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Letters to the Editor
(Aust Prescr 2002;25:51-3)
Letters, which may not necessarily be published in full, should be restricted to not more than 250 words. When relevant, comment on the letter is sought from the author. Due to production schedules, it is normally not possible to publish letters received in response to material appearing in a particular issue earlier than the second or third subsequent issue.
Editor, - I refer to the article 'Hypertension in diabetes'
(Aust Prescr 2002;25:8-10).
The author suggests that while AT1 receptor
antagonists may have the same benefits as ACE inhibitors, this has yet to be
shown in clinical trials. I would draw your attention to the recently published
PRIME program1,2,
which evaluated the effects of irbesartan on morbidity and/or mortality in patients
with hypertension and type 2 diabetes across the continuum of early and advanced
stages of diabetic renal disease.
The PRIME program consisted of two trials, IRMA 2 and IDNT.
In IRMA 2, the irbesartan 300 mg group demonstrated a 70% relative risk reduction
in the primary end-point of progression to overt proteinuria, compared with
a control group (placebo in addition to other non-excluded antihypertensive
therapies), p = 0.0004.1
In IDNT, the primary end-point was the time until the first occurrence of doubling
of serum creatinine, or end-stage renal disease, or all-cause mortality. The
irbesartan group demonstrated:
In a recently updated position statement by the American Diabetes Association on diabetic nephropathy3, the recommendation is that in treatment of albuminuria/nephropathy both ACE inhibitors and the AT1 receptor antagonists can be used. The recommendations are as follows:
While the AT1 receptor
antagonists are a newer class of drug, and data in the past have been limited,
there is certainly a growing body of evidence such as PRIME on their use in
hypertensive diabetic patients.
Victoria Elegant
Medical Director
Sanofi-Synthelabo Australia
R E F E R E N C E S
Dr Julia Lowe, author of the
article, comments:
I am grateful for the opportunity to comment on three studies which have evaluated
the effects of AT1 receptor antagonists
on morbidity and/or mortality in patients with hypertension and diabetes. These
studies were published after I had completed my article for Australian Prescriber
and are concerned with patients who already have either microalbuminuria1
or overt nephropathy.2,3
My article was concerned solely with cardiovascular outcomes in patients
with hypertension and diabetes, rather than the more specific question of patients
who have already developed complications such as microalbuminuria or nephropathy.
I note that none of these studies used an ACE inhibitor in the placebo group.
Comparison with amlodipine in one of these trials2
was interesting given the uncertainty about the value of calcium channel antagonists
in prevention of diabetic nephropathy. Only the RENAAL trial of losartan addressed
death as part of its composite primary outcome.3
There was no difference in deaths in the losartan group (158/751) compared to
controls in the placebo group (155/762). In the other two studies there was
no difference in the number of deaths between groups, but the studies were not
designed with sufficient power to detect a difference in deaths as an outcome.1,2
In summary, I see no need to change the statement in my article that 'While
AT1 receptor antagonists may have the same
benefits as ACE inhibitors, this has yet to be shown in clinical trials'.
R E F E R E N C E S
1. Parving HH, Lehnert H, Brochner-Mortensen
J, Gomis R, Andersen S, Arner P. The effect of irbesartan on the development
of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001;345:870-8.
2 Lewis EJ, Hunsicker LG, Clarke WR, Berl
T, Pohl MA, Lewis JB,
et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan
in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001;345:851-60.
3. Brenner BM, Cooper ME, de Zeeuw D, Keane
WF, Mitch WE, Parving HH, et al. Effects of losartan on renal and cardiovascular
outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001;345:861-9.
Editor, - I was fortunate to read the excellent article about
missed doses (Aust Prescr 2002;25:16-8)
but I did find myself questioning the advice given in the table 'Information
for consumers' for progestogen only contraceptives. This indicated that if a
dose of the progestogen only pill is delayed for more than three hours then
back-up contraception is required for 14 days. This would seem contrary to the
evidence that the cervical mucus protection afforded by this method begins after
only about three hours and that the suppressive effect on the endometrium only
takes a few days to occur. It is accepted practice in most family planning organisations
worldwide that women are advised that should they be more than three hours late
taking a dose of their progestogen only pill they should use additional contraceptive
cover for two days, not 14 as stated in the article. I agree that many of the
recommendations around the use of progestogen only contraceptives are 'fuzzy'
to say the least!
Perhaps at some stage in the future someone will have the energy to apply to
the appropriate authorities to lift the restrictions on the use of progestogen-only
contraceptives in women who are lactating or have thrombophilia. It is hard
enough for the poor doctor just trying to do the right thing without having
product information that is palpably inaccurate as well.
Terri Foran
Medical Director FPA Health
Ashfield, NSW
Dr Andrew Gilbert, one of the authors of 'I've
missed a dose; what should I do?', comments:
We thank Dr Foran for her comments. Our article presented information as it
is printed in the Consumer Medicine Information (CMI) sheet for levonorgestrel
(Microval). The information in the CMI is required to be consistent with the
Australian approved product information. It is clear from Dr Foran's comments
that the product information, and therefore the CMI, does not reflect current
clinical knowledge about the use of progestogen-only pills. With regard to missed
doses, the product information for Microval states that in cases where a woman
misses either one or two tablets 'she should use a mechanical method of contraception
until 14 consecutive tablets have been taken'. The product information for the
Micronor brand of norethisterone states even more strongly that if one dose
is missed the pill 'should be discontinued immediately and a method of non-hormonal
contraception should be used until menses have appeared or pregnancy has been
excluded'.
We believe that it is extremely important that the product information and CMI
reflect the evidence we have about the safe, effective and convenient use of
these products in practice. We support strongly Dr Foran's contention that a
mechanism needs to be found to require the pharmaceutical companies to update
their product information in light of good practice-based evidence.
Editor, - In an otherwise excellent article ('Influenza
immunisation' Aust Prescr 2002;25:5-7) Dr Robert Hall dismisses antiviral
drugs as 'conferring little public health benefit'. While this may be true under
normal circumstances, it may not be so during an influenza pandemic which could
strike with little warning and at any time of the year. The long lead time necessary
for large-scale vaccine production against a pandemic influenza virus implies
that at least in the initial stages we will have to rely on organisational strategies
and antiviral drugs. A pandemic virus of high virulence would constitute a public
health emergency with potentially severe consequences including breakdown of
social order. Selective antiviral prophylaxis then becomes a very important
public health measure. To quote the World Health Organization influenza pandemic
preparedness plan1 'it
would be appropriate… to maintain a supply [of anti-influenza drugs] adequate
for critical needs which might arise, such as protection of health care staff
and laboratory workers'.
Peter Lake
Senior Medical Officer
Port Adelaide Community Health Service
Port Adelaide, SA
R E F E R E N C E
1. World Health Organization. Influenza
pandemic preparedness plan: the role of WHO and guidelines for national and
regional planning. Annex E. Geneva: WHO; 1999 Apr.
http://www.who.int/emc-documents/influenza/docs/index.htm
Editor, - Dr Herxheimer rightly said in his editorial 'The
importance of independent drug bulletins' (Aust
Prescr 2002;25:3-4) that some over-enthusiastic colleagues talk about their
preferred treatment. This is done not out of enthusiasm or devotion, but because
of inducements offered by drug companies. There is now an unhealthy practice
of drug companies hiring specialists to speak about their new products to select
groups of medical practitioners especially invited to hill stations or costly
hotels. How do medical associations and medical councils allow such a partisan
practice by their members?
Wishvas Rane
Pune
India
