Adverse effects of low-dose oral minoxidil for androgenetic alopecia in 435 patients

To the Editor: There is a growing interest in using low-dose oral minoxidil (LDOM) for treatment of androgenetic alopecia (AGA). Nevertheless, tolerability and adverse effects (AEs) are still concern.1Sharma A.N. Michelle L. Juhasz M. Muller Ramos P. Atanaskova Mesinkovska N. Low-dose as non-scarring alopecia: systematic review.Int J Dermatol. 2020; 59: 1013-1019Crossref PubMed Scopus (9) Google Scholar,2Randolph Tosti A. Oral hair loss: review efficacy safety.J Am Acad https://doi.org/10.1016/j.jaad.2020.06.1009Abstract Full Text PDF (29) Scholar We evaluated AEs LDOM (?5 mg/d) AGA correlated them to dose, weight, sex, skin color. reviewed all patients who were prescribed from January 2017 May 2020 at 3 clinics Brazil. Of 669 invited participate, 435 (65%) completed telephone interview regarding possible (Supplemental Methods, available via Mendeley https://data.mendeley.com/datasets/zhd6nxr92m/1). The main treatment-related data reported Table I. Hypertrichosis was most common AE, by 55.4% (Table II). In men, it associated with younger age (odds ratio age, 0.97; P = .022), dose/weight 1.03; < .001) Tables I Among those hypertrichosis, 68.9% mentioned up 2 body areas, just men (1.4%) perceived generalized. Topographic patterns hypertrichosis displayed Supplemental Fig 1. co-occurrence lower limbs-pubis, forehead-eyelashes, back-chest.Table IMain demographic sample (N 435)VariablesFemaleMaleTotalP value?Bivariate analysis. Bold values statistically significant (P .05).Sample, No. (%)215 (49)220 (51)435 (100)…Age mean (SD), y43.7 (13.0)38.0 (11.3)40.8 (12.5)<.001Skin color, (%) White185 (86)189 (86)374 (86).967 Non-White30 (14)31 (14)61 (14)Body kg66.4 (11.5)82.8 (12.9)74.7 (14.7)<.001Body mass index, kg/m224.9 (4.3)26.6 (3.5)25.7 (4.0)<.001Comorbidities, Heart disease1 (1)0 (0)1 (1).494 Hypertension21 (10)13 (6)34 (8).155 Renal disease0 (0)0 (0)… Diabetes13 (6)5 (2)18 (4).056Postmenopausal FPHL, (%)†Among women (n 215).48 (22)…48 (22)…Length use, mo7.5 (6.8)5.9 (3.8)6.7 (5.5).003Time intake, Morning70 (32)57 (26)127 (29).190 Afternoon10 (5)7 (3)17 (3) Night135 (63)156 (71)291 (70)Minoxidil dosage (mg/d), ?0.54 (2)0 (0)4 (1)<.001 0.6-1.0195 (91)22 (10)217 (50) 1.1-1.55 (2)1 (1)6 (1) 1.6-2.511 (5)106 (48)117 (27) 2.6-5.00 (-)91 (41)91 (21)Dosage per mg/kg/d0.016 (0.005)0.041 (0.019)0.029 (0.019)<.001Topical 5% previously, No.(%)86 (40)130 (59)216 (50)<.001Reported (%)‡Hypertrichosis used topical 216).56 (65)64 (49)120 (56).021LDOM discontinuation, (%)27 (13)8 (4)35 (8)<.001Time since discontinuing, mo§Among discontinued 35).4 (3)5 (3)4 (3).106FPHL, Female-pattern loss; LDOM, minoxidil; No., number; SD, standard deviation.? Bivariate .05).† 215).‡ 216).§ 35). Open table new tab IIAdverse according sex 435)VariablesFemaleMaleTotal95% CI?95% CI calculated bootstrap (10,000 resamples) bias-corrected accelerated.P value†Bold .05).Hypertrichosis, Any117 (54)124 (56)241 (55)51-60.683 Beard/mustache72 (34)80 (36)152 (35)31-39.529 Sideburns66 (31)52 (24)118 (27)23-31.097 Eyebrows48 (22)45 (21)93 (21)18-24.634 Upper limbs45 (21)49 (22)94 (22)18-25.734 Lower limbs41 (19)35 (16)76 (18)14-21.385 Forehead42 (20)26 (12)68 (16)13-18%.026 Back9 (4)47 (21)56 (13)10-16%<.001 Chest1 (1)49 (22)50 (12)9-14%<.001 Pubis30 (14)15 (7)45 (10)8-13%.014 Eyelashes18 (8)20 (9)38 (9)7-11%.791Headache, (%)22 (10)17 (8)39 (9)7-12.360Insomnia, (%)14 (7)15 (7)29 (7)5-9.898Edema (lower limbs), (%)19 (9)6 (3)25 (6)4-8.005Dizziness, (%)15 (7)7 (3)22 (5)3-7.068Palpitation, (%)8 (4)8 (4)16 (4)2-5.963Nightmares, (%)5 (2)4 (2)9 (2)1-3.710Increased appetite, (2)3 (1)8 (2)1-3.453Facial edema, (%)2 (1)3 (1)5 (1)0-2.670Indigestion, (1)1 (1)0-1.545Syncope, (%)0 (-)1 (-)0-1.243Dry mouth, (-)0-1.243Hair shedding, (%)95 (44)45 (21)140 (32)28-36<.001 Duration mo‡Among shedding 140).1.6 (1.0)1.4 (0.8)1.5 (1.0)1.4-1.7.234CI, Confidence interval; 95% accelerated.† .05).‡ 140). deviation. CI, Hair onset occurred 32% patients; not immediately previous use .620). 0.95; .002), but .227). Five (1.1%) generalized including face: 1 mg, 2.5 5 mg. length medication or color > .05). Treatment stopped 35 (8.0%; confidence interval, 5.5%-10.6%) due lack 13), 7), edema 6), fear interaction other drugs 3), desire get pregnant 3). Our cohort had higher rates (55% vs 24%) (6% 2%) than studies.3Jimenez-Cauhe J. Saceda-Corralo D. Rodrigues-Barata R. et al.Safety loss. A pooled-analysis individual patient data.Dermatol Ther. : e14106https://doi.org/10.1111/dth.14106Crossref (5) Other symptoms, such headaches (9%), insomnia (7%), nightmares (2%), also reported. This could be explained active questioning instead passive recording spontaneous complaints. Moreover, studies aimed evaluate its efficacy, so only least 6 months assessed. absence an evaluation prematurely explain these differences. Temporary beginning 17.5% minoxidil.4Blume-Peytavi U. Hillmann K. Dietz E. Canfield Bartels N.G. randomized, single-blind trial foam once daily versus 2% solution twice women.J 2011; 65: 1126-1134Abstract (99) this series, frequency (32%). headache understanding differences optimize nonstandard (obese/very thin) well children/adolescents.5Lemes L.R. Melo D.F. de Oliveira D.S. La-Rocque Zompero C. P.M. Topical disorders pediatric patients: what do we know far?.Dermatol e13950PubMed study's limitations retrospective design, selection bias, blood pressure, electrocardiogram, heart rate assessment. summary, relatively well-tolerated option AGA, should advised risk headache, insomnia, dizziness, AEs. None disclosed.