A combination of two hypertension
drugs slashes mortality in type II diabetes patients
by one fifth — even when they have normal blood
pressure, says a new study published online September
2 in The Lancet. Patients on the combo treatment
— perindopril, an ACE-inhibitor, and indapamide,
a diuretic — were 18% less likely to die of cardiovascular
disease, and 14% less likely to die from any other cause
of death, including kidney disease.
The findings could change the way
docs treat diabetes, says lead author Dr Anushka Patel,
of the George Institute for International Health in
Australia. "Traditionally, the approach has been to
treat hypertension, but the results of the ADVANCE study
provide support for a strategy of routine blood pressure
lowering, regardless of initial blood pressure levels,"
she told NRM by email.
Over two million Canadians suffer
from the disease, and most will die or be disabled from
complications of diabetes. If doctors add this pill
— available in Canada under the name Coversyl Plus
— to the routine diabetes treatment, Dr Patel expects
it could save one in 79 patients over the next five
years. That's almost 1.5 million deaths prevented worldwide.
ADVANCE
TREATMENT
Researchers figured that since most diabetes deaths
occur from blood pressure-related complications, an
intense lowering of BP for those patients could only
help. The study — the largest ever for diabetes
— looked at over 11,000 patients with type II diabetes,
the adult onset form of the disease, in 20 different
countries. Participants also had to have at least one
other CVD risk factor like smoking or high cholesterol
level.
Patients were then randomized to
receive a daily dose of either placebo or the perindopril/indapamide
combo pill. The drug was added to all their regular
meds, even if they had normal blood pressure or were
already taking anti-hypertension medication.
HOW
LOW CAN YOU GO
The fact that non-hypertensive diabetics benefited from
the treatment blasts the current set BP values for diabetes.
"People with diabetes are at higher risk of vascular
disease at all blood pressure levels compared to people
without diabetes," says Dr Patel. The researchers believe
there shouldn't be any pre-set BP value to go for, but
that doctors should just aim lower as a rule.
But if the patient is already on
hypertension meds, would the drug combo make them hypotensive?
Only 1.2% of patients taking the combo pill developed
low blood pressure, compared to 0.4% on placebo, Dr
Patel says. In fact, the pill has mild enough doses
of the ACE-inhibitor and diuretic that it made little
difference to actual blood pressure levels. The impact
was felt more on the overall vascular risks associated
with diabetes.
NOT
BUYING IT
Not everyone is convinced that only a perindopril/indapamide
combo will do the trick. "I believe that other drugs
— if they lower blood pressure as much and do not
have metabolic side-effects — would be as protective
as this combination treatment," writes hypertension
expert Dr Norman M Kaplan, in an accompanying editorial
in The Lancet. He suggests that a generic ACE-inhibitor
and diuretic would do the same at a fraction of the
cost.
Dr Patel says that's reasonable
but she isn't ready to extrapolate yet. "The evidence
we have is for this specific combination of perindopril
and indapamide," she says.
This combo pill was very well tolerated,
with few side effects, says Dr Patel. Almost three quarters
of the patients were still on it by the end of the study.
Coughing proved to be a problem for some patients, and
about 3% had to be taken off the medication because
of it. But docs can anticipate potential problems by
doing a short trial run — for six weeks or so.
If the patients tolerate it well, then they can be put
on the treatment for the long haul, suggests Dr Patel.
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