Citalopram-lithium combination treatment of elderly depressed patients: A pilot study

Fourteen elderly depressive patients (age 67-88 yr), phenotyped with dextromethorphan and mephenytoin before and during the trial, were treated for 4 weeks with citalopram (final dose 20-30 mg/day, except one patient 60 mg/day). The clinical state of the patients was recorded weekly using the Hamilton Depression Rating Scale, the CGI (psychopathology) scale, the VAS and the UKU scale for side-effects. As assessed by the Hamilton Depression Rating Scale, nine patients improved by more than 50% and continued with their citalopram treatment. The treatment of the five non-responders was then continued for another 2 weeks by addition of lithium (target plasma levels 0.4-0.8 mmol/l) to the ongoing citalopram medication. After 1 week, one patient had to be withdrawn for non-response, three were responders, while the fifth patient was a responder only after 2 weeks of lithium addition. Due to side-effects, the lithium dose had to be decreased in one patient who had responded to the combination therapy. Plasma levels of citalopram were within 145-459 nmol/l after 4 weeks of citalopram treatment. All patients were extensive metabolizers of dextromethorphan, and all but possibly one also of mephenytoin. After 4 weeks of citalopram, there was a highly significant correlation between the ratios of S/R-mephenytoin in urine and citalopram/desmethylcitalopram in plasma, which suggests a common mechanism in the metabolism of these drugs. The preliminary finding that a citalopram-Li combination therapy may be useful in elderly depressive patients resistant to citalopram alone needs to be replicated by a controlled double-blind study.     

Stories of meaning: lay perspectives on the origin and management of noninsulin dependent diabetes mellitus among older women in the United States

Researchers have sought to explain nonadherence to standard medical regimens by investigating a variety of sociodemographic variables, and, less often, by exploring variations between the health perspectives and life circumstances of the individual. While divergence between lay and professional perspectives on the etiology and treatment of chronic diseases, such as noninsulin dependent diabetes mellitus, may possibly account for the documented low rates of adherence to biomedical recommendations, health beliefs and activities are best understood as connected to an individual's personal history and circumstances. In order to evaluate the relationship between causal explanation of NIDDM and adherence, ethnographic interviews were conducted among 51 older (65+) women with diabetes and their physicians. We chose to investigate adherence to dietary recommendations because it represents one of the most challenging lifestyle modifications and is particularly important to maintaining glycemic control. The interviews involved ethnomedical and food frequency intake questionnaires and semi-structured interviews. Results reveal a stronger association between dietary adherence and etiological perspectives on diabetes than any sociodemographic factors, including ethnicity, education and income or other health belief factors. Informants suggested five categories that they believed were responsible for the onset of their NIDDM; poor past dietary practices (n = 22); familial tendency to have diabetes (n = 10); improper bodily functioning (n = 10); personal risk factors (n = 6); and currently being overweight (n = 3). Analyses indicated that those who implicate former dietary practices, currently being overweight, or having improper bodily functions were more likely to follow a standard recommended diet for individuals with diabetes. These findings also highlight the attempt by individuals with NIDDM to create 'stories' of meaning of their diabetes by linking their current management strategies for NIDDM with past practices and history. In addition, our results question the utility of the 'biomedical/alternative' labels.     

Seasonal patterns of plasma steroid hormones in males and females of the bearded dragon lizard, Pogona barbata

Pogona barbata is an Australian lizard that produces several large clutches of eggs between August and December (spring to early summer). Mating takes place around ovulation. The seasonal pattern of reproductive hormones in males and females of P. barbata was determined by radioimmunoassay of plasma progesterone (P), estradiol-17beta (E-17beta), corticosterone (B), and total androgen (TA). In females, P began to rise in August and was elevated from September to December. Corticosterone and TA were detectable but low and did not vary with time of year or reproductive condition. Estradiol-17beta was only detectable in a few females and exhibited no elevation with vitellogenic activity. These results suggest that B and TA are not involved in female reproduction. Estrogens may be either so low they could not be detected or they were present in a form other than estradiol-17beta. The high sensitivity of the estradiol-17beta radioimmunoassay suggests the latter. In males, TA peaked at the beginning of spring. They then declined to a minimum during November and December. However, concentrations recovered in the postbreeding activity period, January to April (summer and autumn). These patterns are consistent with the observation of maximum spermatogenic activity in spring, followed by the cessation of spermatogenesis directly after the breeding period and testicular recrudescence in February (late summer).     

Safety reporting through a comprehensive and pragmatic pharmcovigilance process for India and emerging markets: an industry perspective

Introduction: Pharmacovigilance (PV) deals with the drug-related adverse reactions ensuring patients’ safety. Emerging markets of India, South East Asia (SEA), Russia, Latin America (LA), Middle East and North Africa (MENA) have developed their own PV programs. However, under/manual reporting accompanied with lack of awareness regarding adverse drug reactions (ADRs) are major drawbacks that continue to exist due to lack of co-ordination and disparity in the regulatory approach.

Areas covered: Of the 118 studies identified using various databases, 60 were included for the review. The authors discuss the present PV scenario of India, SEA, Russia, LA and MENA, and explain a basic process for uniform PV data input–output across industry, which includes data collection, analysis, processing, causality assessment and data distribution systems.

Expert opinion: As the number of clinical trials conducted are rising in the emerging markets, there is a need to understand and implement a robust PV system, where electronically globalized, evidence based, public health oriented and regulatory compliant PV system is established. This would also improve transparency in system and ensure enhancement in safety data reporting ensuring premature and trouble-free detection of ADRs. It might result in implementing various PV boosting activities, which could yield robust patient safety data from India and emerging markets.