• June 25, 2008

  Risedronate (Actonel®) prevents bone loss in IBD patients on steroids

  Summary This randomized controlled trial found that risedronate (Actonel®) prevents steroid-induced bone loss in IBD.

  Basis for Study/Article  The authors of this study from England examined the efficacy of risedronate for preventing steroid-related bone loss in patients with IBD.

  Detailed Summary of Study  Patients receiving prednisolone for an IBD flare-up were randomized to receive placebo or risedronate, in addition to calcium and vitamin D. DEXA scans of the lumbar spine and hips were done at baseline and 8 weeks later in 73 patients (42 with ulcerative colitis, 31 with Crohn’s disease; average age 43.5 years; 42 patients were men).

  Results/Body  In the lumbar spine, the patients taking risedronate had a 1% gain in BMD vs. no change in the placebo group after 2 months of treatment. In the total hip, neither group experienced BMD change. In Ward’s triangle (neck of the femur), the risedronate group had a 1% loss and the placebo group had a 2% loss.

  Sources & Other Links  Kriel MH, et al. Risedronate protects against bone loss when a relapse of IBD is treated with steroids. Abstract #T1122 presented at Digestive Diseases Week, May 2008.

  Article Link (DOWNLOAD)

   

• June 25, 2008
  IM dexamethasone + antibiotics useful for acute exudative pharyngitis

  Summary  This randomized controlled trial found that for acute exudative pharyngitis, adding a single dose of IM dexamethasone to the antibiotic regimen relieves symptoms better than antibiotics alone.

  Basis for Study/Article  The authors of this single-center trial from Turkey tested the efficacy of a single dose of IM dexamethasone in the treatment of acute exudative pharyngitis.

  Detailed Summary of Study  Adults with acute exudative pharyngitis, sore throat, and/or odynophagia were randomized to receive either an 8-mg IM dose of dexamethasone (n = 31) or placebo (n = 42), in addition to 3 days of azithromycin and paracetamol (acetaminophen). Time to onset of pain relief and time to complete pain relief were compared.

  Results/Body  Onset of pain relief occurred in 8.06 hours in the dexamethasone group vs. 19.90 hours in the placebo group. Corresponding figures for complete pain relief were 28.97 hours and 53.74 hours.

  Sources & Other Links  Tasar A, et al. Clinical efficacy of dexamethasone for acute exudative pharyngitis. J Emerg Med. 2008 May 10. [Epub ahead of print]

  Article Link (NCBI)

   

• June 25, 2008
  Tight diabetes control lowers incidence of nephropathy, vascular events

  Summary  This large study with 5 years of follow-up found that tight diabetes control (using gliclazide [Diamicron®] and other drugs to obtain an HbA1c of 6.5% or less) lowers the incidence of macrovascular and microvascular events together, in particular reducing the relative risk of nephropathy by 21%.

  Basis for Study/Article  The ADVANCE Collaborative Group tested the effects of intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes.

  Detailed Summary of Study  11,140 patients with type 2 diabetes were randomized to receive either standard glucose control or intensive control (using modified-release gliclazide [Diamicron®] and other drugs to obtain an HbA1c of 6.5% or less). After a median follow-up of 5 years, the number of major macrovascular events (CV death, nonfatal MI, nonfatal stroke) and major microvascular events (nephropathy, retinopathy) was assessed.

  Results/Body  At follow-up, mean HbA1c levels were 6.5% in the intensive group vs. 7.3% in the standard group. Combined major and minor macrovascular events occurred in 18.1% of the intensive group vs. 20% of the standard group (p = 0.01). Major microvascular events occurred in 9.4% of the intensive group vs. 10.9% of the standard group (p = 0.01). Nephropathy occurred in 4.1% of the intensive group vs. 5.2% of the standard group. There were no differences between the groups in the incidence of major macrovascular events alone, retinopathy, CV death or all-cause mortality. Severe hypoglycemia occurred in 2.7% of the intensive group vs. 1.5% of the standard group (p <0.001).

  Sources & Other Links  ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-2572.

  Article Link (NCBI)

• June 25, 2008
  Sequential therapy is better than standard triple therapy for H. pylori

  Summary  This meta-analysis found that 10-day sequential therapy is better than standard triple therapy for the treatment of H. pylori infection in treatment-naïve patients. However, the authors caution that most of the patients in the studies they reviewed were from Italy, only one study was double-blinded, and publication bias may have played a role.

  Basis for Study/Article  Because standard triple therapy for H. pylori infection is unsuccessful in about a quarter of patients, the authors conducted a meta-analysis on the efficacy of sequential therapy in treatment-naïve patients.

  Detailed Summary of Study  The reviewers analyzed data from 10 randomized controlled trials (n = 2,747) comparing sequential vs. standard therapy.

  Results/Body  H. pylori eradication rates were 93.4% in the 1,363 patients receiving sequential therapy and 76.9% in the 1,384 patients receiving standard triple therapy. The success rate was affected by the patient’s smoking status, diagnosis and method of diagnosis, resistance to clarithromycin or imidazoles, and duration of triple therapy. Adherence rates were 97.4% for sequential therapy and 96.8% for standard therapy. Adverse effects were similar. The authors believe that if trials in other countries confirm the findings, “10-day sequential therapy could become a standard treatment for H. pylori infection in treatment-naïve patients.”

  Commentary  What is sequential therapy? Triple therapy has been common for some time. One article detailing one sequential regimen is available at: http://www.annals.org/cgi/content/abstract/146/8/556

  Briefly; the protocol used was:

  •		Days 1-5 ›   40 mg pantoprazole BID ›   1 gram amoxicillin BID
  •		Days 6-10 ›   40 mg pantoprazole BID ›   500 mg clarithromycin BID ›   500 mg tinidazole BID

  Grant E. Fraser, M.D.
  MedAlert Editor

  Sources & Other Links  Jafri NS, et al. Meta-analysis: Sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 May 19. [Epub ahead of print]

  Article Link (NCBI)

   

• June 18, 2008
  Depression and too much or too little activity can lead to persistent adolescent fatigue

  Summary Teenagers with depressive symptoms and either sedentary or highly active lives are at risk for persistent fatigue.

  Basis for Study/Article The authors of this British study identified risk factors for persistent adolescent fatigue, defined as extreme tiredness twice weekly or more often in the previous month.

  Detailed Summary of Study 1,880 subjects age 11 to 16 (49% boys, 81% nonwhite) at 28 London schools completed questionnaires in 2001 and 2003 asking about persistent fatigue, activity level, depressive symptoms, BMI and smoking status.

  Results/Body  4% (84 students) of the students reported persistent fatigue; however, in both surveys (2001 and 2003) only 3 students reported chronic fatigue syndrome. Persistent fatigue was more common in teens who had depressive symptoms (odds ratio 2.0), who were sedentary more than 4 hours a day (odds ratio 1.6) or who were extremely active (odds ratio 1.5). BMI and smoking were not factors. Severe fatigue occurred in 11% of students aged 11 to 14 years and 17% of those aged 13 to 16 years.

  Sources & Other Links  Viner RM, et al. Longitudinal risk factors for persistent fatigue in adolescents. Arch Pediatr Adolesc Med. 2008 May;162(5):469-75.

  Article Link (NCBI)

   
• TABLE FOR CHRONIC  ANTIHYPERTENSIVE DRUGS FROM THE USFDA - 2008

  Pharmacologic Class	Approved Drugs
  aldosterone antagonists Works on the blood side of the nephron-binds to aldosterone.	eplerenone, spironolactone
  alpha adrenergic blockers	doxazosin, phenoxybenzamine, phentolamine, prazosin, terazosin
  angiotensin converting enzyme inhibitors	benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril
  angiotensin II receptor blockers	candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan
  arteriolar vasodilators	hydralazine, minoxidil
  autonomic ganglionic vasodilators	mecamylamine
  beta adrenergic blockers	acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, carteolol, esmolol, labetolol, metoprolol, nadolol, penbuterol, pindolol, propranolol, timolol
  catecholamine-depleting sympatholytics	deserpidine, reserpine
  central alpha-2 adrenergic agonists	clonidine, guanabenz, guanfacine, methyldopa
  calcium channel blockers	diltiazem, verapamil
  dihydropyridine calcium channel blockers	amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine
  loop diuretics	bumetanide, ethacrynic acid, furosemide, torsemide
  potassium-sparing diuretics	amiloride, triamterene
  renin inhibitors	aliskiren
  thiazide diuretics ↓ Left ventricular hypertropy.	chlorothiazide, hydrochlorothiazide, hydroflumethiazide, methyclothiazide, polythiazide
  thiazide-like diuretics	chlorthalidone, indapamide, metolazone

• BLACK BOX WARNING FROM FDA June 16, 2008

Audience: Neuropsychiatric, Geriatrics and Family medicine healthcare professionals

FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

• FALLS AND FALL-RELATED INJURIES AMONG PERSONS AGED 65 YEARS OLD OR GREATER

• DRUG RECALLS LISTED BY AUDIENCE OF IMPORTANCE:

  June 11, 2008

  Having 1/2 to 1 alcoholic drink per day protects against hip fracture

  Summary  This meta-analysis found that people who have 1/2 to 1 alcoholic drink per day have a lower risk of hip fracture compared to nondrinkers and heavier drinkers.

  Basis for Study/Article  The authors performed a literature review to assess the effects of moderate alcohol consumption on bone density and the risk of osteoporotic hip fracture.

  Detailed Summary of Study  Effect sizes were pooled for hip fracture and bone density, and results were synthesized for four outcomes: non-hip fracture, bone density loss over time, bone response to estrogen replacement, and bone remodeling.

  Results/Body  People who had 1/2 to 1 alcoholic drink per day had a lower risk of hip fracture compared to nondrinkers (relative risk 0.80); the relative risk was 1.39 for those who had more than 2 drinks a day. “A linear relationship existed between femoral neck bone density and alcohol consumption,” but “a precise range of beneficial alcohol consumption cannot be determined.”

  Sources & Other Links  Berg KM, et al. Association between alcohol consumption and both osteoporotic fracture and bone density. Am J Med. 2008 May;121(5):406-18.

  Article Link (NCBI)

  June 11, 2008

  Obstructive sleep apnea is common in women with nocturia

  Summary  Obstructive sleep apnea is common in women with nocturia, and 88% of women with dilute nighttime urine have OSA. “We should consider a diagnosis of OSA in all patients with nocturia,” even those with daytime overactive bladder symptoms.

  Basis for Study/Article  The authors explored the association between obstructive sleep apnea and nocturia in women and tested urine samples to see whether urine concentration was predictive for sleep apnea.

  Detailed Summary of Study 21 women with nocturia (16 of them also had daytime overactive bladder) and 10 control subjects completed nocturia questionnaires, underwent a home sleep study and provided evening and morning urine samples.

  Results/Body  17 of the 21 women with nocturia (81%) were found to have sleep apnea (13 of the 16 with daytime overactive bladder and 4 of the 5 without) vs. 4 of the control group. “The presence of diluted nighttime urine in a patient with nocturia was 88% sensitive for the presence of OSA.”

  Sources & Other Links  Lowenstein L, et al. The relationship between obstructive sleep apnea, nocturia, and daytime overactive bladder syndrome in women. Am J Obstet Gynecol. 2008 May;198(5):598.e1-5.

  June 10, 2008

  Audience: Healthcare professionals, consumers

  ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

  June 4, 2008

  Adverse events associated with PCA and insulin pumps in adolescents

  Summary  Over a 10-year period, there were 1,594 reports to the FDA of adverse events associated with adolescents’ use of insulin pumps (including 13 deaths) and 53 reports of adverse events associated with patient-controlled analgesia pumps. “Studies need to further identify safety problems in this age group.”

  Basis for Study/Article  After receiving five reports of deaths in adolescents associated with insulin pumps in 2005, the FDA conducted an assessment of the safety of insulin and PCA pumps in this population.

  Detailed Summary of Study  The authors reviewed reports submitted to the FDA from 1996 through 2005 about adverse events associated with use of insulin or PCA pumps by adolescents (ages 12 to 21). Demographics, type of adverse event, outcomes and contributing factors were analyzed.

  Results/Body  Over a 10-year period, there were 1,594 reports of adverse events associated with insulin pumps, including 13 deaths, 2 possible suicide attempts, and several reports of apparently device-related hyperglycemia or hypoglycemia. Some of the contributing factors were compliance problems, lack of education, “sports-related activities” and “dropping or damaging the pump.” In 82% of the events the patient was hospitalized. There were 53 reports of adverse events associated with PCA pumps. In half the patients received too much medication; “tampering and noncompliance were evident in some cases.”

  The authors suggest more studies on the safety of these devices in adolescents.

  Sources & Other Links  Cope J, et al. Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics. 2008 May;121(5):e1133-8.

  Article Link (NCBI)

   

• DRUG RECALLS LISTED BY AUDIENCE OF IMPORTANCE: 

  June 02, 2008

  Audience: Consumers, pediatricians, other healthcare professionals

  Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.

  May 30, 2008

  Audience: Consumers, healthcare professionals

  International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.

  May 29, 2008

  Audience: Nursing mothers, pediatricians, other healthcare professionals

  FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of decreases in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color.

  May 27, 2008

  Audience: Consumers, healthcare professionals

  FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.