גלוקמין

מצ"ב מה שהיצרנית פרסמה על התרופה אנו מעדיפים להתחיל בגלולות ופעילות גופנית. ear Colleague,Takeda Pharmaceuticals North America, Inc. and Eli Lilly and Company would like to provide youinformation regarding recent changes to the prescribing information for Actos®(pioglitazone HCl),an oral agent approved for the treatment of type 2 diabetes. The updated information reflects adverseevent experience gained from U.S. controlled clinical trials, as well as from post-marketing experience. Thechanges are discussed below. A copy of the revised package insert is enclosed.Actos is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2diabetes as:*Monotherapyand in combination with:*Sulfonylureas, or*Metformin, or*InsulinChanges to the package insert:A new "WARNINGS"section has been added to further emphasize the importance of cardiac safetyconcerns with Actos, particularly fluid retention which may contribute to heart failure, as well as specificconcerns when Actos is used in combination with insulin:Actos, like other thiazolidinediones, can cause fluid retention when used alone or in combination withother antidiabetic agents, including insulin. Fluid retention may lead to or exacerbate heart failure. Actosshould be discontinued if any deterioration in cardiac status occurs. Actos is not recommended in patientswith New York Heart Association (NYHA) Class III and IV cardiac status.In a 16-week, double-blind, placebo-controlled trial involving 566 patients with type 2 diabetes and a highprevalence of pre-existing cardiovascular disease, there were four episodes of CHF among patients treatedwith Actos plus insulin (two each in the 15 mg and 30 mg Actos groups, respectively) for a rate of 1.1%compared to no episodes of CHF in the group treated with insulin plus placebo. All four of these patientshad previous histories of cardiovascular conditions including coronary artery disease, previous CABG, andprevious MI. However, analysis of these data did not identify specific risk factors that could predictincreased risk of CHF on combination therapy with insulin.The "PRECAUTIONS"section has been modified to include additional information about Actosmonotherapy and combination therapy:The incidence of serious cardiac adverse events (e.g., CHF) related to intravascular volume expansion hasnot been shown to be increased in patients treated with Actos as monotherapy or in combination withsulfonylureas or metformin compared to placebo-treated patients. In insulin combination studies, a smallnumber of patients with a history of previously existing cardiac disease developed CHF when treated withActos in combination with insulin. -------------------------------------------------------------------------------- Page 2 In post-marketing experience with Actos, cases of CHF have been reported in patients both with andwithout previously known heart disease.Dose related weight gain was seen with Actos alone and in combination with other hypoglycemic agents. Weight changes from baseline during clinical trials with Actos are presented in tabular form (see Table 6).Patients who experience an unusually rapid increase in weight or edema or who develop shortness ofbreath or other symptoms of heart failure while on Actos should immediately report these symptoms totheir physician.The "ADVERSE REACTIONS"section has been modified to include additional information about adverseevents observed with Actos and insulin in combination:In the 16-week trial of Actos plus insulin versus insulin plus placebo,10 patients treated with combinationtherapy developed dyspnea and also, at some point during their therapy, developed either weight changeor edema. Seven of the 10 patients received diuretics to treat these symptoms. These events were notreported in the insulin plus placebo group.In combination therapy studies, edema was reported for 7.2% of patients treated with Actos andsulfonylureas compared to 2.1% of patients on sulfonylureas alone. In combination therapy studies withmetformin, edema was reported in 6.0% of patients on combination therapy compared to 2.5% ofpatients on metformin alone. In combination therapy studies with insulin, edema was reported to 15.3%of patients on combination therapy compared to 7.0% of patients on insulin alone.The ongoing incorporation of updated information into the labeling for Actos is appropriate forcontinued safe and effective use of this agent in the clinical setting. Takeda and Lilly will continue toclosely monitor patient experiences.It is important that any adverse event information associated with the use of Actos or any questions beforwarded to Takeda Pharmaceuticals North America, Inc. at (877) Takeda-7.Sincerely yours,Wayman Wendell Cheatham, M.D., FACEVice PresidentMedical & Scientific AffairsTakeda Pharmaceuticals North America, Inc.