Formulary Watch |

Adjuvant Zoledronic Acid Decreases Breast Ca Recurrence in Premenopausal Women

Adding zoledronic acid to anastrozole or tamoxifen therapy decreased recurrence by 35% and increased disease free survival by 36% in premenopausal breast cancer patients, according to results of the Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12). The multicenter, Phase III trial is the first large trial to demonstrate the significant antitumor benefit of zoledronic acid, said Michael Gnant, MD, Medical University of Vienna. "Adjuvant treatment with zoledronic acid should be considered in order to improve the standard of care in premenopausal breast cancer patients," he said.

Modafinil appears to alleviate chemotherapy-induced fatigue

Modafinil appears to reduce the severity of chemotherapy-induced severe fatigue, reported Gary R. Morrow, PhD, MS.

Vaginal Brachytherapy Is Effective, has Fewer Side Effects, Gives Better Quality of Life

Vaginal brachytherapy is as effective as external beam radiation therapy in preventing the recurrence of higher-risk endometrial cancer but with fewer side effects and results in superior quality of life, according to a Phase 3 study presented by Remi A. Nout, MD.

Intervention Program Improves Sleep Quality During Chemotherapy

Adherence to a four-point Individualized Sleep Promotion Plan (ISPP) intervention consisting of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene practices significantly lowered fatigue and increased sleep quality for patients undergoing adjuvant chemotherapy. Fatigue and sleep disturbances are the most frequently reported symptoms during adjuvant chemotherapy for breast cancer. One-third of breast cancer patients report persistent fatigue and abnormal sleep/wake cycles, said Ann M Berger, PhD, RN, professor, College of Nursing, University of Nebraska Medical Center, Omaha.

Sunitinib Recipients Should Receive Cardiac Monitoring

Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.

Everolimus may Be Effective Second-line Option After Failure of First-line Tx in Renal-cell Ca

Everolimus, an experimental oral agent that targets the mTOR protein, may represent an effective second-line option for patients with metastatic renal-cell carcinoma whose disease has progressed despite treatment with a tyrosine kinase inhibitor.

Bevacizumab, docetaxel combination is effective first-line treatment for metastatic breast cancer

Phase 3 trial results show that adding bevacizumab to docetaxel as first-line therapy for newly diagnosed HER2-negative, locally recurrent, or metastatic breast cancer resulted in significantly less disease progression. "This shows that the antiangiogenic approach to treating breast cancer is effective, regardless of which taxane drug it is combined with," said lead author David Miles, MD, professor, Mount Vernon Cancer Center, Middlesex, UK. Previous studies have shown that the combination of bevacizumab to paclitaxel doubled progression-free survival among patients with metastatic breast cancer.

Cancer Is Independent Predictor of Increased Vulnerability in Elderly Persons

Cancer is an independent predictor of increased vulnerability, functional limitations, geriatric syndromes, frailty, and fair or poor health status among older Medicare beneficiaries. "Up until now, a lot of this has been more opinion rather than numbers," said Gary R. Morrow, MD, professor of radiation oncology, University of Rochester Cancer Center. "This gives us a method to let us know if we have changed anything.

Greetings from the American Society of Clinical Oncology (ASCO) meeting in Chicago!

Live daily coverage beginning June 1 from the ASCO meeting in Chicago.

ASCO show daily images

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Istradefylline: An adenosine receptor antagonist for the treatment of Parkinson disease

Istradefylline, a highly selective adenosine A2A receptor antagonist, is a new agent being investigated for the adjunctive treatment of the motor signs and symptoms of idiopathic Parkinson disease.

Current and emerging treatment options for postmenopausal osteoporosis

Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.

First-time generic drug approvals, May 2008

Generic drugs approved by FDA (through May 2008) including amifostine for injection, clobetasol foam, granisetron oral solution, calcium acetate capsules, and irinotecan injection.

FDA Pipeline preview, May 2008

Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.

FDA actions in brief, May 2008

Recent FDA approvals and indications (through May 2008) related to Janumet, PegIntron, Rebetol, Xyzal, Liquadd, and NovoLog.

Bendamustine (Treanda): Alkylating agent approved for the treatment of chronic lymphocytic leukemia

NME: Bendamustine (Treanda), an alkylating agent, was approved on March 20, 2008, for the treatment of chronic lymphocytic leukemia (CLL).

Physicians urged to return to statins after announcement of ENHANCE results

Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.

Drug Watch: Antibiotics in late-stage development (May 2008) (PDF)

Antibiotics in deveopment for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and infectious diarrhea

ONTARGET: ARB noninferior to ACE inhibitor in patients with cardiovascular disease

According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.

Medicare commission explores national reporting of industry gifts to physicians; House expands mental health coverage

At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.

High- and low-tech solutions to reduce the incidence of hospital-acquired infections and antibiotic resistance

Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.

CDER gains Woodcock as permanent chief

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

Research disclosure and drug safety monitoring requirements raise new challenges

The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.

International Stroke Conference 2008: EPITHET: Patients who suffer a stroke and have a perfusion-diffusion mismatch may benefit from tPA beyond the 3-hour window

Data from EPITHET presented at the International Stroke Conference 2008 demonstrates that extending the standard 3-hour window for tPA could benefit patients who suffer a stroke and have a perfusion-diffusion mismatch.

Medication safety labeling updates and new warnings, April 2008

Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.

Off-label stent use: DES associated with equal safety risks and reduced risk of repeat PCI compared with BMS

Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.

Process steps and suggestions for creating drug monographs and drug class reviews in an evidence-based formulary system

How-to guide for creating drug monographs and drug class reviews for evidence-based formulary consideration.

DPP-IV inhibitors: A review of sitagliptin, vildagliptin, alogliptin, and saxagliptin

Treatment of diabetes with DPP-IV inhibitors; sitagliptin, vildagliptin, alogliptin, and saxagliptin.

First-time generic drug approvals, April 2008

Generic drugs approved by FDA (through April 2008) including cefuroxime for oral suspension, pramipexole tablets, alendronate once-daily tablets, and alendronate once-weekly tablets.

FDA actions in brief, April 2008

Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.