* Polypill cuts blood pressure, cholesterol in study
* Doubts remain about commercial prospects
* Four-drug combination pill manufactured by Cipla
By Ben Hirschler
LONDON, July 18 A four-in-one pill cut blood
pressure and cholesterol significantly in over-50s with no
history of heart disease in a small British study, fuelling
debate about the use of a so-called polypill to ward off heart
attacks and strokes.
The idea of a "one-size-fits-all" cocktail of cheap generic
heart drugs has been touted for 10 years, but its path to market
remains unclear given regulatory hurdles and a lack of interest
from big drugmakers focused on selling new patented medicines.
The randomised trial, results of which were published in the
journal PLoS One on Wednesday, is the first to test a polypill
in people selected on age alone.
While rival polypills have been tried in patients with known
cardiovascular risks, David Wald and colleagues at Queen Mary
University of London believe there is a good case for everybody
over 50 getting treatment.
Their polypill -- manufactured by India's Cipla
and combining three blood pressure medicines plus the
cholesterol fighter simavastatin -- cut blood pressure by 12
percent and "bad" LDL cholesterol by 39 percent.
Wald said this suggested the polypill could reduce heart
attacks and strokes in the general population by around
two-thirds, based on the known importance of these two factors.
"This represents a milestone in that we've made a polypill
that does exactly what it was predicted to do, and it was well
accepted when offered to people purely on a basis of their age,"
he said in an interview.
Although more patients experienced side effects when taking
the polypill, including muscle aches due to the statin, these
did not prompt any of them to stop treatment.
The trial is unlikely to be viewed as conclusive by the
medical community, however, since it only involved 84 patients,
each of whom took the polypill for three months and a dummy pill
for three months, in random sequence.
Larger trials, involving hundreds of patients, are now
underway in India, following discussions with British regulators
about what data would be needed to win marketing approval. Wald
said that process could take one to two years.
He hopes that the Indian trials will satisfy regulators,
especially since the component medicines in the polypill are
already prescribed separately to millions of patients and are
known to significantly cut heart risk.
What happens then is still uncertain. In order to gain
traction, the polypill would need a pharmaceutical company to
back it, in addition to the manufacturing deal with Cipla. But
the profits to be made from selling a capsule that mixes old
off-patent medicines will be modest.
"There are challenges in commercialising it but we want to
try and make it available to the public so people can make up
their own minds as to whether it is for them or not," Wald said.
Other polypills are being developed with the less ambitious
goal of treating patients with a history of heart risk factors
by teams working with two rival Indian drugmakers, Dr. Reddy's
Laboratories and Cadila Pharmaceuticals.