, to not let him prescribe beta blockers for her high BP. I didn't want her to have the fatigue as a side effect. Well, he started her on hctz, which didn't lower her BP much. She went back and he prescribed her the same beta blocker that I am taking (atenolol). I guess he knew more than I thought, lol. To my surprise, she hasn't had the fatigue that I get from atenolol, and is taking the same dosage as I do.

Take care and btw, I am salt sensitive also, in regard to retaining fluid. It doesn't seem to effect my BP though.

 
Old 11-29-2004, 09:38 AM   #6
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Re: ALLHAT trial results

I think I'll stick with my calcium channel blocker right now. Diuretics are no panacea.
This from the Texas Heart institute [url]http://www.tmc.edu/thi/diurmeds.html[/url]

Talk to your doctor about your medical history before you start taking a diuretic. The risks of taking the medicine need to be weighed against the good it will do. Here are some things to consider if you and your doctor are deciding whether you should take a diuretic.

You have allergies to other medicines.
You are thinking of becoming pregnant, you are pregnant, or you are breast feeding your baby.
You have diabetes. Thiazide and loop-acting diuretics can increase your blood sugar levels.
You become dehydrated easily.
You have pancreatitis. Loop-acting diuretics can make this condition worse.
You have kidney problems.
You have lupus or a history of lupus. Thiazide diuretics can make this condition worse.
You have gout or are at high risk for developing gout, especially if your doctor is going to prescribe a thiazide diuretic.
You have menstrual problems. Potassium-sparing diuretics can make these problems worse.

And that doesn't even list the possible side effects. I for one do not want to develop diabetes, and there is a slight tendency in my family to do so.

 
Old 11-29-2004, 05:19 PM   #7
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Re: ALLHAT trial results

Lenin and all,

Going to throw some fuel on the fire here regarding CCB's...Playing Devil's Advocate for a minute....what about the INVEST study which came out after ALLHAT?

And please don't shoot the messenger!


zuzu xxx_____________________________________ ________________________

ACC 52nd Annual Scientific Session: Late breaking Clinical Trials III. Presented April 2, 2003.

CALCIUM CHANNEL BLOCKERS. AMERICAN COLLEGE OF CARDIOLOGY. INTERNATIONAL VERAPAMIL SR -TRANDOLAPRIL (I.N.V.E.S.T.) STUDY:

INVEST Demonstrates Efficacy of Calcium Channel Blocker Regimen.


April 3, 2003 (Chicago) — A treatment strategy using verapamil (calcium channel blocker) as part of multidrug regimen was as effective for management of hypertension as combination therapy with beta-blockers and diuretics, according to results of the 22,576-patient International Verapamil SR-Trandolapril (INVEST) study.

Results were presented here during the final late-breaking clinical trials session of the American College of Cardiology (ACC) 52nd Annual Scientific Session.

"Now there's an alternative to what's considered the standard of care," said Carl Pepine, MD, chief of cardiovascular medicine at the University of Florida College of Medicine and lead investigator of the study.

Patients on the verapamil-based regimen showed an 18.6-point drop in systolic pressure and a 9.9-point drop is diastolic pressure, while the patients on the beta-blocker regimen achieved an 18.9-point drop in systolic blood pressure and a 10.2-point drop in diastolic pressure — essentially IDENTICAL results.

In addition, Pepine adds, there were no statistically significant differences in deaths, heart attacks, strokes, or other events between the two groups of patients.

Patients in the verapamil arm also received the angiotensin-converting enzyme (ACE) inhibitor trandolapril and/or a diuretic to achieve target blood pressure. The ACE inhibitor could be added to the other treatment arm as needed, Dr. Pepine said.

Dr. Pepine noted that virtually all aspects of treatment between the two groups were indistinguishable from each other, and that more than 72% of the patients in the trial were able to reach the blood pressure goal.

The finding comes just months after the results of the ALLHAT trial suggested that a diuretic-based treatment strategy was the most effective treatment for hypertension.

Moreover, in last 10 years numerous articles and studies have scrutinized the use of calcium channel blockers for the treatment of patients with high blood pressure and other related diseases. Several of those studies questioned the efficacy and safety of calcium channel blockers.

"Calcium channel blockers have been oft-maligned," said James Ferguson III, MD, associate director of cardiovascular research at the Texas Heart Institute. "However, I don't think that calcium channel blockers needed to be 'rehabilitated.'

'This study confirms their utility in treating patients with high blood pressure and should give confidence to doctors who prescribe them and to patients who are taking these drugs that they are getting therapy that is up to the standard of care'."

"Blood pressure control by either strategy was excellent in INVEST," said Dr. Pepine, who is president-elect of the ACC.

About 20% of patients in each group experienced a cardiovascular event, and 848 people in the study in the calcium channel blocker group died compared with 862 people in the beta blocker group, showing that both strategies were similar in safety.

Franz Messerli, MD, a co-investigator in the trial, said the results give him and other clinicians another option for treating patients. "Beta-blocker type drugs, for example," he said, "are not very well tolerated." In the trial, Dr. Pepine noted that more patients in the beta-blocker group switched regimens than in the calcium channel blocker group.

zuzu
________________________________________ ______________________

 
Old 11-30-2004, 05:19 AM   #8
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Re: ALLHAT trial results

Hi zuzu,

Unfortunately so much the bad science has come from this kind of thing:
Quote:
Patients in the verapamil arm also received the angiotensin-converting enzyme (ACE) inhibitor trandolapril and/or a diuretic to achieve target blood pressure. The ACE inhibitor could be added to the other treatment arm as needed, Dr. Pepine said.
If they want to show the effectiveness of verapamil, GIVE VERAPAMIL! Basically giving patients a CCB, an ACE and a diuretic and claiming benefits for the CCB almost shouts to me: "the CCB is no good and we are trying to disguise the fact!"
(INVEST is an EXCELLENT term for a drug test protocol...I'll bet there are also P.R.O.F.I.T and R.I.P.O.F.F. studies .

Gee, these hucksters try SOOOOO HARD to sell a drug that costs $3 or more a pill. They must cry at the thought of thiazides at $.10 a piece. Imagine if EVERYONE was switched to HCTZ...I'll bet it would be a loss of near a $$$TRILLION$$$ for the industry (without exaggeration.)

BTW,
The reason the ARB's and CCB's got FDA approval was that qualifying tests were run only against PLACEBO. Imagine that! If they had run them against diuretics and beta blockers, they'd never have gotten approval. Really REALLY dirty business all-round.

Last edited by Lenin; 11-30-2004 at 05:25 AM.

 
Old 11-30-2004, 06:12 AM   #9
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Re: ALLHAT trial results

As far as CCB's are concerned, I believe Norvasc (amlodopine) did fairly well in ALLHAT. I sometimes wonder about some of the conclusions drawn. For example, just look at the follow-up data of confirmed deaths... Clorthalidone (14.4%), Amlodipine (13.9%), Lisinopril (14.5%)

And, the concusion... "Neither amlodipine (representing CCB) nor lisinopril (representing ACEI) was superior to clorthalidone (representing thiazide-type diuretics) in preventing major coronary events or increasing overall survival."

Now, when I compare 14.4% to 13.9% and use the traditional deceiving way of comparing numbers by using relative %'s, this indicates that diuretics had a 4.3% increase in the overall death rate compared to CCBs. And, this is from the data in the very study that proclaims diuretics are superior to everything else on the planet.

And, finally, the cost arguments are really pathetic. If cost is a concern, there are very cheap options available in every major class except for ARBs. The following are all available at <$50 for an entire year supply from US sources:

HCTZ (diuretic)
captopril (ACE)
verapamil (CCB)
atenolol (BB)

Pal

 
Old 11-30-2004, 06:54 AM   #10
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Re: ALLHAT trial results

Quote:
Originally Posted by Lenin

If they want to show the effectiveness of verapamil, GIVE VERAPAMIL! Basically giving patients a CCB, an ACE and a diuretic and claiming benefits for the CCB almost shouts to me: "the CCB is no good and we are trying to disguise the fact!"
I certainly don't want to shoot the messeger, lol, but the above quote was my initial thoughts exactly. I'm here to learn about all of the common meds we take. We need to discuss these meds, I believe. But when I found out that the manufacturers of VERAPAMIL sponsored the research, I immediately had second thoughts. Approximately 30% of the subjects smoked (I think), and I wonder which "arm" of the study received these unhealthy individuals? Participants were signed up over the internet, from around the world. Who was in charge of assigning people to each arm of the study? Probably some lower level employees of Abbot Pharmaceuticals. If the study was fixed or weighted to the advantage of Abbot, the good Doctor Pepine could have never known or cared, if the money for him was right. He declared no financial disclosures, even though he was a professor at the University of Florida, where the majority of the data was assimulated. Then spoke as president of the American College of Cardiology, when the results were in.

It's funny, but I have never heard of a drug trial or test, that was sponsored by the drug manufacturer, to end with bad test results for the drug being tested.
---------------------------------------------------------------------
Because INVEST adhered to the stringent JNC VI blood pressure targets for high-risk populations, this study demonstrates that control can be extended even to those high-risk patients requiring aggressive blood pressure management.

"Abbott is pleased to sponsor research that provides the medical community with new information on how to aggressively manage blood pressure in patients with coronary artery disease," said Jeffrey M. Leiden, M.D., Ph.D., chief scientific officer, and president and chief operating officer, Pharmaceutical Products Group, Abbott Laboratories.

 
Old 11-30-2004, 08:49 AM   #11
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Re: ALLHAT trial results

Quote:
Originally Posted by Lenin
"the CCB is no good and we are trying to disguise the fact!"
Everyone is different, and everyone can react differently to the same med.

I've got advanced heart disease, including heart failure, and hypertension, and about seven years ago my symptoms were getting progressively worse, fast. The only medicine, at that time, that brought my blood pressure down, and helped to bring my heartbeat under control, was the CCB Verapamil. If it were not for Verapamil, I probably would have died years ago.

Like the old say: "What is poison to one is honey to someone else."

 
Old 11-30-2004, 09:03 AM   #12
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Re: ALLHAT trial results

I am fairly healthy except for my hypertension. The only major class of drug that works for me is the calcium channel blocker. Others either don't work or give me unacceptable side effects. Some gave me bad side effects and didn't work to boot.

As Beerzoids says different people react differently to medications. Calcuim channel blockers are my answer. If they don't work for you, don't take them. But don't declare they are useless. For some people they clearly are not.

I believe beta blockers would have killed me if I'd tried to stay on them. But, they are the salvation for some people. I would not deny the class of drugs to people they clearly help.

No drug is without risk. Each person has to assess the risk vs the benefit and act accordingly.

 
Old 11-30-2004, 09:58 AM   #13
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Re: ALLHAT trial results

Lenin and gang,

Going back to ALLHAT...there's a phrase (I've typed it in bold font) that caught my eye and raised the ol' eyebrows:
Quote:
Participants were randomly assigned to receive one of four drugs–a diuretic (chlorthalidone); a calcium channel blocker (amlodipine); an angiotensin converting enzyme (ACE) inhibitor (lisinopril); and an alpha-adrenergic blocker (doxazosin). They received additional antihypertensive drugs if their doctor thought it necessary to control their blood pressure.
So again, if each "arm" of the study wasn't "clean" so to speak, it leaves me with more questions than ever...or am I missing something?

zuzu xx

 
Old 11-30-2004, 10:26 AM   #14
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Re: ALLHAT trial results

Quote:
Originally Posted by zuzu8
Lenin and gang,

Going back to ALLHAT...there's a phrase (I've typed it in bold font) that caught my eye and raised the ol' eyebrows:


So again, if each "arm" of the study wasn't "clean" so to speak, it leaves me with more questions than ever...or am I missing something?

zuzu xx
I've had heart disease for many decades, starting when I was a teen. I didn't pay any attention to my tachycardia, and smoked and drank and had lots of fun, until it led to heart failure. I didn't even pay much attention to my heart failure, and took all the meds like a good little patient, and suffered with the side effects, until my symptoms got much worse, and I started suffering from hypertension along with the heart failure and tachycardia. Then I had no choice but to pay attention. My heart disease slowly got worse and worse, over the years. I thought that the increasing tireness was because I was aging, not due to my heart disease getting worse.

What does this have to do with ALLHAT and the different arms of the study not being clean?

Well.... the "not being clean" caught my attention. In my case, I have found out that, what I eat, when I eat it, and when I take my meds, has a significant effect on how well my meds work and on the side effects.

In the ALLHAT study, I wonder how closely each entrant's diet was followed during the study, and their medicine schedule.

 
Old 12-02-2004, 03:53 PM   #15
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Re: ALLHAT trial results

I beleive it was Beerzoids who mentioned that every one reacts different to every type of med. Since we all disagree on this one that is probably the answer--beta blocker on Beerzoids = success and diuretic on Zuzu = success. Just hypothetical examples, but you gat what I mean. I am going to a Hypertension Guru that specializes in all sorts of blood pressure problems in north jersey on Dec 17, I will run this by him. bh

 
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