Evaluation of efficacy and safety of doxofylline 800mg sustained release tablet in treatment of patients with COPD: an open label, prospective and RCT

Background: COPD is a major cause of health care burden worldwide and leading cause of death that is increasing in prevalence. Methylxanthines are used in the treatment of patients with asthma and COPD. Doxofylline (methylxanthine) shows improved disease control, reduced total daily dose of inhaled b2 agonists and improved patient compliance.Methods: This was a prospective, open labelled, randomized, two-arm, parallel group, controlled, clinical trial. 115 patients were randomized to two groups. Patients in group A received tablet doxofylline 400mg BD whereas patients in group B received tablet doxofylline 800mg SR for 4 weeks. Primary outcome measure of trial was change in FEV1 and secondary outcome measure were change in FVC/FEV1, change in symptoms score, effect on health-related quality of life (HRQOL) and safety of study medication.Results: At 4 week the FEV1increase by 13.028% and 17.647% in group A and B respectively. In group A FEV1/FVC increase by 5.79% and in group B it increases by 9.57% at 4 weeks. The symptom score of cough decrease by 77.35% and 97.43% in group A and group B respectively at 4 weeks. In group A shortness of breath decrease by 77.60% and in group B it decreases by 95.90% at 4 weeks. Tightness in chest decrease by 86.29% and 98.40% in group A and group B respectively at 4 weeks.Conclusions:Doxofylline 800mg sustained release tablet provided significantly greater improvement in FEV1, symptomatic control and health related quality of life compared to doxofylline 400mg.

Evaluation of efficacy and safety of doxofylline 800mg sustained release tablet in treatment of patients with COPD: an open label, prospective and RCT

Background: COPD is a major cause of health care burden worldwide and leading cause of death that is increasing in prevalence. Methylxanthines are used in the treatment of patients with asthma and COPD. Doxofylline (methylxanthine) shows improved disease control, reduced total daily dose of inhaled b2 agonists and improved patient compliance.Methods: This was a prospective, open labelled, randomized, two-arm, parallel group, controlled, clinical trial. 115 patients were randomized to two groups. Patients in group A received tablet doxofylline 400mg BD whereas patients in group B received tablet doxofylline 800mg SR for 4 weeks. Primary outcome measure of trial was change in FEV1 and secondary outcome measure were change in FVC/FEV1, change in symptoms score, effect on health-related quality of life (HRQOL) and safety of study medication.Results: At 4 week the FEV1increase by 13.028% and 17.647% in group A and B respectively. In group A FEV1/FVC increase by 5.79% and in group B it increases by 9.57% at 4 weeks. The symptom score of cough decrease by 77.35% and 97.43% in group A and group B respectively at 4 weeks. In group A shortness of breath decrease by 77.60% and in group B it decreases by 95.90% at 4 weeks. Tightness in chest decrease by 86.29% and 98.40% in group A and group B respectively at 4 weeks.Conclusions:Doxofylline 800mg sustained release tablet provided significantly greater improvement in FEV1, symptomatic control and health related quality of life compared to doxofylline 400mg.

Synchronizing pharmacotherapy in acne with review of clinical care

Acne is a chronic inflammatory skin disease that involves the pathogenesis of four major factors, such as androgen-induced increased sebum secretion, altered keratinization, colonization of Propionibacterium acnes, and inflammation. Several acne mono-treatment and combination treatment regimens are available and prescribed in the Indian market, ranging from retinoids, benzoyl peroxide (BPO), anti-infectives, and other miscellaneous agents. Although standard guidelines and recommendations overview the management of mild, moderate, and severe acne, relevance and positioning of each category of pharmacotherapy available in Indian market are still unexplained. The present article discusses the available topical and oral acne therapies and the challenges associated with the overall management of acne in India and suggestions and recommendations by the Indian dermatologists. The experts opined that among topical therapies, the combination therapies are preferred over monotherapy due to associated lower efficacy, poor tolerability, safety issues, adverse effects, and emerging bacterial resistance. Retinoids are preferred in comedonal acne and as maintenance therapy. In case of poor response, combination therapies BPO-retinoid or retinoid-antibacterials in papulopustular acne and retinoid-BPO or BPO-antibacterials in pustular-nodular acne are recommended. Oral agents are generally recommended for severe acne. Low-dose retinoids are economical and have better patient acceptance. Antibiotics should be prescribed till the inflammation is clinically visible. Antiandrogen therapy should be given to women with high androgen levels and are added to regimen to regularize the menstrual cycle. In late-onset hyperandrogenism, oral corticosteroids should be used. The experts recommended that an early initiation of therapy is directly proportional to effective therapeutic outcomes and prevent complications