Norfloxacin versus trimethoprim-sulfamethoxazole in the treatment of urinary tract infections.

In a controlled, randomized trial of 133 patients with proven urinary tract infections (UTIs), significantly more pathogens were found to be susceptible to norfloxacin than to trimethoprim-sulfamethoxazole (TMP-SMZ) (p less than 0.01). Among patients with pathogens susceptible to both drugs, more of those treated with norfloxacin were cured or improved (p = 0.06). When at least one patient variable, i.e., prior history of therapy, was corrected for, this difference became significant (p = 0.03). Norfloxacin eradicated 11 of 13 infections due to Pseudomonas aeruginosa and 6 of 7 due to enterococci. Five patients treated with norfloxacin and two treated with TMP-SMZ had relapses within 6 weeks. Significantly fewer adverse experiences occurred in patients receiving norfloxacin (p less than 0.01).

Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.

Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.

PIP: 313 women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding or spotting) associated with the use of 3 triphasic oral contraceptives. Triphasil (n=107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n=97) and Tri-Norinyl (n=109), both of which contain norethindrone and ethinyl estradiol, were administered over 4 cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimes. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first 4 cycles of use.

Clinical comparison of cefadroxil, new oral cephalosporin, and cephalexin in uncomplicated urinary tract infection.

Efficacy and safety of cefadroxil, a new oral cephalosporin, were compared with that of cephalexin in the treatment of 28 women with acute urinary tract infections. According to a randomized double-blind design, each patient received cefadroxil 1,000 mg. twice daily or cephalexin 500 mg. four times a day for ten days. Cures based on urine culture five to nine days post-treatment were obtained for all but 1 patient receiving cefadroxil; reinfection after eradication of the original pathogen was recorded for only 1 patient in each treatment group. No drug-related side effects or significant clinical laboratory abnormalities were observed during the study. Cefadroxil 1,000 mg. given twice daily was as effective and as well tolerated as cephalexin 500 mg. given four times daily. The significance of this dosage schedule advantage is discussed.

Micronized 17 beta-estradiol for oral estrogen therapy in menopausal women.

Micronized 17beta-estradiol (E2) was used as oral replacement therapy in 369 patients with estrogen deficiency and related menopausal symptoms. Over 95 percent of 319 patients evaluable for efficacy gained satisfactory relief of their symptoms from cyclic (on 21 days/off 7 days) E2 therapy. Approximately 77 percent required no adjustment of their initial daily dose, viz, 1 mg (5 or less hot flushes per day) or 2 mg (6 or more flushes daily). In addition, 80 percent (58/72) of the patents who did not obtain adequate control from their starting dose were successfully titrated, either upward to a maximum of 4 mg/day or downward for maintenance. Overall, a higher percentage of patients were treated successfully with 2 mg daily (209/319; 66 percent) than with 1 mg/day (22 percent). About 8 percent of the patients required 3 or 4 mg daily, while 4 percent failed to derive adequate benefit from micronized E2. Oral E2 therapy was well tolerated; hence, the attrition rate due to side effects or lack of control was only 6 percent (22/369). Moreover, all laboratory fingings were within normal limits, even in patients treated with E2 for over 12 months. Coincidental endometrial changes were found in 9 patients, all of whom had received long-term (9 months-3 years) estrogen therapy prior to entering this study. Thus, the stste of the endometrium should be determined before any estrogens are given for the monopause. It is concluded that micronized E2 is highly efficacious, well accepted, and safe for oral estrogen-replacement therapy in menopausal women.