[Intracavernous auto-injection therapy with papaverine phentolamine via an auto-injection pen for patients with an erectile dysfunction: similar results achieved in family practice and urology]. / Intracaverneuze auto-injectietherapie met papaverine-fentolamine via een auto-injectiepen bij patiënten met een erectiestoornis: vergelijkbare resultaten bij huisarts en uroloog.

OBJECTIVE: To determine the results of an auto-injection therapy with papaverine-phentolamine (using an auto-injection pen) prescribed by a GP or a urologist, in patients with erectile dysfunction. DESIGN: Prospective, comparative, descriptive. METHOD: A total of 603 men with erectile dysfunction who were prescribed papaverine-phentolamine auto-injection by 59 GPs and 76 urologists participated in the study. The physician completed a questionnaire at the first visit and during the three follow-up visits (the last at 6 months) and the patient kept a diary and gave a satisfaction score on a nine-point scale. RESULTS: The cause of the erectile dysfunction was most commonly psychogenic/mixed somatic-psychogenic in the GP group and most commonly vascular in the urologist group (p > 0.05). The somatic comorbidity was the same (70%), whereas the prevalence of psychological symptoms differed (GP group: 6%; urologist group: 7%; p < 0.001). Attendance at all of the follow-up examinations was 38% for the GP group and 17% for the urologist group. The mean starting dose in the GP group was 0.49 ml and in the urologist group 0.70 ml (p < 0.001). The mean end dose was the same (about 1 ml). The frequency of adverse reactions was 9%: haematoma (5%), prolonged erection (1.8%). During the course of the investigation, 38% of the patients (31% in the GP group; 40% in the urologist group) discontinued the treatment owing to a limited effect, adverse reactions, difficult administration or problems related to the partner. In both the GP and the urologist group, 72% of the patients and 77% of the partners were satisfied or very satisfied with the auto-injection pen treatment. The patient's mean satisfaction score was 7.2. CONCLUSION: Whether the patient was treated by a GP or a urologist, the auto-injection therapy with papaverine-phentolamine for erectile dysfunction, using an auto-injection pen, was well tolerated and was highly appreciated by both the patients and their partners. Nevertheless one third of the patients discontinued the treatment prior to the end of the study. The mean end dose of the medication was the same in both groups.

Tolerability and effects of high doses acipimox as additional lipid-lowering therapy in familial hypercholesterolemia.

BACKGROUND: Acipimox, a derivative of nicotinic acid, lowers serum lipid levels by reducing the production of very-low-density and low-density lipoproteins (LDL). METHODS: We studied the additional lipid-lowering effect of high doses of acipimox in 12 patients with severe familial hypercholesterolemia (FH) who were on treatment with an HMG CoA reductase inhibitor, in some cases in combination with a resin. RESULTS: There was a significant reduction in total serum cholesterol (-9%), LDL-cholesterol (-9%) and serum triglycerides (-21%) when the standard doses of acipimox (750 mg/day) was added to treatment with simvastatin (and a resin). However, higher doses had no further hypolipidemic effect. In concordance with the reduction of serum cholesterol and LDL-cholesterol there was a significant decrease in apolipoprotein (apo)-B (-11%). There was no change in HDL-cholesterol, apo-A1 and lipoprotein(a). Acipimox in high doses up to 2250 mg/d was well tolerated except for initial gastric complaints and of flushing; because of these side effects one patient dropped out of the study. CONCLUSIONS: Acipimox in high doses, which were well tolerated, has no additional lowering effect on LDL-levels compared to the standard dose in patients with severe FH who are already treated with simvastatin.

Treatment of elderly patients with isolated systolic hypertension with isosorbide dinitrate in an asymmetric dosing schedule.

Nitrates decrease pulse pressure more than mean arterial pressure (MAP) and are advocated for the treatment of isolated systolic hypertension (ISH). Nitrates show drug tolerance during chronic treatment so an asymmetric dosing regimen may prevent loss of effect of nitrates. This study investigates the anti-hypertensive effect of isosorbide dinitrate (ISDN) given in a twice daily asymmetric dosing regimen in elderly patients with ISH. After a 6-week placebo run-in period, patients entered the double-blind study. Ten patients received placebo and 11 patients ISDN 20 mg b.i.d. for 8 weeks. This dose could be doubled once. Office systolic and diastolic blood pressures (SBP/DBP) and ambulatory BP were measured. Pulse pressure was calculated as SBP-DBP. Office pulse pressure was more reduced during ISDN (17.9%) than with placebo (5%; P < 0.05). SBP and MAP decreased compared to baseline, but the changes were not statistically significant between the two groups. DBP tended to increase with ISDN compared to placebo. Mean 24-h, mean daytime and mean night-time pulse pressure decreased after treatment with ISDN (10.7%, 12.1%, 7.9%, respectively). Pulse pressure tended to decrease more during the day than during the night with ISDN. No changes could be demonstrated with placebo. In conclusion, pulse pressure decreased with ISDN, resulting in a lower SBP without a decrease in DBP. The latter may preserve coronary perfusion in ISH. With the asymmetric dosing regimen the decrease in pulse pressure was not clear at night. Whether a decrease in nocturnal BP, in addition to the spontaneous decrease, is advisable in ISH remains a matter of debate.

Comparison of multiple-dose and once-daily nitrate therapy in 1212 patients with stable angina pectoris: effects on quality of life indices. Dutch Mononitrate Quality of Life (DUMQOL) Study Group.

BACKGROUND: Nitrates, although important for the management of anginal symptoms, produce significant side effects. Little is known about their net effects on health-related, quality-of-life indices. METHODS: In a self-controlled, 6-month study, the effects on symptoms and quality of life of multiple-dose and once-daily nitrate therapy were evaluated in 1212 patients with stable angina pectoris. Quality of life was assessed by a test battery based on the exercise-tolerance index of Wiklund, the psychological well-being index of Dupuy, and the Short Form 36 questionnaire of Stewart. The internal consistency and reliability of the multi-item scales were estimated by Cronbach's alpha coefficients. RESULTS: The effects of the two treatment regimens on pain index and number of additional sublingual nitrate tablets required were not different. However, based on the New York Heart Association (NYHA) angina classification, patients improved better on the once-daily than on the multiple-dose regimen: by > 1 category in 281 vs 62 of the patients (P < 0.0001); mobility and psychological distress indices also improved (P = 0.006, and P = 0.007). CONCLUSIONS: Once-daily nitrate therapy not only provides a better NYHA angina classification than multiple-dose therapy does, but also provides a better quality of life as estimated by improvement of mobility and distress indices, the most important indicators of quality of life in this category of patients.

Comparison of the effects of urapidil and sodium nitroprusside on haemodynamic state, myocardial metabolism and function in patients during coronary artery surgery.

We have compared, in an open randomized study, the effects of sodium nitroprusside (SNP) and urapidil on haemodynamic state and myocardial function and metabolism in two groups of patients undergoing elective coronary artery surgery. Sixty patients were allocated randomly to one of two groups: group SNP (n = 29) received SNP at an initial rate of 1-2 micrograms kg-1 min-1; group URA (n = 31) received one or more bolus injections of urapidil 25 mg and an i.v. infusion at an initial rate of 11-21 micrograms kg-1 min-1. Baseline measurements were obtained 10 min after introduction of an echotransducer into the oesophagus. Subsequently, vasodilator therapy was started in both groups. Infusion rates were adjusted to maintain systolic arterial pressure at 80-120% of baseline values (or mean arterial pressure < 100 mm Hg). Additional measurements were obtained 10 min after the start of vasodilator therapy and after sternotomy when the pericardium was opened. At each measuring time a complete haemodynamic profile, coronary sinus blood flow (CSBF) curves, transoesophageal echocardiographic images, and arterial and coronary venous blood samples were obtained. Arterial pressure was controlled adequately in both groups. After sternotomy, heart rate and cardiac index increased in both groups. At that time, there was a significant increase in myocardial oxygen consumption and CSBF in group URA (P < 0.05). However, the ratio between myocardial oxygen demand and oxygen supply remained unchanged and there was no difference in the number of ischaemic episodes between the groups.