Monday, May 29, 2023
This article is intended for primary care clinicians, endocrinologists, cardiologists, infectious disease specialists, and other specialists who care for patients with type 2 diabetes mellitus, hypertension, or serious infections caused by methicillin-resistant Staphylococcus aureus.
The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.
Upon completion of this activity, participants will be able to:
As an organization accredited by the ACCME, MedscapeCME requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.
MedscapeCME encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.
MedscapeCME is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
MedscapeCME designates this educational activity for a maximum of 0.25
AMA PRA Category 1 Credit(s)™
. Physicians should only claim credit commensurate with the extent of their participation in the activity. Medscape Medical News has been reviewed and is acceptable for up to 350 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins 09/01/08. Term of approval is for 1 year from this date. This activity is approved for 0.25 Prescribed credits. Credit may be claimed for 1 year from the date of this activity.
Note: Total credit is subject to change based on topic selection and article length.
Medscape, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Medscape designates this continuing education activity for 0.25 contact hour(s) (0.025 CEUs) (Universal Program Number 461-000-09-077-H04-P).
For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]
There are no fees for participating in or receiving credit for this online educational activity. For information on applicability
and acceptance of continuing education credit for this activity, please consult your professional licensing board.
This activity is designed to be completed within the time designated on the title page; physicians should claim only those
credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the
activity online during the valid credit period that is noted on the title page.
Follow these steps to earn CME/CE credit*:
You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it.
Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print
out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.
*The credit that you receive is based on your user profile.
CME/CE Released: 5/21/2009
Valid for credit through: 5/21/2010
processing....
May 21, 2009 — The US Food and Drug Administration (FDA) has approved pioglitazone HCl and metformin HCl extended-release tablets for the adjunctive treatment of type 2 diabetes mellitus, amlodipine and olmesartan medoxomil tablets for first-line use in the treatment of hypertension, and a 10-g vial size for vancomycin HCl injection.
Pioglitazone HCl/Metformin HCl Extended-Release Tablets (ACTOplus met XR) for Type 2 Diabetes
On May 12, the FDA approved pioglitazone HCl and metformin HCl extended-release tablets (ACTOplus met XR; Takeda Pharmaceutical Co, Ltd) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already receiving pioglitazone and metformin or who have inadequate glycemic control with either drug alone.
According to a company news release, it is the first and only prescription once-daily oral antidiabetic fixed-dose combination product available with the extended-release form of metformin.
The recommended starting dose for pioglitazone-metformin extended-release tablets is one 15-mg/1000-mg or 30-mg/1000-mg tablet administered once daily with the evening meal; this dose may be gradually uptitrated to a maximum of 45 mg/2000 mg depending on clinical response and tolerance. Patients initiating therapy or receiving dose increases should be monitored carefully for signs and symptoms of heart failure, including excessive and rapid weight gain, dyspnea, and/or edema. Use of the product in the setting of New York Heart Association class III or IV heart failure is contraindicated.
Patients receiving pioglitazone-metformin therapy should be informed that the extended-release tablets must be swallowed whole and not chewed, cut, or crushed, and that inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.
Because metformin is substantially excreted by the kidneys and its accumulation has been linked to a risk for potentially fatal lactic acidosis, pioglitazone-metformin products should not be used in patients with kidney disease or renal impairment.
Similarly, treatment with pioglitazone-metformin should not be initiated in patients with clinical evidence of active liver disease or increased serum transaminase levels (alanine aminotransferase > 2.5 the upper limit of normal). Liver enzyme monitoring is recommended before initiation of therapy and periodically thereafter.
A pioglitazone and immediate-release metformin combination product (ACTOplus met) previously was approved by the FDA for the adjunctive treatment of type 2 diabetes mellitus.
Amlodipine and Olmesartan Medoxomil (Azor) Approved as First-Line Antihypertensive
On May 11, the FDA approved an expanded indication for amlodipine and olmesartan medoxomil tablets (Azor; Daiichi Sankyo, Inc), allowing use of the dihydropyridine calcium channel blocker plus angiotensin II receptor blocker combination product as first-line therapy in patients likely to require multiple antihypertensive agents to achieve their blood pressure goals.
"The approval of Azor as a first-line therapy gives doctors an important treatment option that may help the many patients who require multiple medications avoid several treatment steps to achieve their blood pressure goals," said Keith C. Ferdinand, MD, in a company news release. "Fixed-dose combinations like Azor provide patients with a more convenient option than separate monotherapies, which may help simplify the treatment regimen and decrease overall pill burden."
Dr. Ferdinand is chief science officer of the Association of Black Cardiologists and a clinical professor at the Emory School of Medicine in Atlanta, Georgia.
Approval of the product for first-line use was based on data from an 8-week, placebo-controlled, parallel-group factorial study that provided estimates of the probability of patients attaining blood pressure goals with amlodipine-olmesartan vs either component alone, based on baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling from all available data.
These figures are included in the prescribing monograph to provide an approximation of the likelihood of reaching a targeted blood pressure goal.
Amlodipine and olmesartan tablets previously were approved by the FDA for second-line use alone or with other agents in the treatment of hypertension.
Vancomycin Injection Now Available in 10-g Pharmacy Bulk Vials
On April 29, the FDA approved a 10-g pharmacy bulk vial of sterile vancomycin HCl injection (Hospira, Inc).
"This approval means Hospira now offers the most complete product portfolio of this important drug, which is an effective agent for fighting methicillin-resistant Staphylococcus aureus (MRSA)," the company said in a news release, noting that MRSA infections are often resistant to other antibiotics.
The glycopeptide antibiotic previously was approved in 500-mg, 750-mg, and 1-g dosages; and in 5-g pharmacy bulk packages.
Vancomycin is indicated for the treatment of serious, life-threatening infections by gram-positive bacteria that are unresponsive to other less toxic antibiotics.
To control the spread of vancomycin resistance, the Centers for Disease Control and Prevention advises that vancomycin therapy be restricted to the treatment of serious infections caused by susceptible organisms resistant to penicillins, pseudomembranous colitis refractory to metronidazole, infections caused by gram-positive microorganisms in patients with severe allergies to beta-lactam antimicrobials, antibacterial prophylaxis for endocarditis after certain procedures in penicillin-hypersensitive individuals at high risk, and as surgical prophylaxis for major procedures involving implantation of prostheses in institutions having a high rate of MRSA or methicillin-resistant S epidermidis.
