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Study of Vioxx suggests heart risks


Study of Vioxx suggests heart risks -- Posted by Roman Bystrianyk on 08-31-04 09:23


http://www.healthsentinel.com/news.php?id=183&title=Study+of+Vioxx+suggests+heart+risks&event=news_print_list_item

"Study of Vioxx suggests heart risks", CNN, August 27, 2004,
Link: http://money.cnn.com/2004/08/26/news/fortune500/vioxx_kaiser.reut/

Patients taking Merck & Co.'s Vioxx arthritis drug had a 50 percent
greater chance of heart attacks and sudden cardiac death than
individuals using rival Pfizer's Celebrex, according to a large study
financed by the Food and Drug Administration.

Kaiser Permanente, one of the biggest U.S. health-maintenance
organizations with more than 8 million members, is reconsidering its
use of Vioxx following the study, the Wall Street Journal said
Thursday.

Physician committees from Kaiser will decide how to address the
findings, which were based on data from its patients, in the next few
weeks, the newspaper said.

A call to Kaiser was not immediately returned.

The study, presented at an epidemiologists conference in Bordeaux,
France on Wednesday, is the latest to suggest that the
$2.5-billion-a-year drug increases the danger of heart attacks.
Lingering safety concerns have badly hurt sales of Vioxx in recent
years.

The study also found patients taking the highest recommended daily
dosage of Vioxx had three times the risk of heart attack and sudden
cardiac death as those not taking standard painkillers.

Sudden cardiac death, an electrical disturbance of the heart that is
not considered a heart attack, is the biggest cause of death in the
United States.

Three times the risk

Researchers came up with the potentially damaging findings on Vioxx
after analyzing the medical records of 1.4 million people insured by
Oakland, Calif.-based Kaiser.

The study found 8,199 heart attacks and cases of sudden cardiac death
among the Kaiser members between 1999 and 2001.

Dr. David Graham, lead investigator for the trial, said another major
finding was that patients taking the typical starting dose of Vioxx
had a 50 percent greater chance of heart attack and sudden cardiac
death than patients taking any dose of Celebrex.

"Based upon the evidence in this study, I don't think doctors should
prescribe high-dosage Vioxx, and patients shouldn't take it," Graham
said in an interview.

Asked if the FDA might consider banning use of high-dose Vioxx, given
the findings, Graham said, "The FDA has to decide whether they think a
three-fold increase in heart attacks outweighs the benefits of the
drug."

Alise Reicin, vice president of clinical research at Merck (MRK:
Research, Estimates), said the study was merely "observational," and
not the preferred formal kind of study in which patients are enrolled
and then randomly placed into different treatment groups.

"Observational studies have inherent limitations," she said, and often
produce inaccurate results.

Most patients take daily Vioxx doses of 12.5 milligrams and 25
milligrams for arthritis. But a higher dose of 50 milligrams is
approved by the FDA for treatment of pain for no longer than five
days.

"The problem is that some patients continue to take it for 30, 60 or
90 days," Graham said, putting themselves at elevated risk of heart
attack and sudden cardiac death.

Graham, senior scientist for the FDA's Office of Drug Safety, said his
own interpretations of the data did not necessarily reflect the views
of the FDA.

Unfair comparison?

In Merck's own 8,000 patient trial of Vioxx before the drug was
launched in 1999, over twice as many arthritis patients taking it had
heart attacks and strokes than those who took naproxen -- one of the
most popular older arthritis treatments.

Merck has argued that Vioxx itself did not cause the heart attacks but
that naproxen was somehow preventing them -- putting Vioxx in an
unfair bad light in the head-to-head trials.

But Graham said his trial suggested that naproxen actually slightly
increases the risk of heart attacks, casting doubt on Merck's theory.

Reicin said a group of smaller Merck trials have not shown any greater
risk of heart attack for Vioxx than Celebrex.

Although Merck has steadfastly defended the safety of Vioxx, its sales
have flattened in recent years amid the lingering safety concerns and
cardiovascular risks cited by independent researchers.

That has allowed Celebrex and a sister Pfizer (PFE: Research,
Estimates) drug, called Bextra, to dominate the market for their class
of arthritis drugs, called Cox-2 inhibitors.

The newer drugs are designed to fight inflammation and pain while
reducing the risk of ulcers caused by traditional non-steroidal
anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen and
ibuprofen.


Re: Study of Vioxx suggests heart risks -- Posted by Gwen Love on 08-31-04 13:18


I had some Vioxx left (12.5) from when I had to stop taking it. My PT was
quite painful so I decided I would just try some of the Vioxx to see if it
helped along with my pain tablets. It did help, but after 5 days of having
taken it just twice, my BP was 158/93. Had been 120s and 130s over 70s
until then. Decided I didn't really need it!
Gwen


"Roman Bystrianyk" wrote in message
news:4f28e591.0408310823.444dbf30@posting.google.com...
>
http://www.healthsentinel.com/news.php?id=183&title=Study+of+Vioxx+suggests+heart+risks&event=news_print_list_item

>
> "Study of Vioxx suggests heart risks", CNN, August 27, 2004,

> Link: http://money.cnn.com/2004/08/26/news/fortune500/vioxx_kaiser.reut/
>
> Patients taking Merck & Co.'s Vioxx arthritis drug had a 50 percent

> greater chance of heart attacks and sudden cardiac death than
> individuals using rival Pfizer's Celebrex, according to a large study
> financed by the Food and Drug Administration.
>
> Kaiser Permanente, one of the biggest U.S. health-maintenance

> organizations with more than 8 million members, is reconsidering its
> use of Vioxx following the study, the Wall Street Journal said
> Thursday.
>
> Physician committees from Kaiser will decide how to address the

> findings, which were based on data from its patients, in the next few
> weeks, the newspaper said.
>
> A call to Kaiser was not immediately returned.

>
> The study, presented at an epidemiologists conference in Bordeaux,

> France on Wednesday, is the latest to suggest that the
> $2.5-billion-a-year drug increases the danger of heart attacks.
> Lingering safety concerns have badly hurt sales of Vioxx in recent
> years.
>
> The study also found patients taking the highest recommended daily

> dosage of Vioxx had three times the risk of heart attack and sudden
> cardiac death as those not taking standard painkillers.
>
> Sudden cardiac death, an electrical disturbance of the heart that is

> not considered a heart attack, is the biggest cause of death in the
> United States.
>
> Three times the risk

>
> Researchers came up with the potentially damaging findings on Vioxx

> after analyzing the medical records of 1.4 million people insured by
> Oakland, Calif.-based Kaiser.
>
> The study found 8,199 heart attacks and cases of sudden cardiac death

> among the Kaiser members between 1999 and 2001.
>
> Dr. David Graham, lead investigator for the trial, said another major

> finding was that patients taking the typical starting dose of Vioxx
> had a 50 percent greater chance of heart attack and sudden cardiac
> death than patients taking any dose of Celebrex.
>
> "Based upon the evidence in this study, I don't think doctors should

> prescribe high-dosage Vioxx, and patients shouldn't take it," Graham
> said in an interview.
>
> Asked if the FDA might consider banning use of high-dose Vioxx, given

> the findings, Graham said, "The FDA has to decide whether they think a
> three-fold increase in heart attacks outweighs the benefits of the
> drug."
>
> Alise Reicin, vice president of clinical research at Merck (MRK:

> Research, Estimates), said the study was merely "observational," and
> not the preferred formal kind of study in which patients are enrolled
> and then randomly placed into different treatment groups.
>
> "Observational studies have inherent limitations," she said, and often

> produce inaccurate results.
>
> Most patients take daily Vioxx doses of 12.5 milligrams and 25

> milligrams for arthritis. But a higher dose of 50 milligrams is
> approved by the FDA for treatment of pain for no longer than five
> days.
>
> "The problem is that some patients continue to take it for 30, 60 or

> 90 days," Graham said, putting themselves at elevated risk of heart
> attack and sudden cardiac death.
>
> Graham, senior scientist for the FDA's Office of Drug Safety, said his

> own interpretations of the data did not necessarily reflect the views
> of the FDA.
>
> Unfair comparison?

>
> In Merck's own 8,000 patient trial of Vioxx before the drug was

> launched in 1999, over twice as many arthritis patients taking it had
> heart attacks and strokes than those who took naproxen -- one of the
> most popular older arthritis treatments.
>
> Merck has argued that Vioxx itself did not cause the heart attacks but

> that naproxen was somehow preventing them -- putting Vioxx in an
> unfair bad light in the head-to-head trials.
>
> But Graham said his trial suggested that naproxen actually slightly

> increases the risk of heart attacks, casting doubt on Merck's theory.
>
> Reicin said a group of smaller Merck trials have not shown any greater

> risk of heart attack for Vioxx than Celebrex.
>
> Although Merck has steadfastly defended the safety of Vioxx, its sales

> have flattened in recent years amid the lingering safety concerns and
> cardiovascular risks cited by independent researchers.
>
> That has allowed Celebrex and a sister Pfizer (PFE: Research,

> Estimates) drug, called Bextra, to dominate the market for their class
> of arthritis drugs, called Cox-2 inhibitors.
>
> The newer drugs are designed to fight inflammation and pain while

> reducing the risk of ulcers caused by traditional non-steroidal
> anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen and
> ibuprofen.




Re: Study of Vioxx suggests heart risks -- Posted by Roman Bystrianyk on 08-31-04 19:32


"Gwen Love" wrote in message news:...
> I had some Vioxx left (12.5) from when I had to stop taking it. My PT was
> quite painful so I decided I would just try some of the Vioxx to see if it
> helped along with my pain tablets. It did help, but after 5 days of having
> taken it just twice, my BP was 158/93. Had been 120s and 130s over 70s
> until then. Decided I didn't really need it!
> Gwen
>

For your information:

Safety and efficacy of S-adenosylmethionine (SAMe) for osteoarthritis
A meta-analysis
Karen L. Soeken, PhD; Wen-Lin Lee, RN, PhD; R. Barker Bausell, PhD;
Maria Agelli, MD, MS; and Brian M. Berman, MD, "Safety and efficacy of
S-adenosylmethionine (SAMe) for osteoarthritis A meta-analysis",
Journal of Family Practice, May 1, 2002, Vol. 51, Num. 5, pp. 425-430

"CONCLUSIONS SAMe appears to be as effective as NSAIDs in reducing
pain and improving functional limitation in patients with OA without
the adverse effects often associated with NSAID therapies."

http://www.healthsentinel.com/nutandcond.php?id=23&art_id=53&event=conditions_print_article

Treatment of Rheumatoid Arthritis with Gammalinolenic Acid
Leventhal L. J., MD, Boyce E. G., PharmD, and Zurier R. B., MD,
"Treatment of Rheumatoid Arthritis with Gammalinolenic Acid", Annals
of Internal Medicine, November 1, 1993, Vol. 119, Num. 9, pp. 867-873

"A randomized, double-blind placebo-controlled, 24 week trial.
Results: Treatment with gammolinolenic acid resulted in clinically
important reduction in the signs and symptoms of disease activity in
patients with rheumatoid arthritis. In contrast, patients given a
placebo showed no change or showed worsening of disease.
Gammolinolenic acid reduced the number of tender joints by 36%, the
tender joint score by 45%, swollen joint count by 28%, and the swollen
joint score by 41%, whereas the placebo group did not show significant
improvement in any measure."

http://www.healthsentinel.com/nutandcond.php?id=23&art_id=25&event=conditions_print_article

Evening Primrose Oil In Patients With Rheumatoid Arthritis And
Side-Effects Of Non-Steroidal Anti-Inflammatory Drugs
Brzeski, M., Madhok, R., and Capell, H. A., "Evening Primrose Oil In
Patients With Rheumatoid Arthritis And Side-Effects Of Non-Steroidal
Anti-Inflammatory Drugs", British Journal of Rheumatology, January 1,
1991, Vol. 30, Num. 0, pp. 370-372

"Our study found that only 23% (3/13) of patients completing treatment
with EPO could reduce their NSAID dose and none could stop, similar to
that found with placebo. This contrasts with previous study in which
the same dose of EPO enabled 25% to stop and a further 38% to reduce
NSAID dose after 6 months without clinical deterioration."

http://www.healthsentinel.com/nutandcond.php?id=23&art_id=26&event=conditions_print_article


Re: Study of Vioxx suggests heart risks -- Posted by bewellkel on 09-21-04 18:39


rbystrianyk@gmail.com (Roman Bystrianyk) wrote in message news:<4f28e591.0408310823.444dbf30@posting.google.com>...
> http://www.healthsentinel.com/news.php?id=183&title=Study+of+Vioxx+suggests+heart+risks&event=news_print_list_item
>
> "Study of Vioxx suggests heart risks", CNN, August 27, 2004,
> Link: http://money.cnn.com/2004/08/26/news/fortune500/vioxx_kaiser.reut/
>
> Patients taking Merck & Co.'s Vioxx arthritis drug had a 50 percent
> greater chance of heart attacks and sudden cardiac death than
> individuals using rival Pfizer's Celebrex, according to a large study
> financed by the Food and Drug Administration.

Thank you for printing that information! It is a real eye opener.

I recall seeing that either Vioxx or Celebrex, not sure which,
actuually increases inflamation while reducing pain. I think it was
Celebrex. So in 6 month studies it worked to reduce pain, but after a
year, it stopped working due to the increased inflamation.

I prefer natural treatments myself. I won't mention any since so many
appear to work, but different ones seem to work for different people.

Thanks again for the informative posting.
Kelley
------------------------------------------------------
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