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Anemia treatment with Q2W darbepoetin alfa in patients with chronic kidney disease naive to erythropoiesis-stimulating agents
Silver, M R; Geronemus, R; Krause, M; Chen, C Y; Kewalramani, R; Stehman-Breen, C
OBJECTIVE: To evaluate the efficacy and safety of darbepoetin alfa dosed every-other-week (Q2W) to treat anemia in subjects with chronic kidney disease (CKD), not receiving dialysis, who were naive to erythropoiesis-stimulating agent (ESA) therapy. RESEARCH DESIGN AND METHODS: This was an open-label, multicenter, single-arm study enrolling ESA-naive CKD subjects with baseline hemoglobin (Hb) < 11.0 g/dL. Q2W darbepoetin alfa treatment was initiated at a dose of 0.75 microg/kg and titrated to achieve and maintain Hb levels at 11.0-13.0 g/dL. Treatment was administered from week 1 to week 19. MAIN OUTCOME MEASURES: The primary endpoint was the proportion of subjects who achieved Hb > or = 11 g/dL at any study visit, except in week 1. Hb levels, darbepoetin alfa dose, and safety were also assessed. RESULTS: Of the 128 subjects who received at least one dose of darbepoetin alfa and of the subjects who completed the study, 118 (92%) and 112 (97%), respectively, achieved a Hb > or = 11 g/dL in a median time of 5 weeks. Median darbepoetin alfa dose at week 1 and at the time of achieving a Hb > or = 11 g/dL were 60 and 80 microg, respectively. Darbepoetin alfa was well-tolerated, and short-term adverse events were consistent with those expected in CKD subjects. CONCLUSIONS: This study demonstrates that de novo Q2W darbepoetin alfa was effective in correcting and maintaining Hb levels in ESA-naive subjects with CKD who were not receiving dialysis. Study limitations, including lack of a control arm for the study and multiple race information for subjects, must be considered in interpreting the results. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00112008.
PMCID:3133722
PMID: 19210145
ISSN: 0300-7995
CID: 167375
TREATMENT OF SUPERFICIAL INFANTILE HEMANGIOMAS OF THE EYELID WITH THE 595 nm PULSED DYE LASER [Meeting Abstract]
Hunzeker, Christopher; Geronemus, Roy
ISI:000267524700058
ISSN: 0196-8092
CID: 2305792
BLEPHAROPLASTY-LIKE RESULTS WITH PERIORBITAL FRACTIONAL CO2 LASER [Meeting Abstract]
Brightman, Lori; Chapas, Anne; Hunzeker, Chris; Weiss, Elliot; Karen, Julie; Hale, Elizabeth; Bernstein, Leonard; Geronemus, Roy
ISI:000267524700077
ISSN: 0196-8092
CID: 2305802
IMPROVEMENT IN ARM SKIN LAXITY AND FAT DEPOSIT USING A NOVEL RADIOFREQUENCY, INFARED AND SUCTION DEVICE [Meeting Abstract]
Brightman, Lori; Weiss, Elliot; Hunzeker, Christopher; Chapas, Anne; Karen, Julie; Hale, Elizabeth; Bernstein, Leonard; Geronemus, Roy
ISI:000267524700239
ISSN: 0196-8092
CID: 2305812
IMPROVEMENT IN POST-PARTUM ABDOMINAL SKIN USING A NOVEL RADIOFREQUENCY, INFARED AND SUCTION DEVICE [Meeting Abstract]
Brightman, Lori; Anolik, Robert; Chapas, Anne; Hunzeker, Christopher; Weiss, Elliot; Karen, Julie; Hale, Elizabeth; Bernstein, Leonard; Geronemus, Roy
ISI:000267524700240
ISSN: 0196-8092
CID: 2305822
NECK REJUVENATION AND TIGHTENING WITH FRACTIONAL CO2 LASER [Meeting Abstract]
Brightman, Lori; Chapas, Anne; Weiss, Elliot; Hunzeker, Christopher; Karen, Julie; Hale, Elizabeth; Bernstein, Leonard; Geronemus, Roy
ISI:000267524700256
ISSN: 0196-8092
CID: 2305832
Eyelid tightening and improved eyelid aperture through nonablative fractional resurfacing
Sukal, Sean A; Chapas, Anne M; Bernstein, Leonard J; Hale, Elizabeth K; Kim, Karen H; Geronemus, Roy G
BACKGROUND AND OBJECTIVE: The effects of fractional resurfacing on eyelid tightening and aperture are unknown. Our purpose was to retrospectively examine the potential for eyelid tightening and eye-aperture opening in patients treated with nonablative fractional resurfacing for facial photorejuvenation. STUDY DESIGN/MATERIALS AND METHODS: Fractional laser treatments using a 1,550-nm erbium-doped fiber laser system on the upper and lower eyelids were given at a pulse energy of 17 to 20 mJ at 125 micro-thermal zones (MTZ)/cm(2) to a final density of 500 to 750 MTZ/cm(2). Each patient had 3 to 7 treatments. Standard pre- and post-treatment photographs were taken at each visit. Physicians who graded 31 preselected patient photographs using a 4-point scale evaluated eyelid tightening. Increase in eyelid aperture was also evaluated. RESULTS: All patients had some degree of eyelid tightening; 19% achieved 1% to 25% tightening, 26% achieved 25% to 50%, 26% achieved 50% to 75%, and 29% achieved 75% to 100%. Increase in eyelid aperture was seen in 55.9% of patients. Postoperative wounding, hypopigmentation, hyperpigmentation, persistent erythema, and scarring were not observed. All patients experienced mild or no edema for a few days after treatment. CONCLUSION: Fractional resurfacing tightens and increases eyelid aperture without wounding, downtime, or long-term complications
PMID: 18798758
ISSN: 1524-4725
CID: 93759
Thermage: the nonablative radiofrequency for rejuvenation
Sukal, Sean A; Geronemus, Roy G
Thermage is a noninvasive nonablative device that uses monopolar radiofrequency energy to bulk heat underlying skin while protecting the epidermis to produce skin tightening. It is used for the treatment of rhytids on the face including the periorbital region and lower face, and more recently, for off-face applications. Studies have shown that it can impart mild tightening of periorbital mid, and lower facial laxity. Other radiofrequency devices have also shown objective improvements in cellulite of the buttocks and thigh regions. Thermage is an efficacious and safe nonsurgical alternative for treating mild skin laxity
PMID: 18940540
ISSN: 0738-081x
CID: 93758
Reversal of laser-induced hypopigmentation with a narrow-band UV-B light source in a patient with skin type VI [Case Report]
Reszko, Anetta; Sukal, Sean A; Geronemus, Roy G
PMID: 18637814
ISSN: 1524-4725
CID: 93761
Topical methyl-aminolevulinate photodynamic therapy using red light-emitting diode light for treatment of multiple actinic keratoses: A randomized, double-blind, placebo-controlled study
Pariser, David; Loss, Robert; Jarratt, Michael; Abramovits, William; Spencer, James; Geronemus, Roy; Bailin, Philip; Bruce, Suzanne
BACKGROUND: The use of light-emitting diode light offers practical advantages in photodynamic therapy (PDT) with topical methyl-aminolevulinate (MAL) for management of actinic keratoses (AK). OBJECTIVE: We sought to evaluate the efficacy of MAL PDT using red light-emitting diode light. METHODS: We conducted a multicenter, double-blind, randomized study. A total of 49 patients with 363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47 patients with 360 AK lesions had vehicle cream similarly applied. The lesions were then illuminated (630 nm, light dose 37 J/cm2) with repeated treatment 1 week later. Complete lesion and patient (all lesions showing complete response) response rates were evaluated 3 months after last treatment. RESULTS: MAL PDT was superior (P<.0001) to vehicle PDT with respect to lesion complete response (86.2% vs 52.2%, odds ratio 6.9 [95% confidence interval 4.7-10.3]) and patient complete response (59.2% vs 14.9%, odds ratio 13.2 [95% confidence interval 4.1-43.1]). LIMITATIONS: The study population may not be representative of all patients with AK. CONCLUSION: MAL PDT using red light-emitting diode light is an appropriate treatment alternative for multiple AK lesions.
PMID: 18707799
ISSN: 0190-9622
CID: 167376