Rosiglitazone maleate - Rosiglitazone side effects
Rosiglitazone maleate is an oral diabetes medicine that helps control blood sugar levels. This medication helps your body respond better to insulin produced by your pancreas. Rosiglitazone maleate is for people with type 2 diabetes who do not use daily insulin injections. GlaxoSmithKline Plc makes the pharmaceutical drug rosiglitazone maleate.
Side effects of Rosiglitazone
maleate
Rosiglitazone maleate can cause an allergic reaction. Allergic rosiglitazone side effects include
hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Additional rosiglitazone serous side effects include signs of congestive heart failure
(swelling or rapid weight gain, shortness of breath, chest pain).
Gastrointestinal rosiglitazone side effects include nausea, vomiting, stomach pain, or
loss of appetite, and jaundice. other rosiglitazone side effects could include
fatigue, hypoglycemia, headache, weakness, sweating, and rapid heart beat.
Rosiglitazone side effect - bone loss
Patients taking the diabetes drug rosiglitazone maleate may have an
additional side effect - a higher risk of hip and other fractures because the
medicine decreases bone formation. A study of 50 postmenopausal women found
those on rosiglitazone had a 1.9 percent fall in total
hip bone density after 14 weeks of treatment, while those on a placebo
experienced a reduction of 0.2 percent. Lumbar spine bone density also fell
significantly compared with starting levels but not compared with the placebo.
The small New Zealand study comes on the heels of a major clinical trial of
rosiglitazone, called ADOPT, reported in December, 2006 which found an unexpected rise
in peripheral fractures, most commonly involving the foot and upper limbs. An
osteoporosis warning will be added to the drug's label, providing additional
ammunition for Merck & Co Inc and Novartis AG as they roll out a new class of
diabetes pills known as DPP-IV inhibitors. Merck has Januvia while Galvus is
made by Novartis. Rosiglitazone is Glaxo's second-biggest seller, with sales of $2.5
billion in 2005.
Does Rosiglitazone reduce diabetes
risk?
Treatment of high-risk patients with the oral antidiabetic drug rosiglitazone may
reduce their risk of developing type 2 diabetes by nearly two thirds. In a
clinical trial of patients with poor glucose tolerance, 5,269 adults were
assigned to receive rosiglitazone or a placebo (sugar pill) daily for an average of 3
years. At follow-up, the subjects in the rosiglitazone group were less likely to
develop the disease or die than those in the placebo group, and their risk of
progressing to full diabetes was reduced by 60 percent. The rosiglitazone patients
were also 70-percent more likely to return to normal blood sugar levels. These
patients did, however, have an increased risk of non-fatal heart failure, a
condition where the heart muscle is weakened and becomes unable to maintain
adequate blood supply to the body's tissues. The researchers, based at McMaster
University, Hamilton, Ontario, Canada concluded that for every 1,000 people
treated with rosiglitazone for 3 years, about 144 cases of diabetes would be prevented
and an extra 4 to 5 cases of heart failure would occur. The Canadian study also
looked at the value of a blood pressure drug called ramipril, but found it did
not reduce the risk of diabetes or death, although it did help some patients to
return to normal blood sugar levels. Ramipril is sold as Altace by King
Pharmaceuticals Inc. The study DREAM study (Diabetes REduction Assessment with
ramipril and rosiglitazone Medication) was funded by the Canadian Institutes of
Health Research, Sanofi-Aventis, GlaxoSmithKline and King Pharmaceuticals. The
Lancet, September 15, 2006.
Comments: Before prescribing rosiglitazone to
prevent diabetes, It would be prudent tosee a minimum of a seven year study to
determine if rosiglitazone has side effects that we are currently not aware of. It is
possible that rosiglitazone could reduce the risk of diabetes, but the cardiac side
effects could lead to people on this drug to die sooner. And now we find out
that rosiglitazone has side effects involving bone loss and potential osteoporosis.
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