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Biomedical subjects

J M Keppel Hesselink

Publications and source records attributed to J M Keppel Hesselink.

At least 19 recordsLinked to original sources
PubMed2002

Iloperidone (Novartis).

Iloperidone (HP-873) is a mixed 5-HT(2a)/(D2) antagonist under development by Novartis for the potential treatment of schizophrenia. Phase III trials started in 1998 and the company had predicted a filing in 2001, with a possible launch in 2002 [295127], [342937], [364082]. By February 2001, the company had revised its predicted launch date to 2003 [400976]. This was further revised in November 2001, and NDA filing was anticipated for mid-2003 with launch expected in mid-2004 [429516], [431614]. Novartis was also developing a depot formulation, with the aim of providing 1 month of treatment; by March 2001, this was in phase II trials [389740], [402747]. The compound was previously being developed by its originator, Hoechst Marion Roussel, for the potential treatment of schizophrenia and psychosis. It had reached phase II trials. In May 1996, the company announced that it had discontinued further development, and in January 1997, it licensed the compound to Titan Pharmaceuticals on a worldwide exclusive basis [229500], [216445]. Subsequently, Titan granted Novartis worldwide development, manufacturing and marketing rights, excluding Japan [270037]. In April 2001, Titan executed a further development and commercialization agreement with Novartis, granting the latter rights to iloperidone in Japan [407075]. In October 2001, Lehman Brothers predicted a 60% chance of iloperidone reaching the market. The analysts predicted that launch would take place in 2004, with sales of 50 million US dollars, rising to peak sales of 400 million US dollars in 2011 [429750].

Journal Article↗
PubMed1998

['Smart drugs' enticements on the Internet].

'Smart drugs' are drugs supposed to enhance certain physical or mental functions, without harmful side effects. The target group for the misleading advertisement campaigns on the Net is mostly the younger generation. Smart drugs clearly are pharmacologically active: phenytoin, selegilin and growth hormone are examples of compounds that can be ordered from mail order pharmacies without prescription. Misleading medical information on the Internet is undesirable and potentially harmful and the widespread availability of smart drugs should be realised by pharmacists and physicians. Screening the Net for this kind of information should be implemented as a standard procedure and specific, targeted information to put these drugs in a realistic perspective could be the first step leading to 'debunking' the Internet.

Advertising↗
PubMed1997

[Prasterone (dihydroepiandrosterone): a modern source of eternal youth?].

The function of adrenal cortical hormone dihydroepiandrosterone (DHEA) is currently unknown. The use of this hormone as a food supplement is widely recommended in the USA for the elderly, as DHEA serum concentrations decrease dramatically after the age of about fourty. DHEA is available without prescription. Many sources suggest a causal relation between the decrease of DHEA production during aging and the emergence of degenerative disorders. To substantiate this relationship animal experimental and epidemiological literature is cited. However, data from clinical trials are rare and neither the safety nor the efficacy of DHEA is documented. Via the modern media such as the Internet the consumer is stimulated to use and order DHEA, 'the fountain of youth'. Consumers willing to follow this recommendation should be informed about the absence of proof of safety and efficacy. However, the compelling suggestions from animal and epidemiological literature of DHEA activity are intriguing, and further clinical trials to document the efficacy and safety of DHEA are urgently needed.

Aging↗
PubMed1996

Evolution of concepts and definitions of Parkinson's disease since 1817.

In the first half of the nineteenth century many patients suffering from multiple sclerosis, amyotrophic lateral sclerosis, tabes dorsalis, neuropathy and myopathy were in general described as a paralysis, paralysis agitans, and used 'lessened muscular power' to characterize the disorder. In this article we will review various definitions of Parkinson's disease, which appeared in textbooks since the original description and demonstrate that the number of symptoms as well as the selection of the symptoms in those definitions varied, although the different definitions clearly referred to the same disease.

History, 19th Century↗
PubMed1995

Placebo-controlled comparison of the clinical effects of rapid discontinuation of ipsapirone and lorazepam after 8 weeks of treatment for generalized anxiety disorder.

One hundred and sixty patients (mean age 39.8 years; 67% female) diagnosed with generalized anxiety disorder (GAD) who had completed a prospective, 8 week, double-blind comparison of lorazepam (mean daily dose 4.2 mg) and ipsapirone (mean daily dose 19.5 mg) were rapidly tapered by a substitution of half-strength medication for 3 days, then substitution of matched placebo for an additional 11 days. Patients treated with ipsapirone showed no rebound anxiety on discontinuation, nor any other significant increase in withdrawal symptomatology compared to patients who had been prospectively treated with placebo. In contrast, patients treated with lorazepam showed significant emergent anxiety and/or withdrawal-related symptomatology by almost all clinical measures employed. Overall, 25% of patients treated with lorazepam showed rebound anxiety, and 40% of them utilized reserve medication because they found drug discontinuation to be intolerable. The clinical implications for discontinuation of benzodiazepines after short-term therapy are discussed.

Adult↗
PubMed1993

A double-blind, placebo-controlled study comparing the efficacy and safety of ipsapirone versus lorazepam in patients with generalized anxiety disorder: a prospective multicenter trial.

This multicenter, double-blind, placebo-controlled, randomized study compared the efficacy, safety, and tolerability of ipsapirone (an azapirone anxiolytic) at daily dose levels of 10.0 to 30.0 mg with a daily dose of 2.0 to 6.0 mg of lorazepam (a benzodiazepine) or placebo when given to outpatients with generalized anxiety disorder (GAD) of moderate or greater severity. A total of 317 outpatients with a primary diagnosis of GAD according to DSM-III criteria (at least 1 month's duration) were randomized. Study entry criteria at the time of screening and at baseline included a Hamilton Rating Scale for Anxiety (HAM-A) score of 18 or more, a Covi Anxiety Scale score of 8 or more, and a Raskin Depression Scale score of 7 or less. The study design consisted of a 1-week, single-blind placebo evaluation, a 4-week, double-blind acute treatment period, and a 4-week extension period, followed by a 2-week, single-blind placebo withdrawal period. Efficacy was measured by changes in the HAM-A and Clinical Global Impression Scale and by evaluations of the Hamilton Rating Scale for Depression and Zung-Anxiety Self-Rating scale. The Raskin and Covi scales were performed at screening and baseline only. Withdrawal reactions were assessed during the withdrawal period by the Physician Withdrawal Checklist and by a patient self-rating checklist. Two-hundred sixty-three patients were valid for the analysis of efficacy in the ipsapirone (N = 87), lorazepam (N = 89), and placebo (N = 87) groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗