The effect of mesalazine therapy on quality of life in patients with mildly and moderately active ulcerative colitis.

BACKGROUND: Ulcerative colitis (UC) has a major impact on the quality of life (QoL) of affected patients. Patient-reported outcomes have not been thoroughly evaluated in patients with UC receiving oral mesalazine (mesalamine). AIM: To examine the effect of mesalazine on QoL of patients with mildly and moderately active UC and assess the time course of change, baseline disease severity, mesalazine dose and responder status on QoL parameters. METHODS: Inflammatory Bowel Disease Questionnaire (IBDQ) data were combined from two double-blind, randomized, multicentre, active-controlled trials assessing 2.4 and 4.8 g/day oral delayed-release mesalazine in 687 patients. Mean score changes from baseline were compared at 3 and 6 weeks and effects of baseline severity, mesalazine dose and response to therapy were examined. RESULTS: Mesalazine significantly improved IBDQ scores at 3 and 6 weeks (mean increase, 29.6 and 39.7 points, respectively; P < 0.0001 for both). Improvement was greater for patients with moderate disease. Greater week 6 changes occurred in clinical responders than nonresponders (50.1 vs. 23.6 points, respectively; P < 0.0001). CONCLUSIONS: Delayed-release oral mesalazine produces significant clinical and statistical improvements in QoL of patients with UC by 3 weeks, with further improvement at 6 weeks.

Delirium associated with zolpidem.

OBJECTIVE: To report a case of an elderly woman sustaining an episode of delirium after one dose of zolpidem. CASE SUMMARY: An 86-year-old white woman was admitted to the hospital for headaches and diplopia. On hospital day 3, the patient received zolpidem 5 mg and, approximately two hours later, became restless, disoriented, and physically agitated. She was treated with haloperidol and was restrained for her safety. The patient's symptoms resolved by day 5, and she had no recollection of the incident. No rechallenge was attempted. DISCUSSION: Pharmacokinetic factors may play an important role in zolpidem-induced adverse drug reactions. Elderly women can achieve up to a 63% higher serum concentration than men. The patient in our report had factors such as age, gender, and hypoalbuminemia, which may have increased the maximum concentration and the AUC of zolpidem and possibly increased her risk of an adverse reaction. CONCLUSIONS: This case, along with previous reports, warrants the cautious use of zolpidem. Clinicians should be aware that a majority of these reactions occur in women. It appears that the reactions are concentration dependent, therefore, dosage reductions should be made in elderly patients and those with hepatic insufficiency.

Candesartan cilexetil: an angiotensin II-receptor blocker.

The mechanism of action, pharmacokinetics, pharmacodynamics, clinical efficacy, and adverse effects of candesartan cilexetil are reviewed. Candesartan is an angiotensin II-receptor blocker (ARB). It is administered as a pro-drug that undergoes activation during gastrointestinal absorption. The agent is excreted mostly unchanged and has a terminal half-life of about nine hours (slightly longer in the elderly). Candesartan differs from other agents in its class in that it is tightly bound to angiotensin II type 1 receptors, allowing prolonged activity. In clinical trials, candesartan cilexetil has produced a dose-dependent effect when given in dosages of 2-32 mg/day. Observed trough-to-peak blood pressure ratios support a once-daily dosage regimen. The antihypertensive effect of candesartan cilexetil 4-16 mg/day was as great as that of enalapril 10-20 mg/day and amlodipine 5 mg/day and larger than that of losartan potassium 50 mg/day. Adding candesartan cilexetil to hydrochlorothiazide 12.5-25 mg/day and amlodipine 5 mg/day led to enhanced blood-pressure reductions and was well tolerated. It appears that candesartan can decrease renal perfusion without adversely affecting renal blood flow and may mediate a decrease in albuminuria in hypertensive patients with type 2 diabetes. No clinically important drug interactions have been reported. Adverse effects include headache, dizziness, nausea, diarrhea, and transient elevations in liver transaminases. The frequency of cough is similar to that seen with placebo. Candesartan cilexetil is an effective antihypertensive agent that can be used alone or in combination with other antihypertensive drugs. It is generally well tolerated and may be an option for patients who cannot tolerate angiotensin-converting-enzyme inhibitors because of cough.

Thalidomide-induced toxic epidermal necrolysis.

Toxic epidermal necrolysis (TEN) is a severe dermatologic disorder associated with mortality of up to 30%. Withdrawal of the causative agent is crucial in its management. Although thalidomide-induced dermatologic disorders rarely were reported before thalidomide was administered to patients positive for the human immunodeficiency virus, hypersensitivity reactions including rash are the agent's major dose-limiting toxicities in this population. As it is prescribed for other immunosuppressed patients, such as those with malignancies, the frequency of dermatologic reactions (including TEN) may increase. A 62-year-old woman developed TEN after approximately 5 weeks of thalidomide therapy for the treatment of a glioblastoma.