Sanofi-Aventis announces availability of insulin pen in the United States
BRIDGEWATER, N.J. A disposable insulin pen for patients ages 4 and older with Type 1 diabetes and adults with Type 2 diabetes has become available in the United States.
Sanofi-Aventis U.S. announced Monday the availability of the Apidra SoloSTAR, a pen with the fast-acting insulin analog Apidra (insulin glulisine [rDNA origin]). The pen received Food and Drug Administration approval in February, following the approval and launch of the long-acting Lantus SoloSTAR (insulin glargine [rDNA origin]).
“Sanofi-Aventis is committed to providing innovative tools to patients with diabetes that can help ease some of the challenges of blood sugar management,” stated Jerry Durso, Sanofi-Aventis U.S. VP Specialized Therapeutics Business Unit. “Apidra SoloSTAR provides patients with a convenient option for administering their Apidra.”
Study: Taking epilepsy drug during pregnancy can impair child’s cognitive development
ATLANTA Exposure to the epilepsy drug Depakote (valproate) during pregnancy can impair a child’s cognitive development, according to a study published in the April 16 edition of the New England Journal of Medicine.
Three-year-olds whose mothers took the antiepileptic drug valproate during pregnancy had average IQs six to nine points lower than children exposed to three other antiepileptic drugs, according to the research.
The study’s authors say that women of childbearing age should avoid valproate as a first choice drug for the treatment of epilepsy.
The Neurodevelopmental Effects of Antiepileptic Drugs study is following more than 300 children born to women with epilepsy between 1999 and 2004. Investigators at 25 epilepsy centers in the United States and the United Kingdom are participating. At enrollment, the women were taking a single antiepileptic agent: carbamazepine, lamotrigine, phenytoin or valproate.
The NEAD study previously found that valproate exposure also increases the risk of anatomical birth defects, even though it was not designed to look for them.
“There are clear risks associated with valproate, and physicians have an obligation to inform women about them,” stated lead study author Kimford Meador, professor of neurology at the Emory University School of Medicine. “Valproate still has an important role in treating epilepsy, because some patients’ seizures can only be controlled with valproate. However, we are recommending that women with epilepsy try another drug first.”
Around 15% of patients with primary generalized epilepsy respond only to valproate, but this selectivity does not apply to other forms of epilepsy, Meador said.
A child’s IQ is usually strongly influenced by the mother’s IQ. Out of the four antiepileptic drugs studied, only valproate disrupted this relationship.
Valproate is also prescribed for bipolar disorder and migraine headaches. It is sold under the brand name Depakote. Last year the FDA approved a generic version.
New studies find that impotence drugs used by males are effective in females
AUGUSTA, Ga. New studies indicate the three drugs used to treat male impotence also appear to work in females, albeit a little differently, and should give the scientific community pause to take a second look at their potential in the 40% of women who report sexual dysfunction, researchers reported Friday.
In one of the first studies of the effect of phosphodiesterase type 5 inhibitors – Viagra (sildenafil citrate), Levitra (vardenafil) and Cialis (tadalafil) — on the pudendal arteries that supply the penis, vagina and clitoris the blood needed to produce a satisfying sexual experience, Medical College of Georgia researchers showed the drugs relax the artery in male and female rats.
“It shows the drugs need to be investigated more for women and small alterations could make these compounds more effective for women living with these disorders,” stated Kyan Allahdadi, postdoctoral fellow in physiology at MCG.
He’s presenting the findings during the 122nd Annual Meeting of the American Physiological Society held in New Orleans April 18 through 22 as part of the Experimental Biology 2009 scientific conference.
Although there was talk years ago of a pink pill for women to parallel the blue Viagra for men, early clinical trials found essentially no response in women.
MCG researchers decided to look again, first giving a drug to constrict the internal pudendal arteries in male and female rats — as they would be in a non-erect state — then giving doses of each impotency drug to see the impact. The arteries from male rats displayed a relatively standard concentration-dependent relaxation – the more drugs they got, the more they relaxed — while in females’ arteries, there was an initial relaxation then an odd oscillation between relaxation and contraction with subsequent dosing.
While they don’t fully understand the swing, the unique female response likely provides more evidence that sexual function is more complex in females, offered Clinton Webb, chair of the MCG Department of Physiology and a study author. Scientists define female sexual dysfunction as a multifaceted disorder that includes anatomical, psychological, physiological and social-interpersonal aspects.
MCG researchers have shown part of that complexity may be the smooth muscle cells in the internal pudendal arteries of females communicate, agreeing to contract and relax, while male smooth muscle cells make independent decisions to just relax.
They found one other distinction: females were more sensitive to Viagra, while males were most sensitive to Levitra.
Previous studies on the effectiveness of these drugs focused on the cavernosal tissue, or penis. The internal pudendal artery actually feeds the penile artery which is buried deep in the penis where numerous caverns enable it to be flaccid when not engorged with blood. Physical stimulation of the area causes the tissue, endothelial cells and nerves to release nitric oxide, a powerful dilator of blood vessels. The system works pretty much the same way in the vagina and clitoris.
“If you have too much constriction or not enough relaxation to allow blood to go through the internal pudendal artery, you are not going to get the net effect of an erection,” Allahdadi said. “That is why we wanted to begin to characterize what was going on in this blood vessel.”
The MCG scientists and others are beginning to believe sexual dysfunction provides an early, or at least visible, clue of vascular disease. Vascular problems, which can result from diabetes, hypertension, high cholesterol and the like, are a major cause of sexual dysfunction in men and women.
“What we have seen preliminarily is there is big difference in responsiveness in these arteries. The diabetic pudendal arteries are much more sensitive to contraction,” Allahdadi said.
For future research, they will look at how drugs like Viagra impact that contraction.
In fact, MCG scientists suspect one reason that many of the women participants in previous studies of Viagra did not seem to respond is because they did not have vascular problems that could have been circumvented by a drug that relaxes arteries so blood can enter. In men with a healthy vasculature, the drugs likely would still produce a longer erection.