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The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: R1810198 Title: An actual use study in support of the over-the-counter switch of Flonas3 Allergy Rationale: The purpose of this study was to evaluate adherence compliance ; with labeling instructions and evaluate the safety profile of fluticasone propionate nasal spray in an OTC setting. Phase: III Study Period: 4 March 2003 -29 November 2003. Study Design: Pharmacy-based, open-label, all-comers, naturalistic OTC actual-use trial Centres: Multicenter trial conducted at 63 sites in the USA Indication: Consumers Treatment: Adults: fluticasone propionate aqueous nasal spray, 50 mcg per spray. Two sprays into each side of the nose once a day. After 4-7 days of use, if the symptoms had improved, the dose could be reduced to one spray into each side of the nose once a day. Teens: fluticasone propionate aqueous nasal spray, 50 mcg per spray. One spray into each side of the nose once a day Objectives: The primary objective was to assess subjects' overall compliance with the Flonasr AllergyTM Drug Facts label. Primary Outcome Efficacy Variable: This study was not designed to evaluate efficacy. Secondary Outcome Efficacy Variable s ; : Not applicable Statistical Methods: Incidences and numbers of adverse events were tabulated by system organ class and preferred term. Safety Population: All purchasers All Purchasers Number of Subjects: Planned, N 850 Purchasers, N 1, 616 Completed, n % ; 935 57.85 ; Total Number Subjects Withdrawn, N % ; 681 42.14 ; Withdrawn due to Adverse Events n % ; 95 5.88 ; Withdrawn due to Lack of Efficacy n % ; 89 5.51 ; Withdrawn for other reasons n % ; 497 30.75 ; Demographics All Purchasers N Females: Males Mean Age, years SD ; , n Caucasian, n % ; Primary Efficacy Results: Not applicable Safety Results: Most Frequent Adverse Events Subjects with any AE s ; , n % ; Rhinitis allergic Headache Sinus headache Nasopharyngitis Tension headache Cough Epistaxis Back pain Pharyngolaryngeal pain Sinus infection 1, 616 948: ; , 1611 1, 352 Serious Adverse Events n % ; [n considered by the investigator to be related to study medication] All Purchasers Subjects with any SAEs, n % ; 46 2.8 ; Includes both fatal and non-fatal events n % ; [related] 3 0.2 ; [0, 1 unknown] Death 2 0.1 ; [0] Basal cell carcinoma 2 0.1 ; [0] Skin carcinoma 2 0.1 ; [0] Pancreatitis 2 0.1 ; [0] Appendicitis 2 0.1 ; [0] Cholecystitis 1 ; [0] Bladder cancer 1 ; [0] Bladder neoplasm 1 ; [0] Breast cancer 1 ; [0] Lymphoma 1 ; [0] Uterine leiomyoma 1 ; [0] Cerebrovascular accident 1 ; [0] Hypoaesthesia 1 ; [0] Loss of consciousness 1 ; [0] Myelopathy 1 ; [0] Sleep apnoea syndrome 1 ; [0] Abdominal pain 1 ; [0] Inguinal hernia 1 ; [0] Cellulitis orbital 1 ; [0] Pneumonia 1 ; [0] Wound abscess 1 ; [0] Arthritis 1 ; [0] Back disorder 1 ; [0] Pain in extremity 1 ; [0] Rotator cuff syndrome 1 ; [0] Angina pectoris 1 ; [0] Cardiac failure congestive 1 ; [0] Supraventricular tachycardia 1 ; [0] Bladder repair 1 ; [unknown] Hospitalisation 1 ; [0] Hysterectomy 1 ; [0] Surgery 1 ; [0] Head injury 1 ; [0] Hip fracture 1 ; [0] Prostatic hypertrophy 1 ; [0] Uterine haemorrhage 1 ; [0] Hyperparathyroidism 1 ; [0] Anaphylactic reaction 1 ; [0] Heart rate irregular 1 ; [0] Abortion spontaneous 1 ; [0] Alcohol withdrawal syndrome 1 ; [0] Cystocele 1 ; [0] Pleural rub Subjects with fatal SAEs, n % ; Death Head injury 4 0.2 ; n % ; [related] 3 0.2 ; [0] 1 ; [0] and glucophage!
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This is gout that is predominantly due to a well-defined underlying cause. Diuretics water tablets ; have already been mentioned; other causes include certain rare blood diseases that raise the level of urate. Low-grade lead poisoning seen in plumbers and painters during the nineteenth century was once a cause of secondary gout. Usually, however, it is impossible to identify such causes, and the condition is then referred to as `primary' gout and glyburide.
Health care workers, especially those who deal with large numbers of HIV-infected patients, have a small but definite risk of becoming infected with HIV as a result of professional activities. As of January 1, 2000, 56 health care workers in the United States had been documented as having seroconverted to HIV following occupational exposure; 25 have developed AIDS. The individuals who seroconverted include 19 laboratory workers 16 of whom were clinical laboratory workers ; , 23 nurses, 6 physicians, 2 surgical technicians, 1 dialysis technician, 1 respiratory therapist, 1 health aide, 1 embalmer morgue technician.
Thrombosis related to atherosclerotic plaques in such arteries can lead to vessel narrowing or occlusion that may remain asymptomatic, but many patients develop clinical features of chronic ischaemia or intermittent claudication IC ; . Typical symptoms include pain in the calves, especially on walking up stairs or slopes, that is relieved by rest. Other symptoms include exercise-induced pain in the thighs or buttocks and impotence. As disease severity increases, some patients may experience pain at rest especially when legs are elevated in bed at night ; . A minority of patients experience critical limb ischaemia. The prevalence of PAD increases with age with most symptomatic patients being over 60 years old ; . It is twice as high in men as in women between 50 and 70 years, but almost identical after the age of 70. Smoking is the most important correctable risk factor and may be even more strongly associated with this condition than with coronary heart disease CHD ; . Other risk factors are similar to those for CHD, including hypertension, hyperlipidaemia and diabetes mellitus. PAD patients have an increased risk of coronary heart disease and stroke; the mortality rate is two to three times that of age-matched controls. The main diagnostic test to confirm the presence of PAD is the ankle-brachial pressure index ABPI ; , although objective testing is not essential in patients with a classic history of claudication. The ABPI is calculated for each leg ; by dividing the systolic pressure recorded at the respective ankle by the highest systolic brachial pressure obtained in recordings from both arms. Resting ABPI is normally greater than 1.0, with figures of 0.5-0.9 indicating mild to moderate claudication. Key nonpharmacological approaches to PAD management include smoking cessation, regular exercise, weight and hydrochlorothiazide.
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