Patient Events

Subgroup Events/ patients (%) Events/ patients (%) Odds ratio 95% Cl... 

The occurrence of mitochondrial damage and oxidative stress has been repeatedly found in the chnical setting and in e q)erimental models of Parkinson s disease [52]. Treatment of Parkinson s disease patients with vitamin E has not provided definite positive results however, a combination of antioxidants [46, 53], including vitamins such as niacin and riboflavin, is strongly recommended [46,54]. Treatment of patients with Alzheimer s disease with vitamin E (2000 mg day ) has been reported to improve the patients event-free-sur-vival (cognitive activity) [55]. It has also been claimed that an increased intake of vitamin E lowers the risk of Alzheimer s disease [56,57]. 

Adverse Events. The Safe Medical Devices Act of 1990 included a provision by which both users and manufacturers (and distributors) of medical devices are required to report adverse patient events that may be related to a medical device. Manufacturers must report to the FDA if a device (a) may have caused or contributed to a death or serious injury, or (b) malfunctioned in such a way as would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. Device users are required to notify the device manufacturer of reportable incidents, and must also notify the FDA in case of a device-related death. In addition, the FDA established a voluntary program for reporting device problems that may not have caused an untoward patient event, but which may have the potential for such an occurrence under altered circumstances. 

Murff, H. J., Patel, V. L., Hripcsak, G., Bates, D. W., Detecting Adverse Events for Patient Events for Patient Safety Research A Review of Current Methodologies, Journal of Biomedical Informatics, Vol. 36, No. 1-2,2003, pp. 131-43. 

Almost 100,000 people die each year from infections, with one report stating that an estimated 13.5% of hospitalized Medicare beneficiaries experienced adverse patient events (APE) during their hospital stays. 

Venlafaxine (48) is a stmcturaHy novel phenylethylamine derivative that strongly inhibits both noradrenaline and serotonin reuptake. It lacks anticholinergic, antihistaminergic, and antiadrenergic side effects. As compared to placebo, most common adverse events are nausea, somnolence, dizziness, dry mouth, and sweating. Venlafaxine-treated patients also experienced more headaches and nausea, but less dry mouth, dizziness, and tremor than patients treated with comparator antidepressants. 

Other agents are also used for the treatment of manic-depressive disorders based on preliminary clinical results (177). The antiepileptic carbamazepine [298-46-4] has been reported in some clinical studies to be therapeutically beneficial in mild-to-moderate manic depression. Carbamazepine treatment is used especially in bipolar patients intolerant to lithium or nonresponders. A majority of Hthium-resistant, rapidly cycling manic-depressive patients were reported in one study to improve on carbamazepine (178). Carbamazepine blocks noradrenaline reuptake and inhibits noradrenaline exocytosis. The main adverse events are those found commonly with antiepileptics, ie, vigilance problems, nystagmus, ataxia, and anemia, in addition to nausea, diarrhea, or constipation. Carbamazepine can be used in combination with lithium. Several clinical studies report that the calcium channel blocker verapamil [52-53-9] registered for angina pectoris and supraventricular arrhythmias, may also be effective in the treatment of acute mania. Its use as a mood stabilizer may be unrelated to its calcium-blocking properties. Verapamil also decreases the activity of several neurotransmitters. Severe manic depression is often treated with antipsychotics or benzodiazepine anxiolytics. 

The Oslo Trial (87) enrolled 785 male patients <50 years of age with DBP <110 mm Hg (15 Pa) and free of clinical evidence of cardiovascular disease. If the initial DBP was <100 mm Hg (13 Pa), there were no differences in mortaUty or cardiovascular events in the placebo- or dmg-treated groups. If the initial DBP was >100 mm Hg, then the incidence of cardiovascular disease was greater in the dmg-treated than in the placebo-treated group. 

Ascites. Patients with cirrhosis, especially fiver cirrhosis, very often develop ascites, ie, accumulation of fluid in the peritoneal cavity. This is the final event resulting from the hemodynamic disturbances in the systemic and splanchnic circulations that lead to sodium and water retention. When therapy with a low sodium diet fails, the dmg of choice for the treatment of ascites is furosemide, a high ceiling (loop) diuretic, or spironolactone, an aldosterone receptor antagonist/potassium-sparing diuretic. 

In patients having Parkinson s disease, both entacapone and tolcapone potentiate the therapeutic effect of L-dopa and prolong the daily ON time by 1-2 h. In the clinic, COMT inhibitors have been well tolerated, and the number of premature terminations has been low. In general, the incidence of adverse events has been higher in tolcapone-treated patients than in entacapone-treated patients. The main events have comprised of dopaminergic and gastrointestinal problems [2,3]. 

---