Formulary Watch |

FDA Pipeline preview, July 2008

Recent FDA action (through July 2008) related to tigecycline, bazedoxifene, balsalazide tablet, tacrolimus, fospropofol injection, bivalirudin, 13-valent pneumococcal conjugate vaccine, pirfenidone, LX1032, palifosfamide, SB1518, oral tetrathiomolybdate, and terguride.

FDA actions in brief, July 2008 (Abilify, Levaquin, Taclonex Scalp, Recothrom, Seroquel)

Recent FDA approvals and indications (through July 2008) related to Abilify, Levaquin, Taclonex Scalp, Recothrom, and Seroquel.

Atomoxetine (Strattera): Selective norepinephrine reuptake inhibitor approved for the maintenance treatment of ADHD in children and adolescents

New indication: Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor, was approved on May 7, 2008, for the maintenance treatment of ADHD in children and adolescents.

Alvimopan (Entereg): Peripherally acting mu-opioid receptor antagonist approved to accelerate the time to upper and lower GI recovery after bowel surgery

NME: Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, was approved on May 20, 2008, to accelerate the time to upper and lower GI recovery after partial large or small bowel resection surgery with primary anastomosis.

AASK: Aggressive blood pressure control has little effect on progression of kidney disease in African American patients

According to the results of an extended follow-up of the African American Study of Kidney Disease and Hypertension (AASK), long-term reduction of blood pressure to a lower goal than the standard demonstrates no significant effect on the progression of chronic kidney disease (CKD) in nondiabetic hypertensive patients, except in patients with baseline urinary protein/creatinine ratio >0.22, said Jackson Wright, MD, professor of medicine and director of the hypertension program at Case Western Reserve University, Cleveland. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.

Integrating Recent Growth Factor Evidence, Practice Guidelines, and FDA Recommendations: Validating the Pharmacist?s Role in Management

Epoetin alfa in 1993 and darbepoetin alfa in 2002 were approved for the management of chemotherapy-induced anemia (CIA).

Drug Watch: Agents in late-stage development for the treatment of adult and juvenile rheumatoid arthritis (July 2008) (PDF)

Drugs in development for the treatment of adult and juvenile rheumatoid arthritis

Dual receptor antagonist demonstrated to be effective in reducing SBP

An investigational first-in-class dual angiotensin and endothelin receptor antagonist lowered systolic blood pressure (SBP) in patients with stage 1 and 2 hypertension in a phase 2a trial, reported Joel M. Neutel, MD, associate professor of medicine, University of California, Irvine, and medical director of clinical pharmacology, Orange County Research Center, Tustin, California. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.

Amlodipine plus olmesartan superior to monotherapy in difficult-to-treat hypertensive populations

The combination of amlodipine and olmesartan was demonstrated to be superior to monotherapy with either agent in difficult-to-treat hypertensive populations in a subgroup analysis of the registrational trial for this combination therapy. These results were presented at the 23rd Annual Scientific Meeting of the American Society of Hypertension, New Orleans, May 14–17, 2008.

Gut hormones key to appetite regulation

Gut hormones play a key and often overlooked role in weight loss and weight regulation. Changes in weight are determined largely by the balance between energy intake and energy expenditure, but gut hormones can affect both sides of the energy equation.

Endovascular interventions for PAD proliferate

The range of endothelial interventions for peripheral artery disease (PAD) is proliferating. Today's choices include traditional balloon angioplasty, stents, drug eluting stents and fabric-covered stents. Newer technologies allow clinicians to cut out occlusions, freeze them, scrape them, laser them and kill them.

Hyperglycemia can affect NO pathway of endothelial function

Hyperglycemia is involved in the dysregulation of endothelial nitric oxide (NO) synthase, leading to endothelial dysfunction and an increased risk of vasculopathy, said Markku Laakso, MD.

Basal insulin plus pramlintide at mealtime controls glucose, with lower hypoglycemia risk

Pramlintide injection added to basal insulin at mealtime is similar to titrated rapid-acting insulin in achieving glycemic control but with a lower risk of hypoglycemia and no weight gain in patients with type 2 diabetes, said Matthew Riddle, MD, head, section of diabetes, division of endocrinology/diabetes/clinical nutrition, Oregon Health and Sciences University, Portland.

Coronary and aortic calcium burden strongly predictive of cardiovascular events in type 2 diabetes

Coronary artery calcium and abdominal aortic calcium both predicted future cardiovascular events in a Veterans Administration population with type 2 diabetes. The relationship between calcium scores and cardiovascular events was independent of standard cardiovascular risk factors, said Peter Reaven, MD.

Surrogate endpoints in drug approval process examined, found wanting

Surrogate endpoints in clinical trials (ie, hemoglobin [Hb] A1c) on which drug approvals may be based only explain narrow aspects of complex conditions. For this reason, even when using a drug as labeled, there is always a level of uncertainty over outcomes with the drug, said Saul Malozowski, MD, PhD, MPH.

Be wary of trace element claims

Clinicians should be wary of health claims made for trace elements such as iron or chromium. While there is no doubt that trace elements are needed for health, there is significant doubt about their utility in preventing or curing diabetes and other diseases, said Eliseo Guallar, MD, DrPH, Johns Hopkins Bloomberg School of Public Health, Baltimore. There are many hypotheses about the beneficial effects of trace elements, but little high-quality data, little reliable population data, few useful biomarkers, relatively crude analytical methods and few mechanistic studies.

Separate drug classes prevent development of type 2 diabetes in susceptible patients

Pioglitazone prevented progression to type 2 diabetes in patients with impaired glucose tolerance (IGT), reported Ralph DeFronzo, MD. The effect was marked?81% fewer patients assigned to pioglitazone compared with placebo converted from IGT to type 2 diabetes in a randomized, double-blind, placebo-controlled clinical study.

UK study: Subpar glycemic control associated with poor pregnancy outcomes

British women who have poorer glycemic control before and during pregnancy have poorer outcomes and less-healthy babies. That's the take home message from CEMACH, the Confidential Enquiry into Maternal and Child Health, a year-long survey of pregnant women with type 1 and type 2 diabetes across the United Kingdom.

Diabetic atherosclerotic disease evolves in stages

Atherosclerosis and its complications develop in stages. Each of each of these stages is affected by different metabolic abnormalities, said Scott Grundy, MD, PhD, during the annual Edwin Bierman lecture.

Pedal osteolysis can be biomarker for diabetic disease

Current research suggests that pedal osteolysis, the loss of bone mineral density (BMD) in the foot, may be a useful biomarker for Charcot's arthropathy and other diabetic foot diseases.

ACCORD trial reveals increased risk of death

An intense glucose-lowering strategy in high-risk patients with type 2 diabetes was associated with an excess of mortality in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial, the U.S. counterpart to the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron-MR Controlled Evaluation) study.

Novel agents for glycemic control are under investigation

Several novel classes of agents designed to treat hyperglycemia are under investigation. These agents were the subjects of a symposium here. One such novel class is the sodium glucose co-transporter (SGLT) type 2 inhibitors, which reduce glucose levels by increasing kidney excretion of glucose. The kidney plays an important role in the handling of glucose, said Robert R. Henry, MD, professor of medicine and chief of VA endocrinology and metabolism at the University of California, San Diego. SGLT-2 is expressed almost exclusively in the kidney. About 90% of glucose reabsorption by the kidney is mediated by SGLT-2 under normal circumstances.

Putting weight loss into clinical practice

Translating weight loss research into clinical programs is not easy. Too many clinical protocols exist in isolation, according to Donald Williamson, PhD, Pennington Biomedical Research Center, Baton Rouge, LA. The key gap is extending methods that contribute to weight loss into programs that maintain weight loss.

Type 2 diabetes increases fracture risk to minor degree

The risk of fracture is probably only slightly increased in persons with type 2 diabetes, said Peter Vestergaard, MD, PhD, DrMedSc, from the Osteoporosis Clinic, Aarhus Amtssygehus, Denmark.

Human factors make or break continuous glucose monitoring

Real-time continuous glucose monitoring (CGM) can significantly improve glycemic control, but it will not help all patients. "Real-time CGM will add significantly to glucose management for some people, but not for all," said Irl Hirsch, MD, University of Washington, Seattle. "Human factors make all the difference between success and failure. Some patients will never figure it out. That?s why real-time control is so challenging.

Pharmacologic options for painful diabetic neuropathy reviewed

Good glycemic control is not sufficient to relieve painful diabetic neuropathy, necessitating investigation of other modalities to achieve analgesic efficacy. Dan Ziegler, MD, German Diabetes Clinic, German Diabetes Center, and professor of internal medicine, Leibniz Institute at the Heinrich Heine University, Düsseldorf, provided an overview of pharmacologic treatments that have been explored for painful diabetic neuropathy and the success achieved with each.

Progress is rapid in islet cell transplants

Islet cell transplants are effective in both the short- and long-term in freeing patients with diabetes from insulin injections and have proven to be safe, said Bernhard J. Hering, MD. The use of embryonic pig pancreatic precursor tissue as the source of islets appears promising and would expand the number of transplant recipients, which is currently limited by number of potential donors.

GLP-1 secretion: No acute affect on insulin

Take another look at the popular hypothesis that suggests type 2 diabetes has an acute effect on the secretion of GLP-1 and that lower GLP-1 secretion has an acute effect on insulin. It doesn't work that way, said Michael Nauck, MD, PhD, Diabeteszentrum Bad Lauterberg, Bad Lauterberg, Germany. Decreased GLP-1 secretion is not part of the pathophysiology of type 2 diabetes.

Hepatic steatosis new worry in type 2 diabetes

Clinicians and type 2 diabetes patients have a new worry: hepatic steatosis, or nonalcoholic fatty liver disease. Liver disease is a less-obvious problem than kidney disease but may have equally grave consequences.

Reducing excess iron levels encourages diabetic wound healing

Researchers at Stanford University are reporting positive results in healing diabetic wounds with a pharmaceutical agent already approved by the FDA, but only in mice so far.