Abstract
Background
Minocycline, a second-generation tetracycline, is widely used for the management of several dermatologic and infectious conditions. Large-scale real-world studies demonstrating its tolerability, utilization patterns, and effectiveness in Indian clinical practice remain limited.
Objectives
The aim of this study was to evaluate real-world tolerability, utilization patterns, and effectiveness of oral minocycline formulations.
Methods
This retrospective, real-world, observational, multicentric electronic medical records (EMR)-based study analyzed anonymized patient data retrieved from the HealthPlix EMR database between January 2017 and February 2023. Patients of either gender aged ≥12 years prescribed oral minocycline with at least one follow-up visit were included. The primary endpoint was tolerability, assessed as the proportion of patients with physician-documented complaints. Secondary outcomes included assessment of prescribing patterns and effectiveness.
Results
A total of 2161 patients from 189 centers across India met the eligibility criteria. The mean age ± standard deviation (SD) was 30.15 ± 12.50 years, and 62.56% (1352) of the patients were females. Acne was the most common indication, documented for 1230 patients (56.92%), with acne vulgaris being the most predominant subtype. Minocycline 100 mg once daily was the most frequently prescribed regimen. The most common prescription duration at baseline was 11–20 days. Adverse events were documented in a smaller proportion of patients (n = 29; 1.34%).
Conclusion
In routine real-world practice, oral minocycline was prescribed for a range of indications, predominantly acne, with prescription patterns largely aligned with contemporary recommendations. These findings suggest that oral minocycline was rationally utilized, well tolerated and associated with positive clinical outcomes in routine clinical practice. Despite inherent limitations of the retrospective design, the study provides robust real-world evidence supporting the continued use of oral minocycline in Indian clinical practice. These findings should be interpreted cautiously in the view of the retrospective design and inherent limitations of EMR-based data.
Registry and the Registration No. of the Study
The study was registered with the Clinical Trials Registry–India (CTRI) under the registration number CTRI/2023/08/056338—Retrospectively registered.
Supplementary Information
The online version contains supplementary material available at https://doi.org/10.1007/s40801-026-00577-3.
Key Points
| The study analyzed real-world use of oral minocycline in 2,161 patients across India. |
| It provided insights into the routine clinical prescription pattern. |
| Oral minocycline was observed to be well-tolerated. |
| It demonstrated positive clinical outcomes. |
Introduction
Minocycline is a lipophilic, second-generation semisynthetic tetracycline with established utility in the management of both infectious and non-infectious conditions [1, 2]. Owing to its high lipid solubility, minocycline effectively crosses the blood–brain barrier and exerts broad-spectrum bacteriostatic activity against Gram-positive and Gram-negative organisms, as well as atypical pathogens including chlamydiae, mycoplasmas, rickettsiae, and certain protozoan parasites [1, 3]. Its antimicrobial action is mediated through inhibition of bacterial protein biosynthesis by binding to the 30S ribosomal subunit, thereby preventing ligation of aminoacyl-transfer ribonucleic acid (tRNA) [3]. In addition to its antibacterial effects, minocycline also exhibits clinically relevant anti-inflammatory properties.
Clinically, minocycline is widely prescribed for inflammatory dermatologic conditions, including acne, rosacea, bullous dermatoses, and neutrophilic dermatoses, with acne and rosacea representing the most common indications. Beyond dermatology, it has also been used in the management of infections such as urinary tract, respiratory tract, skin infections, as well as sexually transmitted infections (STIs) such as chlamydia, gonorrhea, and syphilis [3]. Oral administration of minocycline is associated with a favorable pharmacokinetic profile, characterized by rapid absorption, excellent tissue penetration, a prolonged half-life and high bioavailability [1]. Oral minocycline was approved by the US Food and Drug Administration (FDA) in 1971 [4]. In India, it was approved by the Central Drugs Standard Control Organization (CDSCO) in 1988 for infections such as urinary tract, respiratory tract, skin and soft tissue, ear, nose, and throat (ENT), STIs, and others [5].
In India, acne is among the most common conditions encountered in dermatology outpatient practice. Expert consensus recommends systemic therapy for patients with moderate to severe inflammatory acne, with minocycline and doxycycline considered as the first-line treatment options [6]. Minocycline is often preferred due to its superior sebaceous gland penetration and a lower incidence of gastrointestinal disturbances compared with doxycycline [7]. Consequently, minocycline continues to be extensively prescribed in routine clinical practice.
Despite its widespread and long-standing use over several decades, most of the evidence supporting the efficacy and safety of minocycline is derived from randomized controlled trials (RCTs) and prospective studies conducted in controlled environments with stringent eligibility criteria [8–10]. While RCTs remain the gold standard for evaluation of novel interventions, their findings often have limited generalizability to routine clinical practice [11]. In contrast, evidence generated from real-world clinical settings is increasingly recognized to complement the RCT data by providing insights into prescribing patterns, treatment tolerability, and effectiveness across heterogeneous patient populations [12].
However, despite the extensive real-world use of minocycline for acne and other indications in India, there remains a paucity of large-scale real-world evidence evaluating drug utilization patterns, tolerability, and real-world effectiveness. Evidence derived from real-world data sources can help address this gap by capturing routine prescribing practices and clinical outcomes in real-world settings across diverse patient populations.
In this context, the present retrospective, real-world study using electronic medical records (EMR) data was undertaken to assess the drug utilization pattern, tolerability, and real-world effectiveness of oral minocycline formulations among Indian patients in routine clinical practice.
Methodology
Study Design
This was a retrospective, real-world, observational, multicentric, EMR-based study. Aggregated and anonymized data of eligible patients were extracted from the HealthPlix EMR database (https://www.healthplix.com/), which is used by healthcare providers across India in private outpatient settings and specialty practices such as dermatology clinics. This database captures longitudinal patient records documented on the EMR platform during routine clinical care including advised investigations, investigation results, prescribed medications, duration of prescription, daily recommended frequency and other relevant details. The study included records from January 2017 to February 2023.
The study was conducted in accordance with the protocol and applicable ethical and regulatory standards, including the Declaration of Helsinki, the Indian Council of Medical Research (ICMR)—National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), and the International Council for Harmonization (ICH) GCP.
Ethical approval was obtained from the Royal Pune Independent Ethics Committee (RPIEC 350723) on 27 July 2023. A waiver of informed consent was granted in accordance with the ICMR guidelines (National Ethical Guidelines for Biomedical and Health Research Involving Human Participants), as the study was retrospective in nature and involved completely deidentified and anonymized data. The study was registered with the Clinical Trials Registry–India (CTRI) under the registration number CTRI/2023/08/056338.
Inclusion and Exclusion Criteria
Patients of either sex aged ≥12 years who were prescribed oral minocycline during the study period with at least one follow-up visit recorded on the EMR platform were included. For patients with multiple oral minocycline prescriptions during the study period, only the first prescription was considered and was included in the analysis. Patients who were not prescribed oral minocycline or who did not have documentation of at least one follow-up visit after minocycline prescription were excluded from the study.
Study Outcomes
The primary endpoint was tolerability of oral minocycline formulations, measured as the proportion of patients with adverse events recorded during the treatment period. Secondary endpoints included evaluation of drug utilization patterns of oral minocycline formulations, including prescribed indications, dose strength, daily dosing frequency, and duration of prescription. Secondary endpoints also included assessment of real-world effectiveness, based on documentation of symptom resolution following minocycline treatment, including assessment in the subset of patients diagnosed with acne.
Tolerability was assessed by screening the ‘complaints’ section (a free-text field) of the EMR for adverse events documented by the treating physician during follow-up visits. Assessment of tolerability was primarily based on keyword searches for terms such as hyperpigmentation and related terms (e.g. skin pigmentation, darkening of skin, etc.) as documentation practices varied among physicians. Other terms such as itching, urticaria, dizziness, etc. were also screened along with their related terms.
Effectiveness was assessed by reviewing the same section for clinician-documented terms indicative of symptom resolution or improvement (e.g. improved, improving, pimples decreased, and related descriptors), with a separate assessment for patients with a documented diagnosis of acne.
These free-text entries were initially screened using a keyword-based strategy, including relevant related terms, and were subsequently reviewed for confirmation by two independent reviewers. Any discrepancies in the interpretation of the free-text entries were resolved by consensus through discussion.
Drug utilization patterns were evaluated using prescription data captured in the EMR.
Statistical Analysis
Statistical analyses were performed using Statistical Analysis System (SAS) version 9.4. Continuous variables were summarized descriptively as the number of observations (n), mean, standard deviation (SD), and the median. Categorical variables were summarized as counts (n) and percentages (%). Analysis was done based on the available data, and missing values were not imputed.
Demographic and baseline characteristics were summarized descriptively. Proportions of patients with reported adverse events or symptom improvement were summarized as counts and percentages. Drug utilization patterns and use of concomitant medications were also presented as counts and percentages.
Results
Patient Disposition
Between January 2017 and February 2023, a total of 13,352 patients aged ≥12 years were prescribed oral minocycline on the HealthPlix EMR platform. Among them, 2161 patients (16.18%) from 189 centers across India had documentation of at least one follow-up visit after initiation of oral minocycline therapy and were therefore included in the study. The patient disposition is summarized in Fig. 1.
Fig. 1.
Patient disposition. N Number of patients
Demographic Characteristics
The mean age of the study cohort was 30.15 ± 12.50 years. The majority of the patients (n = 1700; 78.67%) were aged 18–39 years. A higher proportion of females (n = 1352; 62.56%) were prescribed oral minocycline compared with males (n = 809; 37.44%). Demographic characteristics of the study population are summarized in Table 1.
Table 1.
Demographic characteristics
| Category | Patient count, n (%) | Mean ± SD | Median |
|---|---|---|---|
| Age (years) | |||
| Overall | 2161 | 30.15 ± 12.50 | 27.0 |
| 12–17 | 129 (5.97) | 15.53 ± 1.45 | 16.0 |
| 18–39 | 1700 (78.67) | 26.59 ± 5.32 | 26.0 |
| 40–64 | 265 (12.26) | 49.11 ± 7.14 | 48.0 |
| ≥65 | 67 (3.10) | 73.61± 8.74 | 71.0 |
| Gender | |||
| Female | 1352 (62.56) | ||
| Male | 809 (37.44) | ||
n number of patients, SD standard deviation
Tolerability (Primary Endpoint)
The primary endpoint of the study was to assess the proportion of patients with adverse events recorded on the EMR platform during the treatment period with oral minocycline formulations. This was evaluated by screening the ‘complaints’ section of the EMR.
Adverse events were documented in 29 patients (1.34%). Among patients who reported adverse events, hyperpigmentation was reported in 0.42% (n = 9) of patients, and among patients with acne, it was reported for 0.57% (n = 7) of patients. Itching/pruritus was reported in 0.37% (n = 8) of patients. Other events reported in the study cohort included urticaria, dizziness/giddiness, loose motions, myalgia and fatigue. Information on the severity and causality of the events was not available in the EMR database. The proportion of patients with recorded complaints is summarized in Table 2.
Table 2.
Adverse events
| Adverse event | Overall (N = 2161) | Acne (n = 1230) |
|---|---|---|
| n (%) | n (%) | |
| Total | 29 (1.34) | 14 (1.14) |
| Hyperpigmentation | 9 (0.42) | 7 (0.57) |
| Itching/pruritus | 8 (0.37) | 3 (0.24) |
| Urticaria | 4 (0.19) | 3 (0.24) |
| Dizziness/giddiness | 3 (0.14) | 1 (0.08) |
| Loose motions | 2 (0.09) | |
| Myalgia | 2 (0.09) | |
| Fatigue | 1 (0.05) |
Each patient reported one event
n number of patients
Drug Utilization Pattern
Baseline Clinical Indications for Oral Minocycline Therapy
Baseline indications for oral minocycline were evaluated. More than half of the study population was diagnosed with acne (n = 1230; 56.92%), with acne vulgaris being the most common subtype among these patients (n = 731; 59.43%). Oral minocycline was also prescribed for other dermatologic and infectious conditions, including dermatitis (n = 66; 3.05%), folliculitis (n = 53; 2.45%), and secondary infection (n = 31; 1.43%). A complete distribution of indications is presented in Table 3.
Table 3.
Clinical indications for oral minocycline prescription
| Indications at baseline | n (%) |
|---|---|
| Acne (total) | 1230 (56.92) |
| Acne vulgaris | 731 (59.43) |
| Acnea | 336 (27.32) |
| Acne excoriée | 60 (4.88) |
| Nodular/nodulocystic | 52 (4.23) |
| Hormonal acne | 21 (1.71) |
| Steroidal acne | 14 (1.14) |
| Acne tarda | 5 (0.41) |
| Occlusion acne | 3 (0.24) |
| Acne conglobate | 3 (0.24) |
| Acne simplex | 3 (0.24) |
| Acne fulminans | 2 (0.16) |
| Dermatitis | 66 (3.05) |
| Folliculitis | 53 (2.45) |
| Alopecia | 41 (1.90) |
| Secondary infection | 31 (1.43) |
| Acne rosacea | 28 (1.30) |
| Tinea infections | 26 (1.20) |
| Hirsutism | 17 (0.79) |
| Urinary tract infection | 12 (0.56) |
| Respiratory tract infection | 10 (0.46) |
| Sexually transmitted diseases | 6 (0.28) |
| Pityriasis lichenoides | 3 (0.14) |
| Vitiligo | 3 (0.14) |
| Pneumonia | 2 (0.09) |
| Actinomycosis | 2 (0.09) |
| Hailey-Hailey disease | 2 (0.09) |
| Othersb | 629 (29.11) |
The percentage for different indications was calculated by taking 2161 as the denominator. The percentage for various subtypes of acne was calculated by taking the total number of patients diagnosed with acne (1230) as the denominator
aType undefined—where the doctor has not defined any type of acne
bIncludes miscellaneous diagnoses and missing diagnoses. Examples of miscellaneous diagnoses include candidiasis, striae distensae, amoebic dysentery, cosmetic-damaged face, and other infrequently reported conditions that may not have been directly related to oral minocycline prescription
n number of patients
Dose Strength and Frequency of Prescription
At baseline, minocycline 100 mg was the most commonly prescribed dose strength (n = 799; 36.97%), with once a day (OD) being the most frequent regimen (n = 648; 29.99%). The mean duration of prescription among these patients was 18.69 ± 14.48 days. The next most commonly prescribed regimen was minocycline 65 mg OD (n = 469; 21.70%). Among patients prescribed minocycline 50 mg (n = 440; 20.36%), twice-a-day (BID) dosing (n = 282; 13.05%) was more frequently prescribed than OD dosing (n = 138; 6.39%), in contrast to other dose strengths, for which OD dosing predominated. A summary of drug utilization patterns by dose strength and frequency is presented in Fig. 2.
Fig. 2.
Drug utilization pattern by dose strength and frequency. n number of patients, OD once a day, BID twice a day, TID thrice a day. Number of patients: 2161
Duration of Prescription
The majority of patients, both overall and within the acne subgroup, were prescribed oral minocycline for a window of 11–20 days (overall: n = 605; 28.00%; acne: n = 408; 33.17%) at baseline. The next most common duration of prescription was 21–30 days in both the overall study population (n = 525; 24.29%) and the acne subgroup (n = 389; 31.63%). Other prescription duration categories, including 31–60 days, <5 days, 61–90 days, and >90 days, were observed in smaller proportions and are detailed in Fig. 3.
Fig. 3.
Duration of prescription of oral minocycline formulations
Dose Strength of Prescription by Indications
The preferred dose strengths of oral minocycline varied across indications. Among patients with acne, minocycline 100 mg was the most commonly prescribed dose strength (n = 427; 19.76%), followed by minocycline 65 mg (n = 350; 16.20%). The 100-mg dose strength was also predominant for patients diagnosed with dermatitis (n = 24; 1.11%), folliculitis (n = 26; 1.20%), as well as for other indications, including secondary, respiratory tract and urinary tract infections. In contrast, among patients with tinea infections, minocycline 50 mg was the most commonly prescribed dose strength (n = 11; 0.51%). The distribution of dose strength preferences across indications is summarized in Fig. 4.
Fig. 4.
Drug utilization pattern by dose strength and indication
Drug Utilization Pattern for Acne Subtypes
Among overall patients with acne (n = 1230), minocycline 100 mg was the most commonly prescribed dose strength. However, dose preference varied across acne subtypes. In patients with acne vulgaris, minocycline 100 mg was the most frequently prescribed dose strength (n = 249; 20.24%), followed by 65 mg (n = 212; 17.24%), and 45 mg (n = 156; 12.68%). Minocycline 100 mg was also the preferred dose strength for patients diagnosed with acne excoriée (n = 56; 4.55%), nodular acne (n = 28; 2.28%), and acne conglobate (n = 2; 0.16%). In contrast, among patients with an unspecified acne subtype, minocycline 50 mg was the most commonly prescribed dose strength (n = 109; 8.86%), followed by 65 mg (n = 108; 8.78%), and 100 mg (n = 80; 6.50%). The distribution of oral minocycline dose strengths across subtypes of acne is presented in Table 4.
Table 4.
Dose strength of oral minocycline for acne subtypes
| Indication | Dose strength | n (%) |
|---|---|---|
| Acne vulgaris | Minocycline 100 mg | 249 (20.24) |
| Minocycline 65 mg | 212 (17.24) | |
| Minocycline 45 mg | 156 (12.68) | |
| Minocycline 50 mg | 113 (9.19) | |
| Minocycline 55 mg | 1 (0.08) | |
| Acne† | Minocycline 50 mg | 109 (8.86) |
| Minocycline 65 mg | 108 (8.78) | |
| Minocycline 100 mg | 80 (6.50) | |
| Minocycline 45 mg | 38 (3.09) | |
| Minocycline 55 mg | 1 (0.08) | |
| Acne excoriée | Minocycline 100 mg | 56 (4.55) |
| Minocycline 65 mg | 2 (0.16) | |
| Minocycline 45 mg | 1 (0.08) | |
| Minocycline 50 mg | 1 (0.08) | |
| Nodular/nodulocystic | Minocycline 100 mg | 28 (2.28) |
| Minocycline 45 mg | 13 (1.06) | |
| Minocycline 50 mg | 9 (0.73) | |
| Minocycline 65 mg | 2 (0.16) | |
| Hormonal acne | Minocycline 65 mg | 13 (1.06) |
| Minocycline 100 mg | 4 (0.33) | |
| Minocycline 45 mg | 3 (0.24) | |
| Minocycline 50 mg | 1 (0.08) | |
| Steroidal acne | Minocycline 65 mg | 6 (0.49) |
| Minocycline 100 mg | 6 (0.49) | |
| Minocycline 45 mg | 2 (0.16) | |
| Acne tarda | Minocycline 65 mg | 4 (0.33) |
| Minocycline 100 mg | 1 (0.08) | |
| Occlusion acne | Minocycline 45 mg | 2 (0.16) |
| Minocycline 65 mg | 1 (0.08) | |
| Acne conglobate | Minocycline 100 mg | 2 (0.16) |
| Minocycline 65 mg | 1 (0.08) | |
| Acne simplex | Minocycline 50 mg | 3 (0.24) |
| Acne fulminans | Minocycline 65 mg | 1 (0.08) |
| Minocycline 100 mg | 1 (0.08) |
†Type undefined
n number of patients; n = 1230
Medications Co-prescribed with Oral Minocycline
Among medications co-prescribed with oral minocycline, topical antibiotics were the most frequently used (n = 946; 43.78%), followed by retinoids and retinoid-based combinations (n = 690; 31.93%), and emollients and protectives (n = 639; 29.57%). A substantial proportion of patients were also prescribed creams/lotions/soaps (n = 402; 18.60%), antifungal agents (n = 310; 14.35%), and fluoroquinolone antibiotics (n = 364; 16.84%). Approximately 15% (n = 321) of the patients were also prescribed sunscreen. Among topical antibiotics, benzoyl peroxide was the most commonly prescribed agent (n = 331; 15.32%), followed by the combination of clindamycin and vitamin B (n = 299; 13.84%). A combination of adapalene and clindamycin (n = 251; 11.61%) was the most prescribed retinoid, followed by tretinoin (n = 143; 6.62%). Table 1 of the electronic supplementary material provides a summary of concomitantly prescribed medications.
Effectiveness of Oral Minocycline
Overall Study Population
The effectiveness of oral minocycline was assessed by evaluating documented resolution of symptoms in the EMR database. Symptom resolution was identified through keyword screening of the complaints section using terms indicative of clinical improvement (e.g. pus-filled lesions better, pimples decreased, better than before, improving, pimples subsiding, resolving, acne decreased etc.) Of the 2161 patients, symptom resolution was documented in 160 patients, and all of them exhibited resolution at follow-up.
Patients with Acne
Among patients diagnosed with acne who were prescribed minocycline (n = 1230), symptom resolution was captured in 143 patients. All these patients showed improvement at follow-up.
Discussion
This retrospective, real-world, observational, EMR-based study provides insights into the prescription patterns, tolerability, and effectiveness of oral minocycline formulations in routine outpatient practice across India. Using data from a large, multicentric EMR database, the study enables assessment of prescribing practices and clinical outcomes in a heterogeneous patient population, thereby complementing evidence from clinical trials and prospective studies.
The study population was predominantly young, with a mean age of 30.15 ± 12.50 years. More than three-quarters of the patients belonged to the age group of 18–39 years. This age distribution is consistent with the epidemiology of acne, which was also the most common indication for oral minocycline prescription in the study cohort. Similar findings have also been reported in the literature, where Shah et al. observed a mean age of 30.1 years among a large cohort of patients with acne (n = 24,056) [13]. A higher proportion of females were prescribed oral minocycline compared with males in this study. This pattern is consistent with the existing evidence and may reflect a higher burden of dermatologic conditions, specifically acne, among females. Budamakuntla et al. also reported a greater proportion of females (55%) compared with males (45%) in their epidemiological study of acne in the Indian population [14]. Overall, the age and gender distribution observed in the present study reflects real-world clinical practice and published epidemiological trends.
Acne, encompassing multiple clinical subtypes, was the most predominant indication for oral minocycline prescription in the present study, accounting for more than half of the study population. This observation is consistent with routine dermatology practice, where minocycline remains a widely used systemic therapy for managing moderate to severe inflammatory acne. The continued preference for its use in clinical practice may be attributed to its pharmacological properties, including high lipophilicity, which enables effective penetration and accumulation within the sebaceous glands. Minocycline is characterized by a high absorption rate, requirement of low doses, and reduced retention of active drug in the gastrointestinal (GI) tract, factors which contribute to a lower incidence of gastrointestinal disturbances [15].
In addition to its antibacterial effects, mediated through inhibition of bacterial protein synthesis via binding to the 16S ribosomal ribonucleic acid (RNA) of the bacterial ribosome 30S subunit, minocycline also exerts anti-inflammatory effects. These include inhibition of neutrophil chemotaxis, matrix metalloproteinases and downregulation of inflammatory cytokines [16]. Within the acne subgroup, acne vulgaris was the most common subtype, indicating its higher prevalence in routine outpatient dermatology settings and aligning with the published epidemiological data [17, 18]. Beyond acne, oral minocycline was also prescribed for a range of other dermatologic and infectious conditions. This observation is consistent with the broad-spectrum use of minocycline across infectious and non-infectious conditions reported in the literature [2, 19]. These findings reinforce the continued relevance of oral minocycline in the management of dermatologic, inflammatory and infectious conditions in everyday clinical care.
A dose of 50–100 mg, administered OD or BID, is recommended for non-modified release minocycline, typically coupled with topical therapies like benzoyl peroxide and/or retinoid [20]. This recommendation closely mirrors the prescribing patterns observed in the present study, where most of the patients were prescribed minocycline 100 mg with OD dosing preferred across most indications. This predominance of the OD regimen may reflect improved patient adherence and convenience in routine clinical practice [21]. A substantial proportion of patients (n = 946; 43.78%) were also prescribed concomitant topical antibiotics followed by retinoids, further aligning with the established treatment recommendations.
The Global Alliance to Improve Outcomes in Acne (2018) recommends reassessment of systemic antibiotic therapy at 6–8 weeks and limiting treatment duration to <3–4 months [22]. Similarly, recent consensus recommendations based on Indian clinical practice advocate the use of oral minocycline for a duration of 6–8 weeks [7]. In the present study, the most common prescription duration at baseline was 11–20 days, followed by 21–30 days, in both the overall cohort and acne subgroup. This prescription pattern reflects contemporary recommendations favoring shortest effective and most prudent use of systemic antibiotics to minimize the incidence of adverse events and limit the development of antimicrobial resistance [23]. In a smaller proportion of patients, a longer duration of prescription was observed, likely reflecting individualized clinical judgement based on the severity and persistence of the condition. Furthermore, the duration reported in this study represents baseline prescriptions; some patients may have received additional courses of oral minocycline at subsequent follow-up visits, depending on the clinical need. The recommended durations generally reflect total therapy exposure, whereas the present analysis captures initial prescription patterns. Overall, the observed dosing and duration patterns indicate cautious and rational use of oral minocycline in real-world clinical settings.
In the present study, oral minocycline was generally well tolerated, with adverse events documented in a small proportion of the overall study population (n = 29; 1.34%). Hyperpigmentation and itching/pruritus accounted for the largest proportion of reported events. Other adverse events, including dizziness/giddiness, loose motions, myalgia, and fatigue, were infrequently observed. Previous studies have reported adverse events occurring in 13.6% of patients treated with minocycline, with hyperpigmentation occurring in 3–15% and vestibular side effects such as dizziness, vertigo, and tinnitus reported in 1–10% of the patients [3]. The lower incidence of adverse events observed in the present study might be attributed to cautious prescribing practices in routine outpatient care. Additionally, the low incidence of GI adverse events aligns with the favorable pharmacokinetic profile of minocycline, including reduced retention of active drug in the GI tract compared with other tetracyclines [15].
It is imperative to acknowledge that the assessment of tolerability in this study relied on clinician-documented complaints within the EMR, and detailed information on the severity and causality of events was not available. Furthermore, underreporting of mild or transient events cannot be excluded. However, the low proportion of adverse events in a large, heterogeneous real-world population supports overall tolerability of oral minocycline when used in routine clinical practice.
Improvement or resolution of symptoms—captured through clinician-documented terms such as improvement in lesions, reduction in pimples or any other terms—was recorded in 160 of the overall study population and 143 patients in the acne subgroup at follow-up, and all these patients showed improvement. These findings should be interpreted in the context of real-world EMR-based data capture, where documentation of such terms might be inconsistent and is dependent on physician recording practices rather than standardized outcome measures. In routine outpatient settings, improvement might not be consistently documented, specifically when the clinical response is partial or gradual. The findings provide evidence for the clinical effectiveness of oral minocycline in routine practice, particularly among patients with a diagnosis of acne.
The study has certain limitations inherent to its retrospective, EMR-based model. Patient follow-up was limited to visits recorded within the HealthPlix network, and longitudinal tracing of patients was not available for the patients who switched healthcare providers, sought care outside the HealthPlix network, or discontinued follow-up. Reliance on clinician-documented events and treatment effectiveness based on free-text entries may have resulted in underreporting of mild or transient events and variability related to physician-documentation practices. Furthermore, assessment of tolerability was based on physician-documented complaints and did not include causality assessment, severity grading, or duration of exposure. Additionally, the absence of standardized severity scores limited quantitative assessment of effectiveness. Also, tolerability assessment was done at an overall level and was not stratified by indications. Given the heterogeneous study population with multiple conditions, outcomes for effectiveness were not evaluated beyond acne subgroup. Further, the study relied on prescribed medications rather than confirmed dispensing or medication adherence; therefore, actual medication exposure could not be verified. Since many patients were co-prescribed concomitant medications, the effectiveness observed in the current study cannot be solely attributed to oral minocycline therapy. Additionally, owing to the absence of a comparator group in the current study, a causal relationship pertaining to the effectiveness and tolerability of oral minocycline could not be established. The findings from the present study should be interpreted in the context of the retrospective, observational, EMR-based design and are primarily descriptive in nature. The study is strengthened by its large sample size, multicentric coverage, and heterogeneous patient population from routine outpatient settings across India. These factors improve the generalizability of findings and provide valuable real-world insights into prescribing patterns, tolerability and effectiveness of oral minocycline beyond the controlled environment of clinical trials.
Conclusion
This large, multicentric real-world study demonstrates that oral minocycline is prescribed for a range of indications, with acne being the most predominant. It is majorly prescribed in young adults, with dosing regimens and duration largely aligned with the contemporary prescribing recommendations. The findings reflect real-world insights into utilization patterns, tolerability, and clinical effectiveness inferred from physician-documented details related to oral minocycline use in routine Indian clinical practice. These findings describe real-world prescribing patterns and physician-documented outcomes among patients with recorded follow-up, but should be interpreted cautiously given the retrospective design, absence of a comparator group, and incomplete ascertainment of adherence, adverse events, and clinical response. Despite the inherent limitations of this analysis, the study provides robust real-world evidence supporting the continued role of oral minocycline in both dermatologic and non-dermatologic conditions. Further, long-term prospective studies incorporating standardized outcome measures, including validated severity scales, may further strengthen understanding of its long-term effectiveness and safety profile.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgement
The authors are thankful to HealthPlix Technologies Private Limited for being the data source and for providing medical writing support. Authors are also thankful to Musigmadelta for carrying out the statistical analysis.
Author’s contributions
Conceptualization: Dr Sanjiv Kandhari, Dr Jayakar Thomas, Dr K. Yogiraj, Dr Rakhesh SV, Dr Rathish T. Pillai, Dr Anupam Das, Dr Geetanjali Shetty, Dr Pranav Sheth, Dr Bhavesh Lalan, Dr Chintan Khandhedia; Methodology: Dr Sanjiv Kandhari, Dr Jayakar Thomas, Dr K. Yogiraj, Dr Rakhesh SV, Dr Rathish T. Pillai, Dr Anupam Das, Dr Geetanjali Shetty, Dr Pranav Sheth, Dr Bhavesh Lalan, Dr Chintan Khandhedia; Formal analysis and investigation: Dr Sanjiv Kandhari, Dr Jayakar Thomas, Dr K. Yogiraj, Dr Rakhesh SV, Dr Rathish T. Pillai, Dr Anupam Das, Dr Geetanjali Shetty; Writing—original draft preparation: Dr Pranav Sheth, Dr Bhavesh Lalan, Shruti Dharmadhikari, Dr Chintan Khandhedia, Dr Prashant Devkare; Writing—review and editing: Dr Sanjiv Kandhari, Dr Jayakar Thomas, Dr K. Yogiraj, Dr Rakhesh SV, Dr Rathish T. Pillai, Dr Anupam Das, Dr Geetanjali Shetty, Dr Pranav Sheth, Dr Bhavesh Lalan, Shruti Dharmadhikari, Dr Chintan Khandhedia, Dr Prashant Devkare, Dr Amey Mane, Dr Suyog Mehta; Funding acquisition: Dr Pranav Sheth, Dr Bhavesh Lalan, Shruti Dharmadhikari, Dr Chintan Khandhedia, Dr Prashant Devkare, Dr Amey Mane, Dr Suyog Mehta; Resources: Dr Bhavesh Lalan, Dr Chintan Khandhedia, Dr Prashant Devkare, Dr Amey Mane, Dr Suyog Mehta; Supervision: Dr Bhavesh Lalan. All authors read and approved the final version.
Funding
The study was funded by Sun Pharma Laboratories Ltd.
Availability of data and material
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Code availability
Not applicable.
Declarations
Conflict of Interest
Authors Dr Pranav Sheth, Shruti Dharmadhikari, Dr Chintan Khandhedia, Dr Amey Mane, and Dr Suyog Mehta, are employees of Sun Pharma Laboratories Private Limited. Dr Bhavesh Lalan and Dr Prashant Devkare are employees of Sun Pharmaceutical Industries Limited. Dr Sanjiv Kandhari, Dr Jayakar Thomas, Dr K. Yogiraj, Dr Rakhesh SV, Dr Rathish T. Pillai, Dr Anupam Das, and Dr Geetanjali Shetty do not have any conflict of interest.
Ethical Statement
The study was approved by the Royal Pune Independent Ethics Committee (RPIEC 350723) on 27 July 2023. The study was performed in accordance with the standards of ethics outlined in the Declaration of Helsinki.
Consent to participate
Not applicable.
Consent for publication
Not applicable.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Not applicable.