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1.
J Assoc Physicians India ; 69(6): 11-12, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34472787

RESUMO

BACKGROUND: The present study intended to estimate the comorbidities and risk factors among patients with hypertension in India. Further, the current practice of hypertension management was evaluated and the choice of therapy was assessed based on hypertension grade, risk factors, and comorbidities. METHODS: Electronic medical record data (June 2017-June 2019) of Indian adult hypertensive patients (≥140/90 mmHg) who had two blood pressure (BP) readings were retrospectively analyzed. Demographic characteristics, BP readings, comorbidities, medications and co-medications, and laboratory data were collected at baseline. Grids based on hypertension grade (I, II, and III), demographic factors, risk factors, and comorbidities were created and prescribed antihypertensive drugs (AHDs) in each grid were evaluated. RESULTS: Among 100,075 patients, the proportion of patients in 18-40 year, 40-65 year, and >65 year age groups were 11.4%, 65.1%, and 23.4%, respectively. Proportion of men and women was similar (52.0% vs 47.9%). Proportion of patients with BMI <25 Kg/m2 was 8.1%, 25-29.9 Kg/m2 was 11.9%, and >30 Kg/m2 was 8.8%. Mean BP of patients with hypertension was: grade I (145.05/90.73 mmHg), grade II (160.07/95.64 mmHg), and grade III (180.82/102.76 mmHg). Mean low density lipoprotein (113.26 mg/dL), serum creatinine (2.28 mg/dL), mean HbA1c (8.7%) levels were highest among patients with grade III hypertension. Commonly observed comorbidities were type 2 diabetes mellitus (T2DM: 51.5%), dyslipidemia (36.4%), and chronic kidney disease (CKD: 4.4%). Top concomitant medications included anti-diabetic therapies (34.6%), drugs for dyslipidemia (30.0%), and anti-platelet therapies (6.9%). CONCLUSION: Most prescribed AHD monotherapies were angiotensin receptor II blockers (ARBs) and calcium channel blockers (CCBs) and most prescribed combination therapies were ARBs + diuretics and ARBs + CCBs. Telmisartan and amlodipine+telmisartan for patients with comorbid T2DM or dyslipidemia and metoprolol for those with coronary artery disease were the commonly prescribed AHDs.


Assuntos
Diabetes Mellitus Tipo 2 , Hipertensão , Adolescente , Adulto , Idoso , Antagonistas de Receptores de Angiotensina/farmacologia , Inibidores da Enzima Conversora de Angiotensina , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Morbidade , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
2.
Artigo em Inglês | MEDLINE | ID: mdl-34453262

RESUMO

INTRODUCTION: Clobetasol propionate (0.05% standard dose formulation), a topical corticosteroid, leads to systemic side-effects like hypothalamic-pituitary-adrenal (HPA) axis suppression at doses as low as 2 g/day. The aim of this study was to evaluate HPA axis suppression, efficacy, and safety of clobetasol propionate (0.025%, formulation 5 and 13) versus currently marketed 0.05% cream in Indian patients with moderate-to-severe psoriasis. METHODS: In this phase 2a investigator-blinded study, patients aged ≥ 18 years with moderate-to-severe psoriasis were randomized 1:1:1 to receive clobetasol propionate 0.025% formulation 5, or 13, or 0.05% cream; twice daily for 28 days. Safety endpoints included adrenocorticotropic hormone (ACTH) test results at day 28 (primary), and local tolerability at each visit (burning/stinging/pruritus, secondary). Efficacy endpoints included Psoriasis Global Assessment (PGA) score. RESULTS: Overall, 88 patients received clobetasol propionate 0.025% formulation 5 and 13 (n = 29 for both) and 0.05% cream (n = 30). At day 28, the proportion of patients with an abnormal ACTH stimulation test (cortisol levels ≤ 18 µg/dl) was numerically lower in 0.025% formulations: 5 (20.7%) and 13 (17.2%) compared with 0.05% cream (30.0%), (p = 0.320). Decrease in burning/stinging /pruritus scores were comparable in all treatment groups and PGA success rates were higher with 0.025% formulations: 5 (38.9%) and 13 (36.8%) compared with 0.05% cream (30.8%). CONCLUSION: Clobetasol propionate 0.025% could be an effective treatment for moderate-to-severe psoriasis compared with 0.05% cream, demonstrating comparable efficacy with a better systemic safety profile. TRIAL REGISTRATION NUMBER: REF/2018/01/016779.

3.
J Assoc Physicians India ; 69(7): 11-12, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34431273

RESUMO

BACKGROUND: Various clinical trials have established anti-inflammatory and antipyretic properties of Nimesulide in a controlled setting, however, the fever management in real-world settings is quite different. OBJECTIVE: To assess the effectiveness of Nimesulide in acute fever management in real-world clinical practice. METHODOLOGY: A retrospective, multicenter study was conducted on electronic medical records (EMR) of 302 patients visiting out-patient departments at three centers between Jan 2016 and Jan 2020 and were prescribed Nimesulide for acute fever. The effectiveness of Nimesulide was analyzed as a change in fever from baseline to follow-up visit within 14 days and tolerability as the number of side effects captured post-Nimesulide ingestion. RESULTS: The provisional diagnosis at the baseline visit reported major complaints like fever, fever with abdominal pain, body-ache, cough and myalgia. The mean baseline body temperature was 103.2±1.5°F with a mean duration of 4.4±2.8 days significantly (p 0.0001) decreased to 99.7±1.8°F on the administration of Nimesulide. The liver and the renal profiles were found to be normal on records, and the side effects such as nausea and dyspepsia were reported only in 2% of patients. CONCLUSION: Nimesulide was found to be well-tolerated and effective as an antipyretic for acute fever management in adults during short-term use in real-world clinical practice.


Assuntos
Registros Eletrônicos de Saúde , Pacientes Ambulatoriais , Adulto , Anti-Inflamatórios não Esteroides , Humanos , Estudos Retrospectivos , Sulfonamidas
4.
Artigo em Inglês | MEDLINE | ID: mdl-34435340

RESUMO

BACKGROUND: Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. OBJECTIVE: To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. METHODS: Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. RESULTS: The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). CONCLUSIONS: The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.

5.
Expert Rev Cardiovasc Ther ; 19(8): 769-775, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34126829

RESUMO

Background: This is the first detailed Indian electronic medical record (EMR)-based real-world observational study to understand the clinical characteristics, associated comorbidities/risk factors and treatment(s) of CAD patients across India.Methods: EMR data of adult Indians (aged ≥ 18 years) diagnosed with CAD was retrospectively analyzed.Results: The majority of the participants had stable IHD (93%), were men (68.5% in ACS, 59.8% in stable IHD), most common age group was 40-64 years in ACS (56.6%) and stable IHD (51.4%). Both are common in metros (ACS 52%, 62% stable IHD). There is a high frequency of hypertension (38.2% in ACS, 59% in stable IHD) and diabetes mellitus (32.3% in ACS, 57.6% in stable IHD). Most common treatments are antiplatelet drugs and lipid-lowering drugs (96%).Conclusions: In India, stable IHD is the most prevalent form in vast majority of patients. The patients with CAD are mostly males, are mainly located in metros and majority fall between the age group of 40-64. The major comorbidities are hypertension and diabetes mellitus. Sociodemographic and clinical characteristics for CAD in India may not be similar to what is reported from the west. There is a significant difference in drug usage and adherence to guidelines in India for CAD.


Assuntos
Doença da Artéria Coronariana , Adulto , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/epidemiologia , Demografia , Registros Eletrônicos de Saúde , Feminino , Humanos , Índia/epidemiologia , Recém-Nascido , Masculino , Estudos Retrospectivos , Fatores de Risco
6.
Cardiol Ther ; 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-34115326

RESUMO

INTRODUCTION: The renoprotective effects of dihydropyridine calcium channel blockers (CCBs) have been established as non-inferior to other classes of antihypertensive drugs. Studying their effect on renal outcome parameters, specifically for amlodipine as monotherapy, in real-world settings can further help in expanding its usage among Indian patients. This study was performed to assess the effects of amlodipine and other dihydropyridine CCBs (cilnidipine, benidipine and azelnidipine) on renal parameters and effectiveness in blood pressure reduction in Indian patients. METHODS: The retrospective data of adult patients (> 18 years) with essential hypertensive who were prescribed amlodipine (n = 92), cilnidipine (n = 91), benidipine (n = 70) or azelnidipine (n = 71) as monotherapy were analyzed. The renal outcomes, serum creatinine, estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), microalbumin, urine albumin-to-creatinine ratio (UACR), sodium and potassium levels, and mean changes in BP were analyzed from baseline to 12 months. Appropriate statistical methods were used to determine the significance (p value < 0.05). RESULTS: From baseline to the end of the study, mean serum creatinine changed from 0.98 ± 0.17 to 1.07 ± 0.28 mg/dL with amlodipine, 0.97 ± 0.18 to 1.13 ± 0.50 mg/dL with cilnidipine, 0.98 ± 0.30 to 0.97 ± 0.27 mg/dL wi th benidipine, and 0.99 ± 0.23 to 0.98 ± 0.25 mg/dL with azelnidipine (p = 0.01). The mean microalbumin and UACR were reduced from baseline to the end of the study (p = 0.06 and p > 0.05). No significant changes were observed in BUN, sodium or potassium levels. Overall, for all CCBs, the mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were reduced from baseline to the end of the study (p = 0.002). At the end of the study, the average dose of amlodipine was 7.25 mg, and the average reduction in SBP and DBP per mg dose was 1.54 and 0.57 mmHg. The corresponding numbers for the other CCBs were as follows: cilnidipine, 14.28 mg, 0.26 and 0.01; benidipine, 5.71 mg, 0.41 and 0.11; azelnidipine, 15.88 mg, 0.13 and 0.06. CONCLUSION: Amlodipine and other CCBs demonstrated good efficacy and similar effects on renal parameters from baseline to end of study. Amlodipine also showed higher potency by demonstrating greater BP reduction at a lower dose. Thus, amlodipine can remain a preferred choice among CCBs, even with the advent of the newer CCBs.

7.
Cardiol Ther ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33830460

RESUMO

INTRODUCTION: The effectiveness of telmisartan has been reported in Indian clinical trials; however, real-world data are limited. We aimed to provide real-world evidence regarding the effectiveness of telmisartan as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients diagnosed with essential hypertension (≥ 140/90 mmHg) and who were prescribed telmisartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified according to the number of AHD classes prescribed on initiating telmisartan. Change in systolic and diastolic blood pressure (SBP and DBP) after a month of treatment and the proportion of patients who achieved treatment goals according to the 2018 European Society of Cardiology/European Society of Hypertension guidelines were evaluated. RESULTS: A majority (90.6%) of the 1304 patients included in the study were on telmisartan monotherapy or telmisartan + 1 AHD. The mean (95% confidence interval [CI]) change in the telmisartan monotherapy group was SBP (-13.3 [-14.6, -12.0] mmHg) and DBP (-7.2 [-7.9, -6.5] mmHg), and the mean (95% CI) change in the telmisartan + 1 AHD group was SBP (-10.8 [-13.1, -8.5] mmHg) and DBP (-6.5 [-7.7, -5.3] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 35.9% and 47.3% of patients on telmisartan monotherapy and by 35.9% and 46.8% of patients on telmisartan + 1 AHD. Among patients with comorbid diabetes, the mean (95% CI) change in the telmisartan monotherapy group was SBP (-13.3 [-15.0, -11.6] mmHg) and DBP (-7.3 [-8.2, -6.5] mmHg), and the mean (95% CI) change in the telmisartan + 1 AHD group was SBP (-13.0 [-16.5, -9.5] mmHg) and DBP (-6.9 [-8.7, -5.1] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 31.7% and 39.7% of patients on telmisartan monotherapy and by 31.9% and 41.8% of patients on telmisartan + 1 AHD. CONCLUSION: Telmisartan may be a good candidate for blood pressure control in Indian patients with essential hypertension and comorbidities.

8.
Drugs Real World Outcomes ; 7(4): 281-293, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32901435

RESUMO

BACKGROUND: The effectiveness of amlodipine has been reported in clinical trials in India. However, real-world data on the effectiveness of amlodipine in India is limited. OBJECTIVE: To provide real-world evidence regarding the effectiveness of amlodipine as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥ 140/90 mmHg) and were prescribed amlodipine as monotherapy or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of amlodipine. Change in systolic (SBP) and diastolic (DBP) blood pressure from baseline was the primary endpoint. Evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines was the secondary endpoint. Readings were obtained before initiating amlodipine and after at least a month of therapy with amlodipine. RESULTS: Among the 462 included patients, the majority (90.7%) were on amlodipine monotherapy or amlodipine + 1AHD. Mean (95% confidence interval [CI]) change in the amlodipine monotherapy group was: SBP (- 12.1 [- 14.9, - 9.3] mmHg) and DBP (- 7.5 [- 8.9, - 6.1] mmHg) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 17.8 [- 21.0, - 14.6] mmHg) and DBP (- 9.5 [- 11.0, - 8.0] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 31.4% and 42.9% of patients on amlodipine monotherapy and by 38.9% and 51.8% of patients on amlodipine + 1AHD, respectively. Among patients aged ≤ 45 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (- 11.7 [- 16.0, - 7.4] mmHg; P < 0.001) and DBP (- 7.2 [- 9.7, - 4.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 14.6 [- 21.9, - 7.3] mmHg; P < 0.05) and DBP (- 10.6 [- 14.8, - 6.4] mmHg; P < 0.01). SBP and DBP goals were achieved by 35.4% and 33.8% of patients on amlodipine monotherapy and by 48.0% and 56.0% of patients on amlodipine + 1AHD, respectively. Among patients aged ≥ 65 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (- 13.9 [- 20.2, - 7.6] mmHg; P < 0.01) and DBP (- 8.5 [- 11.4, - 5.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (- 22.4 [- - 28.8, - 16.0] mmHg; P < 0.001) and DBP (- 10.8 [- 14.0, - 7.6] mmHg; P < 0.001). SBP and DBP goals were achieved by 25.5% and 13.7% of patients on amlodipine monotherapy and by 29.8% and 14.0% of patients on amlodipine + 1AHD. CONCLUSION: Amlodipine prescribed as monotherapy or add-on therapy during routine clinical practice significantly reduced BP in ≤ 45- and ≥ 65-year-old Indian patients with mild to moderate hypertension, emphasizing that amlodipine may be a good candidate for BP control in Indian patients with essential hypertension in these age groups.

9.
J Assoc Physicians India ; 68(8): 66-72, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32738844

RESUMO

Background: Real-world data on the effectiveness of antihypertensive drugs (AHDs) in India is limited. The present study aims to provide updated evidence regarding the effectiveness of olmesartan as monotherapy or in combination with other AHDs in Indian patients with essential hypertension. Methods: Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥140/90 mmHg) and were prescribed olmesartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of olmesartan. Change in systolic and diastolic blood pressure (SBP and DBP) from baseline was the primary endpoint. Secondary endpoint was evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines. Readings were obtained before initiating olmesartan and after at least a month of therapy with olmesartan. Results: Among the 459 included patients, majority were on olmesartan monotherapy or olmesartan+1AHD (91.7%). Mean (95% confidence interval [CI]) change in olmesartan monotherapy group was: SBP (-13.4 [-15.7, -11.1] mmHg) and DBP (-8.3 [-9.5, -7.1] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-11.7 [-15.1, -8.3] mmHg) and DBP (-6.6 [-8.3, -4.9] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 40.4% and 50.3% of patients on olmesartan monotherapy and by 36.1% and 46.2% of patients on olmesartan+1AHD. Among patients with comorbid diabetes, mean (95% CI) change in olmesartan monotherapy group was: SBP (-15.5 [-18.6, -12.4] mmHg) and DBP (-8.7 [-10.2, -7.2] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-13.5 [-18.3, -8.7] mmHg) and DBP (-7.6 [-9.8, -5.4] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 38.5% and 49.4% of patients on olmesartan monotherapy and by 31.7% and 42.9% of patients on olmesartan+1AHD. Conclusion: Olmesartan prescribed as mono- or add-on therapy during routine clinical practice significantly reduced blood pressure in Indian patients with essential hypertension as well as in patients with comorbid diabetes.


Assuntos
Registros Eletrônicos de Saúde , Hipertensão/tratamento farmacológico , Adulto , Bloqueadores do Receptor Tipo 1 de Angiotensina II , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Humanos , Imidazóis , Índia , Olmesartana Medoxomila/farmacologia , Estudos Retrospectivos , Tetrazóis/farmacologia
10.
Drugs Real World Outcomes ; 7(4): 271-279, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32648242

RESUMO

BACKGROUND: The efficacy of gliclazide has been reported in clinical trials in India. However, real-world data on the effectiveness of gliclazide in India is unavailable. OBJECTIVE: To provide real-world evidence regarding the effectiveness of gliclazide or gliclazide + metformin fixed-dose combination or separate medications, used either as monotherapy or as the latest add-on to other antihyperglycemic agents in reducing glycated hemoglobin (HbA1c) levels in Indian patients with type 2 diabetes mellitus (T2DM). METHODS: Electronic medical record data of adult patients who were diagnosed with T2DM who were newly initiated on or had been prescribed gliclazide or gliclazide + metformin combination for < 30 days as monotherapy or as add-on therapy to other antihyperglycemic agents, and had HbA1c ≥ 6.5% were retrospectively analyzed. Mean change in HbA1c from baseline was the primary endpoint. Secondary endpoints were assessment of dosages and formulations of gliclazide or gliclazide + metformin prescribed in the HbA1c spectrum and antihyperglycemic agents to which gliclazide or gliclazide + metformin was added as an adjunct. Readings were obtained before initiating gliclazide or gliclazide + metformin and after at least 90 days of treatment with gliclazide or gliclazide + metformin. RESULTS: Included patients (n = 498) were categorized into gliclazide only (n = 66), gliclazide + metformin only (n = 179), gliclazide add-on (n = 169), and gliclazide + metformin add-on (n = 84) groups. Mean (95% confidence interval [CI]) change in HbA1c among patients with baseline HbA1c > 7% was - 0.8% (- 1.26, - 0.34) in gliclazide only group; - 1.6% (- 1.89, - 1.31; p < 0.001) in gliclazide + metformin group; - 1.2% (- 1.50, - 0.90; p < 0.001) in add-on gliclazide group; and - 1.4% (- 1.75, - 1.05; p < 0.001) in add-on gliclazide + metformin group. Gliclazide once daily was the most prescribed regimen in the gliclazide only group (72.7%), with 60 mg being the most prescribed modified-release dose (62.5%). Gliclazide + metformin twice daily was the most prescribed regimen in the gliclazide + metformin group (69.3%) with 80 mg + 500 mg being the most prescribed immediate-release dose (62.9%). Gliclazide and gliclazide + metformin were most added as an adjunct to existing prescriptions of biguanides (83.4%) or insulin (64.3%), respectively. CONCLUSION: Gliclazide or gliclazide + metformin prescribed as mono- or add-on therapy during routine clinical practice effectively reduced HbA1c in Indian patients with T2DM, thus validating the use of gliclazide and gliclazide + metformin for managing T2DM in India.

12.
Dermatol Ther (Heidelb) ; 10(3): 469-479, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32277388

RESUMO

INTRODUCTION: Patients with androgenetic alopecia treated with alcohol-based minoxidil topical solutions often report local irritation, dryness, and redness of the scalp. We evaluate the in-use tolerance of 5% minoxidil novel formulation topical solution-test product (TP)-compared with 5% minoxidil alcohol-based topical solutions-reference product 1 (RP1) and reference product 2 (RP2)-in Indian men with androgenetic alopecia. METHODS: In this randomized double-blind study, patients aged ≥ 18 years with androgenetic alopecia were randomized 1:1:1 to apply TP, RP1, and RP2 twice daily for 30 days. The safety endpoints included mean hydration, mean redness, and mean scaling on scalp. RESULTS: All screened patients (N = 100) were enrolled and randomized to TP (n = 33), RP1 (n = 33), or RP2 (n = 34). At day 30, the mean (SD) hydration was significantly increased in patients treated with TP [9.74 (4.98)] but significantly reduced in patients treated with RP1 [3.28 (2.67)] or RP2 [3.03 (1.57)] (p-value 0.001). The mean (SD) score for redness was significantly decreased in the TP group [0.01 (0.04)], (p-value, 0.009) at day 30 compared with baseline, while no change was observed in the RP1 [0.08 (0.13)] or RP2 [0.11 (0.17)] group. After 30 days of treatment, no significant difference was observed in the mean score of scaling in any of the three groups. CONCLUSIONS: Twice daily application of 5% minoxidil novel formulation for 30 days significantly improved hydration and reduced redness of the scalp. Hence, 5% minoxidil novel formulation could be a safer alternative in treating men with androgenetic alopecia who are sensitive to alcoholic formulations. TRIAL REGISTRATION: Clinical Trial Registry of India; CTRI/2018/11/016431.

13.
J Assoc Physicians India ; 68(3): 59-63, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32138486

RESUMO

Introduction: Doxycycline acts against a broad range of gram-positive, gramnegative and 'atypical' bacteria as well as some protozoan pathogens such as malaria. In this era of increasing multidrug-resistance, recycling of old antimicrobials should be considered and need more focus in this domain of research. We, therefore, aimed to assess the antimicrobial susceptibility patterns of commonly isolated pathogens against doxycycline, azithromycin, cefuroxime, and amoxicillin from common clinical specimens by using laboratory-based diagnostic data from western India. Materials and Methods: The non-interventional retrospective study was conducted on secondary data extracted from multi-center diagnostic laboratory based in Mumbai, India. Susceptibility data of bacteria isolated from blood, urine, pus, and sputum were used in the study and culture positive samples were segregated. Antimicrobial susceptibility status of doxycycline was checked and compared with azithromycin, cefuroxime, and amoxicillin. Chi-square tests of significance were carried out to assess significant differences in susceptibility patterns. Association between variables was considered statistically significant if the p-value was <0.05. Results: Percentage susceptibility of collective bacterial isolates was found to be highest for doxycycline in all four specimens (93.1%). Individual percentage susceptibility was observed to be highest for sputum isolates (97.5%) followed by blood (93.8%), pus (92.7%) and urine (70.0%). The activity of doxycycline was found to be 93.5% for the samples resistant to azithromycin. Doxycycline also showed good susceptibility for the isolates resistant to amoxicillin and cefuroxime which was 75.9% and 64.8%, respectively. Conclusion: Several bacterial isolates from all four sources were found to be susceptible to Doxycycline. It has an important role in the form of a better alternative of major antimicrobial agents like azithromycin, cefuroxime, and amoxicillin against gram-positive cocci. Doxycycline appeared to show better activity against isolates which were resistant to other three antimicrobials.


Assuntos
Antibacterianos/farmacologia , Amoxicilina/farmacologia , Azitromicina/farmacologia , Cefuroxima/farmacologia , Doxiciclina/farmacologia , Índia , Testes de Sensibilidade Microbiana , Estudos Retrospectivos
14.
Value Health Reg Issues ; 18: 65-73, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30502662

RESUMO

OBJECTIVES: To simulate the long-term health outcomes of canagliflozin 100 mg versus glimepiride over 20 years in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin from the perspective of the Indian health care system. METHODS: Health outcomes were simulated using the validated Economic and Health Outcomes Model of T2DM. Patient demographic characteristics, biomarker values, and treatment effects were sourced from a subgroup of Indian patients enrolled in a 52-week, head-to-head study of canagliflozin versus glimepiride (mean maximum dose of 5.6 mg/d) in patients with T2DM inadequately controlled with metformin. Outcomes were discounted at 5%. Sensitivity analyses were conducted using alternative values for key model inputs. RESULTS: Relative to glimepiride, treatment with canagliflozin 100 mg was associated with approximately 14 more patients surviving at year 20 per 1,000 patients treated and 0.43 quality-adjusted life-years gained, largely because of improved body weight and reduced risk of macrovascular and microvascular morbidity over 20 years. Risk reductions were the largest for microvascular complications (e.g., chronic kidney disease and albuminuria). Improved health outcomes were driven by better glycated hemoglobin control associated with canagliflozin versus glimepiride, which also delayed the need for rescue therapy. Key components of quality-adjusted life-year gains included the avoidance of hypoglycemic episodes, chronic kidney disease, and weight gain, as well as increased survival with canagliflozin compared with glimepiride. CONCLUSIONS: Simulation results suggest that canagliflozin 100 mg may provide better long-term health outcomes compared with glimepiride in Indian patients with T2DM inadequately controlled with metformin.


Assuntos
Canagliflozina/normas , Diabetes Mellitus Tipo 2/tratamento farmacológico , Compostos de Sulfonilureia/normas , Canagliflozina/uso terapêutico , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/normas , Hipoglicemiantes/uso terapêutico , Índia , Metformina/normas , Metformina/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/normas , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Compostos de Sulfonilureia/uso terapêutico , Resultado do Tratamento
15.
J Eur CME ; 7(1): 1454251, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29755849

RESUMO

Continuing medical education (CME) is a valuable mechanism to update physicians' knowledge with ever-increasing plethora of contemporary advances within medical fraternity. Over time, scope of CME has seen change from simple clinical updates to comprehensive continuing professional development (CPD), which is accomplished with help of accredited CME programmes. The Medical Council of India, in 2011, made a mandatory resolution for doctors to attend minimum of 30 hours of CME/5 years to ensure recertification. Authorised accreditation councils and licensing authorities award CME credits for maintenance of physicians' licensures. To date, in India, only 9 of 26 State Medical Councils have made re-registration mandatory. Although CME events benefit healthcare professionals by improving their proficiency and awareness, costs even to attend such interventions may be prohibitive. Despite financial help being received through grants and sponsorships, ethics of industry-sponsored CME remains a matter of debate. However, over past 10 years, pharmaceutical companies have started going beyond basic product information in order to focus on building physicians' knowledge in various therapeutic areas. Though CME credit system and criteria for re-licensure for medical practice in India are evolving at a rapid pace, there is a need for harmonisation and robust implementation across all states in India.

16.
Diabetes Metab Syndr ; 11 Suppl 1: S159-S168, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28063802

RESUMO

Excess body weight is a leading cause of metabolic complications such as hypertension and dyslipidemia in T2DM patients. Available antihyperglycemic agents have minimal or no impact on these complications and a majority are known to trigger weight gain, thereby exerting a paradoxical effect on overall metabolic status. This review introduces the concept of 'KgA1c paradox' and underscores the significance of resolving this paradox for comprehensive T2DM management. It provides a therapeutic rationale for inclusion of sodium glucose cotransporter 2 inhibitors in the T2DM treatment algorithm as these agents have demonstrated favorable glycemic effects along with reduction in body weight.


Assuntos
Algoritmos , Diabetes Mellitus Tipo 2/prevenção & controle , Hipoglicemiantes/uso terapêutico , Humanos , Valor Preditivo dos Testes
17.
Indian Pediatr ; 53(2): 154-8, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26897152

RESUMO

JUSTIFICATION: Asthma and allergic rhinitis together are part of the concept of one airway, one disease or united airway disease. The management of allergic airway diseases should address this united concept and manage the issue by educating the patients and their parents and health care providers, along with environmental control measures, pharmacotherapy and immunotherapy. Here, we present recommendations from the module of Airway Diseases Education and Expertise (ADEX) that focused on allergic rhinitis, asthma and sleep disorder breathing as a single entity or Allergic Airway Disease. PROCESS: A working committee was formed by the collaboration of Pediatric Allergy Association of India (PAAI) and Indian Academy of Pediatrics (IAP) Allergy and Applied Immunology chapter to develop a training module on united airway disease. OBJECTIVE: To increase awareness, understanding and acceptance of the concept of United Airway disease and to educate the primary health care providers for children and public health officials, in the management of united airway diseases. RECOMMENDATIONS: Recommendations for diagnosis, management and follow-up of Allergic airway disease are presented in this document. A better compliance by linking education of child, parent, grandparents and other health care providers, and scientific progress by collaboration between practitioners, academicians, researchers and pharmaceutical companies is suggested.


Assuntos
Asma , Pediatria/educação , Rinite Alérgica , Asma/diagnóstico , Asma/terapia , Criança , Pré-Escolar , Humanos , Índia , Guias de Prática Clínica como Assunto , Rinite Alérgica/diagnóstico , Rinite Alérgica/terapia
18.
Rev Recent Clin Trials ; 11(1): 47-55, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26435140

RESUMO

Conduct of clinical trials has undergone substantial changes over the last two decades. Newer markets, evolving guidelines and documentation and high cost involved in conducting the trials have led pharmaceutical companies to prepare a risk mitigation plan. Extensive monitoring of potential risks is an essential element of clinical trials which helps to ensure quality and integrity of a clinical investigation. Every clinical trial has pre (before the trial), conduct and post phase. This article which has been developed as a result of extensive research at ground level by a reputed pharmaceutical company to identify the potential stages of risks that could affect the overall quality and safety of a trial and its outcome during the pre-phase of trial (the stage of the trial where the study design is being planned before initiation of the clinical trial). It includes risks associated with basic study concept, protocol design, Confidential Disclosure Agreement (CDA) and Clinical Trial Authorization (CTA) application signing, vendors of central drug laboratory, site and investigator selection, Clinical Research Coordinator (CRC) meet, Informed Consent Form (ICF), Case Report Form (CRF)/ Status Report Form (SRF) preparation, Ethics Committee (EC) submission, etc. have been highlighted. The risk based mitigation strategy (to develop an effective risk monitoring plan before staring a clinical trial) has also been suggested by authors. A well-tailored and integrated plan, recognition of potential risks and their mitigation strategy can result in the pre exclusion or end to end solution of all the risks associated with pre- phase of clinical trials.


Assuntos
Ensaios Clínicos como Assunto/métodos , Avaliação de Medicamentos , Comissão de Ética
19.
Indian Pediatr ; 52(8): 687-90, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26388627

RESUMO

OBJECTIVES: To assess immunogenicity of a single dose of live attenuated hepatitis A vaccine in Indian children, ten years after immunization. METHODS: Of 143 children vaccinated in 2004, 121 children were evaluated in 2014, clinically and for anti-HAV antibodies. RESULTS: 13 children were early vaccine failures who received two doses of HAV vaccine subsequently. 106 (98%) of 108 remaining children had seroprotective levels with a geometric mean titer of 100.5 mIU/mL. On analysis of all 121 children, the immunogenicity was 87.6%. CONCLUSION: Single dose of live attenuated hepatitis A vaccine provides long-term immunity in Indian children.


Assuntos
Anticorpos Anti-Hepatite A/sangue , Vacinas contra Hepatite A/imunologia , Hepatite A/prevenção & controle , Vacinas Atenuadas/imunologia , Adolescente , Adulto , Criança , Pré-Escolar , Seguimentos , Humanos , Índia , Lactente , Adulto Jovem
20.
Gastroenterology Res ; 8(3-4): 216-221, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27785299

RESUMO

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most common therapeutic products used for the management of inflammation and pain. However, their use is associated with gastrointestinal (GI), cardiovascular and renal complications. Although prevalence data regarding NSAID-induced complications are available worldwide, but none of the study has assessed the prevalence of GI, cardiac and renal complications in India. This study aimed to assess the point prevalence of GI, cardiac and renal complications associated with the use of NSAIDs in India. The study also aimed to evaluate the association between the risk factors and GI, renal and cardiac complications in patients using NSAIDs. METHODS: This prospective, cross-sectional, multi-centric study was conducted in eight medical colleges across India (North, East, West, South and Central India). Data related to GI complications including gastric, duodenal and gastroduodenal erosions/ulcers/gastritis, renal complications including acute and chronic renal failure or cardiac complications including acute coronary syndrome (ACS), acute myocardial infarction (AMI) and cardiac failure, were collected from patients. RESULTS: The cut-off date for interim data analysis was July 7, 2014. A total of 2,140 patients out of 3,600 were enrolled from eight centers at the time of interim analysis. The NSAID-associated point prevalence of GI complications was 30.08%; cardiac complication was 42.77%; and renal complication was 27.88%. CONCLUSIONS: Results of the present interim analysis show that the prevalence of GI, cardiac and renal complications among patients is high due to exaggerated usage; however, the final analysis would provide the overall prevalence of these complications.

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