Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care.

To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.

Post-marketing surveillance study of the safety and efficacy of sildenafil prescribed in primary care to erectile dysfunction patients.

In order to investigate the safety and efficacy of sildenafil prescribed in primary care, a post-marketing surveillance study was undertaken. A total of 651 men with erectile dysfunction (ED) were enrolled from 31 family physicians in Korea from December 1999 to July 2002. Patients were regularly followed up to ascertain the safety and efficacy of sildenafil. Of the 651 patients enrolled, 572 (87.9%) returned for safety evaluation and efficacy assessment. In all, 458 (80.1%) of 572 patients reported improved erectile function with sildenafil. Hypertension, diabetes and low-dose sildenafil were associated with poor efficacy. A total of 71 adverse events were reported among 56 patients (8.6%), with the most frequent being hot flushes (5.6%), followed by headache (2.6%), palpitation (1.0%), anxiety (0.5%) and elevated ALT (0.5%). Only six patients (1.0%) discontinued sildenafil as a direct result of adverse events. These results suggest that sildenafil prescribed by primary care physicians was well tolerated and improved erectile function in patients with ED.

Obesity as a risk factor for non-insulin-dependent diabetes mellitus in Korea.

Most Korean patients with non-insulin-dependent diabetes mellitus (NIDDM) have been reported not to be obese, and many of them lost weight significantly during the course of their disease. In this regard, a retrospective cohort study was conducted to determine the relationship between body mass index (BMI, kg/m2) and the risk for NIDDM among Koreans. Subjects who had received a medical examination from 1990 to 1991 and who were available for the detection of NIDDM until September 1999 were included. Subjects who initially had diabetes or were diagnosed as diabetic within 1 yr after enrollment were excluded. We reviewed the medical records of final cohort of 2,531 subjects. Follow-up of this cohort revealed 117 cases with diabetes with an incident of 7.8 per 1,000 person-years. Compared with those with BMI less than 23 kg/m2, the adjusted relative risks for diabetes mellitus for those with BMI of 23-24.9, 25-26.9, and greater than 27 kg/m2 were 0.85 (0.47-1.50), 1.29 (0.72-2.31), and 3.38 (1.22-4.63), respectively, for men (p for trend<0.01) and as for 9.14 (1.99-41.8), 7.36 (1.47-36.8), and 14.5 (3.03-69.2), respectively, for women (p for trend<0.01). These data indicate a direct relationship between obesity and the risk for the development of diabetes, emphasizing the importance of weight control for the prevention of NIDDM in Koreans.

Short-term safety and tolerability of antihypertensive agents in Korean patients: an observational study.

PURPOSE: In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out. METHODS: A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monotherapy, the patients were evaluated for whether treatment was to be continued and the development of any adverse reactions. RESULTS: During the first 12 weeks, the percentage of subjects continuing with their initial angiotensin converting enzyme inhibitors (ACEI) (40.7%) was substantially lower than that of subjects continuing with angiotensin II receptor antagonists (ARA) (66.2%), alpha-blockers (63.0%), calcium channel blockers (CCB) (61.3%), beta-blockers (55.8%), and diuretics (53.5%), respectively (P < 0.01). The following adverse reactions were detected: cough (7.5%), headache (6.1%), dizziness (3.9%), flushing (3.7%) and impotence (2.4%). Cough, headache, and flushing were more frequent in women, and impotence and loss of libido were more frequent in men (P < 0.05). The incidence of cough associated with ACEI (27.9%) was higher than that associated with the other classes of drugs (P < 0.01). CONCLUSIONS: The tolerability of antihypertensive medication was highest in Korean patients treated with ARAs, followed by CCBs, beta-blockers, diuretics, alpha-blockers, and ACEIs. The incidences of adverse reactions were different by sex, age and drug class.