Nicardipine as antihypertensive monotherapy: positive effects on quality of life.

The effects of nicardipine and propranolol on patients' quality of life were compared during a double-blind, multicentre, parallel, randomised study of hypertension therapy. After a placebo run-in period, the doses for each patient were successfully titrated to reduce supine diastolic blood pressure to less than 90 mmHg with either nicardipine 60 or 90 mg/day (123 patients) or with propranolol 90-240 mg/day (120 patients). Both drugs demonstrated similar efficacy in reducing systolic and diastolic blood pressure. Total duration of therapy ranged from 6-12 weeks. The Nottingham Health Profile questionnaire was used to assess the effect of each treatment on the patients' quality of life. The overall quality of life score for patients on nicardipine showed a tendency toward improvement, while for those on propranolol, the trend was toward overall worsening. The differences between the two treatment groups were statistically significant for males (P = 0.02). The analysis of the separate components of this evaluation demonstrated that physical mobility was reported to be decreased more for the propranolol-treated patients than for the nicardipine-treated patients (P = 0.02). In contrast to the propranolol-treated patients, the nicardipine-treated patients reported improvements for sleep, social life, work, sex life, and for activities related to hobbies and interests. A second questionnaire was used to assess the effects of the therapies on work productivity. Among those patients who worked for pay, more patients treated with propranolol than those treated with nicardipine rated themselves as less productive at work (P = 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Randomized double-blind comparison of side effects of nicardipine and nifedipine in angina pectoris. The Nicardipine Investigators Group.

Nicardipine and nifedipine are structurally similar dihydropyridine calcium channel blockers with demonstrated efficacy in the treatment of stable angina pectoris. The present study was a prospective randomized trial designed to evaluate the relative incidence of dizziness, flushing, headache, pedal edema, and palpitations during use of these drugs in patients with angina pectoris. Of 250 patients who entered into the comparative treatment part of the study, 140 patients were susceptible to developing symptoms to nifedipine as identified during a 1-month open-label treatment with nifedipine. These patients were compared with a parallel cohort of 110 patients, who were identified during the same open-label period, but remained mostly asymptomatic. After a 1-week washout of nifedipine, equal numbers of patients in each cohort began an 8-week period of randomized, double-blind treatment with nifedipine (20 mg three times daily) or nicardipine (30 mg three times daily). Patients who experienced these symptoms during the open-label nifedipine treatment had a higher incidence of the same symptoms during the blinded treatment regimen. Nicardipine-treated patients had a lower incidence of each of the symptoms than did the nifedipine-treated patients. Statistically significant differences were reported for dizziness, the most common of the side effects. Patients who were free of these symptoms in the open-label period usually remained free of them in the blinded comparison. However, even among those free of dizziness during the open-label nifedipine treatment, more patients reported experiencing dizziness in the blinded phase from nifedipine than from nicardipine (18% vs 6%; p = 0.02).

Long-term systemic arterial blood pressure control with nicardipine.

Nicardipine was administered orally for up to 1 year to 250 patients with essential hypertension. Phase I, a 2- to 4-week placebo washout to establish baseline supine diastolic blood pressure (BP), was followed by 4 weeks of open-label nicardipine dose titration (phase II) to establish optimal dosage on a 3-times-daily regimen for each patient. After nicardipine administration, approximately 79% of the patients had supine diastolic BP less than 90 mm Hg or greater than or equal to 10 mm Hg below baseline. The reduction in systolic and diastolic BPs was somewhat greater in patients older than 60 years. After phase III--an 8-week double-blind comparison of dosage regimens of 2- and 3-times-daily--all patients returned to a 3-times-daily regimen at their optimal daily dosage for 40 weeks of open treatment (phase IV). Supplemental treatment with a diuretic or a beta blocker was required by 67 patients. By the end of phase IV, more than 100 patients had completed 1 year of nicardipine monotherapy (mean supine diastolic BP = 85 mm Hg, approximately 14 mm Hg below baseline). Finally, patients were randomly assigned to continue nicardipine on a double-blind basis or take a matching placebo for 6 weeks (phase V, n = 101). The nicardipine group had only a slight change in supine diastolic BP, whereas those receiving placebo had statistically significant increases in supine diastolic BP toward baseline values. Adverse experiences, attributed to the vasodilatory effects of nicardipine, tended to occur in the first few months of the study and resulted in early withdrawal of 30 patients. Overall, these results show that nicardipine is a well-tolerated antihypertensive agent with efficacy sustained during 1 year of treatment.

Naproxen tolerability in the elderly: a summary report.

Naproxen tolerability in elderly patients was assessed using data from 9 double blind clinical trials. We analyzed the percentage of patients who (a) withdrew for complaints, (b) reported complaints, and (c) exhibited clinically significant laboratory test abnormalities. Among 1,178 patients with rheumatoid arthritis or osteoarthritis, 26% were 65 years old or older. These elderly patients demonstrated no consistent decrease in tolerability, or increase in toxicity, of naproxen, as compared with younger patients.