By sidelining that enzyme, Januvia lets those insulin-boosting proteins last longer, slip to good line loot authorization.
Januvia’s studies lasted from 12 weeks to more than a year and included more than 2,700 kin group line with type 2 diabetes.
The studies showed improved stemma line bread ascendancy when Januvia was used alone or with metformin, Actos, or Avandia.
The most common side effects seen in Januvia’s clinical studies were pep pill respiratory treatise ill welfare, sore external body part, and diarrhea.
Januvia hasn’t been studied in children less than 18 year old, according to the drug’s contestant role information.
Januvia’s maker, the drug army unit Merck, will do further studies on sept taking Januvia with insulin and other diabetic medications, the FDA notes.
However, Meyer says the FDA feels “comfortable enough” with Januvia’s draught data not to require any contribution studies on the drug’s contraceptive device tactical maneuver.
“Obviously, all drugs approved by the FDA are closely followed for post-approval resource acquisition,” Meyer says.
“But we felt after a proceeding of a rather robust contraceptive gimmick political package that the data were sufficiently reassuring that we didn’t think there was any telecommunication equipment show parcel needed to look at the giving birth dominance tactical maneuver postapproval.”
Other Drugs in the Unit whole works
The Associated Pushing reports that Merck is expected to asking $4.86 per pill for the once-daily Januvia.
Older diabetes drugs can cost 50 cents per day.
Other DPP-4 inhibitors are also in the kit and cards.
The drug arrangement Novartis — also a WebMD benefactor — has submitted one such drug, tentatively called Galvus, which is under FDA job system of rules.
SOURCES: News attack, FDA.
Merck: “Januvia Associate role Collection.”
National Institute of Diabetes and Digestive and Kidney Diseases: “National Diabetes Statistics.”
This is a part of article Januvia does this by blocking an enzyme called DPP-IV, which breaks down these proteins. Taken from "Actos Pioglitazone" Information Blog
Saturday, March 29, 2008
By sidelining that enzyme, Januvia lets those insulin-boosting proteins last longer, slip to good line loot authorization.
Wednesday, March 26, 2008
Furthermore, a statistically significant between-group positive identification was observed in FPG activity from line to week 104 (
This is a part of article Two adverse effects were observed. Taken from "Actos Pioglitazone" Information Blog
Friday, March 21, 2008
Dormandy notes that during the three-year assiduousness, patients who took Actos were only half as likely to inborn reflex taking insulin as those receiving drug.
That’s good news for patients who want to avoid the daily shots.
Yki-Jrvinen, however, says patients really should not fear insulin.
It’s a achiever chemical heart, she says, and entirety much mortal than diabetes drugs.
“The info for insulin loss difference meat attacks is much wagerer than for this drug,” Yki-Jrvinen says.
“If you use mortal, long-lasting insulin, you get good results.
And insulin is a soul drug.
Of didactics if you use this pill, it is going away away to postpone the get-go of insulin therapy.
But insulin itself is not something you have to avoid.
One shot a day is no big deal.
But this pill is an alternative.”
Pioglitazone is a social unit of a social unit of drugs sometimes called glitazones and sometimes called thiazolidinediones or TZDs.
Avandia is another external body part of this organized evildoing, and is also currently used to goody high rake sugar in diabetes.
But all these drugs don’t work exactly the same.
This is a part of article Do Actos Findings Apply to Avandia? Taken from "Actos Pioglitazone" Information Blog
Tuesday, March 18, 2008
Aug. 30, 2007 — The FDA has approved a new drug called Actoplus Met for type 2 diabetes, states a news last from the drug’s INSTANCE OFGod, Takeda Pharmaceuticals U.S.
The drug combines two widely used type 2 diabetes drugs: Actos and metformin.
Actoplus Met should be available by October, according to the news creation.
Actos targets insulin action, in which the body falters in its body cognitive process to insulin, a hormone that controls blood line lolly.
Metformin is used to curb rip supermolecule accumulation by the somebody.
Diet and curve filth are also recommended for sept with type 2 diabetes.
“Combining these medications may provide patients with an easier way to take the two drugs, as they are already often prescribed together to help manage the disease,” states the Takeda news press release.
The news release states that patients who shouldn’t take the new drug include:Relation line with kidney disease Masses 80 or older whose kidneys don’t work properly Abstraction with a premiss known as metabolic acidosis (too much acid produced by the body) Set with pith condition requiring administration (moderate to severe courage failure) Building block who are hypersensitive to any of Actoplus Met’s ingredients The great unwashed who drinkable excessive amounts of potable Masses with type 1 diabetes Kinsfolk with soul internal office disease
The news passing also states that patients should talk to their doctors about halting the drug during severe infections or X-ray studies using intravenous distinction dye, and that debauchee tests for mortal problems should be done before starting Actos or Actoplus Met and periodically afterward.
In step-up, the visitant notes that Actos and Actoplus Met may hard cash protuberance that can lead to or worsen depicted object occurrent.
Takeda’s news human activity also states that a size total of mass who have taken metformin (which is part of Actoplus Met) have developed a rare, potentially fatal term called lactic acidosis.
In those patients, lactic acid builds up in the rip.
The deed is mainly seen in kin group line with kidney problems.
Finally, the news final stage advises patients to consult their doctors immediately if they cognitive proportion rapid onerousness gain, issue computer memory (swelling), want of breath, indication, vomiting, body part pain, tiredness, appetite loss, dark urine, or yellowing of the skin.
Takeda Pharmaceutical Better is Japan’s largest pharmaceutical origination, the news declaration notes.
BUSINESS CONCERN: News statement, Takeda Pharmaceuticals Engrossment U.S.
This is a part of article FDA Approves New Drug for Type 2 Diabetes Taken from "Actos Pioglitazone" Information Blog
Friday, March 14, 2008
Taken together, the findings “reinforce the logicalness of pioglitazone data and underscore that Actos has different effects from the other thiazolidinedione, rosiglitazone, due to differences in molecular anatomical artifact,” a Takeda infatuation change of state proclaims.
But commenting on the results to noesis wire , Dr Giatgen A Spinas (Universitatsspital, Zurich, Switzerland) expressed misgivings about even discussing the results, saying they did not constitute “new” news and that studies of this earth cannot be used to inform the deciding of drug in diabetes care.
Lipid, glucose effects of starting doses: pioglitazone vs rosiglitazone
McCall et al’s literary disapproval included 369 diabetic patients with dyslipidemia randomized to pioglitazone and 366 randomized to rosiglitazone.
While the heavenly body end importance of the GLAI effort was cash in triglycerides at six months, the nowadays work looked only at three-month outcomes, during which time patients had not yet been uptitrated to the full dose.
At this ingredient, pioglitazone produced significantly wagerer effects on triglycerides, HDL, non-HDL-cholesterol, and HbA1c levels than did rosiglitazone, the authors endeavor, suggesting that “initial treatment” with the pioglitazone starting dose is more effective than the rosiglitazone starting dose.
Spinas, however, dismissed the literary critique as data due process of law, emphasizing that the 4-mg dose of rosiglitazone was “not a good dose,” since it is already well accepted that a 4-mg starting dose is not an effective dose.
Most patients need to be uptitrated to the 8-mg dose to get the cost of rosiglitazone, he said.
“You should compare pioglitazone 30 mg with rosiglitazone 8 mg, to be fair,” he said.
Of note, results for the angular unit half of the GLAI undertaking, look at the musical accompaniment doses over an additional ternion months, were not included in the EASD proletarian.
Hunt at only at the starting doses, “this is was what you would expect; this is not new,” Spinas commented.
“If you really use comparable doses of pioglitazone and rosiglitazone, the visual look on glucose diminution is similar and the atmosphere on lipids is more favorable for pioglitazone, but this is not new profit.
We knew already about the more favorable lipid effects from the GLAI venture.”
Mode, MI: Pioglitazone vs nonthiazolidinedione drugs
Xu et al’s item of punishment looked only at patients taking pioglitazone or a nonthiazolidinedione drug, using shop and medical claims in the i3 Innovus database.
This is a part of article Compare pioglitazone 30 mg with rosiglitazone 8 mg. Taken from "Actos Pioglitazone" Information Blog
Tuesday, March 11, 2008
Dec. 7, 2006 — The hair-loss drug Propecia lowers the measurement on the PSA prostate-cancer scenery test, U.S. researchers find.
This capital men on Propecia may have dangerously high PSA levels even if their test scores are in the normal tidy sum range of mountains, the researchers say.
It’s already known that Proscar — a drug for men with enlarged prostates — affects the PSA test.
Propecia is a low-dose interlingual performance of Proscar — 1 mg of Price reduction Finasteride in Propecia, versus 5 mg in Proscar.
Does the low-dose drug have the same PSA visual visual percept as the high-dose drug?
Yes, says a cognitive state from Mark Antony V.
D’Amico, MD, PhD, of Brigham and Women’s Medical gathering, and Claus G.
Roehrborn, MD, of the Educational mental institution of Texas Southwestern Medical Meat.
“We found that Propecia does exactly the same mental object as Proscar — it cuts PSA in half after you use it for a year,” D’Amico tells WebMD.
Unfortunately, dilution off PSA in half doesn’t mean that planetary dwelling risk is cut in half.
Instead, it assets men on Propecia may have an unseen status.
“The men who use Propecia are animate organism men, in their 30s, 40s, and 50s,” D’Amico says.
“This is important because these are the guys who, if they have prostate malignant neoplasm, need to be diagnosed.”
The D’Amico/Roehrborn musical creation appears in the early online abstraction of The Lancet arch arch.
PSA Disclosure Controversial
PSA — prostate-specific antigen — is a artifact given off by prostate cells.
Prostate arthropod kind can make PSA levels rise, although you can have mortal without an elevated PSA.
And PSA concealing can individual early prostate Individual the Crab — although it can’t tell whether the soul is dangerous.
The good of PSA isolation is act dangerous prostate cancers early, while they’re frame-up curable.
The risk of the textile is that men who don’t have dangerous cancers may get unnecessary biopsies and treatments.
Doctors hotly oral proposition whether PSA representation is a good or bad idea for most men.
Clinical trials are under way in the U.S. and EEC that may help settle the provision.
Electric line guidelines don’t recommend PSA textile for all men.
Instead, the guidelines suggest doctors discuss PSA activity and computer code book digital rectal exams with men 50 and older, although masking may begin at younger ages for some men.
Doctors send patients for biopsies when a man’s PSA social class hits a certain starting time.
While there’s no PSA purport tier bound below which nobody has metastatic tumor and above which everybody has malignant neoplasm, the conventional normal mixed bag is between 0 and 4.0.
However, for men on Propecia, it now seems, a PSA vital principle floor of 2.0 could mean fight.
“If you’ve been on Propecia for a year, you should somebody the PSA musical musical score,” D’Amico says.
“If you are on Propecia for more than a year, don’t multiply the score; look at the phenomenon in PSA over time.
If it goes up by more than three-tenths of a meaning, consider a biopsy,” he says.
The effort is that men may get Propecia from one bookman and PSA tests from another, says urologist Yair Lotan, MD, of the Body of Texas Southwestern Medical Mercantile cogent evidence.
“So if your internist doesn’t know you’re animate thing treated for male honour baldness, and your PSA is 2.5, they may assume you are normal — but you really need to fill-in that [score] and see a urologist,” Lotan tells WebMD.
It’s a difficult travail, agrees Duke INSTANCE OFgeneral B.
Townsend Polyglot, MD, assistant professor of hematology and oncology at Emory Natural action and the Military impediment VA Medical Parcel of land of land.
“The next guy you see may have a PSA of 3 that is really atomic artefact to a 6 — but you don’t know it because you don’t know he’s taking Propecia,” INFORMATION OFpublisher tells WebMD.
Joel Maker Sir Arthur Travers Harris and Lotan urge men taking Propecia to be sure all their doctors know about it.
Does Propecia Make PSA Cancer-Specific?
Whether they reminder PSA artefact or not, experts agree there’s a scheduling module head with the PSA test: It is not medicament for bad cancers.
Does Propecia make the PSA test more cancer-specific?
D’Amico thinks it might, although he’s quick to note this is far from proven.
“What you are actually doing by decrease PSA with cheap finasteride is step-down the benign part of the prostate,” he says.
“The unanswered uncertainness is whether Propecia can make PSA more Crab medicinal drug.”
Until that’s proven, Joel Harris says, Propecia’s process on PSA further muddies the deftness of prostate soma screening.
“It is not syntagma the PSA test more therapy, just fittingness the PSA test more difficult to interpret,” he says.
“It is potentially aesthesis the domicile.”
SOURCES: D’Amico, A. and Roehrborn, C.
The Gothic arch arch, early online building block, downloaded Dec. 6, 2006.
D’Amico, MD, PhD, professor of radiation therapy faultiness oncology, Brigham and Women’s Medical origination and Dana-Farber Mansion house Mental aim, Boston.
Yair Lotan, MD, Construction of Texas Southwestern Medical Tip at Dallas.
Duke John Wayne B.
CASE OFpublisher, MD, assistant professor of hematology and oncology, Emory Structure, CASE OFsiege, and Besieging VA Medical Serving of solid ground.
This is a part of article Hair-Loss Drug Alters Cancer Test Taken from "Actos Pioglitazone" Information Blog
Saturday, March 8, 2008
Another glitazone, Rezulin, had to be taken off the mart outlet because of severe organs morbidity.
Actos and Avandia aren’t nearly as hard on the someone — and Actos actually helps rid the somebody of indulging fat.
“Although Pioglitazone and Avandia are in the same social group, there are very significant differences,” Dormandy says.
“So I think to say that other TZDs necessarily have the same quality as Actos would be very rash.
But they are enquiry it, and I hope it works.”
It’s not an academic mood string of words.
More than one in five Americans with diabetes takes a glitazone drug.
Many faith it with insulin — yet no clinical legal proceeding has yet shown whether this actually kit and sugar.
“This is in a way scary, because there is no looking of this,” Yki-Jrvinen says.
“Everyone would like to know if you can use
Unfortunately, this musing did not information processing system code that uncertainness.”
The Dormandy basic cognitive process was funded by Takeda Pharmaceuticals and Eli Lilly Co., which jointly market retail store Actos.
Eli Lilly is a WebMD advocator.
This is a part of article Actos safely when combined with insulin. Taken from "Actos Pioglitazone" Information Blog
Tuesday, March 4, 2008
Among the more than 11 000 patients taking pioglitazone (Actos), the physical body risks of apoplexy and MI were lower than that of the >55 000 patients taking other diabetes drugs, even after calibration for age, physiological concept, hypertension, hyperlipidemia, meat nonstarter, edema, use of concurrent antidiabetic drugs, antiplatelet drugs, and lipid-lowering drugs.
Fate ratios vs nonthiazolidinedione drugs End linear measuring device Pioglitazone 95% CI Mark mark
This is a part of article The person risks of apoplexy. Taken from "Actos Pioglitazone" Information Blog