They found that in 2001, 960 000 deaths were directly assigned
to diabetes in the world. In addition to these deaths, worldwide
1.5 million deaths from ischaemic heart disease and 700 000 deaths
from stroke were caused by blood glucose levels that were high but
lower than the traditional definition of diabetes. These results
show that total mortality from higher-than-optimum blood glucose
is 3•16 million; substantially higher than the 960 000 deaths
coded to diabetes. This figure is comparable to deaths from smoking
(4•8 million), high cholesterol (3•9 million), and overweight
and obesity (2•4 million).
The authors conclude: "Higher-than-optimum blood glucose is a leading
cause of cardiovascular mortality in most world regions. Cardiovascular
risk and diabetes management and control programs need to be more
closely integrated rather than being in different spheres." (Quote
by e-mail; not in published paper)
###
See also accompanying Comment.
*Cardiovascular disease - class of diseases that involve the heart
and/or blood vessels
**Ischaemic heart disease - characterised by reduced blood supply
to the heart muscle
Contact: Joe Santangelo
Lancet
Effective Blood Glucose Control For Type 2 Diabetes Patients Shown
By Landmark Study
Main Category: Diabetes News
Article Date: 09 Dec 2006 - 5:00 PST
Results from ADOPT (A Diabetes Outcome Progression Trial) demonstrated
that initial treatment with Avandia® (rosiglitazone maleate)
reduced the risk of monotherapy failure in people with type 2 diabetes
by32 per cent compared to metformin (p<0.001), and 63 per cent
compared to glibenclamide (p<0.001) at five years. The results
of this international study involving 4,360 people recently diagnosed
with type 2 diabetes were published in the New England Journal of
Medicine and presented at the 19th World Diabetes Congress of the
International Diabetes Federation (IDF).(1)
Rosiglitazone was more effective than metformin or glibenclamide
in delaying the progressive loss of blood sugar control, as measured
in the study by fasting plasma glucose (FPG) and glycosylated (or
glycated) haemoglobin levels (HbA1c).(1) The primary reasons for
loss of blood sugar control are increasing insulin resistance and
declining B-cell function.(2) ADOPT demonstrated that rosiglitazone
significantly improved insulin sensitivity (p<0.001 versus metformin
or glibenclamide) and reduced the rate of loss of B-cell function
(p=0.02 versus metformin; p<0.001 versus glibenclamide).(1)
"ADOPT provides evidence supporting earlier treatment with
rosiglitazone in the management of type 2 diabetes. This is the
first long-term study to demonstrate that the progressive loss of
blood sugar control can be delayed and target blood sugar levels
can be maintained for a longer period with rosiglitazone than with
metformin and glibenclamide - two commonly prescribed oral antidiabetic
agents," said Dr Steven Kahn, professor of medicine, VA Puget
Sound Health Care System and University of Washington School of
Medicine, Seattle, Washington, US and ADOPT study author.
Dr Giancarlo Viberti, professor of diabetes and metabolic medicine,
King's College London School of Medicine, UK, and ADOPT study author
commented: "The more durable effect on blood sugar with rosiglitazone
was also consistent with greater improvements in core defects of
the disease, including significant effects on insulin resistance
and B-cell function."
ADOPT provides an important update to findings from the United
Kingdom Prospective Diabetes Study (UKPDS) released in 1998, which
preceded availability of glitazones (thiazolidinediones, TZDs) and
included only two of the three oral agents evaluated in ADOPT -
metformin and sulphonylurea.(3-5)
Initial therapy with rosiglitazone delayed progressive loss of
blood sugar control more effectively than metformin or glibenclamide
using different blood sugar thresholds - from FPG >10 mmol/l
to a lower blood sugar level more consistent with current therapeutic
approaches, FPG >7.8 mmol/l.(1,6,7) Long-term blood glucose control
as measured by a mean HbA1c less than 7.0 per cent was maintained
for longer with rosiglitazone - 60 months versus 45 months with
metformin and 33 months with glibenclamide.(1)
"With ADOPT, we now have clear evidence from a large international
study that the initial use of rosiglitazone is more effective than
standard therapies for type 2 diabetes in maintaining blood sugar
control," said Dr Lawson Macartney, senior vice president,
Cardiovascular and Metabolic Medicine Development Centre, GlaxoSmithKline.
"ADOPT adds to the growing body of evidence released this year
supporting the rationale for incorporating rosiglitazone as a cornerstone
of treatment of type 2 diabetes by demonstrating patient benefits
in terms of long-term glucose control."
In ADOPT, rosiglitazone was reported to be generally well-tolerated
among the large cohort of people with type 2 diabetes who were followed
for up to six years. There was no significant difference between
the rosiglitazone and metformin groups in treatment discontinuation,
but the rate was higher for the glibenclamide group (44 per cent
in the glibenclamide group; 38 per cent in the metformin group;
37 per cent in the rosiglitazone group). This difference was driven
largely by a higher level of withdrawals due to hypoglycaemia for
people in the glibenclamide group.(1)
The same number of congestive heart failure (CHF) serious adverse
events was reported with rosiglitazone (0.8 per cent) as for metformin
(0.8 per cent); however, people given glibenclamide experienced
a lower rate of CHF events (0.2 per cent).(1)
After the five-year period of study, commonly reported adverse
events across the treatment groups were oedema (rosiglitazone 14.1
per cent; glibenclamide 8.5 per cent; metformin 7.2 per cent); weight
gain (rosiglitazone 6.9 per cent; glibenclamide 3.3 per cent; metformin
1.2 per cent); gastrointestinal side effects (metformin 38.3 per
cent; rosiglitazone 23.0 per cent; glibenclamide 21.9 per cent);
and hypoglycaemia (glibenclamide 38.7 per cent; metformin 11.6 per
cent; rosiglitazone 9.8 per cent).(1)
Recent further analysis showed a lower rate of fractures reported
as adverse events in women taking glibenclamide or metformin versus
rosiglitazone (glibenclamide 3.5 per cent; metformin 5.1 per cent;
rosiglitazone 9.3 per cent), most commonly involving fractures of
the foot and upper limb bones.(1) There was no observed difference
among treatment groups in the number of fractures reported in men.(1)
These observed fracture rates appear to be within the range seen
in a literature-based review of observational studies in women with
diabetes, and analysis of large managed care databases.(8-11) This
evidence suggests that older women with type 2 diabetes are at increased
risk of fractures. (8-11)
About ADOPT
ADOPT is an international, multi-centre, randomised, double-blind
study involving 4,360 drug-naive people who had been recently diagnosed
with Type 2 diabetes (less than or equal to 3 years) at over 400
sites throughout North America and Europe. People included in the
study were randomised to rosiglitazone, a sulphonylurea (glibenclamide),
or metformin and titrated to the maximum daily effective doses (rosiglitazone
4 mg twice daily; metformin 1 g twice daily; glibenclamide 7.5 mg
twice daily). These people were followed for four to six years to
examine the long-term efficacy of each drug used as initial monotherapy
on blood sugar control, insulin resistance and B-cell function.
At the time of monotherapy failure, 99.3 per cent, 98.6 per cent
and 99.0 per cent of participants were receiving maximal doses of
rosiglitazone, metformin and glibenclamide, respectively.(1)
When ADOPT was designed, HbA1c was not chosen as the primary outcome
because the guidelines at the time focused largely on FPG.(12) Nevertheless,
HbA1c data collected in the study as a secondary endpoint provided
results, which are consistent with those for FPG and are applicable
to current clinical practice.(1)
ADOPT was funded by GlaxoSmithKline.
About Rosiglitazone
Rosiglitazone belongs to the glitazone (thiazolidinedione, TZD)
class of drugs and is an approved treatment for Type 2 diabetes
that improves blood sugar control, enabling people to reach recommended
blood sugar levels.(13) It may be taken alone by Type 2 diabetes
patients who are contraindicated or intolerant to metformin, in
combination with metformin or a sulphonylurea, or with both metformin
and a sulphonylurea. It is contraindicated for use in combination
with insulin.
The addition of rosiglitazone to metformin and/or a sulphonylurea
has been shown to help people with type 2 diabetes reach and maintain
treatment goal, and findings from ADOPT support the long-term durability
of rosiglitazone monotherapy.(13)
For full prescribing information please consult the current rosiglitazone
Summary of Product Characteristics.
About Type 2 Diabetes
Type 2 diabetes is a chronic, progressive illness often linked to
premature death, and affects approximately 230 million individuals
worldwide, nearly 6 per cent of the world's adult population. The
IDF estimates that by 2025, more than 350 million people worldwide
will suffer from this disease.(14)
Type 2 diabetes occurs when the body does not respond properly
to, or produce enough, insulin.(15) Over time, the chronic, progressive
nature of type 2 diabetes makes it more difficult to maintain blood
sugar levels and therefore, more than one medication may be required
to reach recommended goals.(16,17) Keeping blood sugar levels in
control is important in preventing diabetes-related conditions such
as eye disease (blindness), kidney disease (kidney failure/dialysis),
nerve damage, amputation, heart disease, stroke and peripheral vascular
disease.(16, 18-21) Such complications can decrease a person's quality
of life and result in increased health care costs.(22) Untreated
diabetes can lead to death. Every ten seconds, a person dies from
diabetes-related causes.(23)
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality
of human life by enabling people to do more, feel better and live
longer. For company information, visit http://www.gsk.com.
References:
1. Kahn SE, Haffner, SM, Heise MA, Herman WH, Holman RR, Jones
NP, Kravitz BG, Lachin JM, O'Neill C, Zinman B, Viberti G for the
ADOPT Study Group. Glycemic Durability of Rosiglitazone, Metformin,
or Glibenclamide Monotherapy. N Eng J Med. 2006;355:2427-2443. Published
online on: December 4, 2006.
2. Gerich JE. Redefining the clinical management of type 2 diabetes:
matching therapy to pathophysiology. Eur J Clin Invest. 2002;32:46-53.
3. UKPDS Group. Intensive blood glucose control with sulphonylureas
or insulin compared with conventional treatment and risk of coplications
in patients with type 2 diabetes. The Lancet. 1998;352:837-853.
4. UKPDS Group. Effect of intensive blood-glucose control with
metformin on complications in overweight patients with type 2 diabetes.
The Lancet. 1998;352:854-865.
5. American Diabetes Association. "Rapid Increase in the Use
of Oral Antidiabetic Drugs in The United States 1990-2001."
Diabetes Care, Vol. 26: 1852-1855, 2003.
6. Harris SB, Lank CN. Recommendations from the Canadian Diabetes
Association. 2003 guidelines for prevention and management of diabetes
and related cardiovascular risk factors. Can Fam Physician. 2004;
50:425-433.
7. Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia
in type 2 diabetes: a consensus algorithm for the initiation and
adjustment of therapy: a consensus statement from the American Diabetes
Association and the European Association for the Study of Diabetes.
Diabetes Care. 2006; 29:1963-1972.
8. Schwartz AV, Sellmeyer DE, Ensrud KE, Cauley JA, Tabor HK, Schreiner
PJ, Black DM, Cummings SR. Older women with diabetes have an increased
risk of fracture: a prospective study. J Clin Endocrinol Metabol.2001;86:32-38.
9. de Liefde II, van der Klift M, de Laet CE, van Daele PL, Hofman
A, Pols HA. Bone mineral density and fracture risk in type 2 diabetes
mellitus: the Rotterdam Study. Osteoporos Int. 2005;16:1713-1720.
10. Strotmeyer ES, Cauley JA, Schwartz AV, Nevitt MC, Resnick HE,
Bauer DC, Tylavsky FA, de Rekeneire N, Harris TB, Newman AB. Nontraumatic
fracture risk with diabetes mellitus and impaired fasting glucose
in older white and black adults: the health, aging, and body composition
study. Arch Intern Med. 2005;165:1612-1617.
11. Data on file.
12. American Diabetes Association. Standards of medical care for
patients with diabetes mellitus. Diabetes Care. 1998; 21::S23-S31.
13. Avandia® Prescribing Information.
14. Unite for Diabetes (International Diabetes Federation). About
diabetes. Available at: http://www.unitefordiabetes.org/assets/files/About_diabetes.pdf.
Accessed on November 3, 2006.
15. Groop LC. Insulin resistance: The fundamental trigger of type
2 diabetes. Diabetes, Obesity & Metabolism 1999; 1 (Supplement
1):S1-S7.
16. Stratton IM, et al. Association of glycaemia with macrovascular
and microvascular complications of type 2 diabetes (UKPDS 35): prospective
observational study. BMJ. 2000:321:405-412.
17. Nathan DM. Initial management of glycemia in type 2 diabetes
mellitus. N Eng J Med. 2002;347:1342-1349.
18. International Diabetes Federation. Fact Sheet: Diabetes and
eye disease. Available at: http://www.idf.org/home/index.cfm?unode=C1CCADE9-4A03-4D17-A662-155B3ED59FDB.
Accessed on November 3, 2006.
19. International Diabetes Federation. Fact Sheet: Diabetes and
kidney disease. Available at: http://www.idf.org/home/index.cfm?unode=BB08E3D8-4036-4C06-B654-5DC24D158820.
Accessed on November 3, 2006.
20. International Diabetes Federation. Complications of diabetes.
Available at: http://www.idf.org/home/index.cfm?node=13. Accessed
on November 3, 2006.
21. International Diabetes Federation. Fact Sheet: Diabetes and
cardiovascular disease (CVD). Available at: http://www.idf.org/home/index.cfm?unode=FCC1DD60-2C39-4D3C-A3C0-85247F1678F3.
Accessed onNovember 3, 2006.
22. Unite for Diabetes (International Diabetes Federation). The
economic impact of diabetes. Available at: http://www.unitefordiabetes.org/assets/files/Diabetes_econ_impact.pdf.
Accessed on November 3, 2006.
23. Unite for Diabetes (International Diabetes Federation). A United
Nations Resolution on diabetes. Available at: http://www.unitefordiabetes.org/assets/files/UNR_overview.pdf.
Accessed on November 3, 2006.
For further information please go to:
GlaxoSmithKline
New Study Shows Cinnamon Extract Lowers Blood Sugar Levels In
People With Type 2 Diabetes
Main Category: Diabetes News
Article Date: 30 Jun 2006 - 0:00 PST
A water-soluble, cinnamon extract has been shown to reduce fasting
blood sugar levels in patients with type 2 diabetes, according to
a new study from the University of Hannover in Hannover, Germany
published in a recent issue of the European Journal of Clinical
Investigation. This was the first study evaluating the effect of
a water-soluble cinnamon extract on glycemic control and the lipid
profile of Western patients with type 2 diabetes. The results further
add to a growing body of clinical evidence demonstrating supplementation
with a water-soluble cinnamon extract may play an important role
in managing blood sugar levels and improving insulin function.
The placebo-controlled, double-blind study was designed to determine
the effect of a water-soluble cinnamon extract on glycemic control
and cardiovascular risk factors in patients with type 2 diabetes.
A total of 79 patients with type 2 diabetes not on insulin therapy
but treated with oral medication or diet therapy were randomly assigned
to take either a cinnamon extract or placebo capsule three times
daily for four months. The cinnamon capsule contained 112 mg of
water-soluble extract, an equivalent of one gram of cinnamon powder.
The cinnamon extract group experienced a significant reduction in
fasting plasma glucose levels (10.3%) versus the placebo group (3.4%).
Changes in HbA1c and lipid profiles were not statistically significant.
In the U.S., Cinnulin PF is the only water-soluble cinnamon extract
ingredient standardized for the recognized active component in cinnamon,
double-linked Type-A Polymers. Despite USDA studies showing the
health benefits of cinnamon, researchers note that when consumed
consistently or in high doses, whole cinnamon and fat-soluble extracts
may be toxic. Cinnulin PF retains the active components without
the potentially harmful compounds, making it completely safe for
everyday use.
"This study, together with a recent clinical trial utilizing
Cinnulin PF, provides compelling evidence for the beneficial effects
of a water-soluble cinnamon extract on blood sugar levels,"
stated Tim Romero, executive vice president, Integrity Nutraceuticals
International, marketer of Cinnulin PF. "We are excited to
see in the coming months results of studies underway that further
substantiate the efficacy and safety of Cinnulin PF."
Integrity Nutraceuticals International, founded in 1999, is a global
raw material supplier of bulk nutraceuticals. They import only the
finest materials from China and India and specialize in custom formulations.
Integrity's focus is to introduce innovative ingredients into the
market based on science and research. Their inventory consists of
a wide variety of products including: amino acids, creatine, sports
enhancing supplements, joint and heath care items, specialty items
and herbs. Integrity's products are verified analytically in their
state-of-the-art in-house laboratory equipped with HPLC, FT-NIR,
GC and microbial testing.
Integrity Nutraceuticals International
http://www.integritynut.com
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