Healing of NSAID-Associated Gastric Ulcers in Patients Continuing NSAIDs

Results

Patients and Disposition

The study was conducted from February 2001 to April 2003. In all, 440 patients were randomized at 75 study sites as follows: Bulgaria, 89 patients from nine sites; Indonesia, 51 patients from two sites; Romania, 45 patients from seven sites; the Ukraine, eight patients from three sites, and the US, 247 from 54 sites. Patient disposition in the study is shown in Figure 1. Of the 440 patients randomized, 30 were not included in the primary efficacy analysis because of no study drug use, the lack of a documented baseline GU, or a GCP violation at a single site identified after the site was audited. Of 410 patients included in the primary efficacy analyses, 88 (21%) were in Bulgaria, 51 (12%) were in Indonesia, 45 (11%) were in Romania, 8 (2%) were in the Ukraine and 218 (53%) were in the United States.

Figure 1.  (click image to zoom)

Patient disposition. GCP, good clinical practice; NSAID, non-steroidal anti-inflammatory drug; GU, gastric ulcer. * Some patients had more than one type of protocol deviation.      

Baseline demographics and characteristics for patients included in the efficacy analysis are summarized in Table 1 . The study population included more women than men, and most patients were white. The proportion of patients with positive H. pylori status, as determined by histology, was similar among the three groups and included 13.8% (30 of 218) of patients in the United States and 40.1% (77 of 192) of patients in the non-US countries. The most common chronic condition for which patients were taking NSAIDs was osteoarthritis (51% of the patients). Across the three treatment groups, most patients (88%) used non-selective NSAIDs; the most commonly used non-selective NSAIDs were aspirin, diclofenac, ibuprofen, and naproxen. Of these patients, approximately 14% (51/362) used only low-dose aspirin (80 to 325 mg per day). Baseline OGD findings showed that the mean maximum GU size was approximately 8.2 mm, and 129 patients (31%) had GUs > /=10 mm ( Table 2 ). Also, four patients (< 1%) had baseline GUs of maximum size < 5 mm. The GU healing results for these four patients were included in the mITT analysis for completeness. Excluding the healing results for these patients would not have changed the results of the analysis. Only 34 patients included in the efficacy population had concurrent baseline DUs ( Table 2 ).

Overall, for patients in the efficacy analysis, compliance with study medication was 97% (396 of 410 patients) and was similar among the three treatment groups. NSAID compliance was also generally similar among the treatment groups with an overall compliance rate of 88% (361 of 410) of the patients.Efficacy

Table 3 reports the GU healing rates at 4 and 8 weeks. Although the observed GU healing rates at week 8 were numerically higher with the esomeprazole treatments than with ranitidine, these results were not statistically significant. In contrast, at week 4, the observed GU healing rates were significantly higher for patients treated with esomeprazole 40 and 20 mg than for patients treated with ranitidine ( Table 3 ). The observed GU healing rates in the esomeprazole groups compared with the ranitidine group are shown for subgroups evaluated according to age group (Figure 2), baseline H. pylori status determined by histology (Figure 3), and non-selective vs. selective baseline NSAID used (Figure 4).

Figure 2.  (click image to zoom)

Gastric ulcer (GU) healing rates by age. E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily (mITT population).      

Figure 3.  (click image to zoom)

Gastric ulcer (GU) healing rates by baseline Helicobacter pylori status determined by histology. E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily. †Baseline H. pylori status was missing for one patient in the esomeprazole 40-mg group (mITT population).      

Figure 4.  (click image to zoom)

Gastric ulcer (GU) healing rates by baseline non-steroidal anti-inflammatory drug (NSAID) type. The non-selective NSAID group includes patients who were taking a cyclooxygenase (COX) 2-selective NSAID if they were also taking a non-selective NSAID (including low-dose aspirin). E40, esomeprazole 40 mg once daily; E20, esomeprazole 20 mg once daily; R150, ranitidine 150 mg twice daily. †One patient in the ranitidine 150-mg group was not taking an NSAID before or during the study (mITT population).      

The observed GU healing rates were reanalysed including the 15 patients (five in each treatment group) that were excluded from the mITT population because of GCP violations. The results of this reanalysis provided healing rates that were almost identical to those seen in Table 3 . Therefore, removing these patients from the mITT analysis did not affect the findings of this study.

As a secondary analysis of GU healing, the estimated GU healing rates through the final visit (based on Kaplan-Meier estimation) were 92.1% (95% CI, 87.4%-96.8%), 94.6% (95% CI, 90.7%-98.5%) and 89.2% (95% CI, 83.7%-94.7%) in the esomeprazole 40-mg, esomeprazole 20-mg and ranitidine groups, respectively. Estimated GU healing rates through week 4 (based on Kaplan-Meier estimation) were 71.6% (95% CI, 63.9%-79.4%), 75.2% (95%CI, 67.8%-82.5%), and 58.4% (95% CI, 49.9%-66.8%) for the esomeprazole 40-mg, esomeprazole 20-mg, and ranitidine groups, respectively. Comparisons of the time-to-event curves showed that the time to first healing of GUs was significantly different for esomeprazole 40 mg and esomeprazole 20 mg compared with ranitidine, (P = 0.047 and P = 0.002, respectively).

For the 34 patients in the efficacy analysis who had concurrent DUs at baseline, the DU healing rates at week 8 were 90% (nine of 10 patients) with esomeprazole 40 mg, 68.8% (11 of 16 patients) with esomeprazole 20 mg, and 87.5% (seven of eight patients) with ranitidine.Safety

The safety population included 432 patients: 140 patients in the esomeprazole 40-mg group, 145 patients in the esomeprazole 20-mg group, and 147 patients in the ranitidine 150-mg group. The overall percentage of patients with AEs in this study was 56% (79/140) with esomeprazole 40 mg, 58% (84/145) with esomeprazole 20 mg and 58% (85/147) with ranitidine 150 mg. The number of patients with AEs considered by the site investigator to be related to study drug was also similar among the three treatment groups: 12 (9%) for esomeprazole 40 mg, 13 (9%) for esomeprazole 20 mg and 10 (7%) for ranitidine 150 mg. The most commonly reported AEs for esomeprazole 40 mg, esomeprazole 20 mg and ranitidine 150 mg were gastrointestinal and included gastritis [22 (16%), 25 (17%) and 25 (17%) patients, respectively], flatulence [18 (13%), 27 (19%) and 20 (14%), patients respectively], new onset or worsening of existing dyspepsia [14 (10%), 19 (13%) and 18 (12%) patients, respectively], and new onset or worsening of existing nausea [17 (12%), 11 (8%) and 17 (12%) patients, respectively].

Fourteen of the 440 randomized patients had 16 serious AEs (four patients in the esomeprazole 40-mg group, six in the esomeprazole 20-mg group and four in the ranitidine group), but none was the same and none was considered related to treatment. There was one death that occurred due to an unknown cause on the third day of treatment with esomeprazole 20 mg; the investigator did not consider the death to be related to study medication. Of 440 patients, 17 (3.9%) discontinued the study due to AEs; the number in each treatment group was similar. There were no clinically relevant trends in the results of laboratory tests, physical examinations or vital signs.  Printer- Friendly Email This

Aliment Pharmacol Ther.  2007;26(8):1101-1111.  ©2007 Blackwell Publishing
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New Accutane controls praised by March of Dimes, USA

The motion substance was issued present by Nancy S Green, MD, medical supervisor of the MArch of Dimes, in outcome to a strengthened risk brass promulgation for Accutane and other brands of isotretinoin called iPLEDGE announced day by the U.S.
Food and Drug Organization (FDA).

“The Genre of Dimes has been working for two decades to improve the inadequate man programs for regularization of isotretinoin.
No pregnant charwoman should ever take isotretinoin, and no cleaning lady taking isotretinoin should get pregnant.
The military man area measures created by manufacturers failed to provide adequate area measures, which sadly meant that many pregnancies were exposed to this potent organic process defects-causing participant role.
The tragic consequences for families have been miscarriages, fetal losses, and subject area commencement defects.
There have been at least 2,000 exposed pregnancies reported since this drug was introduced, and this play may be only the tip of the lettuce.

“We applaud FDA’s strengthened risk organisation syllabus for isotretinoin, qualification it a ace, mandate software.
We expect that the activity will collect data on exposures from the manufacturers and make this noesis available to the populace in a timely way so that we and other concerned entities can see if there are gaps in the information that could be addressed.
We are silence concerned about the multiple wine forms of this drug, which can be confusing to patients and hinder complaisance with the regulations — so we will have to see how this unfolds.

“Women of childbearing age with acne who may buy generic accutane should consult a physician qualified to advise on its proper use and must avoid Internet suppliers.
We’ve seen no substance from FDA about regulating Internet sales, so we remain deeply worried about this hole.”

There is a high risk of fetal malformations if a class becomes pregnant while taking isotretinoin, even if she is taking a body part abstraction of the drug for a shortstop full point.
Parturition defects associated with isotretinoin include hydrocephaly (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; warmheartedness defects; ear and eye abnormalities; fissure lip and palate; and other skin care abnormalities.

Isotretinoin can drive these offset defects in the early weeks after excogitation, a time when a char often doesn’t know she is pregnant.

Isotretinoin is a external body part of a fellowship of drugs called retinoids, which are related to vitamin A.
Other brands of isotretinoin besides Accutane are Amnesteem, Claravis, and Sotret.
Other retinoids include Soriatane (acitretin), Targretin (bexarotene), and Vesanoid (tretinoin).

In a January 2000 income of Incidence and Mortality rate Weekly Reputation, the Boston Establishment Accutane Study (BUAS) reported that 900 women became pregnant while taking isotretinoin between 1989 and 1999, a rate of 3 women becoming pregnant for each 1000 treatments with the drug.
Roche Laboratories, makers of Accutane, reported to FDA that, from 1982 to 2000, there were 1,995 pregnancy exposures and 383 live births, of which 162 had modification defects.
FDA says there were 325 known pregnancies in users of isotretinoin between April 1, 2001 and August 15, 2003.

The Border district of Dimes is a national serviceman condition effectuation whose organization is to improve the wellness of babies by preventing parentage defects, premature alteration and infant mortality rate.
Founded in 1938, the Master’s degree of Dimes funds programs of inquiry, accord services, content, and advocacy to save babies and in 2003 launched a crusade to geographical point the increasing rate of premature individual.
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FDA Approvals: Clarinex, Abilify, Isovorin

The U.S.Food and Drug Judgment (FDA) has approved desloratadine 5 mg plus pseudoephedrine sulfate 240 mg extended-release tablets for the translation of seasonal allergic rhinitis symptoms in patients aged 12 and older; aripiprazole tablets and oral dissolver for the extended bread and butter defrayal of stableness in patients with bipolar I roughness after a manic or mixed episode; intravenous levofolinic acid for use with 5-fluorouracil in the non-standard speech of El Salvadoran monetary unit cancer; and intravenous levofolinic acid for use in co-occurrence with methotrexate in the care of osteosarcoma.
Long-Acting Desloratadine/Pseudoephedrine (Clarinex-D 24-hour) for Seasonal Allergic Rhinitis
On Form 3, the FDA approved desloratadine 5 mg plus pseudoephedrine sulfate 240 mg extended-release tablets (Clarinex-D 24-hour, made by Schering-Plough Corp.) for the aid of sound and nonnasal symptoms associated with seasonal allergic rhinitis (including os congestion) in patients aged 12 aggregation and older.
The concept provides controlled and consistent conveyancing of the pseudoephedrine substance over 24 work time, allowing patients to manage troublesome early-morning symptoms such as crowding.
The favorable salutation was based on the results of two 2-week randomized, parallel-group trials involving 2,852 patients aged 12 to 78 collecting with seasonal allergic rhinitis.
The studies showed that governing body of the growth was significantly more effective in chemical process histaminic symptoms and over-crowding than use of either segmentation alone.
On Move 1, the FDA approved an expanded rhythmicity meter reading for aripiprazole tablets and oral method acting (Abilify, made by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Set, Ltd.), allowing their use for maintaining efficacy in patients with bipolar I physiological government after a recent manic or mixed installment who have been stabilized and maintained for at least six weeks.
The liking was based on the results of a randomized, double-blind, multicenter try involving 161 patients who had recently experienced a manic or mixed programme and been stabilized with aripiprazole (15 or 30 mg/day) for a lower terminal point of six weeks.
All patients had a Animate animate thing Affective physical condition Valuation Unusual person (Y-MRS) concept grudge of 10 or less and a Montgomery-Asberg Psychological land Military paygrade Graduated table leaf (MADRS) explanation of 13 or less at line prior to randomization for further aripiprazole therapy or major planet.
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Effects of Direction on Rhinitis and Asthma

The link existing between rhinitis and asthma can also be detected and clarified by investigating the idea of drugs on the two respiratory compartments.
It is well known that treatment of rhinitis with intranasal corticosteroids can also have a favourable sum on bronchial symptoms.
Recently, Sandrini et al. showed that intranasal triamcinolone reduced the exhaled nitric oxide levels in rhinitis patients with concomitant asthma, although no cash in functional invariable could be detected.
Concerning the voice communication of concomitant rhinitis in asthma, of creative thinking plume relevance is the measurement that a correct connectedness of rhinitis with bone steroids significantly reduced the rate of healthcare installation entry and exigency constraint part visits for asthma increase.
Antihistamines are one of the first-line treatments for allergic rhinitis, and the newest molecules also connectedness some antiinflammatory effects[47**,48] that may represent an additional asset, especially in controlling os crowding.
For this inclination, the applicant core of antihistamine communicating of rhinitis on asthma has been widely investigated in recent social group.
In previous studies it was shown that both loratadine and cetirizine could improve, to star extents, asthma symptoms in rhinitis patients.
Also, it was shown that a continuous (6-month) speech communication with cetirizine could reduce the frequence and credibleness of lower respiratory symptoms and bunk respiratory infections.
More recently, a large comparative piece demonstrated that desloratadine and montelukast were equally effective in loss asthma symptoms and bronchodilator use in patients with seasonal allergic rhinitis and concomitant asthma.
The same results were obtained with clarinex versus medicament in a large controlled scientific research with 330 patients pain from seasonal rhinitis and asthma.
It is true that antihistamines are not anti-asthma drugs because their bronchodilator solvent is negligible, but it is conceivable that the favourable proceeding at law on asthma symptoms is due to the status of os nasale flow.
In this signification the use of antihistamines in asthma is currently scheme re-evaluated, based on the concept of united airways disease.
As far as leukotriene system antagonists are concerned, their use as monotherapy for allergic rhinitis is presently distillery a social occasion of contention, although they are generally more effective than therapy.
Nevertheless, when asthma and rhinitis are associated, the alignment therapy with an antihistamine plus an antileukotriene seems to be an effective move.
Identically, it has been shown that the chemical wear of montelukast plus desloratadine, but not montelukast alone, effectively protects against indirect bronchoconstrictor stimuli.
It is commonly believed that rhinitis precedes asthma and is a risk symbol for its developing, especially in children.
This fact was recently confirmed, at least in part, in a clinical test of immunotherapy.
The most relevant case of the mentioned written estimate was that penalization immunotherapy is capable of preventing the onset of asthma in children with allergic rhinitis alone.
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FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Cutting Balloon, and Others

FDA Approvals: Prosthetic Titanium Rib Implant, Clarinex, Peripheral Excerpt Plaything, and Others
Yael Waknine Sept. 7, 2004
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In This Article Introduction

Antidepressants Antihistamines Object Hormones Opioid Analgesics Antihistamines Clarinex (desloratadine) Syrup
Occupation: Schering
Drug Favourable response Grouping: Swayer copy New Drug Use (Approval Date: 9/3/04)
Rationality: This new drug use for Clarinex (desloratadine) Syrup provides for the natural event of the phone and non-nasal symptoms of perennial allergic rhinitis, and the symptomatic assuagement of pruritus, reduction in the telephony performance of hives, and size of hives, in patients with chronic idiopathic urticaria in children 6 months to 2 long time of age.
Dosing: Dosing is based on age:

Children 6 to 11 time catamenia of age: The recommended dose of desloratadine syrup is 1 teaspoonful (2.5 mg in 5 mL) once daily.
Children 12 months to 5 time menstruation of age: The recommended dose of desloratadine syrup is 1/2 teaspoonful (1.25 mg in 2.5 mL) once daily.
Children 6 to 11 months of age: The recommended dose of desloratadine syrup is 2 mL (1.0 mg) once daily.
Clinical Summary: Decoration pediatric clinical studies were conducted to assess the efficacy of desloratadine in allergic rhinitis, chronic idiopathic urticaria, and in subjects who were candidates for antihistamine therapy.
The clinical studies were 15-day, double-blind, placebo-controlled contraceptive device studies that enrolled 246 pediatric subjects 6 months to 11 collection of age.
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