Nabumetone in the treatment of active adult rheumatoid arthritis.

One hundred patients were entered in a six-month, double-blind comparison of 1,000 mg nabumetone once daily and 250 mg naproxen twice daily. Forty-two patients in each arm of the study were evaluable for efficacy; all were evaluable for safety. There was a low incidence of adverse experiences during this study, with no patients withdrawing from the study because of side effects from either drug. Efficacy was equal, with both compounds sharing the same degree and rate of improvement. All of the patients completing the double-blind phase were then switched to open-label treatment with nabumetone. The dosage of nabumetone was gradually increased. At the end of one year, 84 patients remained in the study (52 taking 1,000 mg per day, 23 taking 1,500 mg, and nine taking 2,000 mg). This gradual increase has continued, and, at this time, 61 patients remain in the study (seven taking 1,000 mg per day, 24 taking 1,500 mg, and 30 taking 2,000 mg). There have been very few side effects. From this study, it can be concluded that nabumetone is at least as effective as naproxen and, even at higher doses, had an acceptable safety profile for extended use in patients with rheumatoid arthritis.

Long-term treatment of rheumatoid arthritis comparing nabumetone with aspirin.

This report summarizes the results of a 17-investigator multicenter six-month randomized double-blind parallel group study. The safety and efficacy of nabumetone 1,000 mg taken at bedtime was compared with that of aspirin 900 mg four times daily in the treatment of adult patients with active class II or III classical or definite rheumatoid arthritis. Two hundred sixty-four patients were entered into the study. Two hundred fifty-seven (126 nabumetone and 131 aspirin) patients were evaluable for safety. Two hundred thirty-four (113 nabumetone and 121 aspirin) patients were evaluable for efficacy. There was significant improvement in each of six clinical measurements of efficacy in both treatment groups and little difference between groups. The somewhat greater improvement in articular index and duration of morning stiffness in the nabumetone-treated group did not reach statistical significance. There was an equal percentage of patient withdrawal for lack of efficacy in each group. Overall, the rate of patient withdrawal due to adverse experiences was greater (p = 0.01) for aspirin-treated patients. These experiences were usually dispepsia, abdominal pain, and tinnitus. It was concluded that nabumetone was an effective anti-inflammatory drug in the treatment of rheumatoid arthritis with less toxicity than aspirin.

Amlodipine versus atenolol in essential hypertension.

The efficacy and safety of amlodipine (2.5-10 mg) once daily was compared with atenolol (50-100 mg) once daily in patients with mild-to-moderate essential hypertension in a randomized, double-blind, parallel, placebo-controlled study. A total of 125 patients were randomly allocated at the end of a 4-week run-in placebo period to 8 weeks of double-blind treatment with amlodipine (n = 41), atenolol (n = 43), or placebo (n = 41). The placebo group had small mean changes in supine and standing blood pressure compared with baseline. The mean blood pressure changes from baseline 24 hours postdose in the amlodipine group (mean daily dose 8.8 mg) were -12.8/-10.1 mm Hg for supine blood pressure and -11.5/-9.8 mm Hg for standing blood pressure (p < 0.001 compared with placebo), and for the atenolol group (mean daily dose 83.7 mg) the changes were -11.3/-11.7 mm Hg for supine blood pressure and -13.3/-12.3 mm Hg for standing blood pressure (p < 0.001 compared with placebo). There were no statistically significant blood pressure differences between active treatments. The responder rates for amlodipine, atenolol, and placebo were 61.1, 64.9, and 11.1%, respectively. The blood pressure values taken over the 24-hour period at final visit revealed that amlodipine and atenolol maintained the supine blood pressure < or = 140/90 mm Hg throughout the period of observation; the corresponding time-effect curve for the placebo group was clearly in the hypertensive range. Both amlodipine and atenolol were well tolerated.(ABSTRACT TRUNCATED AT 250 WORDS)

A randomized, placebo-controlled, double-blind comparison of amlodipine and atenolol in patients with essential hypertension.

The efficacy and safety of amlodipine (2.5 mg, 5 mg, or 10 mg) once daily was compared with atenolol (50 mg to 100 mg) once daily in patients with mild-to-moderate essential hypertension in a randomized, double-blind, parallel, placebo-controlled study. One hundred and twenty-five patients were randomly allocated at the end of a 4-week run-in placebo period to 8 weeks' double-blind treatment with amlodipine (n = 41), atenolol (n = 43), or placebo (n = 41). The mean changes from baseline in blood pressure 24 h postdose for amlodipine (mean daily dose 8.8 mg) were -12.8/-10.1 mm Hg for supine and -11.5/-9.8 mm Hg for standing blood pressure (P < .001). For atenolol (mean daily dose 83.7 mg) the changes were -11.3/-11.7 mm Hg for supine and -13.3/-12.3 mm Hg for standing blood pressure (P < .001). There were no statistically significant differences between treatments. The responder rates for amlodipine, atenolol, and placebo were 61.1%, 64.9%, and 11.1%, respectively. Determinations taken over the 24-h period at the final visit revealed that amlodipine and atenolol maintained the group mean supine blood pressure at or below 140/90 mm Hg throughout the period of observation; the corresponding time-effect curve for the placebo group was clearly in the hypertensive range. Heart rate was significantly lowered by atenolol only. Both amlodipine and atenolol were well-tolerated. Only one patient was withdrawn because of the development of peripheral edema, arthralgia, and fatigue after treatment with amlodipine. This study demonstrates that once-daily administration of amlodipine or atenolol to mild-to-moderate hypertensive patients was well-tolerated and provided adequate blood pressure control throughout the 24-h dosing interval.

Long-term comparison of suprofen and propoxyphene in patients with osteoarthritis.

The analgesic efficacy and safety of suprofen, 200 mg q.i.d., and propoxyphene, 65 mg q.i.d., were compared in 114 patients with chronic pain due to osteoarthritis. Both analgesic agents decreased pain intensity after only 1 week of treatment and considerable pain relief was apparent by week 2 to week 3 of treatment. These beneficial effects persisted with long-term therapy and improvement continued throughout the 24-week treatment period. Overall, the response to suprofen and propoxyphene was good to excellent in most of the patients treated. Long-term administration of suprofen was at least as well tolerated as that of propoxyphene. Only 24% (13 of 55) of suprofen-treated patients and 34% (20 of 59) of propoxyphene-treated patients discontinued therapy, primarily due to gastrointestinal complaints. It was concluded that suprofen, 200 mg q.i.d., is comparable in terms of efficacy to propoxyphene, 65 mg q.i.d., in relieving pain due to osteoarthritis.

A randomized placebo-controlled comparison of amlodipine and atenolol in mild to moderate systemic hypertension.

Amlodipine, a new long-acting dihydropyridine calcium antagonist, was compared with placebo and atenolol in 125 patients with mild to moderate systemic hypertension [supine diastolic blood pressure (DBP) 90-114 mm Hg]. Patients received placebo for 4 weeks, followed by a random allocation to an 8-week double-blind, once-daily treatment with amlodipine (n = 41), atenolol (n = 43), or placebo (n = 41). The changes in 24-h post-dose blood pressure (BP) from baseline to final visit for amlodipine (mean daily dose 8.8 mg, range 5-10 mg) were -12.8 +/- 2.0/ -10.1 +/- 1.2 mm Hg in supine BP and -11.5 +/- 2.3/-9.8 +/- 1.1 mm Hg in standing BP (p less than 0.001); for atenolol (mean daily dose 83.7 mg, range 50-100 mg), the changes from baseline were -11.3 +/- 2.3/-11.7 +/- 1.3 mm Hg in supine BP and -13.3 +/- 3.1/-12.3 +/- 1.5 mm Hg in standing BP (p less than 0.001); for placebo, the changes from baseline were -0.9 +/- 2.8/-3.5 +/- 0.9 mm Hg in supine BP and -1.6 +/- -2.6/-4.0 +/- 1.0 mm Hg in standing BP. In the study, goal response was defined as a supine DBP of less than 90 mm Hg or its decrease by greater than or equal to 10 mm Hg. The response rates were similar for atenolol (65%) and amlodipine (61%). Both active therapies were significantly more effective than placebo. Heart rate was significantly lowered by atenolol only.(ABSTRACT TRUNCATED AT 250 WORDS)

Comparison of quality of life on nitrendipine and propranolol.

A multicenter, randomized, double-blind, comparative study was conducted in 274 patients with mild to moderate hypertension to assess the impact of nitrendipine and propranolol on quality of life. After placebo baseline, 136 patients were given nitrendipine (5-20 mg b.i.d.) and 138 were given propranolol (40-120 mg b.i.d.). Quality of life was evaluated at baseline, weeks 6-10, and weeks 14-18 of the maintenance period. At weeks 6-10, the nitrendipine group became significantly more vigorous (p less than 0.01) and less fatigued (p less than 0.05) than the propranolol group. Propranolol subjects noted decreased problems of trembling hands (p less than 0.01) and alcohol use (p less than 0.05) than the nitrendipine subjects. No other significant differences between groups in mood states, troublesome conditions (insomnia, headaches, and loss of appetite), or sexual satisfaction were noted at this visit, and patient willingness to continue study medication was marginally significantly higher (p less than 0.1) in the nitrendipine group than in the propranolol group. At weeks 14-18, the propranolol subjects perceived significantly decreased problems with the "felt worried, tense, and drank alcohol to cope" factor (p less than 0.05); however, there were no differences between groups at this visit for Profile of Mood States (POMS) scores, sex life variables, or medication preference. Based on within-group analysis, the propranolol group perceived a reduction in partner sexual satisfaction (p less than 0.05). Overall, nitrendipine seemed to be better tolerated than propranolol.