Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma.

PURPOSE: To assess the 12-month efficacy and safety of fixed-combination brimonidine tartrate 0.2%/timolol maleate 0.5% (FCBT) with or without bimatoprost 0.01% (BIM) in primary open-angle glaucoma (POAG), including normal-tension glaucoma (NTG). STUDY DESIGN: Prospective, multicenter, open-label study. METHODS: FCBT was self-administered twice daily after applicable washout (study eye). Intraocular pressure (IOP) was measured at baseline and months 1, 3, 6, 9, and 12. BIM could be added for IOP ≥ 21 mmHg, IOP reduction from baseline < 20%, or the investigator deemed it necessary. Primary endpoint: mean (11-a.m.) month-12 IOP change from baseline. Secondary endpoints included mean IOP changes from baseline at other visits, median time to achieving and patients (%) achieving target IOP reduction with FCBT, and visual field (VF) progression rate over 12 months. Safety was assessed at each visit. RESULTS: Of 118 eyes with POAG (NTG, n = 93), 87 used FCBT; 31 required FCBT + BIM. Mean IOP changes from baseline (16.8 and 15.3 mmHg) to month 12 were - 4.1 mmHg (FCBT, n = 62) and - 3.5 mmHg (FCBT + BIM, n = 15), respectively (both P < 0.0001). Patients who achieved target IOP reduction with FCBT did so in 1 month (median). VF progression rates were 0.17%/year (FCBT, P = 0.8367) and - 0.08%/year (FCBT + BIM, P = 0.9410). Ocular treatment-emergent adverse events occurred in 42.5% (FCBT) and 71.0% (FCBT + BIM) of patients; most were mild and included ocular hyperemia (9.2% and 41.9%, respectively). CONCLUSIONS: Despite low mean baseline IOP, ≥ 20% IOP reduction from baseline persisted over 12 months with FCBT and FCBT + BIM, without clinically significant VF progression. Tolerability was consistent with reported drug safety profiles.

Breast augmentation surgery using an inframammary fold incision in Southeast Asian women: Patient-reported outcomes.

BACKGROUND: This analysis presents patient-reported outcomes of breast augmentation procedures performed in Singapore using an inframammary fold incision and the "5 Ps" best practice principles for breast augmentation. These data are the first of their kind in Southeast Asian patients. METHODS: Through a retrospective chart review, patients who underwent primary breast augmentation with anatomical form-stable silicone gel breast implants using an inframammary fold incision were followed for ≥6 months postoperatively. The BREAST-Q Augmentation Module (scores standardized to 0 [worst] - 100 [best]) and Patient and Observer Scar Assessment Scale (POSAS; 1 [normal skin] to 10 [worst scar imaginable]) were administered. Responses were summarized using descriptive statistics. Patient-reported events were collected. RESULTS: Twenty-two Southeast Asian patients (mean age, 35.1 years) completed ≥1 postoperative BREAST-Q and POSAS assessment and were assessed 11 months to 5.5 years postoperatively. The mean postoperative BREAST-Q satisfaction with breasts and psychosocial well-being scores were 69.2 and 84.0, respectively. The mean POSAS score for their overall opinion of the scar was 4.2; the mean scores for all scar characteristics ranged from 1.2 to 4.2. Over 90% of patients (20/22) said that they would recommend the procedure. Patient complaints following surgery included anisomastia (possibly pre-existing; n=2), sensory loss at the nipple (n=2) or around the nipple (n=3), scarring (n=4), and slight capsular contracture (n=1). No patients required reoperation. CONCLUSIONS: Southeast Asian patients reported high long-term satisfaction scores on the BREAST-Q scale and with their scar characteristics following breast augmentation using an inframammary fold incision, and nearly all said they would recommend this procedure. No reoperations were necessary in patients assessed for up to 5.5 years postoperatively.