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Options Limited for Adult Women with Acne 52 SKIN DISORDERS NOVEMBER 15, 2010 • FAMILY PRACTICE NEWS Options Limited for Adult Women With Acne BY DAMIAN MC NAMARA their 30s, 40s, and 50s – and their acne le- is more sensitive skin, and the topical Acne can have a detrimental effect on sions – can be more resistant to treat- products tend to be quite irritating,” Dr. sexuality, motherhood, and/or returning EXPERT ANALYSIS FROM A SEMINAR ON WOMEN’S AND PEDIATRIC ment, Dr. Baldwin said at the seminar, Baldwin said. to the workplace, and can deepen a DERMATOLOGY which was sponsored by Skin Disease Acne after adolescence also can be midlife crisis, said Dr. Baldwin, who is Education Foundation (SDEF). more psychosocially devastating. Unlike vice chair of the department of derma- SAN FRANCISCO – Dermatologists “One of the problems of treating a teenage girl, an affected woman may tology at the State University of New are seeing an increasing incidence of moderate to severe acne in the adult have no one else in her social group York, Brooklyn. adult women with acne in their offices woman is that topical medications may who has acne. And “because teenagers With fewer topical agents in their ar- and they are a clear challenge to treat, not work particularly well. It may be that are supposed to have acne,” Dr. Baldwin mamentarium for the adult woman with Dr. Hilary E. Baldwin said. she is a little harder to treat, but also she said, “people will question: What is she acne, dermatologists tend to prescribe Compared to teenagers, women in has acne on the neck and the jaw, which doing wrong? Is she not eating right?” oral medication, Dr. Baldwin said. reported in another clinical trial, and may not reflect the rates actually observed in LANTUS® clinical practice. (insulin glargine [rDNA origin] injection) solution for subcutaneous injection The frequencies of treatment-emergent adverse events during LANTUS clinical trials • Severe Hypoglycemia in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Hypoglycemia is the most commonly observed adverse reaction in patients using the tables below. insulin, including LANTUS [See Warnings and Precautions (5.3)]. Tables 5 and 6 summarize the incidence of severe hypoglycemia in the LANTUS individual clinical Table 1: Treatment –emergent adverse events in pooled clinical trials up trials. Severe symptomatic hypoglycemia was defined as an event with symptoms to 28 weeks duration in adults with type 1 diabetes (adverse events with frequency ≥ 5%) consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤56 mg/dL in the 5-year LANTUS, % NPH, % (n=1257) (n=1070) trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. Upper respiratory tract The rates of severe symptomatic hypoglycemia in the LANTUS clinical trials (see infection 22.4 23.1 Section 14 in the full prescribing information for a description of the study designs) * Infection 9.4 10.3 were comparable for all treatment regimens (see Tables 5 and 6). In the pediatric Accidental injury 5.7 6.4 phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups Headache 5.5 4.7 compared to the adult trials with type 1 diabetes. (see Table 5) [See Clinical Studies *Body System not Specified (14) in the full prescribing information]. Table 5: Severe Symptomatic Hypoglycemia in Patients with Type 1 Table 2: Treatment –emergent adverse events in pooled clinical trials up Diabetes to 1 year duration in adults with type 2 diabetes (adverse events with ≥ Study A Study B Study C Study D frequency 5%) Type 1 Type 1 Type 1 Type 1 LANTUS, % NPH, % Diabetes Diabetes Diabetes Diabetes (n=849) (n=714) Adults 28 Adults 28 Adults 16 Pediatrics 26 weeks weeks weeks weeks Upper respiratory tract 11.4 13.3 In In In In infection combination combination combination combination * with regular with regular with insulin with regular Infection 10.4 11.6 insulin insulin lispro insulin Retinal vascular disorder 5.8 7.4 LANTUS NPH LANTUS NPH LANTUS NPH LANTUS NPH *Body System not Specified Percent of 10.6 15.0 8.7 10.4 6.5 5.2 23.0 28.6 patients (31/ (44/ (23/ (28/ (20/ (16/ (40/ (50/ Table 3: Treatment –emergent adverse events in a 5-year trial of adults (n/total 292) 293) 264) 270) 310) 309) 174) 175) with type 2 diabetes (adverse events with frequency ≥ 10%) N) LANTUS, % NPH, % (n=514) (n=503) Table 6: Severe Symptomatic Hypoglycemia in Patients with Type 2 Upper respiratory tract Diabetes infection 29.0 33.6 Study E Study F Study G Edema peripheral 20.0 22.7 Type 2 Type 2 Type 2 Diabetes Adults Diabetes Adults Diabetes Adults Hypertension 19.6 18.9 52 weeks 28 weeks 5 years Influenza 18.7 19.5 In combination In combination In combination with oral agents with regular insulin with regular insulin Sinusitis 18.5 17.9 LANTUS NPH LANTUS NPH LANTUS NPH Cataract 18.1 15.9 Percent Bronchitis 15.2 14.1 of patients Arthralgia 14.2 16.1 (n/total 1.7 1.1 0.4 2.3 7.8 11.9 Pain in extremity 13.0 13.1 N) (5/289) (3/281) (1/259) (6/259) (40/513) (60/504) Back pain 12.8 12.3 • Retinopathy Cough 12.1 7.4 Retinopathy was evaluated in the LANTUS clinical studies by analysis of reported Urinary tract infection 10.7 10.1 retinal adverse events and fundus photography. The numbers of retinal adverse Diarrhea 10.7 10.3 events reported for LANTUS and NPH insulin treatment groups were similar for patients with type 1 and type 2 diabetes. Depression 10.5 9.7 LANTUS was compared to NPH insulin in a 5-year randomized clinical trial that Headache 10.3 9.3 evaluated the progression of retinopathy as assessed with fundus photography using a grading protocol derived from the Early Treatment Diabetic Retinopathy Scale (ETDRS). Patients had type 2 diabetes (mean age 55 yrs) with no (86%) or Table 4: Treatment –emergent adverse events in a 28-week clinical trial mild (14%) retinopathy at baseline. Mean baseline HbA1c was 8.4%. The primary of children and adolescents with type 1 diabetes (adverse events with frequency ≥ 5%) outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. Patients with pre-specified post-baseline eye procedures (pan-retinal photocoagu- LANTUS, % NPH, % lation for proliferative or severe nonproliferative diabetic retinopathy, local photo- (n=174) (n=175) coagulation for new vessels, and vitrectomy for diabetic retinopathy) were also Infection* 13.8 17.7 considered as 3-step progressors regardless of actual change in ETDRS score from Upper respiratory tract baseline. Retinopathy graders were blinded to treatment group assignment. The infection 13.8 16.0 results for the primary endpoint are shown in Table 7 for both the per-protocol and Pharyngitis 7.5 8.6 Intent-to-Treat populations, and indicate similarity of Lantus to NPH in the progres- sion of diabetic retinopathy as assessed by this outcome. Rhinitis 5.2 5.1 *Body System not Specified NOVEMBER 15, 2010 • WWW.FAMILYPRACTICENEWS.COM SKIN DISORDERS 53 Oral antibiotics are an example, such tion; a simultaneous prescription to pre- enone/ethinyl estradiol (Yaz, Bayer); “The difference becomes significant as anti-inflammatory dose doxycycline vent yeast growth; and/or selection of and ethinyl estradiol/norgestimate (Or- with Yaz at about 6 months,” Dr. Bald- (acne is an off-label indication). an antibiotic less likely to cause this ef- tho Tri-Cyclen, Ortho McNeil Janssen) win said. “But waiting for 6 months for This agent does not kill Propionibac- fect. For example, extended-release are FDA-approved for acne treatment this to happen is not something most of terium acnes, but it can improve acne minocycline may be less likely to spur “and others with estrogen may be ef- our patients will do.” through an anti-inflammatory effect that yeast growth than traditional minocy- fective.” Keep potential adverse effects of oral is similar to full-dose doxycycline, Dr. cline, she said. Because their full acne-fighting effects contraceptives in mind. Evidence in Baldwin said. Nonantibiotic alternatives for moder- can take up to 6 months, Dr. Baldwin rec- the literatures suggests there is no in- One caveat: If you prescribe an oral ate to severe acne are limited, especially ommended prescription of oral contra- creased cardiovascular risk among non- antibiotic, you may experience push- in women of child-bearing potential. ceptives in combination with a quicker smokers, Dr. Baldwin said. back from some patients, Dr. Baldwin Oral hormonal contraceptives also onset agent. “For me it’s a medication on In addition, studies indicate no said. “I have women who say that they can improve acne in adult women, Dr. top of a medication that is going to give increase risk of breast cancer. An get a yeast infection every time they get Baldwin said. In the United States, more immediate improvement, one I increased likelihood for a thrombolic an antibiotic.” Strategies include antibi- ethinyl estradiol/norethindrone acetate can take them off when I start to see the event is elevated during the first otic treatment through a yeast infec- (Estrostep, Warner Chilcott); drospir- oral contraceptive kick in.” year then becomes normalized, she said. The FDA added a black box warning Table 7. Number (%) of patients with 3 or more step progression on LANTUS® ETDRS scale at endpoint (insulin glargine [rDNA origin] injection) solution for subcutaneous injection to labeling for spironolactone (Aldac- Lantus (%) NPH (%) Difference*,† 95% CI for niazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, tone, GD Searle, plus generics) in 2008 (SE) difference progestogens (e.g., in oral contraceptives), protease inhibitors and atypical antip- that cites an increased risk for tumors sychotic medications (e.g.
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