Association of Physicians of India: Position Statement on Role of Chirally Pure Molecules in Clinical Practice.

Chirally pure molecules or enantiomers are non-superimposable mirror images of each other with a chiral center (such as carbon, sulphur, nitrogen or phosphorous atom). An equimolar mixture of enantiomers forms a racemate. Chirally pure molecules (single enantiomers) are important in the field of drug discovery as the drug targets such as enzymes and receptors are enantioselective in nature. Clinical studies have demonstrated that chirally pure drugs exhibit different pharmacokinetic and metabolic profiles, reduced adverse events, improved safety profiles and similar therapeutic activity at lowered drug dosage as compared with the racemate in many therapeutic areas. However, since there is a low level of awareness on the advantages of chirally pure molecules among clinicians, pharmacists and patients in India, the Association of Physicians of India (API) developed this position statement to increase awareness on the concept of chirality and the associated advantages of using chirally pure drugs in certain therapeutic areas to maximize patient outcomes. This includes the clinical evidence associated with single enantiomers such as S-metoprolol, S-amlodipine, esomeprazole, escitalopram, levobupivacaine, cisatracurium, S-etodolac, dexketoprofen, levofloxacin in terms of efficacy and safety as compared with their racemates. In addition, the API also provides some tactical recommendations for clinicians, pharmacists, patients, regulatory body and pharmaceutical companies to increase awareness on chirally pure drugs and puts forth the need for expedited availability of chirally pure drugs in the Indian market.

Prevalence of chronic pain, impact on daily life, and treatment practices in India.

OBJECTIVE: Chronic pain is of concern to health professionals, patients, society, and negatively impacts quality of life (QoL). The present epidemiologic study identified point prevalence of chronic pain in India, impact on individual's QoL, unveiling current pain treatment practices, and levels of satisfaction with treatment. METHODS: This epidemiological telephonic survey consisted of two questionnaires: screening questionnaire that assessed prevalence of pain, its frequency during the past week, intensity during last episode, sites of pain, and main causes, and in-depth questionnaire that evaluated demography, frequency, duration, and intensity of pain; impact of pain on QoL; respondent's perception regarding the attitude of their family, friends, and doctors toward their pain. RESULTS: A total of 5004 respondents were included from eight cities across India. The overall point prevalence of chronic pain was 13%, and the mean intensity of pain on NRS scale was 6.93. Respondents with chronic moderate and chronic severe pain were 37% and 63%, respectively. Pain in knees (32%), legs (28%), and joints (22%) was most prevalent. Respondents with chronic pain were no longer able to exercise, sleep, maintain relationships with friends and family, and maintain an independent lifestyle. About 32% of patients lost ≥4 hours of work in the past 3 months. Majority (68%) of respondents were treated for pain with over the counter (OTC) drugs, and most were taking NSAIDs (95%). CONCLUSION: A significant population of India suffers from chronic pain, and their QoL is affected leading to disability. A proportion of respondents receiving pain treatment were taking nonprescription medications with a majority of respondents on NSAIDs. A very few were consulting pain management specialists.

A phase IV observational multi-centre, open-label study on efficacy and safety of tolperisone 150 mg in patients with painful muscle spasm associated with degenerative or inflammatory diseases of the musculoskeletal system.

AIMS: To generate real world clinical data on efficacy and tolerability of tolperisone 150 mg in painful muscle spasms in Indian population. SETTINGS AND DESIGN: Prospective, open-labelled, non-comparative, multi-centre observational, Post Marketing surveillance study conducted at 174 participating orthopaedic care centres across India METHODS AND MATERIAL: Nine hundred and twenty adult patients having painful muscle spasm associated with degenerative or inflammatory conditions were enrolled who received tolperisone 150 mg thrice daily orally for 7 days. Assessment of primary efficacy (muscle spasm) was done by (0-3) Likert scale. Adverse events were monitored for safety and global efficacy assessment was done by clinicians and patients at the end of study period. RESULTS: Significant improvements from baseline (p < 0.0001) in scores for muscle tone, mobility & pain were seen on days 3 & 7. At the end of study there was a significant reduction in scores by more than 80% from baseline. A subgroup analysis revealed no statistical difference in the scores in patients receiving Non-Steroidal AntiInflammatory Drug (NSAID) as compared to those receiving Tolperisone alone suggesting that Tolperisone alone could be offered to patients with painful muscle spasm who are intolerant to NSAIDs or in whom NSAIDs are contraindicated. Tolperisone was well tolerated with no sedation reported by any patient during study period. The incidence of common adverse effects like nausea, gastric irritation was less than 2%. CONCLUSIONS: Tolperisone is a safe, effective and non sedative alternative in management of acute painful spasm conditions associated with degenerative or inflammatory diseases of the musculoskeletal system. Key Messages: Tolperisone is a skeletal muscle relaxant without concomitant sedation or withdrawal phenomena. In this open-labelled, non-comparative, prospective study tolperisone was proved to be a safe & effective alternative to skeletal muscle relaxants in the management of acute painful spasm conditions associated with degenerative or inflammatory diseases of the musculoskeletal system.

Overview of methicillin resistant Staphylococcus aureus mediated bone and joint infections in India.

Staphylococcus aureus is the most common pathogen causing bone and joint infections (BJI). In India, prevalence of Methicillin resistant Staphylococcus aureus (MRSA) is increasing at an alarming rate and emerged as an important contributor towards the difficult to treat BJI. Currently available anti-MRSA agents have their own limitations with regards to reduced susceptibility as well as safety and tolerability. Furthermore, biofilms over the prosthesis with invariably multi-drug resistant strains leads to complex treatment processes. This necessitates the need to develop and screen new antibiotics against MRSA that can easily penetrate the deep pockets of infection and take care of the challenges discussed. This review aims to discuss on MRSA infection in bone and joint infection, current antibiotic regimen, its associated limitations, and finally, the need to develop new antibiotic therapy for effective management of patients with BJI.

Vitamin K2: a novel therapy for osteoporosis.

Development and maintenance of skeletal health is essential since the resultant effect of poor bone health is an increased risk of osteoporotic fracture. Osteoporosis is currently a major public health problem and with predicted demographic changes, its future health and economic impact is likely to be phenomenal. Adult bone health is predominantly governed by two factors: (i) Maximum attainment of peak bone mass; and (ii) rate of bone loss which occurs with ageing. Both aspects are determined by a combination of endogenous and exogenous factors and, although genetic influences are believed to account for up to three-quarters of the variation in bone mass, there is still room for the modifiable factors (including nutrition) to play an important role. This article covers clinical evidences of the positive effect of vitamin K2 on osteoporosis. The activity of vitamin K2 involves both an increase in the bone-building process and decrease in the bone-loss process. Article covers effect of vitamin K2 on bone homeostasis and its safety in children, hepatic and renal impairment. Vitamin K2 should be considered for prevention and treatment in those conditions known to contribute to osteoporosis.